CPT-11 as a second-line treatment for patients with advanced/metastatic gastric cancer who failed S-1 (CCOG0702).

Autor: Mochizuki, Yoshinari, Ohashi, Norifumi, Kojima, Hiroshi, Ishigure, Kiyoshi, Kinoshita, Takashi, Eguchi, Takehiko, Fujitake, Shinichi, Ito, Seiji, Fujiwara, Michitaka, Kodera, Yasuhiro
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Zdroj: Cancer Chemotherapy & Pharmacology; Sep2013, Vol. 72 Issue 3, p629-635, 7p
Abstrakt: 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/m 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/m 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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