TY - JOUR
T1 - Oxaliplatin/fluorouracil/leucovorin (FOLFOX4 and modified FOLFOX6) in patients with refractory or advanced colorectal cancer
T2 - Post-approval Japanese population experience
AU - Shimizu, Toshio
AU - Satoh, Taroh
AU - Tamura, Kenji
AU - Ozaki, Tomohiro
AU - Okamoto, Isamu
AU - Fukuoka, Masahiro
AU - Nakagawa, Kazuhiko
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2007/6
Y1 - 2007/6
N2 - Background. The oxaliplatin/fluorouracil/leucovorin (FOL-FOX regimen) is an effective and generally well-tolerated regimen in Western clinical studies of advanced colorectal cancer. In Japan, oxaliplatin was approved in April 2005. Methods. To evaluate the objective tumor responses and feasibility (toxicities) of FOLFOX regimens (FOLFOX4 and modified FOLFOX6, mFOLFOX6) in a predominantly Japanese population with refractory or advanced colorectal cancer in Japan, 51 consecutive patients with histologically confirmed metastatic colon or rectum cancer who were treated between April 2005 and March 2006 were enrolled in a retrospective study. FOLFOX4 was used for treatment in 39% (first-line, 45%) of these patients, and mFOLFOX6 was used for treatment in 61% (first-line, 61%). Tumor responses were assessed radiologically, and toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 regarding toxicities other than peripheral sensory neuropathy. Results. The objective response rates (in those who underwent first- or second-line therapy) were 50.0% and 8.7%, respectively. The tumor control rate (partial response [PR] + stable disease [SD]) was 80.4%. There were no toxicity-related deaths. Neutropenia grade 3 was experienced in 20% of patients, and often caused delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 78% of patients. The incidence of hypersensitivity reactions to oxaliplatin in our study was lower than that in reported in Western countries. Conclusion. Both FOLFOX regimens have good efficacy in refractory or advanced colorectal cancer in a Japanese population, with an acceptable overall toxicity profile.
AB - Background. The oxaliplatin/fluorouracil/leucovorin (FOL-FOX regimen) is an effective and generally well-tolerated regimen in Western clinical studies of advanced colorectal cancer. In Japan, oxaliplatin was approved in April 2005. Methods. To evaluate the objective tumor responses and feasibility (toxicities) of FOLFOX regimens (FOLFOX4 and modified FOLFOX6, mFOLFOX6) in a predominantly Japanese population with refractory or advanced colorectal cancer in Japan, 51 consecutive patients with histologically confirmed metastatic colon or rectum cancer who were treated between April 2005 and March 2006 were enrolled in a retrospective study. FOLFOX4 was used for treatment in 39% (first-line, 45%) of these patients, and mFOLFOX6 was used for treatment in 61% (first-line, 61%). Tumor responses were assessed radiologically, and toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 regarding toxicities other than peripheral sensory neuropathy. Results. The objective response rates (in those who underwent first- or second-line therapy) were 50.0% and 8.7%, respectively. The tumor control rate (partial response [PR] + stable disease [SD]) was 80.4%. There were no toxicity-related deaths. Neutropenia grade 3 was experienced in 20% of patients, and often caused delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 78% of patients. The incidence of hypersensitivity reactions to oxaliplatin in our study was lower than that in reported in Western countries. Conclusion. Both FOLFOX regimens have good efficacy in refractory or advanced colorectal cancer in a Japanese population, with an acceptable overall toxicity profile.
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U2 - 10.1007/s10147-007-0658-x
DO - 10.1007/s10147-007-0658-x
M3 - Article
C2 - 17566846
AN - SCOPUS:34250650940
VL - 12
SP - 218
EP - 223
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
SN - 1341-9625
IS - 3
ER -