Early results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 and docetaxel/cisplatin/S-1 as neoadjuvant chemotherapy for locally advanced gastric cancer
Early results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 and docetaxel/cisplatin/S-1 as neoadjuvant chemotherapy for locally advanced gastric cancer
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DOI：
10.1093/annonc/mdx236
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发表时间：
2017-08-01
影响因子：
50.5
通讯作者：
Yoshikawa, T.
中科院分区：
文献类型：
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作者：
Aoyama, T.;Nishikawa, K.;Yoshikawa, T.
背景：新辅助化疗(NAC)是一种有前景的提高可切除胃癌生存率的方法。顺铂/S-1(CS)和多西紫杉醇/顺铂/S-1(DC)对转移性胃癌均有效。本报告阐明了这些方案对早期终点的影响，包括病理反应、化疗相关毒性、方法：交界型或硬化型M0、T4或T3型患者接受顺铂(60 mg/m(2)，第8天)/S-1(80 mg/m(2)，21天，休息1周)或多西紫杉醇(40 mg/m(2，第1天))/顺铂(60 mg/m(2)，第1天)/S-1(80 mg/m(2)，14天，休息2周)2~4个疗程的NAC。术后行D2胃大部切除术，辅以S-1化疗，疗程1年。结果：从2011年10月至2014年9月，132例患者被分配到CS组(n=66，2个疗程33例，4个疗程33例)或DC组(n=66，2个疗程33例，4个疗程33例)。主要的3级或4级血液学毒性(CS/DC)分别为白细胞减少(14.1%/26.2%)、中性粒细胞减少(29.7%/47.7%)、贫血(14.1%/12.3%)和血小板减少(3.1%/1.5%)。病理缓解率，定义为完全缓解或残留癌灶的10%，CS组为19.4%，DC组为15.4%，两疗程组为15.6%，四疗程组为19.0%。两个疗程组和四个疗程组的R0切除率分别为72.7%、81.8%、80.3%和74.2%。没有观察到与治疗相关的死亡。结论：我们的结果不支持紫杉烷三联疗法胜过两药疗法，或者任何超过两个周期的进一步治疗都不是NAC试验组的有吸引力的候选方案。
Background: Neoadjuvant chemotherapy (NAC) is a promising method of improving the survival of resectable gastric cancer. Cisplatin/S-1 (CS) and docetaxel/cisplatin/S-1 (DCS) are both effective against metastatic gastric cancer. This report clarified the impact of these regimens on early endpoints, including the pathological responses, chemotherapy-related toxicities, and surgical results.Methods: Patients with M0 and either T4 or T3 in case of junctional cancer or scirrhous type received two or four courses of cisplatin (60 mg/m(2) at day 8)/S-1 (80 mg/m(2) for 21 days with 1 week rest) or docetaxel (40 mg/m(2) at day 1)/cisplatin (60 mg/m(2) at day 1)/S-1 (80 mg/m(2) for 14 days with 2 weeks rest) as NAC. Patients then underwent D2 gastrectomy and adjuvant S-1 chemotherapy for 1 year. The primary endpoint was the 3-year overall survival.Results: Between October 2011 and September 2014, 132 patients were assigned to receive CS (n = 66; 33 in 2 courses and 33 in 4 courses) or DCS (n = 66; 33 in 2 courses and 33 in 4 courses). The respective major grade 3 or 4 hematological toxicities (CS/DCS) were leukocytopenia (14.1%/26.2%), neutropenia (29.7%/47.7%), anemia (14.1%/12.3%), and platelet reduction (3.1%/1.5%). The rate of pathological response, defined as a complete response or< 10% residual cancer remaining, was 19.4% in the CS group and 15.4% in the DCS group, and 15.6% in the two-course group and 19.0% in the 4-course group. The R0 resection rate was 72.7% in the CS group and 81.8% in the DCS group and 80.3% in the two-course group and the 74.2% in the four-course group. No treatment-related deaths were observed.Conclusions: Our results do not support three-drug therapy with a taxane over two-drug therapy, or any further treatment beyond two cycles as an attractive candidate for the test arm of NAC.