A phase II study of biweekly irinotecan plus cisplatin in patients with extensive stage small lung cancer

Abstract

BACKGROUND:

An irinotecan and cisplatin (IP) combination is one of active regimen used in treatment of extensive stage disease (ED) small cell lung cancer (SCLC). However, a 4-week cycle of irinotecan treatment can result in significant myelosuppression and diarrhea. Therefore, the present study was conducted to evaluate the efficacy and safety of biweekly IP in patients with ED SCLC.

METHODS:

Patients with previously untreated ED SCLC received intravenous irinotecan at a dose of 60mg/m(2) and cisplatin at a dose of 30mg/m(2) on days 1 and 15 every 4 weeks.

RESULTS:

Thirty-five patients were enrolled in this study. Three complete responses and 23 partial responses were confirmed, giving an overall response rate of 74.3%. After a median follow-up of 15.1 months, the median time to progression and overall survival were 7.7 months and 12.2 months, respectively. Grade 3/4 neutropenia occurred in seven patients and grade 3 febrile neutropenia was observed in one patient. Grade 3 diarrhea occurred in two patients.

CONCLUSIONS:

The combination chemotherapy of biweekly IP was found to be well tolerated and effective in patients with ED SCLC. Further evaluation of the combination of IP at the dose and schedule in this study is warranted in ED SCLC patients.