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Rose, Peter G. "Chemoradiotherapy." Drugs 60, no. 6 (December 2000): 1239–44. http://dx.doi.org/10.2165/00003495-200060060-00001.
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Chang, Yi-Lin, Ya-Fu Cheng, Hui-Shan Chen, Siao-Chi Wu, Wei-Heng Hung, Heng-Chung Chen, Chang-Lun Huang, Ching-Yuan Cheng, and Bing-Yen Wang. "Propensity score analysis comparing survival between definitive chemoradiotherapy and esophagectomy with adjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma." PLOS ONE 17, no. 10 (October 13, 2022): e0271338. http://dx.doi.org/10.1371/journal.pone.0271338.
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Introduction The purpose of the current study is to compare definitive chemoradiotherapy and esophagectomy with adjuvant chemoradiotherapy in patients with cT1-3/N0-3 esophageal squamous cell carcinoma in survival. Methods Records from 2008 to 2014 of 4931 patients with clinical T1-3/N0-3 esophageal squamous cell carcinoma receiving definitive chemoradiotherapy or esophagectomy with adjuvant chemoradiotherapy were obtained from the Taiwan Cancer Registry. Univariable and multivariable analyses were performed and propensity score matching was used to minimize the bias. Overall survival was compared between definitive chemoradiotherapy and esophagectomy with adjuvant chemoradiotherapy, and also in the three different clinical stages. Results Definitive chemoradiotherapy was performed on 4381 patients, and 550 patients received esophagectomy adjuvant chemoradiotherapy. Each group produced 456 patients for comparison after propensity score matching. The 1-year, 2-year, and 3-year overall survival rates for matched patients in with definitive chemoradiotherapy group were 57.18%, 31.92%, and 23.8%. The 1-year, 2-year, and 3-year overall survival rates for matched patients treated in the esophagectomy with adjuvant chemoradiotherapy group were 72.35%, 45.74%, and 34.04%(p<0.0001). In multivariable analysis, treatment modality was an independent prognostic factor. Esophagectomy with adjuvant chemoradiotherapy provided better survival outcome than definitive chemoradiotherapy for patients with clinical stage II/III disease. As for patients with clinical stage I disease, there was no significant survival difference between definitive chemoradiotherapy and esophagectomy with adjuvant chemoradiotherapy. Conclusions Esophagectomy with adjuvant chemoradiotherapy provided better survival than definitive chemoradiotherapy in clinical II/III esophageal squamous cell carcinoma. However, more data are needed to conduct a convincing conclusion in clinical stage I patients.
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Xu, Guoqiang, Qiaoli Wang, Xingrao Wu, Chunyan Lv, Guilin Zeng, Zhihong Xue, Ruixue Cao, Nan Zhang, Wei Xiong, and Qin Huang. "Comparison of Induction Chemotherapy Plus Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy Alone in Locally Advanced Nasopharyngeal Carcinoma." Technology in Cancer Research & Treatment 20 (January 1, 2021): 153303382199001. http://dx.doi.org/10.1177/1533033821990017.
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Purpose: Induction chemotherapy plus concurrent chemoradiotherapy and concurrent chemoradiotherapy alone are both standard treatment regimens for managing locally advanced nasopharyngeal carcinoma. However, the results of comparisons between them in clinical trials vary. Therefore, we designed this meta-analysis to illustrate their advantages and disadvantages in patients with locally advanced nasopharyngeal carcinoma. Methods: We thoroughly searched the PubMed, EMBASE, and Cochrane Library databases and then merged the effect indicators of hazard ratios and risk ratios using RevMan 5.1. Results: Seven randomized controlled trials totaling 2,319 patients were included in our research. The synthesized results showed that induction chemotherapy plus concurrent chemoradiotherapy improved overall survival (HR = 0.75, 95% CI: 0.63-0.89, P = 0.001), progression-free survival (HR = 0.69, 95% CI: 0.60-0.80, P < 0.001), distant metastasis-free survival (HR = 0.65, 95% CI: 0.53-0.80, P < 0.001) and locoregional recurrence-free survival (HR = 0.68 95%, CI: 0.54-0.86, P = 0.001) versus concurrent chemoradiotherapy alone. It also increased the risk of anemia, thrombocytopenia, and neutropenia during concurrent chemoradiotherapy. However, the incidence of leukopenia and mucositis was similar in induction chemotherapy and induction chemotherapy plus concurrent chemoradiotherapy. Furthermore, the subgroup analysis showed better survival outcomes with induction chemotherapy plus concurrent chemoradiotherapy than with concurrent chemoradiotherapy alone in the triweekly cisplatin subgroup (all P < 0.01), whereas induction chemotherapy plus concurrent chemoradiotherapy could only improve progression-free survival and locoregional recurrence-free survival in the weekly cisplatin subgroup (HR = 0.78, P = 0.02; and HR = 0.66, P = 0.03, respectively). Conclusions: Induction chemotherapy plus concurrent chemoradiotherapy improved survival outcomes in patients with locally advanced nasopharyngeal carcinoma versus concurrent chemoradiotherapy. For the weekly cisplatin regimen subgroup, it did not improve remote control or overall survival versus concurrent chemoradiotherapy alone, warranting further clarification.
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Stahl, Michael, and Wilfried Budach. "Definitive chemoradiotherapy." Journal of Thoracic Disease 9, S8 (July 2017): S792—S798. http://dx.doi.org/10.21037/jtd.2017.05.05.
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Mornex, F., N. Girard, and V. Wautot. "18IN CHEMORADIOTHERAPY." Lung Cancer 64 (May 2009): S10. http://dx.doi.org/10.1016/s0169-5002(09)70141-2.
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Aref, A. "Concomitant chemoradiotherapy." Journal of Clinical Oncology 8, no. 11 (November 1990): 1928–30. http://dx.doi.org/10.1200/jco.1990.8.11.1928.
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Vokes, Everett E., and Ralph R. Weichselbaum. "Concomitant Chemoradiotherapy." Journal of Clinical Oncology 8, no. 8 (August 1990): 1447. http://dx.doi.org/10.1200/jco.1990.8.8.1447.
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The title of Table 4 in the review article "Concomitant Chemoradiotherapy: Rationale and Clinical Experience in Patients With Solid Tumors" by Vokes and Weichselbaum published in the May 1990 issue (J Clin Oncol 8:911–934, 1990) was incorrect. It should have read "Table 4: Selected Randomized Trials in Head and Neck Cancer."
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Vokes, Everett E., David M. Brizel, and Theodore S. Lawrence. "Concomitant Chemoradiotherapy." Journal of Clinical Oncology 25, no. 26 (September 10, 2007): 4031–32. http://dx.doi.org/10.1200/jco.2007.13.8073.
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West, Malcolm A., Zachos Anastasiou, Gareth Ambler, Lisa Loughney, Michael G. Mythen, Thomas Owen, Gerard Danjoux, et al. "The effects of cancer therapies on physical fitness before oesophagogastric cancer surgery: a prospective, blinded, multi-centre, observational, cohort study." NIHR Open Research 1 (June 16, 2021): 1. http://dx.doi.org/10.3310/nihropenres.13217.1.
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Background: Neoadjuvant cancer treatment is associated with improved survival following major oesophagogastric cancer surgery. The impact of neoadjuvant chemo/chemoradiotherapy on physical fitness and operative outcomes is however unclear. This study aims to investigate the impact of neoadjuvant chemo/chemoradiotherapy on fitness and post-operative mortality. Methods: Patients with oesophagogastric cancer scheduled for chemo/chemoradiotherapy and surgery were recruited to a prospective, blinded, multi-centre, observational cohort study. Primary outcomes were changes in fitness with chemo/chemoradiotherapy, measured using cardiopulmonary exercise testing and its association with mortality one-year after surgery. Patients were followed up for re-admission at 30-days, in-hospital morbidity and quality of life (exploratory outcomes). Results: In total, 384 patients were screened, 217 met the inclusion criteria, 160 consented and 159 were included (72% male, mean age 65 years). A total of 132 patients (83%) underwent chemo/chemoradiotherapy, 109 (71%) underwent chemo/chemoradiotherapy and two exercise tests, 100 (63%) completed surgery and follow-up. A significant decline in oxygen uptake at anaerobic threshold and oxygen uptake peak was observed following chemo/chemoradiotherapy: -1.25ml.kg-1.min-1 (-1.80 to -0.69) and -3.02ml.kg-1.min-1 (-3.85 to -2.20); p<0.0001). Baseline chemo/chemoradiotherapy anaerobic threshold and peak were associated with one-year mortality (HR=0.72, 95%CI 0.59 to 0.88; p=0.001 and HR=0.85, 0.76 to 0.95; p=0.005). The change in physical fitness was not associated with one-year mortality. Conclusion: Chemo/chemoradiotherapy prior to oesophagogastric cancer surgery reduced physical fitness. Lower baseline fitness was associated with reduced overall survival at one-year. Careful consideration of fitness prior to chemo/chemoradiotherapy and surgery is urgently needed.
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Terada, Hoshino, Yuzo Shimode, Madoka Furukawa, Yuichiro Sato, and Nobuhiro Hanai. "The Utility of Ultrasonography in the Diagnosis of Cervical Lymph Nodes after Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma." Medicina 57, no. 5 (April 23, 2021): 407. http://dx.doi.org/10.3390/medicina57050407.
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Background and Objectives: There is evidence or consensus on the use of 18F-2-fluorodeoxyglucose-positron emission tomography with computed tomography (PET-CT) in evaluating the effects of treatment at 12 weeks after chemoradiotherapy for head and neck squamous cell carcinoma with cervical lymph node metastasis. However, the use of imaging to evaluate the effects of treatment within 12 weeks after chemoradiotherapy is controversial. The aim of this study was to evaluate the usefulness of ultrasonography in the diagnosis of lymph nodes metastasis after chemoradiotherapy according to the criteria of the “Evaluation of the effects of treatment on metastatic cervical lymph nodes using ultrasonography”, which evaluated lymph nodes metastasis based on size change and presence of degeneration. Materials and methods: This prospective study included 34 head and neck squamous cell carcinoma patients with cervical lymph nodes metastasis. Thirty-two patients who completed treatment were analyzed. Ultrasonography was performed at 4 and 8 weeks after chemoradiotherapy and we judged whether a favorable prognosis could be expected or whether additional treatments should be considered. Ultrasonography and PET-CT were performed at 12 weeks after chemoradiotherapy. Neck dissection was performed if residual disease was suspected based on the PET-CT findings. Results: The accuracy and negative predictive value of ultrasonography were 81.3% and 96.3%, respectively. According to the Ultrasonography findings, the size of lymph nodes metastasis after chemoradiotherapy was significantly smaller than those before chemoradiotherapy (p < 0.05). The fluid and blood flow of lymph nodes metastasis showed a significantly reduced at 12 weeks after chemoradiotherapy (p < 0.05, p < 0.05, respectively). The echo density significantly changed from low to high echoic density after chemoradiotherapy (p < 0.05). Conclusions: Ultrasonography was useful for evaluating cervical lymph nodes metastasis after chemoradiotherapy for head and neck squamous cell carcinoma.
