Health-related quality of life and patient-reported outcomes of ofatumumab plus chlorambucil versus chlorambucil monotherapy in the COMPLEMENT 1 trial of patients with previously untreated CLL

Autor: Stephanie Manson, Fritz Offner, Ira Gupta, Ann Janssens, Peter Hillmen, Chai-Ni Chang, Janusz Kloczko, K Govind Babu, Sebastian Grosicki, Astrid McKeown
Rok vydání: 2016
Předmět:
Male
Oncology
Chronic lymphocytic leukemia
law.invention
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
immune system diseases
law
hemic and lymphatic diseases
Antineoplastic Combined Chemotherapy Protocols
Fatigue
Aged
80 and over
Antibodies
Monoclonal
Hematology
General Medicine
Middle Aged
Fludarabine
Leukemia
Treatment Outcome
030220 oncology & carcinogenesis
Female
medicine.drug
Adult
medicine.medical_specialty
Cyclophosphamide
Antineoplastic Agents
Antibodies
Monoclonal
Humanized
Ofatumumab
Disease-Free Survival
03 medical and health sciences
Internal medicine
medicine
Humans
Radiology
Nuclear Medicine and imaging
Patient Reported Outcome Measures
Aged
Chlorambucil
business.industry
medicine.disease
Leukemia
Lymphocytic
Chronic
B-Cell
Surgery
Clinical trial
chemistry
Quality of Life
Self Report
business
Follow-Up Studies
030215 immunology
Zdroj: Acta Oncologica. 55:1115-1120
ISSN: 1651-226X
0284-186X
Popis: Patients diagnosed with chronic lymphocytic leukemia (CLL) are usually elderly and frequently have a number of comorbidities. Health-related quality of life (HRQoL) for these patients is of utmost importance and should be taken into consideration when assessing new treatment options. The combination of ofatumumab with chlorambucil has shown longer progression-free survival compared with chlorambucil alone. In this study, we aim to assess how this treatment combination affects patients' health-related quality of life and patient-reported symptoms.In this open-label phase III trial, patients with previously untreated CLL for whom fludarabine-based treatment was contra-indicated, were randomized 1:1 to receive oral chlorambucil (10 mg/mPatient-reported improvements from baseline in Global Health Status (GHS)/HRQoL scores and fatigue scores were recorded during treatment with both chlorambucil monotherapy and ofatumumab in combination with chlorambucil. There were no significant differences between the two treatment arms for GHS/HRQoL (p = 0.667) or fatigue (p = 0.103). Following treatment, numerical improvements to GHS/HRQoL and fatigue scores were reported, with no significant differences between the two treatment arms.Small but detectable improvements in patients' quality of life were reported as a result of treatment. The addition of ofatumumab to chlorambucil did not negatively impact HRQoL. Quality of life was maintained in the months following treatment.
Databáze: OpenAIRE
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