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

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 ade...

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Published in:European journal of cancer (1990) 2020-05, Vol.130, p.12-19
Main Authors: Zheng, Yanan, Yang, Xiao, Yan, Chao, Feng, Runhua, Sah, Birendra Kumar, Yang, Zhongyin, Zhu, Zhenglun, Liu, Wentao, Xu, Wei, Ni, Zhentian, Beeharry, Maneesh Kumarsing, Hua, Zichen, Yan, Min, Zhu, Zhenggang, Li, Chen
Format: Article
Language:English
Subjects:
Adenocarcinoma
Apatinib
Chemotherapy
Complications
Confidence intervals
Disease control
Gastric cancer
Neoadjuvant therapy
Oxaliplatin
Patients
S-1
Safety management
Surgery
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Summary: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. Treatment-naïve patients received three preoperative cycles of S-1 (80–120 mg/day on days 1–14) and oxaliplatin (130 mg/m2 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. 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 
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2020.02.013