Artykuły w czasopismach: „Eribulin Mesylate”

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Huyck, Timothy K., William Gradishar, Fil Manuguid i Peter Kirkpatrick. "Eribulin mesylate". Nature Reviews Drug Discovery 10, nr 3 (marzec 2011): 173–74. http://dx.doi.org/10.1038/nrd3389.

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Jain, Sarika, i Linda T. Vahdat. "Eribulin Mesylate". Clinical Cancer Research 17, nr 21 (22.08.2011): 6615–22. http://dx.doi.org/10.1158/1078-0432.ccr-11-1807.

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Edwards, Michael S., Dominic A. Solimando i J. Aubrey Waddell. "Eribulin Mesylate and Denosumab". Hospital Pharmacy 46, nr 4 (kwiecień 2011): 247–53. http://dx.doi.org/10.1310/hpj4604-247.

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Verdaguer, Helena, Idoia Morilla i Ander Urruticoechea. "Eribulin Mesylate in Breast Cancer". Women's Health 9, nr 6 (listopad 2013): 517–26. http://dx.doi.org/10.2217/whe.13.61.

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Nieder, Carsten, Gro Aandahl i Astrid Dalhaug. "A Case of Brain Metastases from Breast Cancer Treated with Whole-Brain Radiotherapy and Eribulin Mesylate". Case Reports in Oncological Medicine 2012 (2012): 1–3. http://dx.doi.org/10.1155/2012/537183.

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Patients with triple receptor-negative breast cancer often develop aggressive metastatic disease, which also might involve the brain. In many cases, systemic and local treatment is needed. It is important to consider the toxicity of chemo- and radiotherapy, especially when newly approved drugs become available. Randomised studies leading to drug approval often exclude patients with newly diagnosed brain metastases. Here we report our initial experience with eribulin mesylate and whole-brain radiotherapy (WBRT) in a heavily pretreated patient with multiple brain, lung, and bone metastases from triple receptor-negative breast cancer. Eribulin mesylate was given after 4 previous lines for metastatic disease. Two weeks after the initial dose, that is, during the first cycle, the patient was diagnosed with 5 brain metastases with a maximum size of approximately 4.5 cm. She continued chemotherapy and received concomitant WBRT with 10 fractions of 3 Gy. After 3 cycles of eribulin mesylate, treatment was discontinued because of newly diagnosed liver metastases and progression in the lungs. No unexpected acute toxicity was observed. The only relevant adverse reactions were haematological events after the third cycle (haemoglobin 9.5 g/dL, leukocytes3.1×109/L). The patient died from respiratory failure 18.5 months from diagnosis of metastatic disease, and 2.7 months from diagnosis of brain metastases. To the best of our knowledge, this is the first report on combined WBRT and eribulin mesylate.

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Barnato, Sara E., Jacqueline Sara Jeruss, Kevin P. Bethke, Nora M. Hansen, Seema Ahsan Khan, Jamie H. Von Roenn, Steven T. Rosen i in. "Phase II neoadjuvant trial with carboplatin and eribulin mesylate in patients with triple-negative breast cancer." Journal of Clinical Oncology 30, nr 15_suppl (20.05.2012): TPS1134. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.tps1134.

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TPS1134 Background: Several neoadjuvant trials have been conducted in triple negative breast cancer (TNBC) with platinum agents with pathologic complete response (pCR) ranging from 16%-32%. Eribulin mesylate, a nontaxane microtubule dynamics inhibitor, has clinical activity as monotherapy in breast cancer and other solid tumors. A recent phase I trial found the combination of eribulin mesylate with carboplatin was well tolerated and showed activity in advanced solid tumors. The recommended dose for future trials was eribulin mesylate 1.1 mg/m2 and carboplatin AUC6. We proposed a neoadjuvant phase II trial with the combination of carboplatin and eribulin in patients with TNBC. Methods: This is a non-randomized, open-label, multi-center, phase II clinical trial of eribulin and carboplatin enrolling histologically-confirmed TNBC patients. Our primary endpoint is to determine the pCR in TNBC patients treated with the combination of carboplatin and eribulin. Secondary endpoints include determination of the clinical response rate, toxicity evaluation and measurement of stem cell and TLE3 as a biomarker of response to eribulin therapy. To obtain an alpha of 0.10 and a power of 0.90, a sample size of 30 patients is required to detect a pCR rate >=30%. 10 of the planned 30 patients have been enrolled to date. Treatment will be given every 3 weeks for a total of 4 cycles of therapy. There will be an initial safety run-in to evaluate the appropriate dose of eribulin in this population. The first 10 patients will receive eribulin at 1.4 mg/m2 (intravenously over 2-5 minutes) followed by carboplatin AUC=6 (intravenously over 30 minutes). After the 10th patient has been enrolled, the study will be temporarily suspended pending review; toxicity will be assessed for these first 10 patients (cycle 1 only) to assess whether this dose of eribulin will be used for the remaining patients or if a reduction to a dose of 1.1 mg/m2 will be required. Definitive surgery will be performed 3-8 weeks after completion of therapy, which will conclude the duration of the study. Clinical Trial Registry Number NCT01372579.

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Pullela, Srinivas Venkata, Vinod Acharya, Nagarjuna Reddy, Jayvant Harlikar, Amar Kulkarni, Rakesh Chavan, Ajay Yadav, Shuvendu Manna i Angshuman Ghosh. "Structural corroboration of two important building blocks of the anticancer drug eribulin mesylate through two-dimensional NMR and single-crystal X-ray diffraction studies". Acta Crystallographica Section C Structural Chemistry 72, nr 1 (1.01.2016): 14–20. http://dx.doi.org/10.1107/s2053229615022305.

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Eribulin mesylate, one of the most synthetically challenging drugs to date, possesses 19 stereocentres in its structure and ascertaining the absolute stereochemistry at every stage of the 64-stage synthesis is crucial. In our quest to synthesize eribulin, we identified two critical building blocks of this molecule, namely 3,4:6,7-di-O-cyclohexylidene-D-glycero-α-L-talo-heptopyranose methanol monosolvate, C19H30O7·CH3OH, and (2R,3R,4R,5S)-5-allyl-2-[(S)-2,3-dihydroxypropyl]-4-[(phenylsulfonyl)methyl]tetrahydrofuran-3-ol, C17H24O6S, for which two-dimensional NMR (2D-NMR) data were not sufficient to prove the absolute configuration. To ensure structural integrity, single-crystal X-ray diffraction data were obtained to confirm the structures. This information provides useful insights into the structural framework of the large eribulin mesylate molecule.

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Nasim, Muhammad Yaser, Ruth Plummer, T. R. Jeffry Evans, Rosemary Morrison, David Alan Anthoney, Sophie Haney, Ayman Madi i in. "A phase Ib dose-escalation study of eribulin mesylate in combination with capecitabine in patients with advanced/metastatic cancer." Journal of Clinical Oncology 30, nr 15_suppl (20.05.2012): 2552. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.2552.

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2552 Background: Eribulin mesylate is a microtubule dynamics inhibitor approved by FDA for patients (pts) with metastatic breast cancer after treatment with at least two prior chemotherapeutic regimens. This Phase Ib, open-label dose-escalation study determined the maximum tolerated dose (MTD) of eribulin in combination with capecitabine. Methods: Pts with advanced solid malignancies refractory to standard therapies, adequate organ function and ECOG performance status ≤2 received eribulin mesylate (2–5-min IV) by Schedule 1 (1.2, 1.6 or 2.0 mg/m2 on Day 1) or Schedule 2 (0.7, 1.1 or 1.4 mg/m2 on Days 1 and 8), in combination with twice-daily oral capecitabine 1000 mg/m2 Days 1-14 every 21 days. The MTD was defined as the highest dose in each schedule where ≤1/6 pts experienced dose-limiting toxicity (DLT). Safety and pharmacokinetics (PK) were assessed. Results: Of the 34 pts recruited, 19 (53% male; median age 62 years; 42% ECOG 0, 58% ECOG 1) and 15 (33% male; median age 61 years; 33% ECOG 0, 60% ECOG 1, 7% ECOG 2) were enrolled in Schedules 1 and 2, respectively. Most common tumor types were large intestine (20.6%), lung/bronchus (17.7%) and breast (14.7%). DLTs are shown in the table; there were no unexpected toxicities with the combination. The MTD for eribulin mesylate was 1.6 and 1.4 mg/m2 for Schedules 1 and 2, respectively, in combination with capecitabine 1000 mg/m2 twice-daily. Eribulin PK were dose proportional and independent of schedule or capecitabine co-administration. Combination with eribulin had no effect on the disposition of capecitabine and its metabolites. Although sample size was small, preliminary signs of efficacy were observed. Conclusions: The combination of eribulin and capecitabine was well tolerated with no unexpected safety findings. Schedule 2 MTD (1.4 mg/m2 Days 1 and 8) delivered a higher dose intensity of eribulin than Schedule 1 and was selected for evaluation in an ongoing Phase II breast cancer study. [Table: see text]

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Iwamoto, Mitsuhiko, Nayuko Sato, Risa Terasawa, Hiroya Fujioka, Yuko Takahashi, Kosei Kimura, Satoru Tanaka i Kazuhisa Uchiyama. "Phase II study of eribulin mesylate as first- or second-line therapy for metastatic HER2-negative breast cancer." Journal of Clinical Oncology 31, nr 15_suppl (20.05.2013): TPS1140. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.tps1140.

