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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

Authors
Kim, Seung TaeHong, Yong SangLim, Ho YeongLee, JeeyunKim, Tae WonKim, Kyu-PyoKim, Sun YoungBaek, Ji YeonKim, Jee HyunLee, Keun-WookChung, Ik-JooCho, Sang-HeeLee, Kyung HeeShin, Sang JoonKang, Hye JinShin, Dong BokLee, Jae WonJo, Sook JungPark, Young Suk
Issue Date
26-11월-2014
Publisher
BIOMED CENTRAL LTD
Keywords
Capecitabine; S-1; Colorectal cancers
Citation
BMC CANCER, v.14
Indexed
SCIE
SCOPUS
Journal Title
BMC CANCER
Volume
14
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/96733
DOI
10.1186/1471-2407-14-883
ISSN
1471-2407
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/m(2) twice daily on days 1-14 and oxaliplatin 130 mg/m(2) on day 1) versus SOX (S-1 40 mg/m(2) twice daily on days 1-14 and oxaliplatin 130 mg/m(2) 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.
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