Symptom improvement in lung cancer patients treated with erlotinib: quality of life analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21.
OBJECTIVE
This report describes the quality of life (QOL) findings of a randomized placebo controlled study of erlotinib, an epidermal growth factor receptor inhibitor, in patients with non-small-cell lung cancer (NSCLC).


METHODS
This double-blind phase III trial randomly assigned 731 patients with NSCLC who had progressed after prior chemotherapy to erlotinib 150 mg daily or placebo, with survival as the primary study outcome. QOL was assessed by European Organisation for Research and Treatment of Cancer QLQ-C30 and the lung cancer module QLQ-LC13. The primary end points for QOL analysis were time to deterioration of three common lung cancer symptoms: cough, dyspnea, and pain.


RESULTS
Survival was significantly longer (hazard ratio, 0.70; P < .0001) in the erlotinib arm. Compliance with QOL was 87% at baseline and more than 70% during treatment. Patients receiving erlotinib had significantly longer median time to deterioration for all three symptoms (4.9 v 3.7 months for cough [P = .04]; 4.7 v 2.9 months for dyspnea [P = .04], and 2.8 v 1.9 months for pain [P = .03]). QOL response analyses showed that 44%, 34%, and 42% of patients receiving erlotinib had improvement in these three symptoms, respectively. This was accompanied by a significant improvement in the physical function (31% erlotinib v 19% placebo, P = .01), and global QOL (35% v 26%, P < .0001). Patients with complete or partial response were more likely to have improvement in the QOL response than patients with stable or progressive disease (P < .01).


CONCLUSIONS
Erlotinib not only improves survival in previously treated patients with NSCLC, but also improves tumor-related symptoms and important aspects of QOL.
Bezjak
Andrea
A
Princess Margaret Hospital/University Health Network, University of Toronto, Toronto, Ontario, Canada. andrea.bezjak@rmp.uhn.on.ca
Tu
Dongsheng
D
Seymour
Lesley
L
Clark
Gary
G
Trajkovic
Aleksandra
A
Zukin
Mauro
M
Ayoub
Joseph
J
Lago
Sergio
S
de Albuquerque Ribeiro
Ronaldo
R
Gerogianni
Alexandra
A
Cyjon
Arnold
A
Noble
Jonathan
J
Laberge
Francis
F
Chan
Raymond Tsz-Tong
RT
Fenton
David
D
von Pawel
Joachim
J
Reck
Martin
M
Shepherd
Frances A
FA
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002170:Canada; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications / Q000188:drug therapy*; D003371:Cough / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D004417:Dyspnea / Q000209:etiology / Q000517:prevention & control; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride