Health-related quality of life and patient-reported outcomes of ofatumumab plus fludarabine and cyclophosphamide versus fludarabine and cyclophosphamide in the COMPLEMENT 2 trial of patients with relapsed CLL
Autor: | K Govind Babu, Sebastian Grosicki, Yaroslav Kulyaba, Steen Lisby, Javier Loscertales, Tadeusz Robak, Grygoriy Rekhtman, Iryna Kryachok, Jerzy Z. Blonski, Krzysztof Warzocha, Kazimierz Kuliczkowski, Astrid McKeown, Wojciech Homenda, V Bal, Kudrat Abdulkadyrov, Chai-Ni Chang, Janusz Kloczko, Ira Gupta |
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Rok vydání: | 2016 |
Předmět: |
Oncology
Male Cancer Research medicine.medical_specialty Cyclophosphamide Phases of clinical research Ofatumumab Antibodies Monoclonal Humanized 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Quality of life Recurrence Internal medicine Antineoplastic Combined Chemotherapy Protocols Medicine Humans Patient Reported Outcome Measures Aged Aged 80 and over business.industry Cancer Antibodies Monoclonal Hematology Middle Aged medicine.disease Leukemia Lymphocytic Chronic B-Cell humanities Fludarabine Leukemia B symptoms chemistry 030220 oncology & carcinogenesis Physical therapy Quality of Life Female medicine.symptom business Vidarabine 030215 immunology medicine.drug Follow-Up Studies |
Zdroj: | Leukemialymphoma. 58(7) |
ISSN: | 1029-2403 |
Popis: | Chronic lymphocytic leukemia (CLL) is an incurable disease. Quality of life during treatment and periods of subsequent remission is therefore vital. Health-related quality of life (HRQoL) was compared in relapsed CLL during and after treatment with ofatumumab combined with fludarabine and cyclophosphamide versus fludarabine and cyclophosphamide alone. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 v3 and QLQ-CLL16 were used to assess HRQoL in this open-label, phase 3 study. Improvements in prespecified domains of patient-reported outcomes (Global Health Status [GHS]/HRQoL and B symptom scores) were recorded in both treatment arms after three cycles and were sustained after 18 months of follow-up. The two treatment arms were not significantly different at the nominal 0.05 level for GHS/HRQoL (p = .7278) or B symptoms (p = .5968). Small improvements in quality of life were maintained after therapy. The addition of ofatumumab was without any adverse impact on HRQoL (NC... |
Databáze: | OpenAIRE |
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