Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial

被引：43

作者：

Zheng, Yanan ^{[1
]}

Yang, Xiao ^{[1
]}

Yan, Chao ^{[1
]}

Feng, Runhua ^{[1
]}

Sah, Birendra Kumar ^{[1
]}

Yang, Zhongyin ^{[1
]}

Zhu, Zhenglun ^{[1
]}

Liu, Wentao ^{[1
]}

Xu, Wei ^{[1
]}

Ni, Zhentian ^{[1
]}

Beeharry, Maneesh Kumarsing ^{[1
]}

Hua, Zichen ^{[1
]}

Yan, Min ^{[1
]}

Zhu, Zhenggang ^{[1
]}

Li, Chen ^{[1
]}

机构：

[1] Shanghai Jiao Tong Univ, Dept Gastrointestinal Surg, Shanghai Inst Digest Surg, Ruifin Hosp,Sch Med,Shanghai Key Lab Gastr Neopla, Shanghai, Peoples R China

来源：

EUROPEAN JOURNAL OF CANCER | 2020年 / 130卷

关键词：

S-1; Oxaliplatin; Neoadjuvant therapy; Apatinib; Gastric cancer; PREOPERATIVE CHEMOTHERAPY; CANCER; S-1; CISPLATIN; OXALIPLATIN; BEVACIZUMAB; DOCETAXEL; MULTICENTER; GASTRECTOMY; THERAPY;

D O I：

10.1016/j.ejca.2020.02.013

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: The evidence of combining neoadjuvant chemotherapy with targeted therapy for patients with locally advanced gastric cancer is inadequate. We conducted a single-arm phase II trial to evaluate the efficacy and safety of S-1, oxaliplatin and apatinib (SOXA) in patients with locally advanced gastric adenocarcinoma. Methods: Treatment-nai<spacing diaeresis>ve patients received three preoperative cycles of S-1 (80-120 mg/day on days 1-14) and oxaliplatin (130 mg/m(2) on day 1) and two cycles of apatinib (500 mg/day for 21 days) at 3-week intervals, followed by surgery. The primary end-point was pathologic response rate (pRR). This trial is registered at ChiCTR.gov.cn: ChiCTR-OPC-16010061. Results: Of 29 patients included, median age was 60 (range, 43-73) years; 20 (69.0%) were male. The pRR was 89.7% (95% confidence interval [CI], 72.7%-97.8%; 26 of 29 patients; P < 0.001) with 28 patients treated with surgery. All 29 patients were available for preoperative response evaluation, achieving an objective response rate of 79.3% (95% CI, 60.3% -92.0%) and a disease control rate of 96.6% (95% CI, 82.2%-99.9%). The margin-free resection rate was 96.6% (95% CI, 82.2%-99.9%). The pathologic complete response rate was 13.8% (95%CI, 1.2% -26.3%). Downstaging of overall TNM stage was observed in 16(55.2%) patients. During neoadjuvant therapy, 10 ( 34.5%) patients had grade >= III adverse events. No treatment- related death occurred. Surgery-related complications were observed in 12 of 28 (42.9%) patients. Conclusion: SOXA followed by surgery in patients with locally advanced gastric adenocarcinoma showed favourable activity and manageable safety. A randomised controlled trial in locally advanced gastric or oesophagogastric junction adenocarcinoma is ongoing (Clinical-Trials.gov:NCT04208347). (C) 2020 The Authors. Published by Elsevier Ltd. This is an open access

引用

页码：12 / 19

页数：8

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