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Takayasu Kurata, Nobuyuki Yamamoto, Takefumi Komiya, Junji Tsurutani, Masaki Miyazaki, Kenji Tamura, Koji Takeda, Kazuhiko Nakagawa, Masahiro Fukuoka, A Phase I Study of Gemcitabine Plus Irinotecan for Advanced NSCLC: Japan Clinical Oncology Group Trial (JCOG9904), Japanese Journal of Clinical Oncology, Volume 40, Issue 10, October 2010, Pages 992–994, https://doi.org/10.1093/jjco/hyq079
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Abstract
A combination Phase I study of gemcitabine and irinotecan in patients with previously untreated advanced non-small-cell lung cancer was conducted. Patients received gemcitabine and irinotecan on Days 1 and 8 every 3 weeks. A total of 11 patients were enrolled. Three of six patients who received the starting dose (gemcitabine, 800 mg/m2; irinotecan, 80 mg/m2) experienced dose-limiting toxicities (Grade 4 neutropenia, Grade 3 elevation of transaminase and Grade 5 interstitial pneumonia). At the reduced dose level (gemcitabine, 800 mg/m2; irinotecan, 60 mg/m2), all two assessable patients could not meet the administration criteria of Day 8 (one, Grade 2 elevation of transaminase; the other, Grade 1 diarrhea). No objective response was observed in eight evaluable patients. We could not determine the recommended dose of this combination because of intolerable toxicities and no efficacy. Therefore, it is difficult to forward this combination chemotherapy toward further studies.