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TPS1140 Background: Eribulin mesylate is a nontaxane microtubule dynamics inhibitor that is approved in patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens (including an anthracycline and a taxane) for metastatic breast cancer. In a previous phase III study, eribulin mesylate demonstrated to significant improvement in overall survival in patients with heavily pretreated, locally recurrent or metastatic breast cancer when compared to treatment of physician’s choice. The majority of patients were HER2-negative and all had previously failed 2 or more regimens. Overall, the tolerability and positive phase III findings in this patient population suggest eribulin mesylate may provide a treatment advantage when given earlier in the course of therapy for HER2-negative, metastatic breast cancer. Methods: This study is phase II, multicenter, open-label, single-arm in patients with HER2-negative metastatic breast cancer who have been treated with chemotherapeutic regimens including an antheracycline and a taxane. Eribulin mesylate (1.4mg/m2) will be given on days 1 and 8 of each 21-day cycle. The primary endpoint is objective response rate, and secondary endpoints include duration of response, progression-free survival, overall survival, the safety of the treatment, and quality of life. Eligibility Criteria: Patients must have confirmed HER2-negative metastatic breast cancer with at least 4 weeks since prior neoadjuvant or adjuvant chemotherapy, and have not received over 2 chemotherapeutic regimens for metastatic disease. Additional eligibility criteria include adequate performance status (ECOG PS:0-2) and end organ/marrow function, and ejection fraction > 50%. Accrual: This study began in December 2012. The expected end of accrual of 35 patients will be the last quarter 2015.

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Raftopoulos, Harry, Joseph Aisner, Kirushna Kumar, Sanjay Goel, Christian Dittrich, Minish Jain, Prashanth Gopalakrishna, Paloma Salazar, Beverley Jones i Daniel Peter Petrylak. "Phase Ib extension study of eribulin mesylate in combination with carboplatin in patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC)." Journal of Clinical Oncology 31, nr 15_suppl (20.05.2013): e19145-e19145. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e19145.

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e19145 Background: Eribulin mesylate as monotherapy has shown antitumor activity in patients with advanced NSCLC that progressed during or after platinum-based doublet chemotherapy (Spira AI et al. Clin Lung Cancer 2012; 13:31-38.). Following evidence of additive activity with eribulin and carboplatin in lung cancer cell lines, a phase Ib, dose-escalation study determined the maximum tolerated dose and optimum administration sequence of the combination as eribulin mesylate 1.1 mg/m2 (0.97 mg/m2 eribulin as free base) followed by carboplatin AUC 6. We report results from an extension arm that investigated the efficacy and safety of this combination in chemo-naïve patients with advanced NSCLC. Methods: Chemo-naïve patients with histologically or cytologically confirmed advanced NSCLC (stage IIIB or IV) with measurable disease were enrolled. Eribulin mesylate was administered intravenously (i.v.) on days 1 and 8 every 21 days, along with carboplatin i.v. on day 1. Efficacy assessments included best overall objective response rate (ORR; RECIST), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and duration of response (DOR). Adverse events (AEs) were also recorded. Results: 12 patients were accrued (11 male, 1 female) with a median age of 66.5 (range 42-74) years. For the 11 patients evaluable for efficacy, overall ORR was 27.3% (all partial responses) and DCR was 63.6%. Median (range) OS was 12.1 (1.6-12.1) months (5 patients still alive); PFS was 4.2 (0.03+-5.8+) months (upper value censored as 1 patient still responding at final visit); and DOR was 2.9 (2.8-3.1+) months. The most common AEs ≥grade 3 were thrombocytopenia (n=6), neutropenia (n=5), febrile neutropenia (n=4), anemia (n=3), and dyspnea, hypokalemia, leukopenia, and pneumonia (n=2 each). Conclusions: The combination of eribulin and carboplatin yielded no unexpected safety findings. Given the evolving treatment practices for NSCLC, further studies involving larger numbers of patients are warranted, with consideration given to specific histologic subgroups. Clinical trial information: NCT00268905.

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Chiba, Hiroyuki, i Katsuya Tagami. "Research and Development of HALAVEN(Eribulin Mesylate)". Journal of Synthetic Organic Chemistry, Japan 69, nr 5 (2011): 600–610. http://dx.doi.org/10.5059/yukigoseikyokaishi.69.600.

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Fujimoto, Etsuko, Kazuhiro Takehara, Tamaki Tanaka, Takanori Yokoyama, Katsuyuki Tomono, Mika Okazawa-Sakai, Shinichi Okame, Yoshifumi Sugawara i Norihiro Teramoto. "Uterine leiomyosarcoma well-controlled with eribulin mesylate". International Cancer Conference Journal 8, nr 1 (12.11.2018): 33–38. http://dx.doi.org/10.1007/s13691-018-0350-1.

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Vahdat, Linda T., Agustin Garcia, Charles L. Vogel, Christine M. Pellegrino, Deborah L. Lindquist, Joseph A. Sparano, Prashanth Gopalakrishna i Nicholas Iannotti. "Comparison of the incidence of peripheral neuropathy (PN) with eribulin versus ixabepilone (IXA) in metastatic breast cancer (MBC) patients: A randomized phase II study." Journal of Clinical Oncology 30, nr 27_suppl (20.09.2012): 121. http://dx.doi.org/10.1200/jco.2012.30.27_suppl.121.

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121 Background: Eribulin mesylate is approved for patients (pts) with MBC who have previously received ≥2 chemotherapeutic regimens for metastatic disease including an anthracycline and taxane in either the adjuvant or metastatic setting. This study compared incidence and severity of neuropathy adverse events (AEs) in pts receiving eribulin or IXA. Methods: Pts (locally recurrent/MBC; prior taxane therapy; ≥1 prior chemotherapy for advanced disease; pre-existing neuropathy Grade 0 [n=51] or 1 [n=53]) were randomized to receive 1.4 mg/m2 eribulin mesylate (2–5-min intravenous (IV), Days 1 and 8 of a 21-day cycle) or 40 mg/m2IXA (3 h IV, Day 1 of a 21-day cycle). The primary objective was to compare incidence of neuropathy AEs by CTCAE grade. Secondary objectives: severity of neuropathy AEs by CTCAE grade, patient neurotoxicity questionnaire (PNQ), and vibration sensitivity using Vibration Perception Threshold (VPT); time to onset of treatment-emergent neuropathy (TEN); efficacy; safety and tolerability. Results: Incidences ofPN and TEN (all grades) with eribulin (n=51) versus (vs) IXA (n=50) were 31.3% vs 44.0%, p=0.1632 and 33.3% vs 48.0%, p=0.1284, respectively. Severity (grade ≥3) was numerically lower with eribulin than IXA (PN: 9.8% vs 20.0%; TEN: 9.8% vs 22.0%). No significant differences were seen in baseline to worst PNQ scores. Median worst post-baseline VPT scores were lower with eribulin than IXA (index finger: 2.3 vs 2.4 vibration units [vu]; great toe: 7.75 vs 8.6 vu). Median time to onset of TEN was earlier with IXA (11.6 weeks [wks]) than eribulin (35.9 wks). TEAEs were comparable. Median treatment duration was 15.0 wks (eribulin) and 10.5 wks (IXA). Reasons for discontinuation (eribulin vs IXA): TEN (3.9% vs 18.0%); any TEAE (11.8% vs 32.0%); progressive disease (68.6% vs 48.0%). Objective response and clinical benefit rates were 15.4% vs 5.8% and 26.9% vs 19.2% for eribulin and IXA, respectively. Conclusions: Although not statistically significant, neuropathy AEs were less common with eribulin than IXA. Eribulin was associated with longer time to onset of TEN and fewer discontinuations due to neuropathy and other toxicities.

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Liu, Liping, Zhe-Yu Hu, Ning Xie, Xiaohong Yang, Huawu Xiao, Jing Li, Can Tian i in. "Eribulin mesylate versus eribulin plus anlotinib in patients with advanced or metastatic breast cancer: Results of a phase II study." Journal of Clinical Oncology 40, nr 16_suppl (1.06.2022): 1094. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.1094.