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Fujita, Shiro, Katsuhiro Masago, and Yasushi Yatabe. "Biopsy of palliative lesions following radiotherapy." BJR|Open 1, no. 1 (July 2019): 20180025. http://dx.doi.org/10.1259/bjro.20180025.
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Objective: Definite radiotherapy and/or chemoradiotherapy is often conducted for the treatment of non-small cell lung cancer. However, there is a potential concern regarding the mutagenic effects on tumor cells derived from the therapies, and genomic information regarding cancer cells that survived definitive radiotherapy/chemoradiotherapy is lacking. To evaluate the mutagenic effect of radiotherapy/chemoradiotherapy, we compared genomic signatures of recurrent non-small cell lung cancer tissue with those of pre-treatment. Methods: We evaluated seven specimens from three patients who developed disease recurrence after definite radiotherapy/chemoradiotherapy, and we ranked the mutations according to the Combined Annotation-Dependent Depletion score. Results: Some mutations remained in the post-therapy state, and others, including driver mutations, either newly occurred or disappeared during the course of disease. Of the four specimens obtained in the post-radiation period, 21 variants were detected. Compared with single nucleotide substitution (5, 23.8%), substantial number of deletions (16, 76.2%) was observed in specimens obtained after definite radiotherapy/chemoradiotherapy. Conclusion: Radiotherapy/chemoradiotherapy effects on tumor cells have a wide spectrum, and resequencing of a recurrent lesion is always recommended to discuss the best course of therapy for recurrent non-small cell lung cancer after definitive radiotherapy/chemoradiotherapy. Advances in knowledge: With regard to cancer cells that survived definitive radiotherapy/chemoradiotherapy, some mutations remained in the post-therapy state, and others, including driver mutations, either newly occurred or disappeared during the course of disease. Compared with single nucleotide substitution, substantial number of deletions was observed in specimens obtained after definite radiotherapy/chemoradiotherapy.
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Skoropad, V. Yu, D. D. Kudryavtsev, E. N. Anikina, M. V. Poluaktova, and L. N. Titova. "ANALYSIS OF HEMATOLOGIC, HEPATIC AND PANCREATIC TOXICITY DURING NEOADJUVANT CHEMORADIOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER." Siberian journal of oncology 17, no. 3 (July 4, 2018): 20–27. http://dx.doi.org/10.21294/1814-4861-2018-17-3-20-27.
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Purpose.We analyzed the frequency and severity of hematologic, hepatic and pancreatic toxicity during and after completion of neoadjuvant chemoradiotherapy in patients with gastric cancer.Material and methods. Phase II clinical trial was conducted to evaluate the efficacy of the combined modality treatment including neoadjuvant chemoradiotherapy followed by D2 gastrectomy for patients with locally advanced gastric cancer. The main inclusion criteria were: histologically verified gastric cancer, cT3-4N0, cT2-4N1-3; M0. Before starting neoadjuvant therapy, all patients underwent thoracic and abdominal CT and laparoscopy to exclude peritoneal carcinomatosis. A total dose of radiation therapy was 45 Gy (1 + 1.5 Gy/fraction/day with a 4–5 hour interval) concurrently with the modified CAPOX chemotherapy regimen. Gastrectomy or subtotal resection of the stomach was planned 4-6 weeks after the completion of chemoradiotherapy. The toxicity assessment of neoadjuvant chemoradiotherapy was performed using the NCI CTC scale, version 3.0. The assessment of hematological, hepatic and pancreatic toxicities was done.Results.Among the toxicity during and after completion of neoadjuvant chemoradiotherapy, thrombocytopenia, neutropenia and leukopenia (grade 1–2) were the most common, requiring no additional symptomatic therapy. Radiation therapy was completed in 45 (98 %) patients. Chemotherapy was completed in 42 (91 %) patients. The median time between the completion of chemoradiotherapy and surgery was 44 days. Surgery following chemoradiotherapy was performed in 100 % of patients, including R0 resection in 93 % of patients.Conclusion.Preoperative chemoradiotherapy was well tolerated by patients, could be completed in most cases and did not prevent subsequent surgical treatment.
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Kuo, Phoebe, R. Peter Manes, Zachary G. Schwam, and Benjamin L. Judson. "Survival Outcomes for Combined Modality Therapy for Sinonasal Undifferentiated Carcinoma." Otolaryngology–Head and Neck Surgery 156, no. 1 (October 5, 2016): 132–36. http://dx.doi.org/10.1177/0194599816670146.
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Objective Sinonasal undifferentiated carcinoma is a rare and aggressive malignancy of the nasal cavity and paranasal sinuses. Multi-institutional studies examining outcomes of combined modality treatment versus other treatment modalities have not been performed. The objective of our study was to present outcomes for multimodality therapy through use of the National Cancer Database. Study Design Retrospective cohort study. Setting National Cancer Database. Methods A total of 435 cases of SNUC diagnosed between 2004 and 2012 were identified. Kaplan-Meier analyses were performed to find 5-year cumulative survival rates. Multivariate Cox regression evaluated overall survival based on treatment when adjusting for other prognostic factors (age, primary site, sex, race, comorbidity, insurance, and TNM stage). Within the surgery + chemoradiotherapy group, survival analysis was also performed to compare outcomes for induction and adjuvant chemotherapy. Results The cumulative 5-year survival rate was 41.5%, and 36.1% of patients received surgery with chemoradiotherapy. In multivariate analysis, surgery + chemoradiotherapy was associated with significantly improved overall survival versus surgery + radiotherapy and radiotherapy but not significantly different from chemoradiotherapy. Within the surgery + chemoradiotherapy group, induction and adjuvant chemotherapy groups did not have associated differences in survival. Conclusion Combined modality therapy (chemoradiotherapy or surgery + chemoradiotherapy) is associated with improved survival outcomes versus other treatment modalities in patients with sinonasal undifferentiated carcinoma.
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Chen, Min, Xue Song, Liang-zhou Chen, Lin Xu, Yi-pu Lu, and Jin-song Zhang. "Adjuvant Second-Dose Chemotherapy before Surgery for Patients with Locally Advanced Rectal Malignancy Is Not Beneficial: A Systematic Review and Meta-Analysis." Gastroenterology Research and Practice 2017 (2017): 1–8. http://dx.doi.org/10.1155/2017/1373092.
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Background. Preoperative chemoradiotherapy is the standard treatment for patients with locally advanced rectal cancer, although tumor responses vary widely; some patients may achieve a pathologic complete response rate (pCR) after chemoradiotherapy. Controversy exists with regard to the efficacy of different preoperative combination chemotherapy regimens and neoadjuvant chemoradiotherapy, compared with chemoradiotherapy alone. Methods. PubMed, the Cochrane Library, and Embase databases were searched for comparative studies of patients with locally advanced rectal cancer that were published between January 1991 and January 2016. Efficacies of different preoperative combination chemotherapy regimens and neoadjuvant chemoradiotherapy (group A) were compared with chemoradiotherapy alone (group B) in a meta-analysis using Review Manager v5.2. Results. Three prospective randomized controlled trials and two prospective nonrandomized controlled trials comprising 444 cases were eligible for analysis. No significant difference was detected in the rate of pCR (50/223, 22.4% versus 35/223, 15.7%; relative risk, RR: 1.42 [95% confidence interval, CI: 0.97–2.09], p=0.07) between the two groups. The rate of tumor regression was similar for both groups (122/203, 60.1% versus 111/203, 54.7%; RR: 1.11 [95% CI: 0.94–1.29], p=0.22). Conclusions. Adjuvant chemotherapy with preoperative chemoradiotherapy did not significantly improve the rate of pCR nor the rate of T and N downstaging.
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Hiraoka, Shinya, Katsuyuki Sakanaka, Takahiro Iwai, Kota Fujii, Hiroyuki Inoo, and Takashi Mizowaki. "Therapy-Related Acute Myeloid Leukemia 2 Months after Chemoradiotherapy for Esophageal Cancer: A Case Report." Case Reports in Oncology 13, no. 1 (March 24, 2020): 299–303. http://dx.doi.org/10.1159/000506449.
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Therapy-related acute myeloid leukemia (AML) is a rare but potentially fatal adverse event caused by chemotherapy or radiotherapy. Herein we report a patient diagnosed with therapy-related AML 2 months after chemoradiotherapy for esophageal cancer. A 61-year-old man with dysphagia was diagnosed with locally advanced esophageal cancer with para-aortic lymph node metastasis. Laboratory blood test did not reveal any abnormality except mild macrocytic anemia. To alleviate dysphagia due to malignant esophageal stenosis, the patient underwent concurrent chemoradiotherapy of 60 Gy in 30 fractions with cisplatin and 5-fluorouracil at a local area in thoracic esophagus. Dysphagia alleviated during chemoradiotherapy; however, pancytopenia did not recover after the completion of chemoradiotherapy, and general fatigue with fever developed 13 weeks after the last day of chemoradiotherapy. To rule out hematological malignancy, bone marrow biopsy was performed. The bone marrow smear and flow cytometry analysis indicated the development of AML. Chromosomal test revealed a complex karyotype, suggesting that AML was associated with myelodysplastic syndrome. The patient died 1 month after the diagnosis of therapy-related AML. Thus, the findings indicate that therapy-related AML may develop during the acute phase of chemoradiotherapy and bone marrow biopsy is necessary when prolonged pancytopenia exists after chemoradiotherapy.
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Liu, Feng, Shengnan Fu, Yanzhu Chen, Ouying Yan, Xiangwei Wu, Yaqian Han, Cuihong Jiang, et al. "A randomized controlled trial of cognitive behavior therapy for reducing anxiety and depressive symptoms in patients with locoregional advanced nasopharyngeal carcinoma." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 12121. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.12121.
