In:
Oncology, S. Karger AG, Vol. 82, No. 4 ( 2012), p. 242-248
Abstract:
〈 i 〉 Objective: 〈 /i 〉 To evaluate the safety and efficacy of combination chemotherapy with 5-fluorouracil (5-FU), leucovorin, irinotecan and oxaliplatin (FOLFOXIRI) in Japanese patients with advanced colorectal cancer. 〈 i 〉 Methods: 〈 /i 〉 This phase I dose-finding study was designed to determine the maximum tolerated dose (MTD), recommended dose (RD) or both of FOLFOXIRI. Patients with 〈 i 〉 UDP-glucuronosyltransferase (UGT) 1A1 〈 /i 〉 * 〈 i 〉 6 〈 /i 〉 /* 〈 i 〉 6 〈 /i 〉 , * 〈 i 〉 28 〈 /i 〉 /* 〈 i 〉 28 〈 /i 〉 and * 〈 i 〉 6 〈 /i 〉 /* 〈 i 〉 28 〈 /i 〉 genotypes were excluded, because these 〈 i 〉 UGT1A1 〈 /i 〉 genotypes are linked to severe neutropenia in Japanese. 〈 i 〉 Results: 〈 /i 〉 A total of 10 Japanese patients with advanced colorectal cancer were studied. The MTD of FOLFOXIRI in these Japanese patients was 165 mg/m 〈 sup 〉 2 〈 /sup 〉 irinotecan, 85 mg/m 〈 sup 〉 2 〈 /sup 〉 oxaliplatin and 2,400 mg/m 〈 sup 〉 2 〈 /sup 〉 5-FU. Accordingly, the RD of FOLFOXIRI was determined to be 150 mg/m 〈 sup 〉 2 〈 /sup 〉 irinotecan, 85 mg/m 〈 sup 〉 2 〈 /sup 〉 oxaliplatin and 2,400 mg/m 〈 sup 〉 2 〈 /sup 〉 5-FU. Toxic effects, evaluated until the completion of 4 cycles, were manageable. Grade 3–4 neutropenia occurred in 27% of cycles, but there was no febrile neutropenia. Among the 9 assessable patients, the objective response rate was 89%. 〈 i 〉 Conclusions: 〈 /i 〉 We thus determined the RD of FOLFOXIRI in Japanese patients with advanced colorectal cancer who do not have 〈 i 〉 UGT1A1 〈 /i 〉 * 〈 i 〉 28/ 〈 /i 〉 * 〈 i 〉 28 〈 /i 〉 , * 〈 i 〉 6/ 〈 /i 〉 * 〈 i 〉 6 〈 /i 〉 or * 〈 i 〉 6/ 〈 /i 〉 * 〈 i 〉 28 〈 /i 〉 genotypes. Our results indicate that FOLFOXIRI is a well-tolerated regimen for these Japanese patients.
Type of Medium:
Online Resource
ISSN:
0030-2414
,
1423-0232
Language:
English
Publisher:
S. Karger AG
Publication Date:
2012
detail.hit.zdb_id:
1483096-6
detail.hit.zdb_id:
250101-6
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