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1094 Background: Eribulin mesylate is a structurally simplified, synthetic, macrocyclic ketone analogue of Halichondrin B. We investigated the efficacy and safety of eribulin monotherapy versus eribulin plus the oral anti-angiogenesis inhibitor anlotinib in patients with advanced or metastatic breast cancer. Methods: This Phase II study included adult Chinese patients with locally advanced or metastatic breast cancer previously treated with at least two chemotherapy regimens, including both anthracycline- and taxane-based therapy (NCT05206656). Patients were randomized (1:1) to receive eribulin (1.4 mg/m2, intravenously, on days 1−8), alone or in combination with anlotinib (12 mg orally once daily), in 21-day cycles. The primary endpoint was investigator-assessed disease control rate (DCR), per RECIST version 1.1. Key secondary endpoints included objective response rate (ORR), progression-free survival (PFS) and safety. Results: Between February 12, 2020, and July 22, 2021, 56 patients were randomized to eribulin (n=32) or eribulin plus anlotinib (n=24) (Table). Sites of metastasis were: bone (60.7%), lung (52.7%), liver (53.6%), lymph nodes (73.2%) and soft tissue (7.1%). Among all patients, the DCR was 66.7% versus 100% (treatment difference, 33.3%; P=0.007), the ORR was 37.0% versus 38.9%, and the median PFS was 3.7 months versus 9.7 months (adjusted hazard ratio, 0.20; 95% CI, 0.04 to 0.91; P=0.04) for patients receiving eribulin versus eribulin plus anlotinib, respectively. Among 36 (64.3%) patients with triple-negative breast cancer, the DCR was 55.6% versus 72.2% (treatment difference, 16.7%; P=0.300) and the median PFS was 3.6 months versus 9.7 months (log rank P=0.030) with eribulin alone versus eribulin plus anlotinib, respectively. The most frequent grade 3-4 adverse events in the eribulin and eribulin plus anlotinib groups were decreased neutrophil count (25.0% [n=8] vs. 29.2% [n=7]) elevated transaminase (6.3% [n=2] vs. 0.0%) and decreased thrombocyte count (3.1% [n=1] vs. 0.0%), respectively. Conclusions: Eribulin plus anlotinib was associated with a significantly better DCR, ORR and PFS than eribulin monotherapy in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes. Clinical trial information: NCT05206656. [Table: see text]

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Senapati, Sibadatta, i Chepuri V. Ramana. "A concise/catalytic approach for the construction of the C14–C28 fragment of eribulin". Organic & Biomolecular Chemistry 19, nr 20 (2021): 4542–50. http://dx.doi.org/10.1039/d1ob00661d.

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A diastereoselective gold cyclisation and a Sharpless asymmetric dihydroxylation–cycloetherification protocol were carried out for the construction of the key disaccharide unit (C14–C28) of eribulin mesylate with a linear sequence of 14 steps.

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Gluck, Stefan, Joyce O'Shaughnessy, Kristi McIntyre, Lee Steven Schwartzberg, Sharon Wilks, Shannon Leigh Huggins-Puhalla, Erhan Berrak, James X. Song, David Cox i Linda T. Vahdat. "Clinical effects of prior anthracycline or taxane use on eribulin as first-line treatment for HER+/- locally recurrent or metastatic breast cancer (BC): Results from 2 phase 2, multicenter, single-arm studies." Journal of Clinical Oncology 32, nr 26_suppl (10.09.2014): 140. http://dx.doi.org/10.1200/jco.2014.32.26_suppl.140.

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140 Background: Eribulin mesylate, a nontaxane microtubule dynamics inhibitor, has demonstrated an overall survival benefit relative to other commonly used agents in patients (pts) with at least 2 prior MBC cytotoxic therapies. Primary data presented from 2 phase 2 trials, Study 206 (eribulin in HER2- BC pts) and Study 208 (combination eribulin + trastuzumab [TRAS] in HER2+ BC pts), showed clinical activity and acceptable tolerability profiles as first-line cytotoxic therapy (tx). Here we present prespecified efficacy data for both trials based on prior anthracycline (A) and taxane (T) use. Methods: In both studies, pts received eribulin mesylate 1.4 mg/m2 IV on days 1 and 8 of each 21-day cycle. Pts in Study 208 (HER2+) also received initial TRAS (8 mg/kg IV/Day 1), followed by 6 mg/kg/day 1 of each subsequent cycle. Objective response rate (ORR), progression-free survival (PFS), and tolerability were assessed. Results: In Study 206 (N=56), 48% and 46% received prior A and T, and in Study 208 (N=52), 21% and 44% received prior A and T, respectively. ORR, the primary endpoint, was similar in pts, regardless of prior A or T, except in pts w/o prior T in Study 208 whose ORR trended higher (table). Clinical benefit rate (CBR), PFS, and duration of response (DOR) were either similar or trended higher in pts w/o prior A or T. PFS was higher in HER2+ BC patients receiving eribulin + TRAS who had not received prior A or T compared with those who had. Grade (G) 3-5 adverse event rates were similar or lower in pts who had not received prior A or T. Conclusions: As first-line therapy, eribulin in HER2- BC pts and eribulin + TRAS in HER2+ BC pts were effective and well tolerated, regardless of prior A or T tx. However, in HER2+ BC pts receiving eribulin + TRAS, the lack of prior A or T tx may be a lead to longer median PFS. Clinical trial information: NCT01268150/NCT01269346. [Table: see text]

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Xie, Xiao-Feng, Jia-Yi Huang, Li-Ping Chen, Xiao-Feng Lan, Qiu-Yi Zhang, Lin Song, Xue Bai i Cai-Wen Du. "Acute-on-chronic liver failure following eribulin treatment for metastatic breast cancer: a case report". Journal of International Medical Research 50, nr 7 (lipiec 2022): 030006052210900. http://dx.doi.org/10.1177/03000605221090097.

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The efficacy and tolerability of eribulin mesylate, a synthetic halichondrin B analog, in patients with metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes have been established. Acute-on-chronic liver failure (ACLF) is a clinical syndrome manifesting as acute and severe hepatic derangement resulting from varied insults in patients with established chronic liver disease or cirrhosis who did not previously receive eribulin. A middle-aged woman diagnosed with MBC and diffuse liver metastases who was pretreated with multi-line chemotherapy received eribulin as eighth-line chemotherapy and presented with hepatic encephalopathy, rapid bilirubin elevation, and significant coagulation dysfunction on day 4 in cycle 1. The patient was diagnosed with ACLF induced by eribulin. Therefore, ACLF may be a lethal and rare adverse event when patients with chronic liver metastases receive eribulin treatment, and clinicians’ awareness should be increased for optimal prevention and prompt diagnosis and treatment.

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O'Shaughnessy, Joyce, Shannon Leigh Huggins-Puhalla, Sharon Wilks, Adam Brufsky, Lee Steven Schwartzberg, Erhan Berrak, James X. Song, David Cox i Linda T. Vahdat. "Clinical effects of prior trastuzumab on combination eribulin mesylate plus trastuzumab as first-line treatment for HER2+ locally recurrent or metastatic breast cancer (MBC): Results from a phase 2, single-arm, multicenter study." Journal of Clinical Oncology 32, nr 26_suppl (10.09.2014): 139. http://dx.doi.org/10.1200/jco.2014.32.26_suppl.139.

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139 Background: Eribulin mesylate, a novel nontaxane microtubule dynamics inhibitor in the halichondrin class of antineoplastic drugs, is indicated for women with MBC who previously received ≥ 2 chemotherapy regimens in the metastatic setting. Primary data from a phase 2 trial on first-line combination eribulin + trastuzumab (TRAS) in HER2+ patients (pts) showed a 71% objective response rate (ORR) and tolerability consistent with the known profile of these agents. Here we present prespecified endpoint data for this study by prior TRAS use. Methods: Pts with HER2+ MBC who had not received prior chemotherapy for MBC received eribulin mesylate 1.4 mg/m2 IV on days 1 and 8 of each 21-day cycle and initial TRAS (8 mg/kg IV/day 1), followed by 6 mg/kg/day 1 of each subsequent cycle. Response, progression-free survival (PFS), and tolerability were assessed in patients who had and had not received prior TRAS treatment. Results: The 52 pts (median age, 59.5 years) received combination eribulin + TRAS, for a median treatment duration of ~30 weeks; 40% (n=21) were previously treated with TRAS in the neo-adjuvant/adjuvant setting. There was median of 23 months since completion of adjuvant treatment prior to retreatment with eribulin + TRAS for first-line MBC.Efficacy, assessed by ORR, clinical benefit rate (CBR), PFS, and duration of response (DOR), was largely consistent in pts who received prior TRAS relative to pts who had not received prior TRAS (see table). Overall, grade (G) 3-5 adverse events (AEs), treatment-related AEs (TRAEs), and discontinuations (d/c) were similar between groups (Table). Conclusions: In this phase 2 single-arm trial in pts with HER2+ MBC, eribulin + TRAS demonstrated activity and was well tolerated as first-line treatment, irrespective of prior (neo) adjuvant TRAS treatment. Clinical trial information: NCT01269346. [Table: see text]

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Moore, M. J., P. Tang, D. Renouf, P. Major, D. Hedley, V. Paterson, L. Wang, B. Dhesy-Thind, B. Southwood i L. Doyle. "A phase II study of Halichondrin B analog eribulin mesylate (E7389) as second-line therapy for patients with advanced pancreatic cancer". Journal of Clinical Oncology 27, nr 15_suppl (20.05.2009): e15634-e15634. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e15634.

