TORONTO, Canada-Erlotinib (Tarceva) not only extended survival in patients with advanced non-smallcell lung cancer (NSCLC) but it also improved their quality of life (QOL), according to data from BR.21, a double- blind randomized placebo-controlled trial in 731 patients. Pain, cough, and dyspnea got worse at a slower rate among patients who took erlotinib than among those who took placebo on the trial, which was conducted by the National Cancer Institute of Canada (NCIC). The primary findings of BR.21, reported last year, showed that erlotinib significantly improved median overall survival time and 1-year survival, compared with placebo, in patients with previously treated stage IIIb or IV NSCLC. The QOL data from BR.21 were reported by Andrea Bezjak, MD, who led the QOL analysis (abstract 7018). Dr. Bezjak is associate professor in the departments of radiation oncology and health policy, management and evaluation at the University of Toronto, and is a staff radiation oncologist at Princess Margaret Hospital, Toronto. "Patients on erlotinib had slower deterioration of their disease-related symptoms and quality of life improved in more patients on the erlotinib arm than on the placebo arm," Dr. Bezjak said. "These differences were clinically as well as statistically significant." To collect the data, Dr. Bezjak and her colleagues used the QOL core questionnaire and lung cancer module of the European Organization for Research and Treatment of Cancer (EORTC); the questionnaire was administered monthly. Compliance wasexcellent, Dr. Bezjak noted, with 85% of patients completing questionnaires in the first year. The results showed that the median time to deterioration of cough was 4.9 months for patients on the erlo-tinib arm of the study vs 3.7 months for those on the placebo arm. For dyspnea, the median time to deterioration was 4.7 months vs 2.9 months; and for pain, it was 2.8 months vs 1.9 months, respectively. The researchers also analyzed global QOL by determining how many patients had an improvement of at least 10 points during the study. Theyfound that 35% of the patients on erlotinib fell into this category vs 26% of those on placebo. The favorable impact of erlotinib included less fatigue, which is usually difficult to achieve, Dr. Bezjak noted. Erlotinib is one of several agents that have been tested as second-line therapy in "this burgeoning population" of patients with advanced NSCLC, said discussant Vincent Miller, MD, associate attending physician in the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center, New York. Dr. Miller reviewed trials with docetaxel (Taxotere), topotecan (Hycamtin), pemetrexed (Alimta), and erlotinib. He concluded that docetaxel, pemetrexed, and erlotinib are all reasonable choices as second- line therapy but further study is needed, including trials of combination therapies. In addition, he said, "erlotinib, though having a favorable quality-of-life profile, has not yet been compared with a cytotoxic agent in this population, and I do think that would be a very appropriate study to undertake."