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12121 Background: The purpose of this randomized trial was to compare the efficacy of cognitive behavioral therapy (CBT) versus treatment as usual (TAU) on anxiety and depression, response rates and acute adverse events in patients with locoregional advanced nasopharyngeal carcinoma (NPC) receiving chemoradiotherapy. To the best of our knowledge, this is the first randomized trial evaluating the effect of CBT for depression and anxiety in patients with locoregional advanced NPC treated with chemoradiotherapy. Methods: A total of 202 patients with diagnosis of stage III-IVa (8th AJCC) NPC were randomly assigned to receive CBT plus chemoradiotherapy (CBT group, n = 101) or treatment as usual (TAU) plus chemoradiotherapy (TAU group, n = 101). Patients in the CBT group received a series of six CBT sessions for 6 weeks during concurrent chemoradiotherapy. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS) score at baseline, the completion of chemoradiotherapy, 1 and 3 months after chemoradiotherapy. Response rates and adverse events were also evaluated. This trial is registered with chictr.org.cn, number ChiCTR2000034701. Results: Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of CBT (P < 0.01). Complete response (CR) rate was significantly higher in CBT group than in TAU group (100% vs. 93.1%，P = 0.014). Compared with the TAU group, the CBT group showed a significantly lower incidence of acute adverse events including anemia, fatigue, mucositis, insomnia and weight losing (P < 0.05). Conclusions: The addition of CBT to chemoradiotherapy significantly reduced depressive and anxiety symptoms. CBT combined with chemoradiotherapy is associated with improved response rates, with reduced incidence of acute toxic effects in patients with locoregional advanced nasopharyngeal carcinoma. Clinical trial information: ChiCTR2000034701.
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Wilson, Kenneth S., Amanda G. Wilson, and Gary J. Dewar. "Curative Treatment for Esophageal Cancer: Vancouver Island Cancer Centre Experience from 1993 to 1998." Canadian Journal of Gastroenterology 16, no. 6 (2002): 361–68. http://dx.doi.org/10.1155/2002/767602.
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OBJECTIVES: To review outcomes after curative treatment for esophageal cancer in the Vancouver Island Cancer Centre from 1993 to 1998. Curative treatments included esophagectomy alone, and chemoradiotherapy with ‘selective surgery’ for patients with post-treatment-positive endoscopic biopsy or less than 75% regression on computed axial tomography scan, or with resectable local recurrence.METHODS: Patients undergoing esophagectomy alone, or primary chemoradiotherapy and ‘selective surgery’ were reviewed. This was a retrospective, nonrandomized, institutional experience. Surgical complication, relief of dysphagia, disease-specific survival rates and prognostic factors were analyzed.RESULTS: Nineteen patients underwent esophagectomy alone. A total of 56 patients underwent primary chemoradiotherapy, of whom 16 had ‘selective surgery’. Relief of dysphagia was similar in both groups of esophagectomy patients. Exploration for ‘selective surgery’ was performed in 12 patients after their first postchemo-radiotherapy endoscopy (two patients had unresectable disease), and in seven for relapse, one of whom died intraoperatively. Overall, the mortality rate due to surgery was 3%. Chemoradiotherapy was not associated with more frequent serious surgical complications. For patients who underwent esophagectomy alone and those who underwent chemoradiotherapy plus selective surgery, the median survival times were 12.9 and 16.4 months, respectively, and the three-year survival rates were 21% and 37%, respectively. Seventeen of 25 patients who underwent chemoradiotherapy and who survived more than two years have not required selective surgery. For the two groups of patients combined, no single prognostic factor for survival was significant in multivariate analysis, but for patients who underwent chemoradiotherapy plus selective surgery, negative endoscopic biopsy was highly significant.CONCLUSIONS: Surgical complication and disease-specific survival rates after primary chemoradiotherapy with selective surgery compare favourably with esophagectomy alone in the curative treatment of esophageal cancer. A prospective, randomized trial is necessary for the definitive evaluation of the strategy of chemoradiotherapy and selective surgery.
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Chen, Wei, Ya-ting Wang, Lili Guo, Zhaohuan Zhu, Hai-fei Zhou, and Genji Bai. "Predictive Value of Early Response to Chemoradiotherapy in Advanced Esophageal Squamous Cell Carcinoma by Diffusion-Weighted MR Imaging." Technology in Cancer Research & Treatment 19 (January 1, 2020): 153303382094322. http://dx.doi.org/10.1177/1533033820943220.
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Objective: To explore the value of diffusion-weighted imaging for early response detection of locally advanced esophageal squamous cell carcinoma with concurrent chemoradiotherapy. Methods: Fifty-five (42 males, 13 females) patients with locally advanced esophageal cancer who were undergoing chemoradiotherapy were recruited for this study. Diffusion-weighted imaging was performed in all patients before therapy, at the first weekend, the second weekend, and the end of chemoradiotherapy. The rate of change in apparent diffusion coefficient value and the maximum diameter between pretherapy and posttherapy were calculated. Results: Fifty-five patients with locally advanced esophageal squamous cell carcinoma were classified as responders (40 cases) and nonresponders (15 cases). Before chemoradiotherapy, the responders group had a significantly lower apparent diffusion coefficient values than the nonresponders group ( t = −4.815, P = .000). At the 3 time points after chemoradiotherapy (first weekend, second weekend, and the end of chemoradiotherapy), there was no statistically significant difference in apparent diffusion coefficient values between responders and nonresponders ( P > .05). The responders group had a significantly higher rate of change in apparent diffusion coefficient value than the nonresponders group at each time point ( P < .05). At the first weekend of chemoradiotherapy, the rate of change in the maximum diameter was not significantly different in the 2 groups ( t = 0.928, P = .357). There was a negative correlation between the tumor apparent diffusion coefficient value of pretherapy and the reduction ratio of tumor maximum diameter at the end of chemoradiotherapy ( r = −0.592, P = .000). Conclusions: The change rate of apparent diffusion coefficient value by the end of the first week after beginning chemoradiotherapy may be a sensitive indicator to detect the early response to locally advanced esophageal squamous cell carcinoma.
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Subir Pal, Anjan Bera, Soumen Mukherjee, Asmita Dasgupta, Srikrishna Mandal, and Saptarshi Banerjee. "Outcome of neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in non-metastatic locally advanced non-small cell lung cancer – A prospective and randomized study." Asian Journal of Medical Sciences 14, no. 1 (January 1, 2023): 211–16. http://dx.doi.org/10.3126/ajms.v14i1.48405.
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Background: Sequential chemoradiotherapy and concurrent chemoradiotherapy are two treatment options for locally advanced non-small cell lung cancer (NSCLC). Still there is limited data regarding which is the better treatment option. Aims and Objectives: This study is to compare the response rate and toxicity pattern between induction (neoadjuvant) chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locally advanced NSCLC patients. Materials and Methods: A total of 48 Stage III NSCLC patients were selected for the study and were randomized into two arms with a 1:1 ratio. Patients of ARM-1 received concurrent chemoradiotherapy alone of a total dose of 66Gy/33# over 6 and ⅟2 weeks with paclitaxel (50 mg/m2) and carboplatin (Area under curve [AUC] 2) once every week. The study arm (ARM-2) received two cycles of induction chemotherapy with paclitaxel (175 mg/m2) and carboplatin (AUC 6) every 3 weeks and concurrent chemoradiotherapy (same CRT as on ARM-1). Results: In our study, overall response rate (Complete response+Partial response) in Arm 1 and Arm 2 was 62% and 71%, respectively. The treatment was very tolerated in our study. A mean follow-up of 12 months by Kaplan–Meier survival analysis showed a statistically non-significant difference in disease-free survival in both arms. Progression-free survival was numerically superior in the induction chemotherapy arm but the difference was statistically non-significant. Acute hematological toxicity was numerically more in the concurrent chemoradiotherapy arm, but statistically not significant. Acute lung toxicity, acute pharynx, and esophagus toxicity were numerically more in the induction chemotherapy arm but statistically non-significant. Conclusion: There was no significant difference between induction chemotherapy followed by concurrent chemoradiotherapy and concurrent chemoradiotherapy alone in the present study population.
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Yang, Qiong, Ying Wei, Yan-Xian Chen, Si-Wei Zhou, Zhi-Min Jiang, and De-Rong Xie. "Indirect Comparison Showed Survival Benefit from Adjuvant Chemoradiotherapy in Completely Resected Gastric Cancer with D2 Lymphadenectomy." Gastroenterology Research and Practice 2013 (2013): 1–7. http://dx.doi.org/10.1155/2013/634929.
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Background. Little data on directly comparing chemoradiotherapy with observation has yet been published in the setting of adjuvant therapy for resected gastric cancer who underwent D2 lymphadenectomy. The present indirect comparison aims to provide more evidence on comparing the two approaches.Methods. We conducted a systematic review of randomized controlled trials, extracted time-to-event data using Tierney methods (when not reported), and performed indirect comparison to obtain the relative hazards of adjuvant chemoradiotherapy to observation on overall and disease-free survival.Results. seven randomized controlled trials were identified. Three trials compared adjuvant chemoradiotherapy with adjuvant chemotherapy, and 4 trials compared adjuvant chemotherapy with observation. Using indirect comparison, the relative hazards of adjuvant chemoradiotherapy to observation were 0.43 (95% CI: 0.33–0.55) in disease-free survival and 0.52 (95% CI: 0.38–0.71) in overall survival for completely resected gastric cancer with D2 lymphadenectomy.Conclusions. Postoperative chemoradiotherapy can prolong survival and decrease recurrence in patients with resected gastric cancer who underwent D2 gastrectomy. Molecular biomarker might be a promising direction in the prediction of clinical outcome to postoperative chemoradiotherapy, which warranted further study.
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Chen, Hui-Hua, Wan-Hua Ting, Hsu-Dong Sun, Ming-Chow Wei, Ho-Hsiung Lin, and Sheng-Mou Hsiao. "Predictors of Survival in Women with High-Risk Endometrial Cancer and Comparisons of Sandwich versus Concurrent Adjuvant Chemotherapy and Radiotherapy." International Journal of Environmental Research and Public Health 17, no. 16 (August 16, 2020): 5941. http://dx.doi.org/10.3390/ijerph17165941.