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e15634 Background: Eribulin mesylate is a halichondrin B analog that inhibits microtubule dynamics by a mechanism that is distinct from other tubulin-targeted agents. Preclinical studies suggest that Eribulin may be effective in pancreatic cancer. The primary objective of this study was to determine the objective response rate (complete and partial) to Eribulin in patients with advanced, pancreatic adenocarcinoma that had progressed after gemcitabine based therapy. Methods: Eligibility criteria included histologically confirmed pancreatic adenocarcinoma; measurable locally advanced, or metastatic disease; disease progression after gemcitabine; and ECOG performance status 0–2. Patients (pts) received Eribulin mesylate 1.4 mg/m2 IV on days 1 and 8. Treatment was repeated every 3 weeks in the absence of disease progression or unacceptable toxicity. Response was assessed by CT scans every 6 weeks while on treatment. Initially 12 pts were to be accrued, if 1 or more pt(s) had an objective response the accrual would increase to a total of 37. Results: 15 pts were accrued,14 received treatment and 12 were evaluable for response. Median age 61; M:F = 8:7; ECOG 1:2 = 11:4; Median number of cycles 2 (1–15). Grade 3+ adverse events included neutropenia (29%), fatigue (14%), peripheral neuropathy (7%) and thrombosis (7%). There were no complete or partial responses, and therefore the study was closed at the first accrual cut off. The best response was stable disease (SD) in 5/12 (42%) pts. Of these 5 pts, 3 (42%) had SD for 12 cycles or greater. Survival data is pending. Conclusions: Eribulin was well tolerated and did not result in any objective responses in refractory pancreatic cancer. However, 42% of pts had stable disease and for 3 pts this was maintained for more than 9 months. Further studies of eribulin in pancreatic cancer may be warranted. No significant financial relationships to disclose.

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Vahdat, Linda T., Brian Pruitt, Carol J. Fabian, Ragene R. Rivera, David A. Smith, Elizabeth Tan-Chiu, Jonathan Wright i in. "Phase II Study of Eribulin Mesylate, a Halichondrin B Analog, in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane". Journal of Clinical Oncology 27, nr 18 (20.06.2009): 2954–61. http://dx.doi.org/10.1200/jco.2008.17.7618.

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Purpose Eribulin mesylate (E7389), a nontaxane microtubule dynamics inhibitor, is a structurally simplified, synthetic analog of the marine natural product halichondrin B. This open-label, single-arm, phase II study evaluated efficacy and tolerability of eribulin in heavily pretreated patients with metastatic breast cancer (MBC). Methods MBC patients who were previously treated with an anthracycline and a taxane received eribulin mesylate (1.4 mg/m2) as a 2- to 5-minute intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle. Because of neutropenia (at day 15), an alternative regimen of eribulin on days 1 and 8 of a 21-day cycle was administered. The primary end point was overall response rate. Results Of the 103 patients treated, the median number of prior chemotherapy regimens was four (range, one to 11 regimens). In the per-protocol population (n = 87), eribulin achieved an independently reviewed objective response rate (all partial responses [PRs]) of 11.5% (95% CI, 5.7 to 20.1) and a clinical benefit rate (PR plus stable disease ≥ 6 months) of 17.2% (95% CI, 10.0 to 26.8). The median duration of response was 171 days (5.6 months; range, 44 to 363 days), the median progression-free survival was 79 days (2.6 months; range, 1 to 453 days), and the median overall survival was 275 days (9.0 months; range, 15 to 826 days). The most common drug-related grades 3 to 4 toxicities were as follows: neutropenia, 64%; leukopenia, 18%; fatigue, 5%; peripheral neuropathy, 5%; and febrile neutropenia, 4%. Conclusion Eribulin demonstrated activity with manageable tolerability (including infrequent grade 3 and no grade 4 neuropathy) in heavily pretreated patients with MBC when dosed as a short IV infusion on days 1 and 8 of a 21-day cycle.

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Ko, Hyemi, Myungsun Lee, Eunyoung Cha, Jiyoung Sul, Junbeom Park i Jinsun Lee. "Eribulin Mesylate Improves Cisplatin-Induced Cytotoxicity of Triple-Negative Breast Cancer by Extracellular Signal-Regulated Kinase 1/2 Activation". Medicina 58, nr 4 (15.04.2022): 547. http://dx.doi.org/10.3390/medicina58040547.

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Background and Objectives; Triple-negative breast cancer (TNBC) is associated with poor patient prognosis because of its multiple molecular features. Thus, more effective treatment for TNBC is urgently needed. This study determined the possible involvement of ERK1/2 activation in cisplatin-induced cytotoxicity in TNBC by providing additional eribulin treatment. Materials and Methods; We investigated cell viability and apoptosis caused by eribulin, cisplatin, or co-treatment in HCC38, MDA-MB-231, and SKBR3 human breast cancer cells. Results; Cisplatin significantly lowered cell viability and caused high apoptotic cell death in all breast cancer cell lines. The viability of TNBC cells was significantly lower in the group co-treated with cisplatin and eribulin than in the cisplatin-only treatment group. Additional eribulin treatment significantly enhanced PARP cleavage and caspase-3 activity in cisplatin-treated TNBC cells. Moreover, cisplatin treatment activated ERK1/2 in all breast cancer cell lines. The cisplatin and eribulin combination synergistically activated ERK1/2 in TNBC cells compared with the cisplatin-only treatment. Administration of the ERK1/2 inhibitor PD98059 increased the viability of TNBC cells treated with cisplatin plus eribulin. Conclusions; Eribulin could synergize the cytotoxic and apoptotic activities of cisplatin and increase ERK1/2 activation, thus enhancing anti-cancer effects against TNBC cells.

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Wilks, Sharon, i Kristi Mcintyre. "Case Studies in the Management of Metastatic Breast Cancer with Eribulin". Clinical Medicine Insights: Oncology 9 (styczeń 2015): CMO.S27962. http://dx.doi.org/10.4137/cmo.s27962.

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Outcomes for triple-negative or hormone-refractory metastatic breast cancer (MBC) are poor and treatment options are limited. Described herein are cases of two women who developed MBC following adjuvant chemotherapy and endocrine therapy for human epidermal growth factor receptor 2 (HER2)-negative ductal carcinoma. Both underwent treatment with fulvestrant, followed by paclitaxel and letrozole or nab-paclitaxel. Following disease progression, both patients started single-agent eribulin mesylate (1.4 mg/m2 on Days 1 and 8 of a 21-day cycle). The first patient is currently continuing on eribulin at full dose, despite interruption for hip surgery and the presence of grade 1 neuropathy in the hands and feet. The second patient had a partial response with eribulin, which was sustained for 4 months. She was able to tolerate the full dose of eribulin despite slight worsening of the neuropathy that was present at baseline. Eribulin may be a beneficial option for hormone-refractory MBC with extensive treatment experience.

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Hussar, Daniel A., i Lisa Pasco. "New drugs: Ceftaroline fosamil, pegloticase, and eribulin mesylate". Journal of the American Pharmacists Association 51, nr 2 (marzec 2011): 316–19. http://dx.doi.org/10.1331/japha.2011.11511.

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Witteveen, P., S. Marchetti, M. Mergui-Roelvink, L. Reyderman, W. Copalu, J. Wanders, A. Jenner, G. Edwards, J. H. Schellens i E. E. Voest. "Eribulin mesylate pharmacokinetics in patients with hepatic impairment." Journal of Clinical Oncology 28, nr 15_suppl (20.05.2010): 2582. http://dx.doi.org/10.1200/jco.2010.28.15_suppl.2582.

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Cigler, Tessa, i Linda T. Vahdat. "Eribulin mesylate for the treatment of breast cancer". Expert Opinion on Pharmacotherapy 11, nr 9 (7.05.2010): 1587–93. http://dx.doi.org/10.1517/14656566.2010.486790.

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Nelson, Ariel Ann, Shivaprasad Manjappa, Yuvraj Choudhary, Cheryl L. Thompson, Jeanine Agler, Bethany Lawrence, Manmeet Singh Ahluwalia i Paula Silverman. "Phase II study of eribulin mesylate for treatment of CNS metastases (mets) in metastatic breast cancer (mBC)." Journal of Clinical Oncology 37, nr 15_suppl (20.05.2019): e12571-e12571. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e12571.

