Introduction: The ability of doublet therapy in the second-line setting in patients with platinum-refractory non-small cell lung cancer (NSCLC) has not yet been proven. In this setting, docetaxel (D) has shown efficacy and irinotecan (I) has only recently been introduced. This study was initiated to explore the activity and tolerability of three D + I regimens in platinum pretreated NSCLC patients.
Methods: From March 2003 to June 2006, 65 patients (age range, 39-71 years; 83% male) with relapsed stage III/IV NSCLC were randomly assigned to receive either I 160 mg/m(2) plus D 60 mg/m(2) on day 1 every 21 days (arm A), I 80 mg/m(2) on days 1,8 plus D 60 mg/m(2) on day 1 every 21 days (arm B), or I 60 mg/m(2) plus D 30 mg/m(2) on days 1, 8, 15, and 22 every 42 days (arm C), for a maximum of 18 weeks.
Results: Per protocol analysis (47 of 65) overall response rates were 5.6% (A), 6.7% (B), and 7.1% (C). Median times to progression were 3.4, 4.0, and 4.3 months, respectively. Overall survival was 8.9 (A), 8.3 (B), and 9.4 (C) months. G3/4 neutropenia was more frequent in arms A (42%) and B (55%) whereas G3/4 nonhematologic toxicity was similarly prevalent in all arms, although diarrhea occurred in 47% of arm C patients.
Conclusions: Single-agent treatment with D or the multitarget antifolate pemetrexed or erlotinib remain the best choices and investigational studies, following first-line therapy, are required.