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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

Andrea Bezjak, Dongsheng Tu, Lesley Seymour, Gary Clark, Aleksandra Trajkovic, Mauro Zukin, Joseph Ayoub, Sergio Lago, Ronaldo de Albuquerque Ribeiro, Alexandra Gerogianni, Arnold Cyjon, Jonathan Noble, Francis Laberge, Raymond Tsz-Tong Chan, David Fenton, Joachim von Pawel, Martin Reck, Frances A. Shepherd

From the Princess Margaret Hospital/University Health Network, University of Toronto, Toronto; National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canada; and OSI Pharmaceuticals Inc, Melville, NY

Address reprint requests to Andrea Bezjak, MD, 610 University Avenue, Room 5-810, Toronto, ON M5G 2M9 Canada; e-mail: andrea.bezjak{at}rmp.uhn.on.ca

PURPOSE: 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).

PATIENTS AND 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).

CONCLUSION: Erlotinib not only improves survival in previously treated patients with NSCLC, but also improves tumor-related symptoms and important aspects of QOL.

Supported in part by a grant to the National Cancer Institute of Canada–Clinical Trials Group from OSI Pharmaceuticals Inc.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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