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A phase II study of biweekly mitomycin C and irinotecan combination therapy in patients with fluoropyrimidine-resistant advanced gastric cancer: a report from the Gastrointestinal Oncology Group of the Japan Clinical Oncology Group (JCOG0109-DI Trial) |
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| Authors: | Tetsuya Hamaguchi Kuniaki Shirao Atsushi Ohtsu Ichinosuke Hyodo Yasuaki Arai Hiroya Takiuchi Hirofumi Fujii Motoki Yoshida Hiroshi Saito Tadamichi Denda Wasaburo Koizumi Hiroaki Iwase Narikazu Boku |
| Institution: | 1. Division of Gastrointestinal Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan 2. Department of Medical Oncology, Faculty of Medicine, Oita University, Oita, Japan 3. National Cancer Center Hospital East, Research Center for Innovative Oncology, Chiba, Japan 4. Department of Internal Medicine, National Hospital Organization Shikoku Cancer Center, Ehime, Japan 5. Department of Diagnostic Radiology, Aichi Cancer Center Hospital, Aichi, Japan 6. Cancer Chemotherapy Center, Osaka Medical College Hospital, Osaka, Japan 7. Department of Medical Oncology, Tochigi Cancer Center, Tochigi, Japan 8. Department of Gastroenterology, Kumamoto Regional Medical Center, Kumamoto, Japan 9. Department of Gastroenterology, Yamagata Prefectural Central Hospital, Yamagata, Japan 10. Division of Hematology/Oncology, Chiba Cancer Center Hospital, Chiba, Japan 11. Department of Internal Medicine, Kitasato University East Hospital, Kanagawa, Japan 12. Department of Gastroenterology, National Hospital Organization Nagoya Medical Center, Aichi, Japan 13. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan |
| Abstract: | BackgroundPreclinical studies have shown that mitomycin C (MMC) acts synergistically with irinotecan (CPT-11). In this phase II study, we evaluated the efficacy and toxicity of MMC/CPT-11 therapy as second-line chemotherapy for patients with fluoropyrimidine-resistant advanced gastric cancer.MethodsEligible patients had evidence of tumor progression despite prior treatment with fluoropyrimidine-based regimens or had relapsed within 6?months after completion of therapy with adjuvant fluoropyrimidines. Treatment consisted of MMC (5?mg/m2) and CPT-11 (150?mg/m2) administered i.v. every 2?weeks. The primary endpoint was the response rate (RR). Our hypothesis was that this combination therapy was efficacious when the lower boundary of the 95% confidence interval (CI) of the RR exceeded 20% of the threshold RR.ResultsBetween April 2002 and July 2003, 45 eligible patients were registered and analyzed. Among the 45 patients, 40 (89%) had previously received chemotherapy for metastasis and 24 (53%) had a performance status (PS) of 0. Thirteen partial responses were obtained among the 45 patients, resulting in an overall RR of 29% (95% CI, 16?C42%). The median time to progression was 4.1?months, and the median survival time was 10?months, with a 1-year survival rate of 36%. Grade 4 neutropenia was observed in 29% of the patients, whereas febrile neutropenia occurred in 9%. The incidence rates of grade 3 nausea and diarrhea were 13 and 2%, respectively.ConclusionsAlthough this study did not achieve the per-protocol definition of activity, the progression-free survival and overall survival appeared to be promising, with acceptable tolerability. Thus, MMC/CPT-11 therapy as second-line chemotherapy for fluoropyrimidine-resistant advanced gastric cancer presents a potential treatment option in patients with a good PS. |
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