This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Google Scholar Articles by Wheatley-Price, P. Articles by Shepherd, F. A. PubMed PubMed Citation Articles by Wheatley-Price, P. Articles by Shepherd, F. A.

Erlotinib for Advanced Non–Small-Cell Lung Cancer in the Elderly: An Analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21

Paul Wheatley-Price, Keyue Ding, Lesley Seymour, Gary M. Clark, Frances A. Shepherd

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

Corresponding author: Paul Wheatley-Price, MBChB, MRCP, Department of Medical Oncology, Princess Margaret Hospital, 610 University Ave, Toronto, Ontario, M5G 2M9 Canada; e-mail: paul.wheatley-price{at}uhn.on.ca

Purpose: National Cancer Institute of Canada Clinical Trials Group Study BR.21 established erlotinib as a standard of care in patients with non–small-cell lung cancer (NSCLC) after failure of first- or second-line chemotherapy. The current study analyzes the influence of age on outcomes in BR.21.

Patients and Methods: BR.21 was a double-blind phase III trial that randomly assigned 731 patients to erlotinib 150 mg daily or placebo. End points included progression-free survival and overall survival (OS), response, quality of life (QOL), drug exposure, and toxicity, which are analyzed in this retrospective study by the following two age groups: 70 years (elderly) or less than 70 years (young).

Results: There were 163 elderly patients (112 on erlotinib, 51 on placebo) and 568 young patients (376 on erlotinib, 192 on placebo). There was no significant difference between age groups randomly assigned to erlotinib or placebo in progression-free survival (elderly: 3.0 v 2.1 months; hazard ratio [HR] = 0.63; 95% CI, 0.44 to 0.90; P = .009; young: 2.1 v 1.8 months; HR = 0.64; 95% CI, 0.53 to 0.76; P < .0001; interaction, P = .77) or OS (elderly: 7.6 v 5.0 months; HR = 0.92; 95% CI, 0.64 to 1.34; P = .67; young: 6.4 v 4.7 months; HR = 0.73; 95% CI, 0.61 to 0.89; P = .0014; interaction, P = .31). Response rates were similar between age groups. Elderly patients, compared with young patients, had significantly more overall and severe (grade 3 and 4) toxicity (35% v 18%; P < .001), were more likely to discontinue treatment as a result of treatment-related toxicity (12% v 3%; P < .0001), and had lower relative dose-intensity (64% v 82% received > 90% planned dose; P < .001).

Conclusion: Elderly patients treated with erlotinib gain similar survival and QOL benefits as younger patients but experience greater toxicity.

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