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Chin J Cancer. 2016 Jan 6;35:8. doi: 10.1186/s40880-015-0061-3.

Phase II study of oxaliplatin combined with S-1 and leucovorin (SOL) for Chinese patients with metastatic colorectal cancer.

Wang ZQ1,2, Zhang DS3,4, Xu N5, Luo DY6, Deng YH7, Wang FH8,9, Luo HY10,11, Qiu MZ12,13, Li YH14,15, Xu RH16,17.

Author information

1
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, 510060, Guangzhou, Guangdong, P. R. China. wangzhq@sysucc.org.cn.
2
Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. wangzhq@sysucc.org.cn.
3
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, 510060, Guangzhou, Guangdong, P. R. China. zhangdsh@sysucc.org.cn.
4
Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. zhangdsh@sysucc.org.cn.
5
Department of Medical Oncology, The First Affiliated Hospital of College of Medicine, Zhejiang University, 310003, Hangzhou, Zhejiang, P. R. China. xunonghz@163.com.
6
Department of Medical Oncology, West China Hospital of Sichuan University, 610041, Chengdu, Sichuan, P. R. China. luodeyun999@163.com.
7
Department of Medical Oncology, The Sixth Affiliated Hospital of Sun Yat-sen University, 510655, Guangzhou, Guangdong, P. R. China. 13925106525@139.com.
8
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, 510060, Guangzhou, Guangdong, P. R. China. wangfh@sysucc.org.cn.
9
Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. wangfh@sysucc.org.cn.
10
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, 510060, Guangzhou, Guangdong, P. R. China. luohy@sysucc.org.cn.
11
Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. luohy@sysucc.org.cn.
12
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, 510060, Guangzhou, Guangdong, P. R. China. qiumzh@sysucc.org.cn.
13
Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. qiumzh@sysucc.org.cn.
14
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, 510060, Guangzhou, Guangdong, P. R. China. liyh@sysucc.org.cn.
15
Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. liyh@sysucc.org.cn.
16
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, 510060, Guangzhou, Guangdong, P. R. China. xurh@sysucc.org.cn.
17
Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, 510060, Guangzhou, Guangdong, P. R. China. xurh@sysucc.org.cn.

Abstract

BACKGROUND:

Fluoropyrimidine and oxaliplatin are widely used for patients with colorectal cancer. This phase II study was conducted to evaluate the efficacy and safety of the combination of S-1, oxaliplatin, and leucovorin (SOL) in the treatment of Chinese patients with metastatic colorectal cancer (mCRC).

METHODS:

Eligible patients with untreated mCRC from four hospitals in China received intravenous oxaliplatin (85 mg/m(2)) on day 1, oral S-1 twice daily (80-120 mg per day) on day 1-7, and leucovorin twice daily (50 mg per day) simultaneously with S-1, every 2 weeks.

RESULTS AND DISCUSSION:

Forty patients were enrolled in our study. In total, 296 cycles of SOL were administered. The overall response rate was 50.0%. At a median follow-up of 27 months, progression-free survival and overall survival were 7.0 months (95% confidence interval [CI] 6.0-10.6 months) and 22.2 months (95% CI 15.1-29.3 months), respectively. The most common grade 3/4 non-hematological adverse events were diarrhea (n = 8, 20.0%), nausea (n = 3, 7.5%), and vomiting (n = 3, 7.5%). The most common grade 3/4 hematological toxicities were thrombocytopenia (n = 3, 7.5%), neutropenia (n = 1, 2.5%), and abnormal alanine transaminase/aspartate transaminase levels (n = 1, 2.5%). There was one treatment-related death.

CONCLUSIONS:

The data indicate that the SOL regimen is effective and moderately tolerated in Chinese patients with mCRC.

TRIAL REGISTRATION:

CLINICAL TRIAL INFORMATION:

ChiCTR-TNRC-100000838.

PMID:
26739998
PMCID:
PMC4704394
DOI:
10.1186/s40880-015-0061-3
[Indexed for MEDLINE]
Free PMC Article

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