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e12571 Background: There is no approved drug therapy for CNS mets from mBC. Eribulin mesylate (eribulin) is a microtubule inhibitor approved for treatment of mBC patients (pts) who have received at least 2 prior chemotherapy regimens. Previously reported cases have demonstrated significant CNS responses in mBC pts treated with eribulin. This study evaluates the CNS response in pts with mBC treated with eribulin. Methods: CASE7113 was a prospective phase II single-arm study to evaluate the 12-week CNS progression free survival (12-wk CNS-PFS) of pts with mBC and CNS mets treated with eribulin. 20 pts were to be enrolled to demonstrate a 40% 12-wk CNS-PFS (95% CI, 8.5% - 61.5%). All pts had radiologically confirmed mBC CNS lesions with at least one lesion that did not receive prior radiation or surgical resection. Eribulin was administered at standard dose of 1.4mg/m2 IV on days 1 and 8 of a 21 day-cycle. Pts underwent baseline and 12-week brain MRI. The study was closed due to slow accrual; an analysis of enrolled pts was performed. Results: 9 female pts were enrolled; median age was 56 (32-82) years. 55% and 67% had ER+ and/or PR+ and Her2+ mBC respectfully. 1 pt had triple negative breast cancer (TNBC). Median number of prior therapies was 3 (0-12). The 12-wk CNS-PFS (95% CI) was 88.9% (51.8% - 99.7%), the median PFS (95% CI) was 22.6 (4.3 - 31.9) weeks, the median OS (95% CI) was 15.7 (4.0 - 27.3) months. 4 pts achieved stable disease and 1 pt had a partial response. There were no unexpected toxicities. Conclusions: For mBCa pts with CNS mets, this estimate of 12-wk CNS-PFS suggests activity of eribulin and merits further investigation in this population in the context of clinical trials. Clinical trial information: NCT02581839.

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Miano, Salvatora Tindara, Edoardo Francini, Roberto Petrioli i Guido Francini. "A case of eribulin-induced regression of liposarcoma of the left funiculus in a heavily pretreated patient". Future Oncology 16, nr 1s (styczeń 2020): 33–38. http://dx.doi.org/10.2217/fon-2019-0600.

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We report the case of a heavily pretreated male subject affected by left funiculus liposarcoma and successfully treated with eribulin mesylate. After three surgical interventions, radiotherapy on the lesion of the penile bulb for satellite nodules and an epirubicin + ifosfamide chemotherapy treatment for six cycles, eribulin was administered at the dose of 1.1 mg/m2 on days 1 and 8, every 3 weeks for a total of nine cycles. A significant reduction of the lesions was achieved after four cycles of therapy, with a good profile of tolerability.

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Jansen, M., M. Vernaz-Gris, C. DesJardins, N. Wong, M. Campone, J. Cortes, J. Wanders, D. Shuster i E. Fuseau. "Population pharmacokinetics (PPK) of eribulin mesylate in patients with locally advanced or metastatic breast cancer (MBC)". Journal of Clinical Oncology 27, nr 15_suppl (20.05.2009): 2524. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.2524.

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2524 Background: Eribulin mesylate (E7389) is a non-taxane microtubule dynamics inhibitor with a novel mechanism of action. A study was conducted to evaluate efficacy, safety and pharmacokinetics of eribulin at a dose of 1.4 mg/m2 for locally advanced or MBC in patients previously treated with an anthracycline, a taxane, and capecitabine. Methods: Eribulin was administered intravenously over 2–5 minutes at a dose of 1.4 mg/m2 on days 1 and 8 of a 21- day cycle to 291 patients. Four plasma samples were collected between 5 min and 120 hours after the first dose. Plasma eribulin concentrations were determined by LC/MS/MS. A total of 774 samples, from 209 patients with complete dose and sampling information were included in the PPK analysis, which was conducted using nonlinear mixed effects modeling (NONMEM). Results: Eribulin PKs were best described by a three-compartment model, with elimination from the central compartment. Distribution was rapid and elimination slow. For a typical patient with AST<ULN and CLCR=101mL/min (Cockroft-Gault), clearance (CL) was 2.98 L/h and central volume of distribution 3.72 L (V1). Volumes and inter-compartmental clearances for the two peripheral compartments were 3.60 L (V2), 126 L (V3), 2.7 L/h (Q2) and 5.6 L/h (Q3). Inter-patient variability on CL was 57%, and ranged from 26- 98% for other parameters. Residual error was 21% (proportional). CL was on average 38% lower in patients with AST>ULN and positively correlated with renal function. The covariate effects only explained a minor fraction of inter-patient variability in this single study dataset. Conclusions: Eribulin PKs were described by a three-compartment model with rapid distribution and slow elimination. Appreciable interpatient PK variability exists, a minor fraction of which was explained by measures of liver and renal function. [Table: see text]

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Kok, Victor C. "Eribulin in the Management of Advanced Breast Cancer: Implications of Current Research Findings". Breast Cancer: Basic and Clinical Research 9 (styczeń 2015): BCBCR.S32787. http://dx.doi.org/10.4137/bcbcr.s32787.

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The search for cytotoxic agents from marine natural products ultimately led to the production of eribulin, which is a synthetic macrocyclic ketone analog of halichondrin B. Eribulin binds to tubulin to induce mitotic arrest and gained approval in Japan in May 2010; it was approved by the US Food and Drug Administration in November 2010 and the European Medicines Agency in March 2011 and was reimbursed by the Taiwan National Health Insurance in December 2014 for patients with metastatic breast cancer who had received at least one anthracycline and one taxane. The recommended regimen for eribulin mesylate comprises intravenous administration of 1.4 mg/m2 (equivalent to 1.23 mg/m2 eribulin) over two to five minutes on days 1 and 8 of a three-week cycle. Since 2011, various clinical investigations of eribulin monotherapy with dose or schedule modifications, combined use with other antineoplastic therapeutics, or head-to-head comparisons with specific agents have been performed in the management of advanced breast cancer. Ethnic-specific data from Japan and Korea indicate higher rates (>85%) of grade 3 or 4 neutropenia. Some anecdotal evidence suggests that eribulin can shrink brain and retinal metastases, which warrants further detailed studies. In this review, current observations of the effects of eribulin monotherapy are summarized and eribulin-backbone combination (bio-) chemotherapy is investigated.

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Cortes, Javier, Linda Vahdat, Joanne L. Blum, Chris Twelves, Mario Campone, Henri Roché, Thomas Bachelot i in. "Phase II Study of the Halichondrin B Analog Eribulin Mesylate in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane, and Capecitabine". Journal of Clinical Oncology 28, nr 25 (1.09.2010): 3922–28. http://dx.doi.org/10.1200/jco.2009.25.8467.

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Purpose The activity and safety of eribulin mesylate (E7389), a nontaxane microtubule dynamics inhibitor with a novel mechanism of action, were evaluated in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline, taxane, and capecitabine. Patients and Methods Eligible patients in this single-arm, open-label phase II study received eribulin mesylate (1.4 mg/m2) administered as a 2- to 5-minute intravenous infusion on days 1 and 8 of a 21-day cycle. The primary end point was objective response rate (ORR) assessed by independent review. Results Of 299 enrolled patients who had received a median of four prior chemotherapy regimens, 291 received eribulin (for a median of four cycles). Of these, 269 patients met key inclusion criteria for the primary efficacy analysis. The primary end point of ORR by independent review was 9.3% (95% CI, 6.1% to 13.4%; all partial responses [PRs]), the stable disease (SD) rate was 46.5%, and clinical benefit rate (complete response + PR + SD ≥ 6 months) was 17.1%. The investigator-reported ORR was 14.1% (95% CI, 10.2% to 18.9%). Median duration of response was 4.1 months, and progression-free survival was 2.6 months. Median overall survival was 10.4 months. The most common treatment-related grade 3 or 4 toxicities were neutropenia (54%; febrile neutropenia, 5.5%), leukopenia (14%), and asthenia/fatigue (10%; no grade 4); grade 3 neuropathy occurred in 6.9% of patients (no grade 4). Conclusion Eribulin demonstrated antitumor activity in extensively pretreated patients who had previously received an anthracycline, taxane, and capecitabine, with a manageable tolerability profile.

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Srinivasa, BJ, Bhanu Prakash Lalkota, Girish Badarke, Diganta Hazarika, Nasiruddin Mohammad, Sulav Sapkota, Mansi Khanderia i in. "Prospective Analysis of Patients with Metastatic Breast Cancer receiving Eribulin Mesylate as Second or More Lines of Chemotherapy: An Indian Experience". Clinical Medicine Insights: Oncology 12 (1.01.2018): 117955491878247. http://dx.doi.org/10.1177/1179554918782475.

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Background: Eribulin mesylate is a non-taxane microtubule inhibitor which can be used after anthracycline and taxane treatment in patients with metastatic breast cancer (MBC). The purpose of this study was to investigate the efficacy and safety of eribulin monotherapy in heavily pretreated patients with MBC. Methods: In this study, a total of 45 eligible patients with MBC who received eribulin in HCG Cancer Speciality Center from November 2014 to March 2016 were prospectively analyzed. Breslow (generalized Wilcoxon) survival analysis was carried out for progression-free survival and for overall survival. Patients were excluded if they had not taken treatment for 3 cycles and defaulted/expired during the treatment. Results: In this study, median age of patients was 52 years. A total of 27 (60%) patients had estrogen receptor and progesterone receptor (PR) positive primary tumors, whereas HER2 was overexpressed or amplified in 7 (15.6%); a triple negative subtype was recorded in 13 patients (28.9%). Regarding toxicity, 30 patients (66.67%) tolerated treatment well and 3 patients (6.67%) got anemia, 6 patients (13.3%) experienced neutropenia, and 7 (15.62%) patients had neurological toxicity. About 14 (31.1%) patients showed PR, 12 (26.7%) patients had stable disease (SD), whereas 19 (42.25%) patients showed progression disease (PD). Response evaluation at 6 cycles was possible in 18 patients and revealed that 4 (22.5%) patients showed PR, 10 (55.5%) patients had SD, whereas 4 (22.2%) patients had PD. Progression-free survival of the overall study population was 3.95 months. Conclusions: Eribulin mesylate is efficacious and tolerable chemotherapy as second- and third-line treatment options for MBC.

