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.
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 (NCT00824265).
a Department of Hematology , Medical University of Łódź, Copernicus Memorial Hospital , Łódź , Poland.
Tadeusz
T
Robak
b Department of Hematology , Institute of Hematology and Transfusion Medicine , Warsaw , Poland.
Krzysztof
K
Warzocha
c Kidwai Memorial Institute of Oncology , Bangalore , India.|d HCG Curie Centre of Oncology , Bangalore , India.
K
K
Govind Babu
e Makiivka City Hospital No. 2 of Donetsk Region , Makiivka , Ukraine.
Yaroslav
Y
Kulyaba
f Department of Medical Oncology , Wrocław Medical University , Wrocław , Poland.
Kazimierz
K
Kuliczkowski
g Russian Research Institute of Hematology and Transfusiology , St. Petersburg , Russian Federation.
Kudrat
K
Abdulkadyrov
h Hospital Universitario de La Princesa, IIS-IP , Madrid , Spain.
Javier
J
Loscertales
i Oncohematology Department , National Cancer Institute , Kiev , Ukraine.
Iryna
I
Kryachok
j Medical University of Białystok , Białystok , Poland.
Janusz
J
Kłoczko
k Khmelnytskyi Regional Hospital , Khmelnytskyi , Ukraine.
Grygoriy
G
Rekhtman
l Department of Hematology , Janusz Korczak Hospital , Słupsk , Poland.
Wojciech
W
Homenda
a Department of Hematology , Medical University of Łódź, Copernicus Memorial Hospital , Łódź , Poland.
Jerzy Z
JZ
Błoński
m Novartis Pharmaceuticals Corporation , Uxbridge , United Kingdom.
Astrid
A
McKeown
n Novartis Pharmaceuticals Corporation , Research Triangle Park , NC , USA.
Chai-Ni
CN
Chang
o Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA.
Vasudha
V
Bal
p Genmab A/S , Copenhagen , Denmark.
Steen
S
Lisby
q Novartis Pharmaceuticals Corporation , King of Prussia , PA , USA.
Ira V
IV
Gupta
r Department of Cancer Prevention, Faculty of Public Health , Medical University of Silesia , Katowice , Poland.
Sebastian
S
Grosicki
D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D012008:Recurrence; D014740:Vidarabine / Q000031:analogs & derivatives
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003520:Cyclophosphamide; D014740:Vidarabine; C527517:ofatumumab; C024352:fludarabine
CLL; Ofatumumab; anti-CD20 antibody; patient-reported outcomes; quality of life; relapsed disease