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可切除局部进展期胃癌新辅助化疗同步放疗 S-1 联合顺铂的 I 期临床研究(KOGC-01)

Phase I study of neoadjuvant chemoradiotherapy consisting of S-1 and cisplatin for patients with resectable advanced gastric cancer (KOGC-01).

机构信息

Keio Cancer Center, School of Medicine, Keio University, Shinjuku, Tokyo, Japan.

出版信息

Anticancer Res. 2011 Sep;31(9):3079-83.

PMID:21868563
Abstract

BACKGROUND

The prognosis for advanced gastric cancer is poor, with surgery as the only treatment for resectable advanced gastric cancer. Therefore, treatment options that might improve the prognosis are needed. To that end, neoadjuvant chemoradiotherapy with S-1 and cisplatin (CDDP) was investigated.

PATIENTS AND METHODS

The chemotherapy schedule included one cycle repeated after 6 weeks. S-1 was administered orally every day on days 1-21 and CDDP was infused on days 1, 8 and 15. Radiation therapy was started concurrently with chemotherapy and repeated daily on days 1-5, 8-12, 15-19, and 22-26.

RESULTS

A total of 10 patients were recruited. The first four patients were entered into level 1 (CDDP, 20 mg/m²). The next six patients were entered into level 0 (15 mg/m²), because of dose-limiting toxicity (delaying the second course of chemotherapy in two patients) that had been observed at level 1. The maximum tolerated dose (MTD) of CDDP was 20 mg/m². Seven patients underwent surgery and all had an R0 (no residual tumor) resection without surgical complications.

CONCLUSION

Neoadjuvant chemoradiotherapy with S-1 and CDDP may cause surgery to be delayed, but shows promise for resectable advanced gastric cancer.

摘要

背景

晚期胃癌预后较差,手术是可切除的晚期胃癌的唯一治疗方法。因此,需要寻找可能改善预后的治疗选择。为此,研究了 S-1 和顺铂(CDDP)的新辅助放化疗。

患者和方法

化疗方案包括每 6 周重复一个周期。S-1 每天口服,第 1-21 天,CDDP 在第 1、8 和 15 天输注。放射治疗与化疗同时开始,每天重复,第 1-5、8-12、15-19 和 22-26 天。

结果

共招募了 10 名患者。前 4 名患者进入 1 级(CDDP,20mg/m²)。由于在 1 级观察到剂量限制毒性(2 例患者延迟第二疗程化疗),随后的 6 名患者进入 0 级(15mg/m²)。CDDP 的最大耐受剂量(MTD)为 20mg/m²。7 名患者接受了手术,所有患者均行 R0(无残留肿瘤)切除术,无手术并发症。

结论

S-1 和 CDDP 的新辅助放化疗可能会延迟手术,但有望治疗可切除的晚期胃癌。

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