566P - Randomized phase II study of oxaliplatin and S-1 (OS) versus oxaliplatin and capecitabine (XELOX) in patients with metastatic or recurrent colorecta...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anticancer agents
Colon and Rectal Cancer
Biological Therapy
Presenter Dae Young Zang
Authors D.Y. Zang1, I.J. Chung2, H. Oh3, K.U. Park4, K.H. Lee5, B. Han6, D.R. Choi6, H.S. Kim6, J.H. Kim6
  • 1Clinical Research Division, Hallym University Medical Center Hallym University College of Medicine, 431-070 - Anyang/KR
  • 2Medical Oncology, Chonnam National University Hwasun Hospital, KR-519-763 - Jeollanamdo/KR
  • 3Internal Medicine, Gangneung Asan Hospital, Gangneung/KR
  • 4Internal Medicine, Dongsan Medical Center, Keimyung University, Daegu/KR
  • 5Internal Medicine, Yeungnam University Hospital, Daegu/KR
  • 6Internal Medicine, Hallym University Medical Center Hallym University College of Medicine, 431-070 - Anyang/KR



Combination oxaliplatin and S-1 (OS) or oxaliplatin and capecitabine (XELOX) chemotherapy have shown significant efficacy in advanced colorectal cancer. To evaluate those efficacy and safety, we performed a randomized phase II study in patients with metastatic or recurrent colorectal cancer.


Eligible patients were those who had measurable lesions and had no previous history of chemotherapy except adjuvant chemotherapy. Eight-eight patients were randomly assigned to receive oxaliplatin 130 mg/m2 was administered intravenously on day 1 and S-1 80 mg/m2 (OS, arm A) or capecitabine 2,000 mg/m2 (XELOX, arm B) was administered orally on days 1-14. Cycles were repeated every 21 days. Patients were treated until proved to have disease progression or unacceptable toxicity. The primary endpoint of the study was to assess the overall response rate (ORR).


Characteristics of the patients were well-balanced between arms, except for primary disease site, where the percentage of colon, rectosigmoid, and rectum were 42%, 16%, and 42% (arm A) and 58%, 22%, and 20% (arm B), and number of metastatic organs, where the percentage of less than 1 and more than 2 were 53% and 47% (arm A) and 67% and 33% (arm B). A total of 284 cycles (median 6, range 1-39) in Arm A; 298 cycles (median 5, range 1-19) in arm B were administered. Eighty-three (41 for arm A and 42 for arm B) patients were evaluated for toxicity and response. The main toxicities were thrombocytopenia [grade 1/2/3/4 = 8/10/7/1 patients (A); 10/10/7/5 (B)], neutropenia [grade 1/2/3/4 = 9/8/1/0 (A); 8/12/5/2 (B)], anemia [grade 1/2/3/4 = 21/13/3/1 (A); 20/11/4/0 (B)], peripheral neuropathy [grade 1/2/3 = 11/10/0 (A); 11/8/3 (B)], and hand-foot syndrome [grade 1/2/3 = 2/0/0 (A); 7/1/2 (B)]. There were 3 CR, 11 PR, 25 SD and 2 PD (A); 5 CR, 13 PR, 16 SD and 7 PD (B). The confirmed ORR in the intention-to-treat population was 32.6% (95% CI: 18.6-47.4%) in arm A and 40.0% (95% CI, 25.0-55.0%) in arm B. The median time to progression was 6.7 (95% CI, 4.8-8.7) months (A) and 8.0 (95% CI, 6.3-9.6) months (B). The median survival time was 19.0 (95% CI, 7.6-30.5) months (A) and 22.1 (95% CI, 17.9-26.3) months (B).


These data suggest that both OS and XELOX regimens are active and are well tolerated regimens in patients with metastatic or recurrent colorectal cancer.


All authors have declared no conflicts of interest.