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

Zhi-Qiang Wang, Dong-Sheng Zhang, Nong Xu, De-Yun Luo, Yan-Hong Deng, Feng-Hua Wang, Hui-Yan Luo, Miao-Zhen Qiu, Yu-Hong Li, Rui-Hua Xu, Zhi-Qiang Wang, Dong-Sheng Zhang, Nong Xu, De-Yun Luo, Yan-Hong Deng, Feng-Hua Wang, Hui-Yan Luo, Miao-Zhen Qiu, Yu-Hong Li, Rui-Hua Xu

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.

Clinical trial information: ChiCTR-TNRC-100000838.

Figures

Fig. 1
Fig. 1
Kaplan-Meier curves of progression-free survival and overall survival for 40 Chinese patients with metastatic colorectal cancer. a The estimated progression-free survival was 7.0 months (95% confidence interval [CI] 6.0–10.6 months). b The estimated overall survival was 22.2 months (95% CI 15.1–29.3 months)

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Source: PubMed

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