Phase I study of etoposide, cisplatin and irinotecan triplet in patients with advanced-stage small-cell lung cancer
Date
2005Author
Briassoulis, E. ChSamantas, E.

Skarlos, Dimosthenis V.
Makatsoris, T.
Christodoulou, C.
Fountzilas, George
Bamias, A. T.
Dimopoulos, M. A.
Kosmidis, Paraskevas A.

Source
Cancer chemotherapy and pharmacologyVolume
56Issue
5Pages
521-528Google Scholar check
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The irinotecan-cisplatin combination has emerged as a new standard for the treatment of advanced-stage small-cell lung cancer (AS-SCLC). To move forward we developed a 3-day regimen of cisplatin, etoposide and irinotecan. Successive cohorts of AS-SCLC patients were treated with irinotecan administered as a single 1-h infusion in combination with fixed doses of cisplatin (20 mg/m 2) and etoposide (75 mg/m2), both given for three consecutive days (ECI regimen). Irinotecan dose was escalated from 60 mg/m 2 by 40-mg/m2 increments. At mid-step between the maximum tolerated dose (MTD) and the previous dose level, patients were randomized for the day of administration of irinotecan (day 1 vs day 3). A total of 36 AS-SCLC patients received 166 courses of treatment at four dose levels. The MTD of irinotecan was 140 mg/m2 (three dose-limiting toxicities, DLTs), and the recommended optimal dose (ROD) 120 mg/m2 (two DLTs). DLTs were febrile neutropenia and grade 3 diarrhea. Other toxicities were mild. No difference in toxicity was seen between the two time schedules. A 77% (95% CI 63.25-90.75%) response rate was recorded among 31 evaluable patients and the median survival was 12 months. The ECI regimen was well tolerated and showed considerable activity in patients with AS-SCLC. Phase II/III evaluation is ongoing. © Springer-Verlag 2005.
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