Background: In this study, we compared the efficacy and safety of the oral fluoropyrimidine S-1 as monotherapy or in combination with leucovorin as the second-line treatment for patients with metastatic pancreatic cancer whose disease had progressed on gemcitabine treatment.
Methods: The study was a randomized, open-label, controlled study. Patients randomly received S-1 or S-1 in combination with leucovorin (SL arm) in 21-day cycles. The primary endpoint was the 6-month survival rate.
Results: A total of 92 patients were randomized to S-1 (n = 47) and SL (n = 45). No statistically significant differences were observed between the two arms with regard to 6-month survival rates (40% vs. 49%), median overall survival (5.5 vs. 6.3 months), median progression-free survival (1.9 vs. 3.0 months), and overall response rate (4.7% vs. 8.3%). The rate of major grade 3-4 adverse events of digestive toxicity was significantly higher in the SL arm than in the S-1 arm.
Conclusion: Compared with S-1, SL did not improve the survival of patients with metastatic pancreatic cancer who had failed to benefit from prior gemcitabine treatment, but SL had a higher adverse event rate.
摘要
背景. 本研究旨在比较口服氟尿嘧啶 S-1 单药或联合亚叶酸钙用于二线治疗吉西他滨治疗后疾病进展的转移性胰腺癌的有效性和安全性。
方法. 本研究为随机、开放标签、对照试验。患者随机接受 S-1 或 S-1 联合亚叶酸钙（SL组）治疗，每 21 天为 1 周期。主要终点为 6 个月生存率。
结果. 共 92 例患者随机分配至 S-1 组（n=47）和 SL 组（n=45）。两组 6 个月生存率（40% vs. 49%）、中位总生存（5.5个月 vs. 6.3个月）、中位无进展生存（1.9个月 vs. 3.0个月）、总缓解率（4.7% vs. 8.3%）无统计学差异。SL 组主要 3∼4 级不良事件发生率显著高于 S-1 组。
结论. 对于吉西他滨治疗后未能获益的转移性胰腺癌患者，与 S-1 相比，SL 并未提高生存率，反而提高了不良事件发生率。The Oncologist 2014;19: 1133-1134
Trial registration: ClinicalTrials.gov NCT01074996.
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