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Background: to elucidate the predictors of progression-free survival (PFS) and overall survival (OS) in high-risk endometrial cancer patients. Methods: the medical records of all consecutivewomen with high-risk endometrial cancer were reviewed. Results: among 92 high-risk endometrial cancer patients, 30 women experienced recurrence, and 21 women died. The 5-year PFS and OS probabilities were 65.3% and 75.9%, respectively. Multivariable Cox regression revealed that body mass index (hazard ratio (HR) = 1.11), paraaortic lymph node metastasis (HR = 11.11), lymphovascular space invasion (HR = 5.61), and sandwich chemoradiotherapy (HR = 0.15) were independently predictors of PFS. Body mass index (HR = 1.31), paraaortic lymph node metastasis (HR = 32.74), non-endometrioid cell type (HR = 11.31), and sandwich chemoradiotherapy (HR = 0.07) were independently predictors of OS. Among 51 women who underwent sandwich (n = 35) or concurrent (n = 16) chemoradiotherapy, the use of sandwich chemoradiotherapy were associated with better PFS (adjusted HR = 0.26, 95% CI = 0.08–0.87, p = 0.03) and OS (adjusted HR = 0.11, 95% CI = 0.02–0.71, p = 0.02) compared with concurrent chemoradiotherapy. Conclusion: compared with concurrent chemoradiotherapy, sandwich chemoradiotherapy was associated with better PFS and OS in high-risk endometrial cancer patients. In addition, high body mass index, paraaortic lymph node metastasis, and non-endometrioid cell type were also predictors of poor OS in high-risk endometrial cancer patients.
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Usychkina, A. Y., D. A. Kobyzeva, V. V. Gornostaev, A. A. Loginova, D. Y. Kachanov, S. R. Varfolomeeva, V. Y. Roshin, and A. V. Nechesnyuk. "Клинический случай химиолучевой терапии недифференцированной плеоморфной саркомы параменингеальной локализации у ребенка." Voprosy gematologii/onkologii i immunopatologii v pediatrii 16, no. 2 (2017): 45–49. http://dx.doi.org/10.24287/1726-1708-2017-16-2-45-49.
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Liu, Sihan, Qianru He, Xiaodan Xing, Tingting Sun, and Chuang Qi. "Changes of immune microenvironment before and after chemoradiotherapy in cervical cancer." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): e17503-e17503. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.e17503.
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e17503 Background: Cervical cancer is the fourth most common cancer in women worldwide. Metastasis and invasion of cervical cancer are closely related to the tumor microenvironment. As an effective treatment, chemoradiotherapy plays a vital role in immune-related cells and factors. However, little is known about the effect of chemoradiotherapy on the immune microenvironment in cervical cancers. Therefore, we studied the immune microenvironment alterations before and after chemoradiotherapy and analyzed their prognostic significance in cervical cancer patients. Methods: We recruited 15 patients with stage IB1-IVA cervical squamous cell carcinoma. Pelvic intensity-modulated radiotherapy (IMRT) was performed with conventional segmentation of 2Gy per irradiation (IB3 stage was treated with synchronous cisplatin for weeks), FFPE samples pre-treatment, and one-week after-chemoradiotherapy were conducted an exploratory biomarker analysis based on gene expression profiling (GEP). The panel of 289 genes was customized based on critical genes and pathways during tumor immunoregulation (e.g., tumor antigen release, T cell activation, and immune metabolism). The differential expressed genes between these two groups were then assessed. Results: Forty-two genes were found to be differentially expressed, with 21 genes having > 1.5-fold mean expression difference after chemoradiotherapy. Analysis of important GO terms and KEGG pathways indicated that the pathways enriched by different genes are located in immune-related pathways, specifically, T cell activation (GO-BP), cytokine activity (GO-MF), and cytokine-cytokine receptor interaction (KEGG). After-chemoradiotherapy, the enrichment of tumor-infiltrating lymphocytes (TILs) varied greatly, especially the macrophages. Conclusions: This study preliminarily demonstrated that chemoradiotherapy caused the release of pro-inflammatory like CCR7 and CD69 and immune cell (macrophages) infiltration alterations after chemoradiotherapy in cervical cancer patients.
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Kurosu, Hiroyuki, Yukiharu Todo, Ryutaro Yamada, Kaoru Minowa, Tomohiko Tsuruta, Shinichiro Minobe, Noriaki Nishiyama, and Hidenori Kato. "Clinical relevance of addition of conventional treatment to concurrent chemoradiotherapy in patients with FIGO stage III–IV cervical cancer: a retrospective analysis of a Japanese cohort." Japanese Journal of Clinical Oncology 52, no. 3 (December 10, 2021): 244–50. http://dx.doi.org/10.1093/jjco/hyab191.
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Abstract Background Concurrent chemoradiotherapy has limited therapeutic efficacy for stage III–IV cervical cancer. We aimed to identify a subgroup of patients with stage III–IV cervical cancer who benefit from concurrent chemoradiotherapy with additional treatment. Methods We retrospectively reviewed 120 patients with stage III–IV cervical cancer who were treated with concurrent chemoradiotherapy from 2002 to 2018. We compared overall survival between patients treated with concurrent chemoradiotherapy alone and those who received concurrent chemoradiotherapy with additional conventional treatments (systemic chemotherapy before and/or after concurrent chemoradiotherapy and/or extended-field radiation). Prognostic factors were statistically analysed. Results Overall, 44 (36.7%) and 21 (17.5%) patients were radiologically diagnosed with pelvic and para-aortic lymph node enlargement, respectively. The median tumour diameter was 5.7 cm. A total of 69 (57.5%) patients received no additional treatment, and 51 (42.5%) received additional treatment. Cox regression analysis identified the following prognostic factors: histological non-squamous cell carcinoma (hazard ratio, 3.9; 95% confidence interval, 1.8–8.2), tumour diameter of ≥6 cm (hazard ratio, 2.1; 95% confidence interval, 1.2–3.7), radiological pelvic lymph node enlargement (hazard ratio, 2.1; 95% confidence interval, 1.1–4.0) and radiological para-aortic lymph node enlargement (hazard ratio, 2.1; 95% confidence interval, 1.1–4.1). Even in the lowest risk group (no risk factors), the 5-year overall survival rate was lower in the additional treatment group than in the concurrent chemoradiotherapy alone group (78.7% vs. 80.9%, respectively; log-rank test, P = 0.79). Conclusions Addition of conventional treatments to concurrent chemoradiotherapy might not improve survival in patients with advanced cervical cancer. Novel treatment strategies including immune checkpoint inhibitors should be considered for such patients.
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Versteijne, Eva, Jacob L. van Dam, Mustafa Suker, Quisette P. Janssen, Karin Groothuis, Janine M. Akkermans-Vogelaar, Marc G. Besselink, et al. "Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial." Journal of Clinical Oncology 40, no. 11 (April 10, 2022): 1220–30. http://dx.doi.org/10.1200/jco.21.02233.
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PURPOSE The benefit of neoadjuvant chemoradiotherapy in resectable and borderline resectable pancreatic cancer remains controversial. Initial results of the PREOPANC trial failed to demonstrate a statistically significant overall survival (OS) benefit. The long-term results are reported. METHODS In this multicenter, phase III trial, patients with resectable and borderline resectable pancreatic cancer were randomly assigned (1:1) to neoadjuvant chemoradiotherapy or upfront surgery in 16 Dutch centers. Neoadjuvant chemoradiotherapy consisted of three cycles of gemcitabine combined with 36 Gy radiotherapy in 15 fractions during the second cycle. After restaging, patients underwent surgery followed by four cycles of adjuvant gemcitabine. Patients in the upfront surgery group underwent surgery followed by six cycles of adjuvant gemcitabine. The primary outcome was OS by intention-to-treat. No safety data were collected beyond the initial report of the trial. RESULTS Between April 24, 2013, and July 25, 2017, 246 eligible patients were randomly assigned to neoadjuvant chemoradiotherapy (n = 119) and upfront surgery (n = 127). At a median follow-up of 59 months, the OS was better in the neoadjuvant chemoradiotherapy group than in the upfront surgery group (hazard ratio, 0.73; 95% CI, 0.56 to 0.96; P = .025). Although the difference in median survival was only 1.4 months (15.7 months v 14.3 months), the 5-year OS rate was 20.5% (95% CI, 14.2 to 29.8) with neoadjuvant chemoradiotherapy and 6.5% (95% CI, 3.1 to 13.7) with upfront surgery. The effect of neoadjuvant chemoradiotherapy was consistent across the prespecified subgroups, including resectable and borderline resectable pancreatic cancer. CONCLUSION Neoadjuvant gemcitabine-based chemoradiotherapy followed by surgery and adjuvant gemcitabine improves OS compared with upfront surgery and adjuvant gemcitabine in resectable and borderline resectable pancreatic cancer.
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Rich, Tyvin A., Robert C. Shepard, and Stephen T. Mosley. "Four Decades of Continuing Innovation With Fluorouracil: Current and Future Approaches to Fluorouracil Chemoradiation Therapy." Journal of Clinical Oncology 22, no. 11 (June 1, 2004): 2214–32. http://dx.doi.org/10.1200/jco.2004.08.009.
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Purpose Chemoradiotherapy, the combination of external radiation therapy and concurrent chemotherapy, has been the basis for the oncologic management of many patients since its development in the 1960s. Fluorouracil (FU) chemoradiotherapy has demonstrated success in several organ sites with multiple dosing schedules that now guide the selection of oral analogs of FU to provide new chemoradiotherapy options. Methods This article reviews the metabolism and pharmacology of FU and the advantages of administration of FU by continuous infusion or bolus. The potential role and impact of the oral fluorouracil prodrugs UFT, S-1, BOF-A2, and capecitabine as replacements for intravenous administration are discussed. The results of recent chemoradiotherapy studies with FU from 2000 to 2003 are summarized in rectal, head and neck, esophageal, gastric, pancreatic, biliary, anal, and cervical cancers. Results Chemoradiotherapy with FU has the potential to widen the therapeutic window by minimizing normal tissue toxicity while maintaining effective tumor toxicity. Overall, FU chemoradiotherapy maximizes local control and, for some tumor sites (such as head and neck, pancreatic, biliary, cervical, esophageal, and gastric cancers), improves survival rates. Moreover, FU chemoradiotherapy results in improved organ preservation with excellent functional outcome in several anatomic sites including head and neck cancer, anal, and rectal cancer, with improved sphincter preservation. Conclusion FU chemoradiotherapy continues to play an important role in the management of many cancer sites. During the last four decades, optimal dosing schedules have produced a therapeutic gain. The introduction of oral prodrug analogs will likely further improve the results of FU therapy in several organ systems, such as the rectum, head and neck, and esophagus.
