title: A Muti-center, Randomized Phase II Study of Oxaliplatin and S-1 versus Capecitabine and Oxaliplatin in Patients with Metastatic Colorectal Cancer.
abstract: BACKGROUND
  Capecitabine plus oxaliplatin (XELOX) is considered one of the primary chemotherapy regimens for patients with metastatic colorectal cancer (CRC). Oxaliplatin plus S-1 (OS) has also demonstrated significant efficacy in CRC. We performed this randomized phase II study to evaluate the efficacy and toxicity of XELOX versus OS as first-line chemotherapy in patients with metastatic CRC.
  
  
  METHODS
  Patients were assigned randomly to receive either OS or XELOX chemotherapy. Oxaliplatin was administered intravenously to all patients at a dose of 130 mg/m(2) on day 1. Patients received either S-1 (40 mg/m(2)) or capecitabine (1,000 mg/m(2)), twice a day for 2 weeks, followed by a 1-week rest.
  
  
  RESULTS
  Forty-two patients were assigned to the OS arm and 44 to the XELOX arm. The overall response rate was 33.3% (95% CI, 18.8-47.2) in the OS arm and 40.9% (95% CI, 25.5-54.4) in the XELOX arm (P = 0.230). The disease control rate was significantly higher in the OS arm than the XELOX arm [92.9% (95% CI, 83.7-100) versus 77.3% (95% CI, 64.5-89.4), P = 0.044]. With a median follow up of 17.9 months, the median progression-free survival was 6.1 months in the OS arm and 7.4 months in the XELOX arm, respectively (P = 0. 599). The median survival time was 18.7 months in the OS arm and 20.1 months in the XELOX arm (P = 0.340). The most common grade 3/4 hematologic toxicity was thrombocytopenia in both arms (19.0% for OS and 28.6% for XELOX). Grade 3/4 neutropenia was observed more frequently in the XELOX arm than the OS arm (16.7% vs. 2.4%, P = 0.026).
  
  
  CONCLUSIONS
  Both OS and XELOX were effective and well tolerated in patients with metastatic CRC. Our results indicate that the combination of oxaliplatin and S-1 is a possible additional therapeutic strategy for such patients.
authors.affiliation: 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Jung Han
authors.initials: JH
authors.lastname: Kim
authors.affiliation: 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
authors.affiliation: 2. Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, South Korea.
authors.forename: Ik-Joo
authors.initials: IJ
authors.lastname: Chung
authors.affiliation: 2. Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, South Korea.
authors.forename: Sang-Hee
authors.initials: SH
authors.lastname: Cho
authors.affiliation: 3. Department of Internal Medicine, Keimyung University College of Medicine, Daegu, South Korea.
authors.forename: Keon Uk
authors.initials: KU
authors.lastname: Park
authors.affiliation: 4. Department of Internal Medicine, Gangneung Asan Hospital, Gangneung, South Korea.
authors.forename: Ho-Suck
authors.initials: HS
authors.lastname: Oh
authors.affiliation: 5. Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea.
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.affiliation: 6. Department of Surgery, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Bong Hwa
authors.initials: BH
authors.lastname: Lee
authors.affiliation: 7. Department of Radiology, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Min-Jeong
authors.initials: MJ
authors.lastname: Kim
authors.affiliation: 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Choong Kee
authors.initials: CK
authors.lastname: Park
authors.affiliation: 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Boram
authors.initials: B
authors.lastname: Han
authors.affiliation: 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Hyeong Su
authors.initials: HS
authors.lastname: Kim
authors.affiliation: 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Dae Ro
authors.initials: DR
authors.lastname: Choi
authors.affiliation: 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Hun Ho
authors.initials: HH
authors.lastname: Song
authors.affiliation: 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
authors.forename: Joo Young
authors.initials: JY
authors.lastname: Jung
keywords: Capecitabine; Colorectal neoplasm; Oxaliplatin; Randomized controlled trial; S-1