Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Department of Biostatistics, Yonsei University College of Medicine, Seoul, Korea.
Cancer Res Treat. 2019 Jan;51(1):1-11. doi: 10.4143/crt.2018.028. Epub 2018 Feb 5.
We conducted a randomized, multicenter, phase III trial to compare S-1 plus docetaxel (DS) with S-1 plus cisplatin (SP) as adjuvant chemotherapy for stage III gastric cancer patients.
Stage III gastric cancer patients who had received curative gastrectomy with D2 lymphadenectomy were randomized into equal groups to receive adjuvant chemotherapy of eight cycles of DS (S-1 70 mg/m2 /day on days 1-14 plus docetaxel 35 mg/m2 on days 1 and 8) every 3 weeks or SP (S-1 70 mg/m2 /day on days 1-14 plus cisplatin 60 mg/m2 on day 1) every 3 weeks. The primary endpoint was 3-year disease-free survival (DFS) rate.
Between November 2010 and July 2013, 153 patients (75 patients to DS and 78 patients to SP) were enrolled from 8 institutions in Korea. After the capecitabine plus oxaliplatin was approved based on the CLASSIC study, itwas decided to close the study early. With a median follow-up duration of 56.9 months, the 3-year DFS rate between two groups was not significantly different (49.14% in DS group vs. 52.5% in SP group). The most common grade 3-4 adverse event was neutropenia (42.7% in DS and 38.5% in SP, p=0.351). SP group had more grade 3-4 anemia (1.3% vs. 11.5%, p=0.037), whereas grade 3-4 hand-foot syndrome (4.1% vs. 0%, p=0.025) and mucositis (10.7% vs. 2.6%, p=0.001) were more common in DS group. Fifty-one patients (68%) in DS group and 52 (66.7%) in SP group finished planned treatment.
Our findings suggest that SP or DS is an effective and tolerable option for patients with curatively resected stage III gastric cancer.
我们进行了一项随机、多中心、III 期临床试验，旨在比较 S-1 联合多西他赛（DS）与 S-1 联合顺铂（SP）作为 III 期胃癌患者的辅助化疗方案。
接受根治性胃切除术并进行 D2 淋巴结清扫术的 III 期胃癌患者被随机分为两组，分别接受 8 个周期的辅助化疗，即每 3 周接受一次 DS（S-1 70mg/m2/天，第 1-14 天；多西他赛 35mg/m2/天，第 1 和第 8 天）或 SP（S-1 70mg/m2/天，第 1-14 天；顺铂 60mg/m2/天，第 1 天）。主要终点是 3 年无病生存率（DFS）。
2010 年 11 月至 2013 年 7 月，来自韩国 8 家机构的 153 名患者（75 名患者接受 DS 治疗，78 名患者接受 SP 治疗）入组。在卡培他滨联合奥沙利铂基于 CLASSIC 研究被批准后，决定提前关闭该研究。中位随访 56.9 个月后，两组 3 年 DFS 率无显著差异（DS 组为 49.14%，SP 组为 52.5%）。最常见的 3-4 级不良事件为中性粒细胞减少症（DS 组为 42.7%，SP 组为 38.5%，p=0.351）。SP 组贫血 3-4 级发生率较高（1.3%比 11.5%，p=0.037），而 DS 组手足综合征 3-4 级发生率较高（4.1%比 0%，p=0.025）和黏膜炎 3-4 级发生率较高（10.7%比 2.6%，p=0.001）。DS 组 51 名（68%）患者和 SP 组 52 名（66.7%）患者完成了计划的治疗。
我们的研究结果表明，SP 或 DS 是可切除 III 期胃癌患者的有效且耐受良好的选择。
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