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Lin, D. J., M. Goodfellow, J. Ong, M. Y. Chin, L. Lazarova, and H. C. Cocks. "Treatment outcomes of laryngectomy compared to non-surgical management of T3 laryngeal carcinomas: a 10-year multicentre audit of 179 patients in the northeast of England." Journal of Laryngology & Otology 134, no. 12 (December 2020): 1103–7. http://dx.doi.org/10.1017/s0022215120002704.
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AbstractObjectiveWide-ranging outcomes have been reported for surgical and non-surgical management of T3 laryngeal carcinomas. This study compared the outcomes of T3 tumours treated with laryngectomy or (chemo)radiotherapy in the northeast of England.MethodsThe outcomes of T3 laryngeal carcinoma treatment at three centres (2007–2016) were retrospectively analysed using descriptive statistics and survival curves.ResultsOf 179 T3 laryngeal carcinomas, 68 were treated with laryngectomies, 57 with chemoradiotherapy and 32 with radiotherapy. There was no significant five-year survival difference between treatment with laryngectomy (34.1 per cent) and chemoradiotherapy (48.6 per cent) (p = 0.184). The five-year overall survival rate for radiotherapy (12.5 per cent) was significantly inferior compared to laryngectomy and chemoradiotherapy (p = 0.003 and p < 0.001, respectively). The recurrence rates were 22.1 per cent for laryngectomy, 17.5 per cent for chemoradiotherapy and 50 per cent for radiotherapy. There were significant differences in recurrence rates when laryngectomy (p = 0.005) and chemoradiotherapy (p = 0.001) were compared to radiotherapy.ConclusionLaryngectomy and chemoradiotherapy had significantly higher five-year overall survival and lower recurrence rates compared with radiotherapy alone. Laryngectomy should be considered in patients unsuitable for chemotherapy, as it may convey a significant survival advantage over radiotherapy alone.
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Versteijne, Eva, Mustafa Suker, Karin Groothuis, Janine M. Akkermans-Vogelaar, Marc G. Besselink, Bert A. Bonsing, Jeroen Buijsen, et al. "Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial." Journal of Clinical Oncology 38, no. 16 (June 1, 2020): 1763–73. http://dx.doi.org/10.1200/jco.19.02274.
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PURPOSE Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven. PATIENTS AND METHODS In this randomized phase III trial in 16 centers, patients with resectable or borderline resectable pancreatic cancer were randomly assigned to receive preoperative chemoradiotherapy, which consisted of 3 courses of gemcitabine, the second combined with 15 × 2.4 Gy radiotherapy, followed by surgery and 4 courses of adjuvant gemcitabine or to immediate surgery and 6 courses of adjuvant gemcitabine. The primary end point was overall survival by intention to treat. RESULTS Between April 2013 and July 2017, 246 eligible patients were randomly assigned; 119 were assigned to preoperative chemoradiotherapy and 127 to immediate surgery. Median overall survival by intention to treat was 16.0 months with preoperative chemoradiotherapy and 14.3 months with immediate surgery (hazard ratio, 0.78; 95% CI, 0.58 to 1.05; P = .096). The resection rate was 61% and 72% ( P = .058). The R0 resection rate was 71% (51 of 72) in patients who received preoperative chemoradiotherapy and 40% (37 of 92) in patients assigned to immediate surgery ( P < .001). Preoperative chemoradiotherapy was associated with significantly better disease-free survival and locoregional failure-free interval as well as with significantly lower rates of pathologic lymph nodes, perineural invasion, and venous invasion. Survival analysis of patients who underwent tumor resection and started adjuvant chemotherapy showed improved survival with preoperative chemoradiotherapy (35.2 v 19.8 months; P = .029). The proportion of patients who suffered serious adverse events was 52% versus 41% ( P = .096). CONCLUSION Preoperative chemoradiotherapy for resectable or borderline resectable pancreatic cancer did not show a significant overall survival benefit. Although the outcomes of the secondary end points and predefined subgroup analyses suggest an advantage of the neoadjuvant approach, additional evidence is required.
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Benzoni, Enrico, Franz Cerato, Alessandro Cojutti, Elisa Milan, Daniele Pontello, Germana Chiaulon, Cosimo Sacco, Vittorio Bresadola, and Giovanni Terrosu. "The Predictive Value of Clinical Evaluation of Response to Neoadjuvant Chemoradiation Therapy for Rectal Cancer." Tumori Journal 91, no. 5 (September 2005): 401–5. http://dx.doi.org/10.1177/030089160509100504.
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Introduction Multimodality therapy has become the standard treatment for patients with locally advanced (T3 and T4) rectal carcinoma. Accurate preoperative staging of the patients with rectal cancer has increased in importance because the selection of patients with transmural rectal cancer (T3 or T4) or node-positive disease leads to a previous nonsurgical neoadjuvant treatment. The purpose of this study was to evaluate the predictive value of the clinical response to neoadjuvant therapy on the basis of pathological results obtained on rectal cancer patients treated by chemoradiotherapy and surgery. Methods From 1994 to 2003, 58 patients with a primary diagnosis of rectal cancer were studied at our department and enrolled in a neoadjuvant protocol of chemoradiotherapy followed by surgery. All patients were treated by 30 days of chemoradiotherapy. At the end of the chemoradiotherapy, each patient underwent clinical examination, including digital rectal examination, proctoscopy and abdominal-pelvic computerized tomography to define the clinical response to the chemoradiotherapy. Surgical resection was performed in all patients three weeks after the end of chemoradiotherapy, and histological analysis was performed on all resected specimens. Results The clinical complete response rate corresponded to the pathological complete response rate, whereas the clinical evaluation overestimated partial response and stable disease. The pathologic examination revealed that 3.5% of clinical partial responses and 3.4% of clinical stable disease were really pathological progressive disease. Clinical partial response and clinical stable disease positive predictive values were 92.8% and 90.9%, respectively, whereas the clinical progressive disease negative predictive value was 20%. Then, 6.9% of patients believed to have responded to the therapy, or not to have responded or worsened, actually had worsened by the end of the chemoradiotherapy. Conclusions Positive and negative predictive values, in particular for partial response and stable disease, of clinical evaluation of the response to chemoradiotherapy were not high enough to consider clinical evaluation accurate enough to make treatment decisions.
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Stram, D. O., K. K. Matthay, M. O'Leary, C. P. Reynolds, G. M. Haase, J. B. Atkinson, G. M. Brodeur, and R. C. Seeger. "Consolidation chemoradiotherapy and autologous bone marrow transplantation versus continued chemotherapy for metastatic neuroblastoma: a report of two concurrent Children's Cancer Group studies." Journal of Clinical Oncology 14, no. 9 (September 1996): 2417–26. http://dx.doi.org/10.1200/jco.1996.14.9.2417.
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PURPOSE To compare event-free survival (EFS) for patients with stage IV neuroblastoma who were treated with induction chemotherapy followed by additional courses of the same chemotherapy or by intensive chemoradiotherapy and autologous bone marrow transplantation (ABMT). METHODS Two hundred seven children who were diagnosed with stage IV neuroblastoma after 1 year of age were given five to seven courses of induction chemotherapy consisting of cisplatin, etoposide, doxorubicin, and cyclophosphamide (CCC-321-P2). This chemotherapy was continued for 13 total courses for some patients, whereas intensive chemoradiotherapy with ABMT was given to others (CCG-321-P3). The decision to continue chemotherapy versus to consolidate with chemoradiotherapy was not randomized but was made by parents and physicians. Marrow used for ABMT was purged ex vivo and was free of immunocytologically detectable neuroblastoma cells. RESULTS One hundred fifty-nine of 207 patients (77%) remained event-free during induction therapy. Of these, 67 received chemoradiotherapy/ABMT (CCG-321-P3) and 74 continued chemotherapy (CCG-321-P2). Using Cox regression analysis, the relative risk (RR) of an event after chemoradiotherapy/ABMT was estimated to be 58% of that for patients who continued chemotherapy (P = .01). Similarly, Kaplan-Meier analysis estimated EFS at four years for the chemoradiotherapy/ABMT and chemotherapy groups to be 40% and 19% respectively (P = .019). Subgroups appearing to benefit from chemoradiotherapy/ABMT were those with only a partial tumor response to induction chemotherapy (RR = 0.43; P = .008; EFS, 29% v 6%) and those whose tumors had amplification of the N-myc gene (RR = 0.26; P = .112; EFS, 67% v 0%). CONCLUSION Consolidation with intensive, myeloablative chemoradiotherapy followed by purged ABMT may be more effective than continuing chemotherapy for patients with stage IV neuroblastoma.
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Monjazeb, Arta Monir, Greg Riedlinger, Mebea Aklilu, Kim R. Geisinger, Girish Mishra, Scott Isom, Paige Clark, Edward A. Levine, and A. William Blackstock. "Outcomes of Patients With Esophageal Cancer Staged With [18F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET): Can Postchemoradiotherapy FDG-PET Predict the Utility of Resection?" Journal of Clinical Oncology 28, no. 31 (November 1, 2010): 4714–21. http://dx.doi.org/10.1200/jco.2010.30.7702.
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Purpose To determine whether [18F]fluorodeoxyglucose positron emission tomography (FDG-PET) can delineate patients with esophageal cancer who may not benefit from esophagectomy after chemoradiotherapy. Patients and Methods We reviewed records of 163 patients with histologically confirmed stage I to IVA esophageal cancer receiving chemoradiotherapy with or without resection with curative intent. All patients received surgical evaluation. Initial and postchemoradiotherapy FDG-PET scans and prognostic/treatment variables were analyzed. FDG-PET complete response (PET-CR) after chemoradiotherapy was defined as standardized uptake value ≤ 3. Results Eighty-eight patients received trimodality therapy and 75 received chemoradiotherapy. Surgery was deferred primarily due to medical inoperability or unresectable/metastatic disease after chemoradiotherapy. A total of 105 patients were evaluable for postchemoradiotherapy FDG-PET response. Thirty-one percent achieved a PET-CR. PET-CR predicted for improved outcomes for chemoradiotherapy (2-year overall survival, 71% v 11%, P < .01; 2-year freedom from local failure [LFF], 75% v 28%, P < .01), but not trimodality therapy. On multivariate analysis of patients treated with chemoradiotherapy, PET-CR is the strongest independent prognostic variable (survival hazard ratio [HR], 9.82, P < .01; LFF HR, 14.13, P < .01). PET-CR predicted for improved outcomes regardless of histology, although patients with adenocarcinoma achieved a PET-CR less often. Conclusion Patients treated with trimodality therapy found no benefit with PET-CR, likely because FDG-PET residual disease was resected. Definitive chemoradiotherapy patients achieving PET-CR had excellent outcomes equivalent to trimodality therapy despite poorer baseline characteristics. Patients who achieve a PET-CR may not benefit from added resection given their excellent outcomes without resection. These results should be validated in a prospective trial of FDG-PET–directed therapy for esophageal cancer.
