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Proffered Paper 2 – Gastrointestinal tumours, non-colorectal

3635 - Perioperative Chemotherapy of Oxaliplatin Combined with S-1 (SOX) versus Postoperative Chemotherapy of SOX or Oxaliplatin with Capecitabine (XELOX) in Locally Advanced Gastric Adenocarcinoma with D2 Gastrectomy: a Randomized Phase III Trial (RESOLVE Trial)

Date

29 Sep 2019

Session

Proffered Paper 2 – Gastrointestinal tumours, non-colorectal

Presenters

Jiafu Ji

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

J. Ji1, L. Shen2, Z. Li1, X. Zhang2, H. Liang3, Y. Xue4, Y. Wang5, Z. Zhou6, J. Yu7, L. Chen8, Y. Du9, G. Li10, G. Xiao11, D. Wu12, Y. Zhou13, C. Dang14, Y. He15, Z. Zhang16, Y. Sun17, Y. Li18

Author affiliations

  • 1 Gastrointestinal Cancer Center, Peking University Cancer Hospital-Beijing Cancer Hospital, 100142 - Beijing/CN
  • 2 Department Of Gastrointestinal Oncology, Peking University Cancer Hospital-Beijing Cancer Hospital, 100142 - Beijing/CN
  • 3 Department Of Surgery, Tianjin Medical University Cancer Institute & Hospital, Tianjin/CN
  • 4 Department Of Surgery, Harbin Medical University Cancer Hospital, Harbin/CN
  • 5 Department Of Surgery, Fudan University Shanghai Cancer Center, Shanghai/CN
  • 6 Department Of Surgery, Sun Yat-sen University Cancer Center, Guangzhou/CN
  • 7 Department Of Surgery, the First Affiliated Hospital, Zhejiang University, 000000 - Zhejiang/CN
  • 8 Department Of Surgery, Chinese PLA General Hospital, 000000 - Beijing/CN
  • 9 Department Of Surgery, Zhejiang Cancer Hospital, 000000 - Zhejiang/CN
  • 10 Department Of Surgery, East theater General Hospital of PLA, 000000 - Jiangsu/CN
  • 11 Department Of Surgery, Beijing Hospital, 000000 - Beijing/CN
  • 12 Department Of Surgery, the Second Affiliated Hospital of Zhejiang University School of Medicine, 000000 - Zhejiang/CN
  • 13 Department Of Surgery, the Affiliated Hospital of Qingdao University, 000000 - Qingdao/CN
  • 14 Department Of Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, 000000 - Xi'an/CN
  • 15 Department Of Surgery, the First Affiliated Hospital, Sun Yat-sen University, 000000 - Guangzhou/CN
  • 16 Department Of Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing/CN
  • 17 Department Of Surgery, Zhongshan Hospital Fudan University, Shanghai/CN
  • 18 Department Of Surgery, The Fourth Hospital of Hebei Medical University, shijiazhuang/CN
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Resources

Abstract 3635

Background

Surgery alone is not sufficient to achieve satisfactory prognosis for locally advanced gastric cancer (LAGC), and perioperative therapies have been proposed to improve survival outcome. However, the optimal modality and regimen of perioperative chemotherapy are yet to be identified. This study compared the efficacy and safety of SOX as perioperative chemotherapy versus SOX or XELOX as postoperative chemotherapy after D2 gastrectomy in patients with LAGC.

Methods

The RESOLVE Trial is a three-arm, randomized, multicenter, open-label phase III trial. Patients with stage cT4a/N+M0 or cT4bNxM0 gastric or gastro-esophageal junction adenocarcinoma were enrolled. All patients received standard gastrectomy with D2 lymphadenectomy. Arms A and B respectively received 8 cycles of adjuvant XELOX (capecitabine 1000 mg/m2, bid, d1-14, oxaliplatin 130 mg/m2, d1, q3W) or SOX (TS-1: 40-60 mg bid, d1-14, oxaliplatin: 130 mg/m2 d1, q3W). Arm C received 3 cycles of neoadjuvant SOX and 5 cycles of adjuvant SOX followed by 3 cycles of TS-1. The primary endpoint was 3-year disease-free survival rate (3yDFS%) in the mITT population.

Results

A total of 1094 patients were randomized between 08/2012 and 02/2017, 364/365/365 in arm A/B/C, and 454 recurrences/deaths were observed by 07/2019. Baseline characteristics were similar between arms (overall, male 75.2%; median age 60.0 years; GEJ 36.5%). Peri-operative SOX improved 3yDFS% compared with post-operative XELOX (3yDFS%, 62.0% in Arm C, 54.8% in Arm A; HR 0.79, 95%CI [0.62-0.99]; p = 0.045). Post-operative SOX was non-inferior to post-operative XELOX (3yDFS%, 60.3% in Arm B, 54.8% in Arm A; HR 0.85, 95%CI [0.67-1.07]; p = 0.162). Resection rate was 90.4% in Arm A, 92.7% in Arm B, and 85.5% in Arm C, respectively. Thirty-day mortality rate was all 0.9% for Arms A, B and C.

Conclusions

Perioperative SOX is superior to post-operative XELOX while post-operative SOX is non-inferior to post-operative XELOX for LAGC after D2 gastrectomy. It provides the evidence of perioperative SOX in LAGC.

Clinical trial identification

NCT01534546.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Taiho Pharmaceutical Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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