Bendamustine With Dexamethasone in Relapsed/Refractory Systemic Light-Chain Amyloidosis: Results of a Phase II Study
| العنوان: | Bendamustine With Dexamethasone in Relapsed/Refractory Systemic Light-Chain Amyloidosis: Results of a Phase II Study |
|---|---|
| المؤلفون: | Heather Landau, Galina G Lagos, Vaishali Sanchorawala, Suzanne Lentzsch, Raymond L. Comenzo, Samuel Pan, Keren Osman, Silva Pregja, Divaya Bhutani, Jeffrey A. Zonder |
| المصدر: | J Clin Oncol |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Male, Bendamustine, Cancer Research, medicine.medical_specialty, Vomiting, Phases of clinical research, Kaplan-Meier Estimate, Immunoglobulin light chain, Gastroenterology, Dexamethasone, Drug Administration Schedule, Refractory, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Bendamustine Hydrochloride, Humans, Immunoglobulin Light-chain Amyloidosis, Fatigue, Multiple myeloma, Aged, business.industry, Amyloidosis, Nausea, ORIGINAL REPORTS, Middle Aged, medicine.disease, Treatment Outcome, Oncology, Drug Resistance, Neoplasm, Relapsed refractory, Female, Neoplasm Recurrence, Local, business, medicine.drug |
| الوصف: | PURPOSE No established treatments exist for relapsed/refractory systemic light-chain (AL) amyloidosis. Bendamustine has shown potential in the treatment of multiple myeloma. We conducted a phase II, multicenter trial to assess the efficacy and safety of bendamustine with dexamethasone (ben-dex) in patients with persistent or progressive AL amyloidosis after ≥ 1 prior therapy. METHODS The trial enrolled 31 patients who received bendamustine on days 1 and 2 (100 mg/m2 intravenously) with 40 mg of weekly dexamethasone in 28-day cycles until disease progression or up to 6 cycles after complete hematologic response. The primary objective was the rate of partial hematologic response (PR) or better. RESULTS Patients received a median of 4 cycles (range, 2-12 cycles) with 57% of patients achieving a PR or better (11% complete response, 18% very good PR). The overall organ response was 29% among the 24 patients who had measurable organ involvement. Treatment was well tolerated with no grade 5 treatment-related adverse events (AEs). Sixty-five percent of patients had a therapy-related grade 3-4 AE. The most common AEs included myelosuppression, fatigue, and nausea/vomiting. The median overall survival was 18.2 months (95% CI, 11.3 to 43.8 months), and hematologic response was associated with prolonged survival ( P = .0291). The median progression-free survival was 11.3 months (95% CI, 5.0 to 15.4 months). CONCLUSION Overall, ben-dex is a viable treatment option with substantial efficacy and limited toxicity for patients with pretreated AL amyloidosis who have limited therapeutic options. This trial was registered at (ClinicalTrials.gov identifier: NCT01222260 ). |
| تدمد: | 1527-7755 0732-183X 0122-2260 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a52bc87fb5668007e47a6af4f74234caTest https://doi.org/10.1200/jco.19.01721Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....a52bc87fb5668007e47a6af4f74234ca |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X 01222260 |
|---|