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Atchariyasathian, V., K. Pruegsanusak, and S. Wongsriwattanakul. "Sensorineural hearing loss following induction chemotherapy plus concurrent chemoradiotherapy for advanced nasopharyngeal carcinoma." Journal of Laryngology & Otology 129, no. 8 (June 26, 2015): 767–72. http://dx.doi.org/10.1017/s0022215115001632.
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AbstractObjective:To compare the incidence of sensorineural hearing loss between those treated with docetaxel, cisplatin and 5-fluorouracil induction chemotherapy followed by carboplatin concurrent chemoradiotherapy and those treated with conventional concurrent chemoradiotherapy for advanced nasopharyngeal carcinoma.Methods:Serial pure tone audiometry was conducted in 36 nasopharyngeal carcinoma patients who were randomised into 2 groups. The first group received docetaxel, cisplatin and 5-fluorouracil induction chemotherapy followed by carboplatin concurrent chemoradiotherapy. The second group received conventional concurrent chemoradiotherapy.Results:The incidence of sensorineural hearing loss at speech frequency in the first group was 10 per cent and in the second group was 50 per cent (p = 0.0027). Bone conduction thresholds were significantly increased after completion of the treatment at 2–4 kHz in the first group and at all frequencies in the second group.Conclusion:The docetaxel, cisplatin and 5-fluorouracil induction chemotherapy regimen followed by concurrent chemoradiotherapy was associated with a lower incidence of sensorineural hearing loss than conventional concurrent chemoradiotherapy. This regimen may be the preferred choice of treatment for hearing preservation.
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Sun, Yan-wu, Pan Chi, Hui-ming Lin, Xing-rong Lu, Ying Huang, Zong-bin Xu, Sheng-hui Huang, and Xiao-jie Wang. "Effect of Neoadjuvant Chemoradiotherapy on Locally Advanced Rectal Mucinous Adenocarcinoma: A Propensity Score-Matched Study." Gastroenterology Research and Practice 2017 (2017): 1–10. http://dx.doi.org/10.1155/2017/5715219.
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Aims. To compare the surgical and oncological outcomes of rectal mucinous adenocarcinomas treated with neoadjuvant chemoradiotherapy versus surgery alone. Methods. A total of 167 locally advanced rectal mucinous adenocarcinoma patients treated with neoadjuvant chemoradiotherapy and surgery alone between 2008 and 2014 were matched using propensity score; the surgical and oncological outcomes were compared. Results. Ninety-six patients were matched. Postoperative morbidity was similar between groups. Sphincter preservation rate was higher in patients receiving neoadjuvant chemoradiotherapy (79.2% versus 60.4%, P=0.045), especially for tumors ≥ 3 cm but ≤5 cm from the anal verge (75.0% versus 44.0%, P=0.036). With a median follow-up of 54.8 months, the 5-year overall survival rate (neoadjuvant chemoradiotherapy versus surgery alone: 79.6% versus 67.1%; P=0.599) and disease-free survival rate (75.6% versus 64.2%; P=0.888) were similar. The 5-year local recurrence rate was lower in patients receiving neoadjuvant chemoradiotherapy (7.7% versus 26.0%, P=0.036), while no difference was observed in distant metastasis. A poor response to chemoradiation was associated with higher local recurrence (P=0.037). Conclusions. Compared with surgery alone, neoadjuvant chemoradiotherapy was found to increase the sphincter preservation rate and reduce local recurrence, thus being beneficial for locally advanced rectal mucinous adenocarcinoma patients.
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Jassem, Jacek. "Paradigms in chemoradiotherapy." European Journal of Cancer Supplements 5, no. 5 (September 2007): 277–85. http://dx.doi.org/10.1016/s1359-6349(07)70053-8.
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Nishimura, Yasumasa. "Rationale for chemoradiotherapy." International Journal of Clinical Oncology 9, no. 6 (December 2004): 414–20. http://dx.doi.org/10.1007/s10147-004-0443-z.
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Brunner, Thomas B., and Thomas Seufferlein. "Pancreatic cancer chemoradiotherapy." Best Practice & Research Clinical Gastroenterology 30, no. 4 (August 2016): 617–28. http://dx.doi.org/10.1016/j.bpg.2016.08.001.
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Leibold, Tobias, Jinru Shia, Leyo Ruo, Bruce D. Minsky, Timothy Akhurst, Marc J. Gollub, Michelle S. Ginsberg, et al. "Prognostic Implications of the Distribution of Lymph Node Metastases in Rectal Cancer After Neoadjuvant Chemoradiotherapy." Journal of Clinical Oncology 26, no. 13 (May 1, 2008): 2106–11. http://dx.doi.org/10.1200/jco.2007.12.7704.
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Purpose After preoperative chemoradiotherapy of rectal cancer, the number of retrievable and metastatic lymph nodes is decreased. The current TNM classification is based on number and not location of lymph node metastases and may understage disease after chemoradiotherapy. The aim of this study was to examine the prognostic significance of location of involved lymph nodes in rectal cancer patients after preoperative chemoradiotherapy. Patients and Methods We prospectively examined whole-mount specimens from 121 patients with uT3-4 and/or N+ rectal cancer who received preoperative chemoradiotherapy followed by resection. Location of involved lymph nodes was compared with median number of lymph nodes involved as well as presence of distant metastasis at presentation. Results Lymph node metastases were detected in 37 patients (31%). Thirteen patients with lymph node involvement along major supplying vessels (proximal lymph node metastases) had a significantly higher rate of distant metastatic disease at time of surgery than patients without proximal lymph node involvement (P < .001); median number of lymph nodes involved was two for patients with proximal lymph node metastases and 1.5 for patients with mesorectal lymph node involvement alone. Conclusion Our data suggest that, after preoperative chemoradiotherapy, proximal lymph node involvement is associated with a high incidence of metastatic disease at time of surgery. Because the median number of involved lymph nodes is low after preoperative chemoradiotherapy, the TNM staging system may not provide an accurate assessment of metastatic disease. Therefore, the ypTNM staging system should incorporate distribution as well as number of lymph node metastases after preoperative chemoradiotherapy for rectal cancer.
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Lunger, Fabian, and Georgios Peros. "Chemoradiotherapy alone or chemoradiotherapy followed by surgery in rectal cancer." memo - Magazine of European Medical Oncology 13, no. 3 (March 13, 2020): 324–28. http://dx.doi.org/10.1007/s12254-020-00586-0.
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Gong, Xiuyun, Limin Wang, Weili Wu, Yuanyuan Li, Jinhua Long, Xiaoxiao Chen, Xiuling Luo, et al. "The Treatment Combining Antiangiogenesis with Chemoradiotherapy Impinges on the Peripheral Circulation Vascular Endothelial Cells and Therapeutic Effect in the Patients with Locally Advanced Nasopharyngeal Carcinoma." BioMed Research International 2022 (July 15, 2022): 1–7. http://dx.doi.org/10.1155/2022/1787854.
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This study was implemented for the evaluation on the circulating endothelial cells’ (CECs) clinical significance in the locally advanced nasopharyngeal carcinoma treatment with endostatin-combined chemoradiotherapy. This study enrolled 47 patients with locally advanced nasopharyngeal carcinoma who were hospitalized from May 9, 2012 to March 10, 2013. These patients were split up into the observation group (25 patients) and control group (22 patients). Patients in the observation group received the endostatin combined with induction chemotherapy and subsequently with concurrent chemoradiotherapy with endostatin. Patients in the control group were treated with inductive chemotherapy followed by concurrent chemoradiotherapy. CECs in peripheral blood were conducted separately before or after inductive chemotherapy and additionally in the end of concurrent chemoradiotherapy. The CEC values of the observation group showed significant statistical differences ( p < 0.05 ) before or after different therapies, whereas those data in the control group were not statistically different. And, the mostly importantly, the CEC values in the observation group and control group turned out a statistical difference. The combination of endostatin and chemoradiotherapy significantly reduced parameters of peripheral blood CECs in these patients. According to the CEC parameters’ variety that we observed in the combined therapies, this study demonstrated that the CECs might be a clinical clue to evaluate this antiangiogenic chemoradiotherapy. And the clinical value of CECs will be further determined along with increasing comparative studies and clinical long-term efficacy observation.
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Hofste, Lisa S. M., Maartje J. Geerlings, Daniel von Rhein, Sofie H. Tolmeijer, Marjan M. Weiss, Christian Gilissen, Tom Hofste, et al. "Circulating Tumor DNA-Based Disease Monitoring of Patients with Locally Advanced Esophageal Cancer." Cancers 14, no. 18 (September 11, 2022): 4417. http://dx.doi.org/10.3390/cancers14184417.
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Patients diagnosed with locally advanced esophageal cancer are often treated with neoadjuvant chemoradiotherapy followed by surgery. This study explored whether detection of circulating tumor DNA (ctDNA) in plasma can be used to predict residual disease during treatment. Diagnostic tissue biopsies from patients with esophageal cancer receiving neoadjuvant chemoradiotherapy and surgery were analyzed for tumor-specific mutations. These tumor-informed mutations were used to measure the presence of ctDNA in serially collected plasma samples using hybrid capture-based sequencing. Plasma samples were obtained before chemoradiotherapy, and prior to surgery. The association between ctDNA detection and progression-free and overall survival was measured. Before chemoradiotherapy, ctDNA was detected in 56% (44/78) of patients and detection was associated with tumor stage and volume (p = 0.05, Fisher exact and p = 0.02, Mann-Whitney, respectively). After chemoradiotherapy, ctDNA was detected in 10% (8/78) of patients. This preoperative detection of ctDNA was independently associated with recurrent disease (hazard ratio 2.8, 95% confidence interval 1.1–6.8, p = 0.03, multivariable Cox-regression) and worse overall survival (hazard ratio 2.9, 95% confidence interval 1.2–7.1, p = 0.02, multivariable Cox-regression).Ultradeep sequencing-based detection of ctDNA in preoperative plasma of patients with locally advanced esophageal cancer may help to assess which patients have a high risk of recurrence after neoadjuvant chemoradiotherapy and surgery.