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Chandrasekhar, Srivari, Vikram Gaddam, Lavanya Nadella, Genji Sukumar i Prathama Mainkar. "Stereoselective Synthesis of Northern Fragment of Eribulin Mesylate from d-Mannose". Synthesis 50, nr 09 (21.02.2018): 1901–6. http://dx.doi.org/10.1055/s-0036-1591769.

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Stereoselective synthesis of northern fragment of eribulin mesylate is reported by coupling of the C1–C13 fragment with the C28–C35 fragment. The key steps involved in this synthesis are butyllithium-facilitated coupling between sulfone and aldehyde, then Dess–Martin periodinane oxidation followed by samarium(II) iodide mediated desulfonylation.

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Twelves, Chris, Ahmad Awada, Javier Cortes, Louise Yelle, Galina Velikova, Martin S. Olivo, James Song, Corina E. Dutcus i Peter A. Kaufman. "Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer". Breast Cancer: Basic and Clinical Research 10 (styczeń 2016): BCBCR.S39615. http://dx.doi.org/10.4137/bcbcr.s39615.

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Purpose and Methods Our secondary analyses compared survival with eribulin versus capecitabine in various patient subgroups from a phase 3, open-label, randomized study. Eligible women aged ≥18 years with advanced/metastatic breast cancer and ≤3 prior chemotherapies (≤2 for advanced/metastatic disease), including an anthracycline and taxane, were randomized 1:1 to intravenous eribulin mesylate 1.4 mg/m2 on days 1 and 8 or twice-daily oral capecitabine 1250 mg/m2 on days 1–14 (21-day cycles). Results In the intent-to-treat population (eribulin 554 and capecitabine 548), overall survival appeared longer with eribulin than capecitabine in various subgroups, including patients with human epidermal growth factor receptor 2-negative (15.9 versus 13.5 months, respectively), estrogen receptor-negative (14.4 versus 10.5 months, respectively), and triple-negative (14.4 versus 9.4 months, respectively) disease. Progression-free survival was similar between the treatment arms. Conclusions Patients with advanced/metastatic breast cancer and human epidermal growth factor receptor 2-, estrogen receptor-, or triple-negative disease may gain particular benefit from eribulin as first-, second-, and third-line chemotherapies. Trial Registration (Primary Study) This study reports the subgroup analyses of eribulin versus capecitabine from a phase 3, open-label, randomized study ( www.clinicaltrials.gov ; ClinicalTrials.gov identifier: NCT00337103).

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Xie, Xuemei, Jangsoon Lee, Jon A. Fuson, Huey Liu, Toshiaki Iwase, Kyuson Yun, Cori Margain, Debu Tripathy i Naoto T. Ueno. "Identification of Kinase Targets for Enhancing the Antitumor Activity of Eribulin in Triple-Negative Breast Cell Lines". Biomedicines 11, nr 3 (28.02.2023): 735. http://dx.doi.org/10.3390/biomedicines11030735.

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Background: Triple-negative breast cancer (TNBC) is the most aggressive molecular subtype of breast cancer, and current treatments are only partially effective in disease control. More effective combination approaches are needed to improve the survival of TNBC patients. Eribulin mesylate, a non-taxane microtubule dynamics inhibitor, is approved by the U.S. Food and Drug Administration to treat metastatic breast cancer after at least two previous chemotherapeutic regimens. However, eribulin as a single agent has limited therapeutic efficacy against TNBC. Methods: High-throughput kinome library RNAi screening, Ingenuity Pathway Analysis, and STRING analysis were performed to identify target kinases for combination with eribulin. The identified combinations were validated using in vivo and ex vivo proliferation assays. Results: We identified 135 potential kinase targets whose inhibition enhanced the antiproliferation effect of eribulin in TNBC cells, with the PI3K/Akt/mTOR and the MAPK/JNK pathways emerging as the top candidates. Indeed, copanlisib (pan-class I PI3K inhibitor), everolimus (mTOR inhibitor), trametinib (MEK inhibitor), and JNK-IN-8 (pan-JNK inhibitor) produced strong synergistic antiproliferative effects when combined with eribulin, and the PI3K and mTOR inhibitors had the most potent effects in vitro. Conclusions: Our data suggest a new strategy of combining eribulin with PI3K or mTOR inhibitors to treat TNBC.

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Patil, S., R. Thippeswamy, HP Shashidara, CT Satheesh, H. Vittal i S. Mishra. "Eribulin mesylate in Indian patients: A single center experience". Indian Journal of Cancer 52, nr 3 (2015): 297. http://dx.doi.org/10.4103/0019-509x.176735.

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Simoneaux, Richard. "Eribulin Mesylate Plus Pembrolizumab Shows Encouraging Efficacy in TNBC". Oncology Times 40 (luty 2018): 15–16. http://dx.doi.org/10.1097/01.cot.0000530523.23834.dc.

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Lee, Hyoseon, Yongseo Park, Heesun Jung, Seong Take Kim, Seunghui Sin, Eunjung Ko, In-Soo Myeong i in. "Synthesis of the C1–C13 fragment of eribulin mesylate". Tetrahedron 75, nr 33 (sierpień 2019): 4570–76. http://dx.doi.org/10.1016/j.tet.2019.06.050.

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Nakai, M., M. Suzuki, T. Kurita, K. Yanagihara i H. Takei. "Eribulin Mesylate improving survival outcomes of metastatic breast cancer". Breast 32 (marzec 2017): S67. http://dx.doi.org/10.1016/s0960-9776(17)30228-x.

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Chiba, Hiroyuki, i Katsuya Tagami. "ChemInform Abstract: Research and Development of HALAVEN (Eribulin Mesylate)". ChemInform 42, nr 50 (17.11.2011): no. http://dx.doi.org/10.1002/chin.201150215.

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Papadaki, Maria A., Anastasia Mala, Aikaterini C. Merodoulaki, Maria Vassilakopoulou, Dimitrios Mavroudis i Sofia Agelaki. "Investigating the Role of CTCs with Stem/EMT-like Features in Metastatic Breast Cancer Patients Treated with Eribulin Mesylate". Cancers 14, nr 16 (12.08.2022): 3903. http://dx.doi.org/10.3390/cancers14163903.

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We herein aimed to assess the effect of eribulin mesylate on the cancer stem cell (CSC)/EMT-like phenotype of CTCs, and to investigate the prognostic role of CTC detection and monitoring for eribulin-treated BC patients. Peripheral blood was obtained at baseline (n = 42 patients) and 8 days after treatment initiation (C1D8: n = 22), and on disease progression (PD: n = 26). PBMCs cytospins were immunofluorescently stained for Cytokeratins/ALDH1/TWIST1/DAPI and analyzed via Ariol microscopy. CTCs were detected in 33.3%, 27.3%, and 23.1% of patients at baseline, C1D8, and PD, respectively. Accordingly, partial-EMT+ CTCs represented 61.3%, 0%, and 37.5% of total CTCs, whereas the CSC-like phenotype was consistently expressed by 87.5%, 75%, and 91.7% of CTCs at the respective time points. Interestingly, the CSC+/partial-EMT+ subset prevailed at baseline, but it was eradicated on C1D8 and resurged again during PD. CTC detection at baseline was associated with reduced PFS (p = 0.007) and OS (p = 0.005), and was an independent risk factor for death (HR: 3.779, p = 0.001; multivariate analysis). The CSC+/partial-EMT+ CTCs emerged as the only subset with adverse prognostic significance, while CTC monitoring during eribulin therapy improved the prediction of disease progression. These results indicate that resistant CTC subsets persevere eribulin treatment and highlight the prognostic implications of CTC analyses for eribulin-treated BC patients.

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Tremblay, Gabriel, Unnati Majethia, Ilias Kontoudis i Jesús De Rosendo. "Cost Effectiveness Analysis of Eribulin Mesylate as a Treatment for Metastatic Breast Cancer in Spain: Management in the Later Line of Therapy". Journal of Health Economics and Outcomes Research 3, nr 2 (21.10.2015): 180–93. http://dx.doi.org/10.36469/9834.

