Both irinotecan and cisplatin are considered standard agents for stomach cancer and NCCN recommends cisplatin or irinotecan based regimens. Cisplatin has been a popular drug for this disease for 2 decades. Recent data have emerged on the use of irinotecan in advanced gastric cancer, both as a single agent and in various combination regimens. Active irinotecan-based combinations include cisplatin–irinotecan, 5-FU–LV–irinotecan, and irinotecan–oxaliplatin. These combinations have produced acceptable response rates and overall survival times but have also been associated with significant grade 3–4 neutropenia and diarrhea. Diarrhea is the major dose-limiting toxicity of irinotecan therapy and occurred in approximately 20% of patients (range, 6%–27%). Overall, results of these trials indicate that these irinotecan combinations are clinically active, justifying the NCCN recommendation.
There is significant support from phase II studies and one second line study versus observation to conclude that single agent irinotecan is medically necessary when a combination cannot be administered.
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Narikazu Boku, Atsushi Ohtsu, Yasuhiro Shimada, Kuniaki Shirao, Shigeki Seki, Hiroshi Saito, Yuh Sakata, Ichinosuke Hyodo, Phase II Study of a Combination of Irinotecan and Cisplatin Against Metastatic Gastric Cancer Journal of Clinical Oncology, Vol 17, Issue 1 (January), 1999: 319