Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial
| Autor: | Ira Gupta, K Govind Babu, Javier Loscertales, Sebastian Grosicki, Grygoriy Rekhtman, Kudrat Abdulkadyrov, Tadeusz Robak, Jerzy Z. Blonski, Chai-Ni Chang, Iryna Kryachok, Michele Gorczyca, Kazimierz Kuliczkowski, Astrid McKeown, Yaroslav Kulyaba, Steen Lisby, Krzysztof Warzocha, Janusz Kloczko, Wojciech Homenda, Jodi L Carey |
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| Rok vydání: | 2016 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Cyclophosphamide Kaplan-Meier Estimate Neutropenia Ofatumumab Antibodies Monoclonal Humanized 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Chemoimmunotherapy Recurrence Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Adverse effect Vidarabine Aged Neoplasm Staging Aged 80 and over business.industry Antibodies Monoclonal Hematology Middle Aged medicine.disease Leukemia Lymphocytic Chronic B-Cell Surgery Fludarabine Treatment Outcome chemistry 030220 oncology & carcinogenesis Female Neoplasm Grading business 030215 immunology medicine.drug |
| Zdroj: | Leukemialymphoma. 58(5) |
| ISSN: | 1029-2403 |
| Popis: | In this multicenter, open-label, phase III study, patients with relapsed chronic lymphocytic leukemia (CLL) were randomized (1:1) to receive ofatumumab plus fludarabine and cyclophosphamide (OFA + FC) or FC alone; the primary endpoint being progression-free survival (PFS) assessed by an independent review committee (IRC). Between March 2009 and January 2012, 365 patients were randomized (OFA + FC: n = 183; FC: n = 182). Median IRC-assessed PFS was 28.9 months with OFA + FC versus 18.8 months with FC (hazard ratio = 0.67; 95% confidence interval, 0.51–0.88; p = .0032). Grade ≥3 adverse events (≤60 days after last dose) were reported in 134 (74%) OFA + FC-treated patients compared with 123 (69%) FC-treated patients. Of these, neutropenia was the most common (89 [49%] vs. 64 [36%]). OFA + FC improved PFS with manageable safety for patients with relapsed CLL compared with FC alone, thus providing an alternative treatment option for patients with relapsed CLL. Trial registration: www.clinicaltrials.gov... |
| Databáze: | OpenAIRE |
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