229P - A single arm, multicenter, phase II trial of oxaliplatin plus capecitabine in the perioperative treatment of locally advanced gastric adenocarcinom...

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Cytotoxic agents
Gastric Cancer
Surgical oncology
Presenter liu Tianshu
Citation Annals of Oncology (2016) 27 (suppl_9): ix68-ix85. 10.1093/annonc/mdw582
Authors L. Tianshu1, Y. Yu1, Y. Sun2, Y. Min3, H. Cao4, L. Yingbin5, Y. Wang1
  • 1Medical Oncology, Zhongshan Hospital, Fudan University, 200032 - Shanghai/CN
  • 2Department Of General Surgery, Zhongshan Hospital, Fudan University, 200032 - Shanghai/CN
  • 3Department Of General Surgery, Shanghai Ruijin Hospital, Shanghai Jiao Tong University, College of Medicine, 200025 - Shanghai/CN
  • 4Department Of Gastrointestinal Surgery, Shanghai Renji Hospital, 201202 - Shanghai/CN
  • 5Department Of General Surgery, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, 200032 - Shanghai/CN

Abstract

Background

Local advanced gastric carcinoma (LAGC) including stage IB, II and III disease is suggested to be potentially cured by R0 resection. Adjuvant chemotherapy such as oxaliplatin plus capecitabine or S1 can increase the overall survival of patients with early stage but not prolong the survival of patients with more progressive, later stage such as stage III gastric cancer. It’s needed to evaluate whether preoperative chemotherapy combined with D2 gastrectomy plus adjuvant chemotherapy can provide longer survival to those patients. In this study, we plan to evaluate the efficacy and safety of neoadjuvant chemotherapy with oxaliplatin plus capecitabine in more progressive LAGC.

Methods

This single arm, open-label, multicenter, phase II trial included 54 patients from 4 clinical sites across China. Patients with newly diagnosed gastric adenocarcinoma, clinically diagnosed stage T2-3/N+M0 or T4aN+M0 according to CT/MRI scan, and judged to be resectable at laparoscopy were enrolled. Patients were treated by capecitabine (1000 mg/m2, bid, day 1∼14 every 3 weeks) plus oxaliplatin (130 mg/m2, d1, every 3 weeks) . After receiving 4 cycles of preoperative XELOX, patients without progressive disease were given surgical evaluation and those who were supposed to be curable were given radical D2 gastrectomy; then the patients will receive another 4 cycles of chemotherapy within 8 weeks after resection. The primary endpoint was the response rate (ORR) of neoadjuvant chemotherapy. Secondary end-points included D2 gastrectomy rate, pathological response, 3-year progression free survival (PFS) rate, 5-year overall survival (OS) rate, health-related quality of life (HRQoL) and safety profiles.

Results

Recruitment finished in Apr 2016. One patient underwent emergency gastrectomy before the first assessment because of tumor hemorrhage. Total 27 patients developed partial response according to Recist 1.1.The ORR was 50%, which met the prospective primary endpoint. The D2 gastrectomy rate was 87%.

Conclusions

These findings suggest that neoadjuvant chemotherapy followed by D2 gastrectomy might be effective in later stage LAGC.

Clinical trial indentification

NCT01880632

Legal entity responsible for the study

Tianshu LIu

Funding

Shanghai Roche Pharmaceuticals Limited

Disclosure

L. Tianshu, Y. Yu, Y. Sun, Y. Min, H. Cao, L. Yingbin: We acknowledge Shanghai Roche Pharmaceuticals Limited for providing Xeloda®. All other authors have declared no conflicts of interest.