Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama.
Department of Surgery, Osaka National Hospital.
Ann Oncol. 2017 Aug 1;28(8):1876-1881. doi: 10.1093/annonc/mdx236.
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.
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/m2 at day 8)/S-1 (80 mg/m2 for 21 days with 1 week rest) or docetaxel (40 mg/m2 at day 1)/cisplatin (60 mg/m2 at day 1)/S-1 (80 mg/m2 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.
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.
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.
新辅助化疗（NAC）是提高可切除胃癌患者生存率的一种很有前途的方法。顺铂/替吉奥（CS）和多西他赛/顺铂/替吉奥（DCS）均对转移性胃癌有效。本报告阐明了这些方案对早期终点的影响，包括病理反应、化疗相关毒性和手术结果。
M0 期且交界部癌或硬癌型为 T4 或 T3 的患者接受两或四疗程顺铂（60mg/m2，第 8 天）/替吉奥（80mg/m2，21 天，休息 1 周）或多西他赛（40mg/m2，第 1 天）/顺铂（60mg/m2，第 1 天）/替吉奥（80mg/m2，14 天，休息 2 周）作为 NAC。患者随后接受 D2 胃切除术和替吉奥辅助化疗 1 年。主要终点是 3 年总生存率。
2011 年 10 月至 2014 年 9 月，132 例患者被分配接受 CS（n=66；2 疗程 33 例，4 疗程 33 例）或 DCS（n=66；2 疗程 33 例，4 疗程 33 例）治疗。各自主要的 3 级或 4 级血液学毒性（CS/DCS）为白细胞减少症（14.1%/26.2%）、中性粒细胞减少症（29.7%/47.7%）、贫血症（14.1%/12.3%）和血小板减少症（3.1%/1.5%）。CS 组病理完全缓解或＜10%残留癌的比例为 19.4%，DCS 组为 15.4%，2 疗程组为 15.6%，4 疗程组为 19.0%。CS 组 R0 切除率为 72.7%，DCS 组为 81.8%，2 疗程组为 80.3%，4 疗程组为 74.2%。未观察到与治疗相关的死亡。
我们的结果不支持用紫杉烷替代两药疗法，或任何进一步的两周期以上治疗作为 NAC 试验组的有吸引力的候选药物。
