腹腔内注射紫杉醇、S-1联合静脉注射顺铂和紫杉醇用于ⅢA期或ⅢB期胃癌新辅助化疗的Ⅱ期试验

Phase II trial of neoadjuvant chemotherapy with intraperitoneal paclitaxel, S-1, and intravenous cisplatin and paclitaxel for stage IIIA or IIIB gastric cancer.

作者信息

Shinkai Masayuki, Imano Motohiro, Chiba Yasutaka, Iwama Mitsuru, Shiraisi Osamu, Yasuda Atsushi, Tsubaki Masanobu, Nishida Shozo, Kimura Yutaka, Yasuda Takushi

机构信息

Department of Surgery, Faculty of Medicine, Kindai University, Osakasayama, Japan.

Clinical Research Center, Kindai University Hospital, Osakasayama, Japan.

出版信息

J Surg Oncol. 2019 Jan;119(1):56-63. doi: 10.1002/jso.25295. Epub 2018 Nov 15.

DOI:10.1002/jso.25295

PMID:30444009

Abstract

BACKGROUND

We carried out a phase II trial to evaluate the feasibility and efficacy of neoadjuvant chemotherapy comprising a single intraperitoneal administration of paclitaxel, followed by intravenous administrations of paclitaxel and cisplatin with S-1 for clinical stage III gastric cancer.

METHODS

Patients with potentially resectable gastric cancer were eligible. A laparoscopic survey was performed to confirm CY0 and P0. Intraperitoneal paclitaxel (60 mg/m ) was administered, followed by systemic chemotherapy. Surgery was performed after two cycles of chemotherapy. The primary endpoint was the response rate of chemotherapy. Secondary endpoints were adverse events, pathological response rate, and overall survival rate.

RESULTS

Twenty patients were enrolled. Planned cycles were completed in all patients. Grade 3/4 leukopenia and grade 3/4 neutropenia were observed in four (20%) and seven (35%) patients, respectively. The overall response rate was 70% (partial response: 14, stable disease: 5, progressive disease: 1). All patients underwent R0 gastrectomy with D2 lymph-node dissection, with no surgery-related deaths. The pathological response rate was 65% (13 of 20). The 3- and 5-year overall survival rates were 90.0% and 77.1%, respectively.

CONCLUSIONS

Neoadjuvant chemotherapy including intraperitoneal paclitaxel followed by sequential intravenous paclitaxel and cisplatin with S-1 for resectable advanced gastric cancer is feasible and effective.

摘要

背景

我们开展了一项II期试验，以评估新辅助化疗的可行性和疗效，该化疗方案为单次腹腔内注射紫杉醇，随后静脉注射紫杉醇和顺铂以及S-1，用于治疗临床III期胃癌。

方法

符合条件的患者为潜在可切除的胃癌患者。进行腹腔镜检查以确认CY0和P0。腹腔内注射紫杉醇（60mg/m²），随后进行全身化疗。化疗两个周期后进行手术。主要终点是化疗的缓解率。次要终点是不良事件、病理缓解率和总生存率。

结果

招募了20名患者。所有患者均完成了计划的周期。分别有4名（20%）和7名（35%）患者出现3/4级白细胞减少和3/4级中性粒细胞减少。总缓解率为70%（部分缓解：14例，病情稳定：5例，病情进展：1例）。所有患者均接受了D2淋巴结清扫的R0胃切除术，无手术相关死亡。病理缓解率为65%（20例中的13例）。3年和5年总生存率分别为90.0%和77.1%。