Feasibility study of biweekly CPT-11 plus CDDP for S-1- and paclitaxel-refractory, metastatic gastric cancer

To confirm the feasibility and efficacy of biweekly irinotecan (CPT-11) plus cisplatin (CDDP) as third-line chemotherapy, the response rate (RR), overall survival and toxicity were evaluated in patients who had been treated with S-1 as a first-line and paclitaxel as a second-line chemotherapy for metastatic gastric cancer.

The eligibility criteria of our study were: i) pathologically-confirmed adenocarcinoma of the stomach, ii) primary non-resectable or recurrent tumors, iii) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 or less, iv) age less than 75 years, v) adequate hepatic, renal and bone marrow functions and vi) patients had received S-1 as a first-line and paclitaxel as a second-line chemotherapy and both regimens had failed. The treatment consisted of CPT-11 (60 mg/m2) and CDDP (30 mg/m2) on day 1 and day 15, repeated every 4 weeks.

Twenty-six patients were enrolled in this study. All the treatment was administered at the out-patient clinic except the first course for the initial 4 patients. The overall RR was 23.1% in all and 30.0% in the patients with target tumors (6 partial response, 11 stable disease, 7 progressive disease, 2 non-evaluable). Overall grade 3/4 toxicity was observed in 5 patients (19.2%) including pancytopenia, neutropenia, anemia, anorexia and elevation of AST/ALT. The time-to-treatment failure and the median survival time were 95 and 299 days, respectively.

Biweekly CPT-11 plus CDDP was feasible for S-1- and paclitaxel-refractory metastatic gastric cancer, with moderate activity and favorable toxicity. This regimen was safely performed at the out-patient clinic as third-line chemotherapy.