A Phase II study of weekly irinotecan and capecitabine in patients with previously treated non-small cell lung cancer.

PURPOSE Irinotecan and capecitabine have synergistic antitumor activity with distinct mechanisms of action but without overlapping major toxicity. We conducted a Phase II study to evaluate the efficacy of weekly irinotecan plus capecitabine in patients with previously treated non-small cell lung cancer (NSCLC). EXPERIMENTAL DESIGN Eligible patients had received at least one prior chemotherapy regimen. The treatment consisted of irinotecan (90-100 mg/m2 i.v.) on days 1 and 8 plus capecitabine (1000 mg/m2 p.o. b.i.d.) on days 1-14 of a 21-day cycle. Treatment was given until disease progression or unacceptable toxicity. RESULTS Thirty-seven patients with median age of 59 years were enrolled. Eighteen (49%) patients had received one prior regimen, and 19 (51%) patients had received two or more prior regimens. The Initial 5 patients received 100 mg/m2 irinotecan with grade 3 diarrhea seen in 3 of 5 patients, and subsequent 32 patients received 90 mg/m2 irinotecan. Four (11.4%) of 35 evaluable patients had partial response and 12 (34.3%) had stable disease. There was no complete response. All responses were noted in patients who had received one prior regimen (4 of 18, 22%), but there was no response among the patients who had received two or more regimens. Median duration of response was 5.6 months (range, 5-8.7 months). At a median follow-up of 6 months, median survival was 7.4 months (95% confidence interval, 3.6-9.0). Grade 3 or 4 toxicities were neutropenia (12%), anemia (13%), and diarrhea (12%) at the dose level of 90 mg/m2. CONCLUSIONS Weekly irinotecan plus capecitabine had favorable antitumor activity and toxicity profile as a second-line treatment for recurrent NSCLC. This regimen may provide an additional treatment option for patients with advanced NSCLC.