Abstract
7018 Background: Erlotinib (Tarceva) prolongs survival in previously treated NSCLC pts (ASCO 2004). In the palliative setting, assessing symptoms and quality of life (QOL) is also important. Methods: BR.21 was a double blind placebo controlled phase III trial which randomized 731 pts with stage IIIB or IV NSCLC, who had failed 1st or 2nd line chemotherapy, to erlotinib 150 mg/day PO or placebo, in a 2:1 ratio. Primary endpoint was survival; QOL was a secondary endpoint, as assessed by EORTC QLQ-C30 and the lung cancer module at baseline and q 4 weeks until progression. Primary endpoint for QOL analysis was time to deterioration of cough, dyspnea and pain. In addition, mean changes from baseline in QOL domains and symptoms were compared between the arms, as well as proportions of patients improving/deteriorating. Results: Compliance to QOL completion was high (87% at baseline, >70% in follow up for >12 cycles). Both arms had comparable baseline QOL, with pts showing greatest impairments in global QOL (mean...
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