This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Han, J.-Y. Articles by Lee, J. S. Search for Related Content PubMed PubMed Citation Articles by Han, J.-Y. Articles by Lee, J. S.

A Phase II Study of Weekly Irinotecan and Capecitabine in Patients with Previously Treated Non-Small Cell Lung Cancer

Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, Korea

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.

This article has been cited by other articles:

				I. E.L.M. Kuppens, E. Dansin, H. Boot, C. Feger, S. Assadourian, M.-E. Bonneterre, J. H. Beijnen, J. H.M. Schellens, and J. Bonneterre Dose-finding phase I clinical and pharmacokinetic study of orally administered irinotecan in patients with advanced solid tumors. Clin. Cancer Res., June 15, 2006; 12(12): 3774 - 3781. [Abstract] [Full Text] [PDF]