Phase II Study of Docetaxel and S-1 (DS) as Neoadjuvant Chemotherapy for Clinical Stage III Resectable Gastric Cancer
Phase II Study of Docetaxel and S-1 (DS) as Neoadjuvant Chemotherapy for Clinical Stage III Resectable Gastric Cancer
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DOI：
10.1245/s10434-014-3594-9
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发表时间：
2014-07-01
影响因子：
3.7
通讯作者：
Maehara, Yoshihiko
中科院分区：
文献类型：
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作者：
Oki, Eiji;Emi, Yasunori;Maehara, Yoshihiko
我们进行了一项II期试验，以评估术前化疗多西紫杉醇（DTX）加S-1治疗可切除的晚期胃癌的疗效和安全性。集中登记了来自14个中心的47例患者。患者在第1天和第15天接受DTX (35 mg/m(2))，并每4周每天口服S-1 （80 mg/m(2)/天），持续第1-14天，共2个疗程，随后进行胃切除术并D2淋巴结切除术。主要终点为病理反应率（pRR）。该研究已在UMIN临床试验注册中心注册（UMIN000000875）。主要终点pRR为47%(90%置信区间（CI）， 34- 60%；P < 0.0001)。采用实体瘤反应评价标准（RECIST）进行术前化疗的有效率为34%。46例（98%）患者行手术治疗，44例患者行根治性切除。37例患者完成了方案治疗。新辅助化疗最常见的毒性是3/4级中性粒细胞减少（42%），发热性中性粒细胞减少（4%），2级厌食症（21%）和疲劳（15%）。本研究未观察到治疗相关死亡和手术死亡率。多西紫杉醇联合S-1耐受良好。这是一种很有前景的术前化疗方案，用于有可能切除的晚期胃癌患者。
We conducted a phase II trial to evaluate the efficacy and safety of preoperative chemotherapy with docetaxel (DTX) plus S-1 for resectable advanced gastric cancer.A total of 47 patients from 14 centers were centrally registered. Patients received DTX (35 mg/m(2)) on days 1 and 15, and daily oral administration of S-1 (80 mg/m(2)/day) for days 1-14 every 4 weeks for two courses, followed by gastrectomy with D2 lymphadenectomy. The primary endpoint was pathological response rate (pRR). This study was registered in the UMIN clinical trial registry (UMIN000000875).The primary endpoint pRR was 47 % (90 % confidence interval (CI), 34-60 %; p < 0.0001). The response rate to preoperative chemotherapy using Response Evaluation Criteria in Solid Tumors (RECIST) was 34 %. Forty-six patients (98 %) underwent surgery, and curative resection was performed in 44 patients. Thirty-seven patients completed the protocol treatment. The most common toxicities of neoadjuvant chemotherapy were grade 3/4 neutropenia (42 %), febrile neutropenia (4 %), grade 2 anorexia (21 %), and fatigue (15 %). Treatment-related death and operative mortality was not observed in this study.The combination of docetaxel and S-1 was well tolerated. This is promising as a preoperative chemotherapy regimen for patients with potentially resectable advanced gastric cancer.