A Muti-center, Randomized Phase II Study of Oxaliplatin and S-1 versus Capecitabine and Oxaliplatin in Patients with Metastatic Colorectal Cancer.

Kim, Jung Han; Zang, Dae Young; Chung, Ik-Joo; Cho, Sang-Hee; Park, Keon Uk; Oh, Ho-Suck; Lee, Kyung Hee; Lee, Bong Hwa; Kim, Min-Jeong; Park, Choong Kee; Han, Boram; Kim, Hyeong Su; Choi, Dae Ro; Song, Hun Ho; Jung, Joo Young
Journal of Cancer
2015NA ; 6 ( 10 ) :1041-8.
저자 상세정보
Kim, Jung Han - 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Zang, Dae Young - 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Chung, Ik-Joo - 2. Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, South Korea.
Cho, Sang-Hee - 2. Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, South Korea.
Park, Keon Uk - 3. Department of Internal Medicine, Keimyung University College of Medicine, Daegu, South Korea.
Oh, Ho-Suck - 4. Department of Internal Medicine, Gangneung Asan Hospital, Gangneung, South Korea.
Lee, Kyung Hee - 5. Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea.
Lee, Bong Hwa - 6. Department of Surgery, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Kim, Min-Jeong - 7. Department of Radiology, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Park, Choong Kee - 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Han, Boram - 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Kim, Hyeong Su - 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Choi, Dae Ro - 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Song, Hun Ho - 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
Jung, Joo Young - 1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea.
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). CONCLUSION: 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.
keyword
Capecitabine; Colorectal neoplasm; Oxaliplatin; Randomized controlled trial; S-1
링크

주제코드
주제명(Target field)
연구대상(Population)
연구참여(Sample size)
대상성별(Gender)
질병특성(Condition Category)
연구환경(Setting)
연구설계(Study Design)
연구기간(Period)
중재방법(Intervention Type)
중재명칭(Intervention Name)
키워드(Keyword)
유효성결과(Recomendation)
Both OS and XELOX were effective and well tolerated palliative treatment regimens in patients with recurrent or metastatic CRC.
연구비지원(Fund Source)
근거수준평가(Evidence Hierarchy)
출판년도(Year)
참여저자수(Authors)
대표저자
DOI
10.7150/jca.12819
KCD코드
ICD 03
건강보험코드