Authors: Hiroki Goya Hiroshi Kuraishi Shigeru Koyama Takashi Ichiyama Fumiaki Yoshiike Kazuya Hirai Toshihiko Agatsuma Kazunari Tateishi Shintaro Kanda Hiroshi Yamamoto Keishi Kubo Tomonobu Koizumi
Publish Date: 2012/09/01
Volume: 70, Issue: 5, Pages: 691-697
Abstract
The study group comprised patients with advanced or metastatic NSCLC who had previously received at least one platinumcontaining chemotherapy Patients received irinotecan on days 1 15 and oral S1 40 mg/m2 twice daily as a fixed dose on day 1 to 14 of a 28day cycleIn the phase I part irinotecan was given in escalating doses of 70 Level 1 80 Level 2 and 90 mg/m2 Level 3 Three of the 5 patients given Level 3 had doselimiting toxicity and Level 2 80 mg/m2 of irinotecan was designated as the recommended dose In phase II 38 patients received a median of 74 cycles of irinotecan at the recommended dose The overall response rate was 158 90 confidence interval CI 61–255 and the median progressionfree and overall survival times were 45 months 95 CI 35–50 and 150 months 95 CI 95–206 months respectively Toxicity was generally mild Grade 3 or higher toxicity included neutropenia in 179 of the patients thrombocytopenia in 51 and nausea in 77
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