title: 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.
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.
  
  
  BACKGROUND
  NCT00677443 and May 12 2008.
authors.forename: Seung Tae
authors.initials: ST
authors.lastname: Kim
authors.forename: Yong Sang
authors.initials: YS
authors.lastname: Hong
authors.forename: Ho Yeong
authors.initials: HY
authors.lastname: Lim
authors.forename: Jeeyun
authors.initials: J
authors.lastname: Lee
authors.forename: Tae Won
authors.initials: TW
authors.lastname: Kim
authors.forename: Kyu-Pyo
authors.initials: KP
authors.lastname: Kim
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Kim
authors.forename: Ji Yeon
authors.initials: JY
authors.lastname: Baek
authors.forename: Jee Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Keun-Wook
authors.initials: KW
authors.lastname: Lee
authors.forename: Ik-Joo
authors.initials: IJ
authors.lastname: Chung
authors.forename: Sang-Hee
authors.initials: SH
authors.lastname: Cho
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Shin
authors.forename: Hye Jin
authors.initials: HJ
authors.lastname: Kang
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.forename: Jae Won
authors.initials: JW
authors.lastname: Lee
authors.forename: Sook Jung
authors.initials: SJ
authors.lastname: Jo
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 135-710, Korea. pys27hmo@skku.edu.
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage*; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000008:administration & dosage*; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000069287:Capecitabine; D005472:Fluorouracil