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

Oka, M Fukuda, M Fukuda, M Kinoshita, A Kuba, M Ichiki, M Rikimaru, T Soda, H Takatani, H Narasaki, F Nagashima, S Nakamura, YI Hayashi, N Kohno, S

M. Oka et al., Phase I study of irinotecan and cisplatin with concurrent split-course radiotherapy in unresectable and locally advanced non-small cell lung cancer, EUR J CANC, 37(11), 2001, pp. 1359-1365

30

INGLESE

Article

Oncology,"Onconogenesis & Cancer Research

EUROPEAN JOURNAL OF CANCER

0959-8049 → ACNP

37

11

2001

1359 - 1365

ISI

0959-8049(200107)37:11<1359:PISOIA>2.0.ZU;2-Q

We conducted a phase I study of irinotecan (CPT-11) and cisplatin with conc urrent split-course radiotherapy in locally advanced stage III non-small ce ll lung cancer (NSCLC). This study aimed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of this therapy. Two chemother apy 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 eac h chemotherapy cycle, with 24 Gy and 36 Gy administered for the first and s econd 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)), a nd 23 patients were evaluated for toxicity and clinical outcome. Only 1 pat ient experienced a DLT with neutropenia and diarrhoea at 60/60 mg/m(2). Dos e escalation was limited to 60/80 mg/m(2) which was the recommended dose fo r CPT-11/cisplatin alone in NSCLC. Tumour responses included one complete r esponse (CR), 15 partial response (PR), and 7 no change (NC), and the overa ll 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 th is modality is recommended for phase II study. (C) 2001 Elsevier Science Lt d. All rights reserved.