Division of Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Invest New Drugs. 2012 Feb;30(1):357-63. doi: 10.1007/s10637-010-9515-2. Epub 2010 Aug 24.
Although its efficacy is unproven, 5-fluorouracil plus cisplatin (FP) is used to prevent postoperative relapse in gastric cancer. We investigated the safety and feasibility of S-1 plus cisplatin (SP) vs. FP for stage IIIB-IV (M0) gastric cancer.
Following curative resection, 41 stage IIIB-IV (M0) gastric cancer patients were assigned to SP (eight 14-day cycles of S-1 [40 mg/m(2) twice daily] plus cisplatin [60 mg/m(2) day 1] administered every 3 weeks) or FP (six 3-day cycles of FU [1 g/m(2) per day] plus cisplatin [80 mg/m(2) day 1] every 4 weeks). Doses were reduced based on predefined criteria.
Patient characteristics were balanced between the two arms. In total, 124 cycles of SP (N = 20, median = 7, range 1-8) and 113 cycles of FP (N = 21, median 6, range 1-6) were administered. The median relative dose intensity per patient was 75% (49.99-100%) for S-1, 100% (75-100%) for cisplatin in SP, and 100% (64-100%) for 5-FU, 100% (60-100%) for cisplatin in FP. The relative dose intensity of FP was stable, while that of SP decreased during treatment. After median follow-up of 7.9 months (3.8-14.55), the median RFS was not reached. Relapse occurred in two (10%) patients on SP and five (23.8%) in the FP arm (P = 0.24). The incidence of grade 3-4 granulocytopenia was 36.8% with SP and 14.3% with FP. Grade 3-4 non-hematologic toxicities included fatigue (5.2% with SP vs. 4.8% with FP), vomiting (10.5% with SP vs. 0% with FP), and infection (5.2% with SP vs. 0% FP).
S-1 plus cisplatin was feasible and tolerable as adjuvant treatment for stage IIIB-IV (M0) gastric cancer. However, because of decreased relative dose intensity during treatment, further study is warranted to determine optimal dosage and combination.
尽管其疗效尚未得到证实，但氟尿嘧啶加顺铂（FP）仍被用于预防胃癌的术后复发。我们研究了 S-1 加顺铂（SP）与 FP 预防 IIIB-IV 期（M0）胃癌的安全性和可行性。
在根治性切除术后，41 例 IIIB-IV 期（M0）胃癌患者被分为 SP 组（8 个 14 天周期的 S-1[40mg/m2，每天 2 次]加顺铂[60mg/m2，第 1 天]，每 3 周给药一次）或 FP 组（6 个 3 天周期的氟尿嘧啶[1g/m2，每天 1 次]加顺铂[80mg/m2，第 1 天]，每 4 周给药一次）。根据预设标准减少剂量。
两组患者的特征均衡。总共给予 SP 组 124 个周期（N=20，中位数=7，范围 1-8）和 FP 组 113 个周期（N=21，中位数 6，范围 1-6）。每位患者的相对剂量强度中位数为 S-1 的 75%（49.99-100%），SP 中顺铂的 100%（75-100%），FP 中氟尿嘧啶的 100%（64-100%），顺铂的 100%（60-100%）。FP 的相对剂量强度稳定，而 SP 的相对剂量强度在治疗期间下降。中位随访 7.9 个月（3.8-14.55）后，中位 RFS 未达到。SP 组有 2 例（10%）患者复发，FP 组有 5 例（23.8%）患者复发（P=0.24）。SP 组的 3-4 级粒细胞减少症发生率为 36.8%，FP 组为 14.3%。3-4 级非血液学毒性包括疲劳（SP 组 5.2%，FP 组 4.8%）、呕吐（SP 组 10.5%，FP 组 0%）和感染（SP 组 5.2%，FP 组 0%）。
S-1 加顺铂作为 IIIB-IV 期（M0）胃癌的辅助治疗是可行和耐受的。然而，由于治疗期间相对剂量强度下降，需要进一步研究以确定最佳剂量和组合。