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Huber, Rudolf M., Michael Flentje, Michael Schmidt, Barbara Pöllinger, Helga Gosse, Jochen Willner, and Kurt Ulm. "Simultaneous Chemoradiotherapy Compared With Radiotherapy Alone After Induction Chemotherapy in Inoperable Stage IIIA or IIIB Non–Small-Cell Lung Cancer: Study CTRT99/97 by the Bronchial Carcinoma Therapy Group." Journal of Clinical Oncology 24, no. 27 (September 20, 2006): 4397–404. http://dx.doi.org/10.1200/jco.2005.05.4163.
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Purpose The aim of this study was to examine whether, after preceding induction chemotherapy, simultaneous chemoradiotherapy is superior to radiotherapy alone. Patients and Methods Patients with non–small-cell lung cancer in inoperable stage IIIA or IIIB received induction chemotherapy with two cycles of paclitaxel 200 mg/m2 and carboplatin area under the curve 6 every 3 weeks. Patients without progression at restaging after induction chemotherapy were randomly assigned to radiotherapy (60 Gy) or chemoradiotherapy (paclitaxel 60 mg/m2 weekly). The primary end point was overall survival; secondary end points were time to progression, response, and toxicity. Results Three hundred three patients entered the study, and 276 completed induction chemotherapy. Two hundred fourteen patients were randomly assigned (radiotherapy alone: n = 113; simultaneous chemoradiotherapy: n = 101). Median follow-up time of all randomly assigned patients was 13.6 months (interquartile range [IQR], 6.4 to 29.0 months), and median follow-up time of the subgroup of censored patients (n = 52) was 37.4 months (IQR, 5.9 to 57.0 months; maximum, 76.1 months). Toxicities during the induction phase were mild. During radiotherapy, overall toxicity rates were not significantly different between the two arms. Median survival times in the radiotherapy group and chemoradiotherapy group were 14.1 months (95% CI, 11.8 to 16.3 months) and 18.7 months (95% CI, 14.1 to 23.3 months; difference not statistically significant, P = .091). Median time to progression significantly favored simultaneous chemoradiotherapy (11.5 months; 95% CI, 8.3 to 14.7 months) versus radiotherapy alone (6.3 months; 95% CI, 5.0 to 7.6 months; P < .001, log-rank test). Conclusion Induction chemotherapy followed by chemoradiotherapy with weekly paclitaxel is feasible. Response, time to progression, and survival favor chemoradiotherapy compared with radiotherapy alone.
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Brunner, Thomas B., Matthias Geiger, Gerhard G. Grabenbauer, Marga Lang-Welzenbach, Tine S. Mantoni, Alexander Cavallaro, Rolf Sauer, Werner Hohenberger, and W. Gillies McKenna. "Phase I Trial of the Human Immunodeficiency Virus Protease Inhibitor Nelfinavir and Chemoradiation for Locally Advanced Pancreatic Cancer." Journal of Clinical Oncology 26, no. 16 (June 1, 2008): 2699–706. http://dx.doi.org/10.1200/jco.2007.15.2355.
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PurposePreclinically, HIV protease inhibitors radiosensitize tumors with activated PI3-kinase/Akt pathway. We determined the toxicity of nelfinavir chemoradiotherapy in borderline resectable and unresectable pancreatic cancer.Patients and MethodsOral nelfinavir (2 × 1,250 mg) was started 3 days before and continued throughout chemoradiotherapy to 50.4 Gy (boost, 59.4 Gy) in 12 patients. Two gemcitabine dose levels (DL) were tested (200 mg/m2and 300 mg/m2on days 1, 8, 22, and 29). Cisplatin was administered on the same days at 30 mg/m2. Phospho-Akt downregulation by nelfinavir was monitored by immunoblotting in patient leukocytes. Restaging positron emission tomography (PET)/computed tomography (CT) and CA19-9 levels served to assess response, and responding tumors were resected.ResultsAt each DL, five of six patients completed chemoradiotherapy, and two of 12 patients had incomplete chemoradiotherapy because of clinical depression (DL1) and peritoneal metastasis (DL2). Grade 4 toxicities were a transaminase elevation (DL2) as a result of biliary stent occlusion and acute cholecystitis as a result of peritoneal metastasis (DL2). Stent occlusions led to dose-limiting toxicities of grade 3 liver enzyme and bilirubin elevations (two patients at DL1, one patient at DL2). Grade 3 nausea and vomiting occurred in a DL2 patient, and weight loss occurred in a DL1 patient who refused supportive feeding. Secondary complete resection was possible in six of 10 patients with complete chemoradiotherapy, including one tumor with pathologic sterilization. Partial CT responses were observed in five of 10 patients who completed chemoradiotherapy. Of nine patients assessable by PET,responses were complete in five patients and partial patients, and stable disease was observed in two patients.ConclusionThe combination of nelfinavir and chemoradiotherapy showed acceptable toxicity and promising activity in patients with pancreatic cancer.
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Kanzaki, Ryu, Naoko Ose, Soichiro Funaki, Yasushi Shintani, Masato Minami, Osamu Suzuki, Hiroshi Kida, Kazuhiko Ogawa, Atsushi Kumanogoh, and Meinoshin Okumura. "The Outcomes of Induction Chemoradiotherapy Followed by Surgery for Clinical T3-4 Non-Small Cell Lung Cancer." Technology in Cancer Research & Treatment 18 (January 1, 2019): 153303381987132. http://dx.doi.org/10.1177/1533033819871327.
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Purpose: Information on the short- and long-term outcomes of induction chemoradiotherapy followed by surgery for cT3-4 non-small cell lung cancer is limited. We analyzed the short- and long-term outcomes of induction chemoradiotherapy followed by surgery for cT3-4 non-small cell lung cancer. Methods: Patients with non-small cell lung cancer who underwent induction chemoradiotherapy followed by surgery for cT3-4 non-small cell lung cancer were retrospectively reviewed (initial treatment group, n = 31). Their results were compared to those patients who underwent surgery as an initial treatment during the same period (initial surgery group, n = 35). Results: Downstaging was achieved in 14 (45%) patients in the initial treatment group. R0 resection was achieved in 28 (90%) patients in the initial treatment group and 31 (88%) patients in the initial surgery group. The 90-day mortality rate was 3% in each group. Postoperative complications occurred in 16 (52%) patients in the initial treatment group and 13 (37%) patients in the initial surgery group. The 5-year overall survival rate of the initial treatment group was significantly higher than that of the initial surgery group (62.6% vs 43.5%, P = .04). The 5-year overall survival rates of the initial treatment N0-1 group and the initial surgery N0-1 group were 88.9% and 49.3%, respectively; the difference was statistically significant ( P = .02). Multivariate analysis using 4 factors (age [≤65 vs >65], cN [cN0-1 vs cN2], general condition [chemoradiotherapy fit vs chemoradiotherapy unfit], and treatment mode [induction chemoradiotherapy followed by surgery vs surgery as an initial treatment]) revealed that treatment mode (induction chemoradiotherapy followed by surgery) and cN status (cN0-1) were significantly associated with good overall survival and disease-free survival. Conclusions: Induction chemoradiotherapy followed by surgery for cT3-4 non-small cell lung cancer could be performed with an acceptable degree of surgical risk. At present, it is thought to be one of the reasonable treatment approaches for selected patients with cT3-4 disease, even those with a cN0-1 status.
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VAN DER MEER1,, FEMKE S., FRANZ M. N. H. SCHRAMEL, MARCO VAN VULPEN, and SHERIF Y. EL SHAROUNI. "Feasibility of Concomitant Chemoradiotherapy in Daily Practice for Patients with NSCLC Stage III." Anticancer Research 36, no. 9 (September 9, 2016): 4673–76. http://dx.doi.org/10.21873/anticanres.11019.
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Eyck, Ben M., J. Jan B. van Lanschot, Maarten C. C. M. Hulshof, Berend J. van der Wilk, Joel Shapiro, Pieter van Hagen, Mark I. van Berge Henegouwen, et al. "Ten-Year Outcome of Neoadjuvant Chemoradiotherapy Plus Surgery for Esophageal Cancer: The Randomized Controlled CROSS Trial." Journal of Clinical Oncology 39, no. 18 (June 20, 2021): 1995–2004. http://dx.doi.org/10.1200/jco.20.03614.
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PURPOSE Preoperative chemoradiotherapy according to the chemoradiotherapy for esophageal cancer followed by surgery study (CROSS) has become a standard of care for patients with locally advanced resectable esophageal or junctional cancer. We aimed to assess long-term outcome of this regimen. METHODS From 2004 through 2008, we randomly assigned 366 patients to either five weekly cycles of carboplatin and paclitaxel with concurrent radiotherapy (41.4 Gy in 23 fractions, 5 days per week) followed by surgery, or surgery alone. Follow-up data were collected through 2018. Cox regression analyses were performed to compare overall survival, cause-specific survival, and risks of locoregional and distant relapse. The effect of neoadjuvant chemoradiotherapy beyond 5 years of follow-up was tested with time-dependent Cox regression and landmark analyses. RESULTS The median follow-up was 147 months (interquartile range, 134-157). Patients receiving neoadjuvant chemoradiotherapy had better overall survival (hazard ratio [HR], 0.70; 95% CI, 0.55 to 0.89). The effect of neoadjuvant chemoradiotherapy on overall survival was not time-dependent ( P value for interaction, P = .73), and landmark analyses suggested a stable effect on overall survival up to 10 years of follow-up. The absolute 10-year overall survival benefit was 13% (38% v 25%). Neoadjuvant chemoradiotherapy reduced risk of death from esophageal cancer (HR, 0.60; 95% CI, 0.46 to 0.80). Death from other causes was similar between study arms (HR, 1.17; 95% CI, 0.68 to 1.99). Although a clear effect on isolated locoregional (HR, 0.40; 95% CI, 0.21 to 0.72) and synchronous locoregional plus distant relapse (HR, 0.43; 95% CI, 0.26 to 0.72) persisted, isolated distant relapse was comparable (HR, 0.76; 95% CI, 0.52 to 1.13). CONCLUSION The overall survival benefit of patients with locally advanced resectable esophageal or junctional cancer who receive preoperative chemoradiotherapy according to CROSS persists for at least 10 years.
