Department of Radiation Oncology, Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College, Beijing 100021, People's Republic of China.
Department of Pancrea-gastric Surgery, Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College, Beijing 100021, People's Republic of China.
Br J Cancer. 2018 Feb 6;118(3):338-343. doi: 10.1038/bjc.2017.424. Epub 2017 Dec 12.
This phase I/II clinical trial investigated S-1 administered with intensity-modulated radiotherapy (IMRT) as adjuvant therapy for node-positive gastric cancer. Patients had undergone radical resection and D1/D2 lymph node dissection.
In phase I, patients received adjuvant chemoradiotherapy of IMRT (45 Gy in 25 fractions) with concurrent S-1 administered on a dose-escalation schedule to determine the recommended dose (RD). In phase II, the safety and efficacy of the RD of S-1 combined with IMRT were assessed.
We consecutively enrolled 73 patients (56 men; median age, 53 years; range, 29-73 years) and the phase I portion of the study included 27 patients. The RD of S-1 administered concomitantly with IMRT was 80 mg m day orally, twice daily. The phase II analysis included 52 patients (46 new patients plus 6 from phase I). 8 patients (15.4%) developed grade 3 or 4 toxicities. There were 21 recurrence events and 15 deaths (1 bowel obstruction, 14 gastric cancer). Three-year disease-free survival and overall survival were 62.2% (95% confidence interval (CI), 48.5-75.9) and 70.0% (95% CI, 56.3-83.7), respectively. The median time to recurrence was 17.5 months (range, 3.8-42.0). The median time from recurrence to death was 7.0 months (range, 1.5-28.7).
S-1 combined with IMRT adjuvant chemoradiotherapy is safe and efficacious for advanced gastric cancer.
这项 I/II 期临床试验研究了 S-1 联合强度调制放疗（IMRT）作为淋巴结阳性胃癌辅助治疗的效果。患者接受了根治性切除术和 D1/D2 淋巴结清扫术。
在 I 期，患者接受 IMRT（45Gy，25 次分割）辅助化疗和同步 S-1 剂量递增方案的辅助放化疗，以确定推荐剂量（RD）。在 II 期，评估 RD 剂量 S-1 联合 IMRT 的安全性和有效性。
我们连续入组了 73 例患者（56 例男性；中位年龄 53 岁；范围 29-73 岁），其中 I 期包括 27 例患者。RD 剂量 S-1 与 IMRT 同步给药剂量为 80mg·m·day，每日 2 次。II 期分析包括 52 例患者（46 例新患者和 I 期的 6 例患者）。8 例（15.4%）患者发生 3 或 4 级毒性。共有 21 例复发事件和 15 例死亡（1 例肠梗阻，14 例胃癌）。3 年无疾病生存率和总生存率分别为 62.2%（95%可信区间（CI），48.5-75.9）和 70.0%（95% CI，56.3-83.7）。中位复发时间为 17.5 个月（范围 3.8-42.0）。从复发到死亡的中位时间为 7.0 个月（范围 1.5-28.7）。
S-1 联合 IMRT 辅助放化疗治疗晚期胃癌安全有效。
