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
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.