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Background: Two thirds (62%) of metastatic breast cancer (MBC) patients in Western Europe have human epidermal growth factor receptor 2 (HER2)-negative disease, for which anthracyclines and taxanes are recommended as first-line treatments, followed by microtubule-targeting agents such as capecitabine, vinorelbine and/or eribulin. The study objective was to compare the cost-effectiveness of eribulin in Spain as a second-line treatment for HER2-negative MBC with its current status as a third-line treatment for patients who have received capecitabine. Methods: A Markov model was developed from the perspective of the Spanish healthcare system. The model had three health states: Stable; Progression and Death. In Stable, patients received eribulin or: capecitabine and vinorelbine for HER2-negative patients; primary treatment of physician’s choice (TPC) for post-capecitabine patients. In Progression, all patients received secondary TPC. Model inputs were overall survival, progression-free survival and costs relating to chemotherapies, grade 3/4 adverse events and healthcare utilization. Sensitivity analyses were conducted to identify uncertainty. Results: As second-line treatment, Eribulin was associated with a greater incremental benefit in life years (LYs) and quality-adjusted life years (QALYs) than capecitabine and vinorelbine. Erubilin as third-line treatment was associated with greater benefit in life years (LYs) and QALYs than TPC. The incremental cost-effectiveness ratios (ICERs) for eribulin were higher in the second-line than the third-line setting in terms of LYs (€35,149 versus €24,884) and QALYs (€37,152 versus €35,484). In both settings, deterministic sensitivity analyses demonstrated that the ICER is most sensitive to the eribulin price. Conclusion: Eribulin is cost-effective as second-line treatment for HER2-negative MBC patients in Spain; albeit, slightly less so than as third-line treatment for MBC patients who have received capecitabine (an ICER per QALY difference of €1,668). This difference may fall within the margin of error for the model and could potentially be addressed by a minor reduction in the eribulin price.

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SM, Bindu, PL Rema i Praveen Jacob Ninan. "Eribulin Mesylate in Treated Metastatic Breast Cancer Patients: A Retrospective Study of Tumor Response and Adverse Effects". Galore International Journal of Health Sciences and Research 6, nr 2 (15.06.2021): 37–44. http://dx.doi.org/10.52403/gijhsr.20210405.

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Introduction: Breast cancer is the most common cancer, majority of patients present in advanced stage and 30% develop distant metastasis. Metastatic Breast Cancer (MBC) is not curable and treatment aims at prolongation of life with good palliation. There is no standard treatment, though the usual first and second lines of chemotherapy include anthracyclines and taxanes. The third line chemo drugs available are gemcitabine, capecitabine, vinorelbine and eribulinmesylate Materials and Methods: This is a retrospective study of MBC patients pretreated with anthracyclines and taxanes and then received 4 cycles of eribulin during the period March 2015-2017 in Medical College, Alappuzha and aims at studying the tumor response and drug toxicities. The tumor response is studied using CR-complete response, PR- partial response, PD-progressive disease and SD-stable disease. Results: There were a total of 18 patients, majority of whom were below 50 years. ECOG performance status of 0-1 was found in 83.3% and 77.8% were receptor positive. No patient had CR, 66.7% of patients had PR, 22.2% had PD and 11.1% had SD. 61.1% of patients who had a PR had good performance status.55.6% of patients who were ERPR positive had a PR and 44.4% patients who were Her2neu positive had a PR. Most common toxicities detected were alopecia (83.3%), neutropenia (72.2%), fatigue (72.2%) and neurotoxicity (55.6%). Conclusion: Eribulin mesylate is a drug having good response with tolerable toxicities and can be considered in our population. Keywords: Metastatic breast cancer, eribulin mesylate, capecitabine.

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Demetri, George D., Patrick Schöffski, Giovanni Grignani, Jean-Yves Blay, Robert G. Maki, Brian A. Van Tine, Thierry Alcindor i in. "Activity of Eribulin in Patients With Advanced Liposarcoma Demonstrated in a Subgroup Analysis From a Randomized Phase III Study of Eribulin Versus Dacarbazine". Journal of Clinical Oncology 35, nr 30 (20.10.2017): 3433–39. http://dx.doi.org/10.1200/jco.2016.71.6605.

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Purpose A phase III study comparing eribulin with dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma showed a significant improvement in overall survival (OS) for the eribulin arm, with a manageable toxicity profile. We now report the histology-specific subgroup analysis of the efficacy and safety of eribulin compared with dacarbazine in patients with LPS, an independently randomized stratified subgroup of this phase III trial. Methods Patients ≥ 18 years with advanced or metastatic dedifferentiated, myxoid/round cell, or pleomorphic LPS incurable by surgery or radiotherapy were included. Patients with Eastern Cooperative Oncology Group performance status ≤ 2 and two or more prior systemic treatment regimens, including one with anthracycline, were randomly assigned 1:1 to receive eribulin mesylate (1.4 mg/m2 intravenously on days 1 and 8) or dacarbazine (850, 1,000, or 1,200 mg/m2 intravenously on day 1) every 21 days. OS, progression-free survival (PFS), and safety were analyzed. Results In the LPS subgroup, OS was significantly improved: 15.6 versus 8.4 months (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P < .001) with eribulin versus dacarbazine, respectively. Longer OS with eribulin was observed in all LPS histologic subtypes and in all geographic regions evaluated. PFS was also improved with eribulin versus dacarbazine (2.9 v 1.7 months, respectively; hazard ratio, 0.52; 95% CI, 0.35 to 0.78; P = .0015). Adverse events were similar between arms. Conclusion In patients with previously treated LPS, eribulin was associated with significantly superior OS and PFS compared with dacarbazine. Eribulin represents an important treatment option for patients with LPS, a sarcoma subtype for which limited effective systemic treatments are available. Further studies are justified to explore the role of eribulin in earlier lines of therapy as well as in combination with other agents.

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Blum, J. L., B. Pruitt, C. J. Fabian, R. R. Rivera, D. E. Shuster, N. L. Meneses, K. Chandrawansa, F. Fang, S. Z. Fields i L. Vahdat. "Phase II study of eribulin mesylate (E7389) halichondrin b analog in patients with refractory breast cancer". Journal of Clinical Oncology 25, nr 18_suppl (20.06.2007): 1034. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.1034.

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1034 Background: Eribulin is a structurally simplified analog of halichondrin B, which inhibits microtubule dynamics via a novel mechanism characterized by suppression of microtubule growth, lack of effect on microtubule depolymerization, and sequestration of tubulin into nonfunctional aggregates. This study was designed to assess the activity and tolerance of eribulin in chemotherapy refractory patients with advanced breast cancer. Methods: Eribulin was evaluated in a single-arm Phase II trial in female patients with refractory breast cancer, ECOG performance status of 0–1, measurable disease, and neuropathy ≤ Grade 2. Patients received ≥ 1 prior chemotherapy regimen, including an anthracycline and a taxane. Eribulin was administered as a 2–5 min IV bolus of 1.4 mg/m2 on Days 1, 8, and 15 of a 28-Day cycle (Group 1). The schedule was modified to Days 1 and 8 of a 21-Day cycle (Group 2), because of dose delays. The primary efficacy endpoint was ORR according to RECIST criteria based upon independent review (IR) of tumor assessment. Results: Of 104 patients enrolled, 103 received eribulin treatment: 70 in Group 1, 33 in Group 2. Median age was 55 yrs (range 32–84). Patients had received a median of 4 prior chemotherapy regimens (range 1–11). Sixty-one percent of tumors were ER+, 14% Her2/neu 3+, and 29% were triple (ER, PR, Her-2) negative. The incidence of dose interruption, delay, or omission during Cycle 1 was 63% (Group 1) and 18% (Group 2). The most common drug related toxicities were neutropenia (75%, Grades 3: 31%, Grade 4: 30%, febrile neutropenia: 3.9%), fatigue (52%, Grade 3: 2.9%, no Grade 4), alopecia (Grade 1/2: 41%), nausea (37%, Grade 3: 1%, no Grade 4), and anemia (36%, Grade 3: 1%, no Grade 4). Peripheral neuropathy occurred in 34% of patients (Grade 3: 3.9%, no Grade 4). Best overall response rate (all PR) by IR was 14.5% and 15.2% in Groups 1 and 2, respectively; the combined ORR was 14.7% (95 % CI: 9–23%). Median PFS was 85 days, and the 6 mo PFS rate was 31%. Conclusions: Eribulin given as a 2–5 min IV infusion on Days 1, 8 of a 21-Day cycle or Days 1, 8, 15 of a 28-Day cycle exhibited a 15% PR rate by IR and a low incidence of Grade 3 neuropathy in this heavily chemotherapy pretreated population. The most common toxicity was neutropenia. The 21-Day schedule had an acceptable toxicity profile. No significant financial relationships to disclose.

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Adamo, Vincenzo, Giuseppina Rosaria Rita Ricciardi, Dario Giuffrida, Giuseppa Scandurra, Antonio Russo, Livio Blasi, Pietro Spadaro i in. "Eribulin mesylate use as third-line therapy in patients with metastatic breast cancer (VESPRY): a prospective, multicentre, observational study". Therapeutic Advances in Medical Oncology 11 (styczeń 2019): 175883591989575. http://dx.doi.org/10.1177/1758835919895755.

