Phase I study of irinotecan and cisplatin with concurrent split-course radiotherapy in unresectable and locally advanced non-small cell lung cancer

Autor: M Oka, M Fukuda, A Kinoshita, M Kuba, M Ichiki, T Rikimaru, H Soda, H Takatani, F Narasaki, S Nagashima, Y.-I Nakamura, N Hayashi, S Kohno
Rok vydání: 2001
Předmět:
Zdroj: European Journal of Cancer. 37:1359-1365
ISSN: 0959-8049
DOI: 10.1016/s0959-8049(01)00099-5
Popis: We conducted a phase I study of irinotecan (CPT-11) and cisplatin with concurrent split-course radiotherapy in locally advanced stage III non-small cell lung cancer (NSCLC). This study aimed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of this therapy. Two chemotherapy cycles of CPT-11 (days 1, 8 and 15) and cisplatin (day 1) were repeated with a 28-day interval. Radiotherapy of 2 Gy/day commenced on day 2 of each chemotherapy cycle, with 24 Gy and 36 Gy administered for the first and second cycle, respectively. 24 eligible patients were enrolled at five dose levels (CPT-11/cisplatin: 40/60, 50/60, 60/60, 60/70 and 60/80 mg/m 2 ), and 23 patients were evaluated for toxicity and clinical outcome. Only 1 patient experienced a DLT with neutropenia and diarrhoea at 60/60 mg/m 2 . Dose escalation was limited to 60/80 mg/m 2 which was the recommended dose for CPT-11/cisplatin alone in NSCLC. Tumour responses included one complete response (CR), 15 partial response (PR), and 7 no change (NC), and the overall response rate was 69.6% (95% confidence interval (CI) 47.1–86.8%). This combined modality is tolerable, and CPT-11/cisplatin of 60/80 mg/m 2 in this modality is recommended for phase II study.
Databáze: OpenAIRE
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