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S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for the first-line treatment of patients with metastatic colorectal cancer: updated results from a phase 3 trial

Cited 14 time in Web of Science Cited 15 time in Scopus
Authors
Kim, Seung Tae; Hong, Yong Sang; Lim, Ho Yeong; Lee, Jeeyun; Kim, Tae Won; Kim, Kyu-Pyo; Kim, Sun Young; Baek, Ji Yeon; Kim, Jee Hyun; Lee, Keun-Wook; Chung, Ik-Joo; Cho, Sang-Hee; Lee, Kyung Hee; Shin, Sang Joon; Kang, Hye Jin; Shin, Dong Bok; Lee, Jae Won; Jo, Sook Jung; Park, Young Suk
Issue Date
2014-11-26
Publisher
BioMed Central
Citation
BMC Cancer, 14(1):883
Keywords
CapecitabineS-1Colorectal cancers
Description
This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited.
Abstract
Abstract

Background
We report updated progression-free survival (PFS) and overall survival (OS) data from a trial that compared capecitabine plus oxaliplatin (CapeOX) versus S-1 plus oxaliplatin (SOX) for the first-line treatment of metastatic colorectal cancer.


Methods
This trial was a randomized, two-armed, non-inferiority phase 3 comparison of CapeOX (capecitabine 1000 mg/m2 twice daily on days 1–14 and oxaliplatin 130 mg/m2 on day 1) versus SOX (S-1 40 mg/m2 twice daily on days 1–14 and oxaliplatin 130 mg/m2 on day 1). The primary end point was to show non-inferiority of SOX relative to CapeOX in terms of PFS. Thus, a follow-up exploratory analysis of PFS and OS was performed.


Results
The intention to treat (ITT) population was comprised of 340 patients (SOX arm: 168 and CapeOX arm: 172). The updated median PFS was 7.1 months (95% CI 6.4-8.0) in the SOX group and 6.3 months (95% CI 4.9-6.7) in the CapeOX group (hazard ratio [HR], 0.83 [0.66-1.04], p = .10). The median OS was 19.0 months (95% CI 15.3-23.0) in the SOX group and 18.4 months (95% CI 14.1-20.7) in the CapeOX group (HR, 0.86 [0.68-1.08], p = .19). Subgroup analyses according to principal demographic factors such as sex, age, ECOG (Eastern Cooperative Oncology Group) performance status, primary tumor location, measurability, previous adjuvant therapy, number of metastatic organs, and liver metastases showed no interaction between any of these characteristics and the treatment.


Conclusions
Updated survival analysis shows that SOX is similar to CapeOX, confirming the initial PFS analysis. Therefore, the SOX regimen could be an alternative first-line doublet chemotherapy strategy for patients with metastatic colorectal cancer.


Trial registration


NCT00677443

and May 12 2008
Language
English
URI
https://hdl.handle.net/10371/100510
DOI
https://doi.org/10.1186/1471-2407-14-883
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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