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Background: In real-world practice, eribulin mesylate provides significant survival benefit, with a manageable safety profile in heavily pretreated patients with metastatic breast cancer (MBC). Methods: In this prospective, open-label, multicentre, observational study we evaluated the effectiveness and tolerability of eribulin as third-line treatment in a homogeneous population. The primary endpoints were the safety profile and response in metastatic sites; secondary endpoints included the response in different subtypes, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). Results: From 2013 to 2016, 118 women were treated in 21 Sicilian institutions; the median age was 58 years (range 29–79), with 69% of patients under 65. The median cycles of eribulin were 5.5 (range 1–26). The most common adverse event was neutropenia (9.3%, 3 cases of grade 3, 4 of grade 4); only 1 case of QT prolongation was reported. Eribulin was effective in controlling metastatic disease in all sites, and it achieved the highest ORR in brain (16%) and liver (14.9%). Median OS was 31.8 months (95% CI 27.9–34.4) and median PFS 5.5 months (95% CI 4.2–6.6). PFS was 5.2 months (95% CI 2.8–8.4) in patients with triple-negative subtype. Median PFS was longer in patients over 65 years (6.1 months, 95% CI 4.4–8.3). In patients who had visceral metastases PFS was 5.5 months (95% CI 95% 3.5–6.6) and OS 33.9 months (95% CI 29.8–40.8). Conclusions: Eribulin as third-line treatment shows an acceptable safety profile and a substantial antitumour activity in the treatment of MBC, even in elderly patients and in those with visceral disease.

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McBride, Ali, Claudio Faria, Xuan Li i Annette Powers. "Eribulin treatment patterns in patients with and without prior anthracycline use." Journal of Clinical Oncology 32, nr 30_suppl (20.10.2014): 292. http://dx.doi.org/10.1200/jco.2014.32.30_suppl.292.

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292 Background: Eribulin mesylate is indicated for patients with metastatic breast cancer after treatment with ≥2 prior chemotherapeutic regimens for metastatic disease. Prior therapy should have included an anthracycline and a taxane. Evidence examining the effects of prior exposure to anthracyclines on eribulin therapy is limited. The purpose of this study was to compare demographic characteristics and treatment patterns for anthracycline-experienced patients vs. anthracycline-naïve patients treated with eribulin. Methods: A retrospective analysis using electronic medical record (EMR) data from 1/1/08 to 3/1/14 was conducted. Chemotherapy drugs were identified by the treatment name field in the EMR. Index date was defined as the first eribulin treatment. Patients with ≥2 eribulin administrations, continuous eligibility including a 6 month pre-period prior to the index date, and no treatment gaps more than 6 months were included. Patients were stratified into an anthracycline experienced cohort (treated prior to eribulin therapy) or without anthracycline cohort (never treated with this drug class prior to eribulin therapy). Demographics (gender, age, receptor status) and treatment characteristics (number and days of eribulin therapy) were compared between the cohorts. Results: 190 patients received eribulin; 46 (24%) with prior anthracycline use, 144 (76%) without. The majority of patients were female (87% for prior anthracycline, 97% without), and the average age of both groups was 59 yrs. Most patients were HR+/HER2- (56% overall; 70% for prior anthracycline, 51% for without), followed by TNBC (29% overall; 24% prior anthracycline, 31% without). Some patients had been treated previously with trastuzumab (15% overall; 7% for prior anthracycline, 17% for without). The number of eribulin administrations did not differ significantly between cohorts (8.2 administrations for anthracycline vs. 9.6 without, p=0.268). Likewise the number of days of therapy did not differ significantly (88.1 days for prior anthracycline vs. 104 without, p=0.369). Conclusions: There was no significant difference detected for prior anthracycline use impacting the number of eribulin administrations or days of therapy.

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Hensley, M. L., S. Kravetz, C. Sima, W. Tew, L. Pereira, P. Sabbatini, C. Whalen, C. A. Aghajanian, C. Zarwan i S. Berlin. "Eribulin mesylate (halichondrin B Analog E7389) in platinum-resistant epithelial ovarian cancer (PR-EOC): A CTEP-sponsored phase II study". Journal of Clinical Oncology 27, nr 15_suppl (20.05.2009): 5561. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.5561.

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5561 Background: Eribulin mesylate is a tubulin inhibitor whose mechanism of action differs from that of other anti-tubulin agents, suppressing microtubule growth without affecting depolymerization, and sequestering tubulin into non-functional aggregates. In NIH:OVCAR-3 human EOC xenograft models, eribulin increased survival and reduced size and number of metastases, with activity superior to paclitaxel. We sought to determine the frequency of objective response to treatment with eribulin in patients (pts) with PR-EOC. Methods: Pts with PR-EOC, fallopian tube or peritoneal cancer (progression-free interval from last platinum-based therapy < 6 months), measurable disease, < 2 prior cytotoxic regimens, ECOG performance status 0–1, and adequate organ function were eligible. Treatment: eribulin 1.4 mg/m2 over 15 minutes IV days 1 and 8, every 21 days. Response assessed by CT for RECIST every other cycle. Results: 36 pts (median age 61, range 38–80; median platinum-free interval 3 months, range 0.1–5.9; all having received platinum-taxane first-line treatment) enrolled. 35 are evaluable for response (1 pt off-study for unrelated myocardial infarction in cycle 1). Two pts achieved partial responses (PR-5.7%), with response durations of 84 days and 128 days. Time to PR was 2.8 months in both. >50% decrease in CA125 for more than two measurements was observed in 3/31 CA125-evaluable pts. 16/35 (46%) had stable disease as best response. Median progression-free survival was 2 months (range 1–7 months). Per patient, at least possibly-related grade 3–4 toxicities were: neutropenia 44%, leucopenia 31%, anemia 3%, lymphopenia 3%, febrile neutropenia 3%, muscle weakness 3%, hypophosphatemia 3%, hypokalemia 6%, infection 6%, thrombosis 6%. Conclusions: Eribulin has minimal activity in PR-EOC with objective response observed in only 5.7% of pts. Time to objective response was nearly 3 months. Median PFS was 2 months. Activity of eribulin in platinum-sensitive patients is being studied in a separate phase II cohort. [Table: see text]

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Traina, Tiffany A., Clifford Hudis, Robert Lehman, Jessicca Rege, Wenquan Wang, David Cox i Andrew David Seidman. "A phase II, single-arm, feasibility study of dose-dense doxorubicin and cyclophosphamide (AC) followed by eribulin mesylate for the adjuvant treatment of early-stage breast cancer (EBC)." Journal of Clinical Oncology 30, nr 15_suppl (20.05.2012): TPS1145. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.tps1145.

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TPS1145 Background: Randomized trials have confirmed the benefit of the combination of an anthracycline (A) and cyclophosphamide (C) for the adjuvant treatment of EBC. The addition of taxane therapy to AC therapy has further improved survival. Despite the improvement in adjuvant therapies for BC, new approaches for improving outcomes are of significant importance and may involve developing improved combination regimens. Eribulin mesylate has demonstrated antitumor activity and significant improvement in overall survival (OS) in patients with heavily pretreated locally advanced or metastatic breast cancer (MBC) and may improve outcomes in EBC as well. Methods: This study will determine the feasibility of eribulin as adjuvant therapy following dose-dense AC for HER2 normal EBC. A completion rate of >80% was set as a threshold for feasibility as established adjuvant regimens have shown feasibility rates ranging from ~65% for trastuzumab to >80%. This is a phase 2, single-center, feasibility study of dose-dense adjuvant chemotherapy in patients with EBC. Dose-dense AC (Doxorubicin 60 mg/m2 IV plus C 600 mg/m2 IV) on day 1 of every 14-day cycle is given for 4 cycles, followed by 4 cycles of eribulin mesylate at 1.4 mg/m2 over 2-5 minutes IV on days 1 and 8 every 21 days. Growth factors are given on day 2 of AC cycles and only for neutropenia events with eribulin treatment. Feasibility is determined by the ability to complete the eribulin portion of the regimen without a dose delay or reduction. Exploratory objectives include efficacy endpoints of 3-year disease-free survival (DFS) and OS. Patients have histologically confirmed HER2 normal stage I-III invasive disease and adequate bone marrow, liver, and renal function. Thirty two of approximately 80 planned patients are currently enrolled. Feasibility rates will be calculated with growth factor support (ie, the successful use of growth factor support following a neutropenia event is not considered a dose delay)and without growth factor support (ie, where need for growth factors is considered a delay). Secondary endpoints include DFS and OS and will be estimated by Kaplan-Meier method.

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Filonenko, D. V., i A. V. Belonogov. "ERIBULIN MESYLATE: OUR EXPERIENCE IN A REAL-LIFE CLINICAL SETTING". Malignant tumours 7, nr 4 (1.01.2017): 21–28. http://dx.doi.org/10.18027/2224-5057-2017-7-4-21-28.

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Aditya, Suruchi. "Eribulin mesylate: A new therapeutic option for metastatic breast cancer". Journal of Basic and Clinical Reproductive Sciences 2, nr 1 (2013): 6. http://dx.doi.org/10.4103/2278-960x.112571.

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