Academic literature on the topic 'Throbocytopenia'

14049 Background: A phase II study was conducted to assess the efficacy and tolerability of combination therapy with cisplatin, epirubicin, oral UFT and leucovorin in patients (Pts) with metastatic gastric cancer. Methods: Pts with previously untreated metastatic or unresectable measurable gastric adenocarcinoma received cisplatin 60 mg/m2 and epirubicin 50 mg/m2 on day (d)1, UFT 300 mg/m2 was administered in conjunction with oral leucovorin 30 mg/day in divided daily doses d 1–22, followed by a 7-day rest period. Results: Thirty-nine pts were enrolled in this study. Two achieved a complete response and 13 a partial response, giving an overall response rate of 38.5%. Disease stabilization was achieved in further 16 pts (41%). Median time to progression and median survival were 6.4 and 10.7 months respectively. Grade 3/4 neutropenia, anemia, throbocytopenia, occurred in 10%, 5%, and 2% of pts respectively, and febrile neutropenia occurred in 7 pts (one episode each). Grade 3 diarrhea occurred in 5% of the pts. There were no treatment related deaths. Conclusions: Cisplatin, epirubicin, and oral UFT plus leucovorin, a convenient outpatient regimen, has significant activity and tolerable toxicities in pts with metastatic gastric carcinoma. No significant financial relationships to disclose.

Abstract Romiplostim is an investigational Fc-peptide fusion protein (peptibody) that has demonstrated the ability to increase platelet counts over prolonged periods in thrombocytopenic patients with chronic ITP. Self-injection of romiplostim offers a convenient treatment option for some patients. The safety and efficacy of romiplostim self-injections were explored in patients participating in a long-term open-label extension study. Patients with chronic ITP (diagnosis per ASH guidelines) were eligible for the openlabel extension study if they had completed a prior romiplostim study and had platelet counts <50×109/L. Romiplostim was injected subcutaneously once weekly, initially by healthcare providers at study centers, with a starting dose of 1 μg/kg and subsequent dose adjustments to maintain a platelet count between 50 and 250×109/L. After achieving a platelet response, patients who received the same romiplostim dose for ≥3 weeks were permitted to self-inject weekly romiplostim or have the injection administered at home by a caregiver. Patients/caregivers were trained to self-inject and were required to return to the study center for platelet count evaluation and dose adjustment every 4 weeks, and to receive the next month’s medication and supplies. Of 143 patients enrolled, 90 (63%) initiated self-injection. Their median age was 53 years (range 21 to 80), and most (62%) were splenectomized. Self-injection was initiated after a median of 12 weeks (range 1 to 99) of romiplostim treatment; and patients continued to receive romiplostim for a median of 64 weeks (range 5 to 117), maintaining self-injection for a median of 74% of their subsequent time on treatment. To compare changes in efficacy and safety following the switch from office-based injection to self-injection, we analyzed data 8 weeks before and 8 weeks after initiation of self-injection. The median average weekly dose was comparable in the 8 weeks before (4 μg/kg, range 1 to 19 μg/kg) and after (5 μg/kg, range 1 to 16 μg/kg) the start of self-injection. The median maximum dose (5 μg/kg) did not change. Platelet counts increased as patients achieved a stable dose of romiplostim and then stabilized once self-injection was initiated: mean (±SD) platelet counts 8 weeks before, at initiation, and 4 and 8 weeks after initiation of self-injection were 85 (±91), 125 (±96), 123 (±121) and 121 (±96), respectively. A similar number of patients experienced adverse events in the 8 weeks before (54/90; 60%) and after (59/90; 66%) initiating self-injection. The most common adverse events before initiation of self-injection were headache (13%), and fatigue and upper respiratory tract infection (both 8%), and after were nasopharyngitis (9%), headache (8%), and diarrhea (6%). The patient incidence of treatment-related adverse events was 14 (16%) 8 weeks before and 9 (10%) 8 weeks after the start of self-injection. Serious adverse events occurred in 2 (2%) patients before and 5 (6%) patients after self-injecting. One treatment-related serious adverse event occurred: an event of thrombosis in a self-injecting patient. No deaths were reported either before or after self-injection. These results indicate that most patients were able to achieve and maintain self-injection of romiplostim with no apparent changes in either their platelet response or safety profiles. Self-injection of romiplostim represented a convenient, effective, and well-tolerated treatment option for ITP patients.

Background: Several poly ADP ribose polymerase inhibitors (PARPis) are currently approved for the treatment of a variety of cancers. The safety profile of PARPis has not yet been systemically analyzed in the real world. We conducted this pharmacovigilance analysis using the US FDA’s Adverse Event Reporting System (FAERS) database to explore the difference in adverse events (AEs) among PARPis.Methods: FAERS data (December 2014 to October 2021) were searched for reports of all FDA-approved PARPis across all indications. We used the standardized MedDRA query (SMQ) generalized search AEs on the preferred term (PT) level based on case reports. After filtering duplicate reports, disproportionality analysis was used to detect safety signals by calculating reporting odds ratios (ROR). Reports were considered statistically significant if the 95% confidence interval did not contain the null value.Results: Within the standardized MedDRA queries, significant safety signals were found, including those for olaparib [blood premalignant disorders (ROR = 17.06)], rucaparib [taste and smell disorders (ROR = 9.17)], niraparib [hematopoietic throbocytopenia (ROR = 28.2)], and talazoparib [hematopoietic erythropenia (ROR = 9.38)]. For AEs on the PT level, we found several significant signals, including platelet count decreased with niraparib (ROR = 52.78); red blood cell count decreased with niraparib (ROR = 70.47) and rucaparib (ROR = 15.09); myelodysplastic syndrome with olaparib (ROR = 35.47); acute myeloid leukaemia with olaparib (ROR = 25.14); blood pressure fluctuation with niraparib (ROR = 20.54); lymphangioleiomyomatosis with niraparib (ROR = 471.20); photosensitivity reaction with niraparib (ROR = 21.77) and rucaparib (ROR = 18.92); renal impairment with rucaparib (ROR = 33.32); and interstitial lung disease with Olaparib (ROR = 11.31). All the detected safety signals were confirmed using signals of disproportionality reporting methods.Conclusion: PARPis differed in their safety profile reports. The analysis of the FAERS database revealed significant safety signals that matched previously published case reports, including serious gastrointestinal, blood and lymphatic system, cardiovascular and respiratory complications, which require individualized drug administration according to patients’ conditions.