Phase III, randomized study of ofatumumab versus physicians' choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia
| Autor: | Jan Moritz Middeke, Andrey Zaritskey, Anders Österborg, Michele Gorczyca, Anna Schuh, Ira Gupta, Grzegorz Mazur, Yaroslav Kulyaba, Steen Lisby, Miklós Udvardy, Michael Steurer, Per Andersson, Chai Ni Chang, Sebastian Grosicki, Marco Montillo, Polina Kaplan, Iryna Kryachok, Siobhan Daly, Grygoriy Rekhtman |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Chronic lymphocytic leukemia Ofatumumab Antibodies Monoclonal Humanized law.invention 03 medical and health sciences chemistry.chemical_compound Time to next therapy 0302 clinical medicine Fludarabine refractory Randomized controlled trial Antibodies monoclonal law Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Medicine Humans In patient Aged Aged 80 and over business.industry Antibodies Monoclonal Hematology Middle Aged medicine.disease Leukemia Lymphocytic Chronic B-Cell Treatment Outcome Oncology chemistry Drug Resistance Neoplasm 030220 oncology & carcinogenesis Physical therapy Female business Vidarabine 030215 immunology |
| Zdroj: | Leukemialymphoma. 57(9) |
| ISSN: | 1029-2403 |
| Popis: | We report results of a randomized, phase III study of ofatumumab versus physicians' choice treatment in patients with bulky fludarabine-refractory chronic lymphocytic leukemia and explore extended versus standard-length ofatumumab treatment. Patients (79 ofatumumab, 43 physicians' choice) completed a median 6 (ofatumumab) or 3 (physicians' choice) months' therapy. Ofatumumab-treated patients with stable disease or better were randomized (2:1) to 6 months' extended ofatumumab treatment or observation. Although the study did not meet the primary endpoint of progression-free survival (PFS) by independent review committee (ofatumumab: 5.4 months, physicians' choice: 3.6 months; p = 0.27), median PFS by investigators was significantly longer for ofatumumab versus physicians' choice (7.0 versus 4.5 months; p = 0.003) as was time to next therapy (median 11.5 versus 6.5 months; p = 0.0004). PFS and time to next therapy were significantly longer with ofatumumab extended treatment than observation (p = 0.026 and p = 0.002, respectively; n = 37). The adverse-event profile of long-term ofatumumab administration showed no unexpected findings (Clinicaltrials.gov identifier: NCT01313689). |
| Databáze: | OpenAIRE |
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