CPT-11 as a second-line treatment for patients with advanced/metastatic gastric cancer who failed S-1 (CCOG0702) |
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Authors: | Yoshinari Mochizuki Norifumi Ohashi Hiroshi Kojima Kiyoshi Ishigure Takashi Kinoshita Takehiko Eguchi Shinichi Fujitake Seiji Ito Michitaka Fujiwara Yasuhiro Kodera |
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Affiliation: | 1. Department of Surgery, Komaki City Hospital, 1-20 Jobushi, Komaki, Aichi, 485-8520, Japan 2. Department of Surgery II, Nagoya University Graduate School of Medicine, Nagoya, Japan 3. Department of Gastroenterological Surgery, Aichi Cancer Center, Aichi Hospital, Okazaki, Japan 4. Department of Surgery, Konan Kosei Hospital, Konan, Japan 5. Department of Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan 6. Department of Surgery, Nakatsugawa Municipal Hospital, Nakatsugawa, Japan 7. Department of Surgery, Gamagori Municipal Hospital, Gamagoori, Japan 8. Department of Gastroenterological Surgery, Aichi Cancer Center, Chuo Hospital, Nagoya, Japan
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Abstract: | Background In Japan, CPT-11 is often used to treat unresectable gastric cancer in the second-line setting. However, evidence regarding benefit of second-line chemotherapy remains sparse, especially after failing S-1. Methods A phase II study to evaluate the efficacy and safety of weekly administration of CPT-11 at a dose of 100 mg/m2 after failing a S-1-containing first-line treatment was planned with response rate as a primary end point. UGT1A1*6, *27, and *28 genotyping were performed in all cases, and those found to have either homozygous for *28, homozygous for *6, heterozygous for both *6 and *28, and heterozygous for *27 were rendered ineligible for the phase II trial. Results Two patients of homozygous for *28, two patients of homozygous for *6, and one patient of heterozygous for *27 were found among 39 recruited patients. The median number of courses delivered was 3 courses. The overall response rate was 15.4 % and disease control rate was 65.4 %. The median time to treatment failure was 87.5 days and median overall survival was 268 days. Twenty-two (73 %) of 30 valuable patients experienced protocol-specified skip of treatment and 8 (30 %) of patients could continue treatment with dose reduction. ≥G3 neutropenia was found in 30 % and ≥G3 anorexia and diarrhea were found in 23 and 17 %, respectively. Conclusion Weekly CPT-11 at 100 mg/m2 showed moderate response among gastric cancer patients who were refractory to S-1, but the disease control rate seemed meaningful. Even after selection of patients by UGT1A1 polymorphism of *6, *27, and *28, severe toxic events could not be prevented completely. |
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