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Mayadev, Jyoti, Ana T. Nunes, Mary Li, Michelle Marcovitz, Mark C. Lanasa, and Bradley J. Monk. "CALLA: Efficacy and safety of concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone in women with locally advanced cervical cancer: a phase III, randomized, double-blind, multicenter study." International Journal of Gynecologic Cancer 30, no. 7 (May 23, 2020): 1065–70. http://dx.doi.org/10.1136/ijgc-2019-001135.
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BackgroundConcurrent chemoradiotherapy is the standard of care for locally advanced cervical cancer. Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.Primary ObjectiveThe CALLA trial is designed to determine the efficacy and safety of the programmed cell death-ligand 1 blocking antibody, durvalumab, with and following concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in women with locally advanced cervical cancer.Study HypothesisDurvalumab concurrent with and following concurrent chemoradiotherapy will improve progression-free survival in patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2 to IVA cervical cancer compared with concurrent chemoradiotherapy alone.Trial DesignCALLA is a phase III, randomized, multicenter, international, double-blind, placebo-controlled study. Patients will be randomized 1:1 to receive either durvalumab (1500 mg intravenously (IV)) or placebo every 4 weeks for 24 cycles. All patients will receive external beam radiotherapy with cisplatin (40 mg/m2) IV or carboplatin (area under the curve 2) IV once a week for 5 weeks, followed by image-guided brachytherapy.Major Inclusion/Exclusion CriteriaThe study will enroll immunotherapy-naïve adult patients with histologically confirmed cervical adenocarcinoma, cervical squamous, or adenosquamous carcinoma FIGO 2009 stages IB2–IIB node positive and stage IIIA–IVA with any node stage. Patients will have had no prior definitive surgical, radiation, or systemic therapy for cervical cancer.Primary EndpointThe primary endpoint is progression-free survival (assessed by the investigator according to Response Evaluation Criteria in Solid Tumors v1.1, histopathological confirmation of local tumor progression or death).Sample SizeApproximately 714 patients will be randomized 1:1 to receive either durvalumab + concurrent chemoradiotherapy or placebo + concurrent chemoradiotherapy.Estimated Dates for Completing Accrual and Presenting ResultsPatient enrollment is continuing globally with an estimated completion date of April 2024.Trial RegistrationNCT03830866.
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Callejas-Valera, Juan L., Daniel W. Vermeer, Christopher T. Lucido, Caitlin Williamson, Marisela Killian, Paola D. Vermeer, William C. Spanos, and Steven F. Powell. "Characterization of the Immune Response to PD-1 Blockade during Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma." Cancers 14, no. 10 (May 19, 2022): 2499. http://dx.doi.org/10.3390/cancers14102499.
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Background: Chemoradiotherapy is a standard treatment for HNSCC. Blockade of the PD-1/L1-2 interaction may represent a target to overcome immune escape during this treatment. Methods: Utilizing a HNSCC mEERL C57BL/6 mouse model, we evaluated a PD-1 blockade alone or in combination with cisplatin-based chemoradiotherapy. Next, we evaluated peripheral blood mononuclear cells (PBMCs) with relative PD-1, TIM-3, and LAG-3 expression, and myeloid-derived suppressor-like (MDSC-like) populations from a clinical trial evaluating PD-1 blockade with chemoradiotherapy in HNSCC. Finally, we analyzed the effect of therapy on human T-cell clonality through T-cell Receptor (TCR) sequencing. Results: Anti-PD-1 monotherapy induced no response in the mEERL model; however, combination with chemoradiotherapy improved tumor clearance and survival. PBMCs from patients treated with this combination therapy demonstrate a decline in circulating T-cell populations with knockdown of PD-1 expressing CD3+CD4+ and CD3+CD8+ T cells during treatment. However, TIM-3, LAG-3 expressing T-cell and MDSC-like populations concordantly rose. During treatment, the TCR repertoire demonstrates overall clonal expansion, with both unique and previously reported T-cell clones. Conclusions: Our murine HNSCC model demonstrates efficacy of PD-1 blockade during chemoradiotherapy. However, while PD-1-expressing T cells decreased with this therapy, human PBMC findings also identified an increase in populations contributing to immune exhaustion. These findings further characterize PD-1 blockade during chemoradiotherapy for HNSCC and highlight potential competing mechanisms of immune evasion.
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Furusawa, Akiko, Munetaka Takekuma, Keita Mori, Tomoka Usami, Eiji Kondo, Shin Nishio, Koji Nishino, et al. "A randomized phase III trial of adjuvant chemotherapy versus concurrent chemoradiotherapy for postoperative cervical cancer: Japanese Gynecologic Oncology Group study (JGOG1082)." International Journal of Gynecologic Cancer 31, no. 4 (March 4, 2021): 623–26. http://dx.doi.org/10.1136/ijgc-2020-002344.
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BackgroundThe standard treatment for stage IB–IIB cervical cancer is radiotherapy or radical hysterectomy; after radical hysterectomy, adjuvant concurrent chemoradiotherapy is recommended for patients with high risk factors. However, adjuvant concurrent chemoradiotherapy can cause severe gastrointestinal and urinary toxicity.Primary ObjectiveTo assess whether postoperative adjuvant chemotherapy is not inferior to adjuvant concurrent chemoradiotherapy for overall survival in patients with high risk cervical cancer.Study HypothesisAdjuvant chemotherapy is not inferior to adjuvant concurrent chemoradiotherapy for overall survival and will reduce severe toxicities.Trial DesignPatients with high risk factors after radical hysterectomy will be randomized 1:1 to receive adjuvant concurrent chemoradiotherapy or adjuvant chemotherapy. Treatment will be started within 6 weeks of surgery. The concurrent chemoradiotherapy group will receive whole pelvis irradiation (50.4 Gy) and cisplatin (40 mg/m2/week). The chemotherapy group will receive paclitaxel (175 mg/m2) plus cisplatin (50 mg/m2) or carboplatin (AUC=6) every 3 weeks for six cycles.Major Inclusion/Exclusion CriteriaPatients with high risk stage IB–IIB cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma) who underwent radical hysterectomy are eligible for the study. High risk is defined as the presence of pelvic lymph node metastasis and/or parametrial invasion.Primary EndpointThe primary endpoint is overall survival.Sample Size250 patients in total are required.Estimated Dates for Completing AccrualThis study began in November 2019, and 250 patients will be accrued within 5 years.Trial Registration NumberThe study has been registered with the Japan Registry of Clinical Trials (jRCTs041190042).
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DiSilvestro, Paul A., Shamshad Ali, Peter S. Craighead, Joseph A. Lucci, Yi-Chun Lee, David E. Cohn, Nicola M. Spirtos, et al. "Phase III Randomized Trial of Weekly Cisplatin and Irradiation Versus Cisplatin and Tirapazamine and Irradiation in Stages IB2, IIA, IIB, IIIB, and IVA Cervical Carcinoma Limited to the Pelvis: A Gynecologic Oncology Group Study." Journal of Clinical Oncology 32, no. 5 (February 10, 2014): 458–64. http://dx.doi.org/10.1200/jco.2013.51.4265.
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Purpose This prospective, randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine (TPZ) to standard cisplatin (CIS) chemoradiotherapy in locally advanced cervix cancer. Patients and Methods Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy. Primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS) and tolerability. Results PFS was evaluable in 387 of 402 patients randomly assigned over 36 months, with enrollment ending in September 2009. Because of the lack of TPZ supply, the study did not reach its original target accrual goal. At median follow-up of 28.3 months, PFS and OS were similar in both arms. Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0% and 64.4%, respectively (log-rank P = .7869). Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5% and 70.6%, respectively (log-rank P = .8333). A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm, with resulting tolerance in both treatment arms. Conclusion TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS, although definitive commentary was limited by an inadequate number of events (progression or death). TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose.
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Tu, Hua, He Huang, Yi Ouyang, Qing Liu, Bingna Xian, Kun Song, Gang Chen, Yuanming Shen, and Jihong Liu. "Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study." International Journal of Gynecologic Cancer 31, no. 1 (June 9, 2020): 129–33. http://dx.doi.org/10.1136/ijgc-2020-001357.
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BackgroundConcurrent chemoradiotherapy is the first-line treatment for FIGO stage IIB cervical cancer. Neoadjuvant chemotherapy followed by radical surgery may provide another treatment option.Primary objectiveTo compare the therapeutic outcomes of neoadjuvant chemotherapy followed by surgery with cisplatin-based concurrent chemoradiotherapy for stage IIB cervical cancer.Study hypothesisWe hypothesize that the therapeutic effect of neoadjuvant chemotherapy combined with surgery and risk-adapted adjuvant treatment will be superior to that of concurrent chemoradiotherapy in stage IIB cervical cancer.Trial designPatients with stage IIB cervical cancer will be randomized 1:1 to neoadjuvant chemotherapy followed by surgery (Arm A) or concurrent chemoradiotherapy (Arm B). In arm A, patients will receive three cycles of paclitaxel and cisplatin followed by a type C radical hysterectomy and pelvic ±paraaortic lymphadenectomy. Patients showing progression after neoadjuvant chemotherapy will be referred to concurrent chemoradiotherapy. Adjuvant therapy will be recommended according to the presence of pathological risks. In Arm B, all patients will receive definitive concurrent chemoradiotherapy, including external beam pelvic radiotherapy combined with concurrent weekly cisplatin followed by brachytherapy.Major inclusion/exclusion criteriaPatients between 18 and 60 years with histologically confirmed, untreated stage IIB cervical squamous carcinoma, adenocarcinoma, or adeno-squamous carcinoma.Primary endpointThe primary endpoint is 2-year disease-free survival.Sample sizeAn estimated sample size of 240 is required to fulfill the study objectives.Estimated dates for completing accrual and presenting resultsAs of February 2020, 115 eligible patients from four institutions have been enrolled. Enrollment is expected to be completed by December 2022.Trial registration numberClinicalTrials. gov identifier: NCT02595554.