- The PRODIGY and RESOLVE trials show that perioperative therapy is superior to postoperative therapy in locally advanced, potentially resectable gastric cancer (T3-T4 and N+) in Asian patients.
- Both showed strong downsizing and downstaging of tumours and improved PFS.
Why this matters
- The trials confirm the results of European studies of perioperative therapy in this setting.
- These regimens are likely to become new standard of care options in locally advanced (cT3-4 and N+) gastric cancer in Asia.
- PRODIGY: 530 patients were randomised 1:1 to neoadjuvant docetaxel (D), oxaliplatin (O) and S-1 (S) (DOS) then surgery (D2 gastrectomy) and adjuvant S-1 (CSC; n=266), or surgery and adjuvant S-1 (SC; n=264). The primary endpoint was 3-year progression free survival (PFS).
- RESOLVE: Patients (n=1094) were randomised to A) adjuvant XELOX chemotherapy, B) adjuvant SOX chemotherapy, or C) 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 (DFS).
- Funding: Sanofi Korea (PRODIGY); Taiho Pharmaceutical Co., Ltd (RESOLVE).
- PRODIGY: addition of neoadjuvant DOS led to significant tumour downstaging and improved PFS, with acceptable safety. PFS at 3 years was 66.3% for CSC versus 60.2% for SC (hazard ratio 0.70 (95% CI 0.52–0.95), P=0.023.
- Overall survival data are immature and showed no significant difference between groups.
- RESOLVE: Perioperative SOX improved 3-year DFS compared with post-operative XELOX (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 noninferior to post-operative XELOX.
- Overall survival data remain immature.
- “The results of PRODIGY and RESOLVE bring into line the data for Asian and Caucasian patients on the perioperative use of chemotherapy,” said Professor Ian Chau (Royal Marsden Hospital, London), speaking to the ESMO Daily Reporter newspaper. Professor Chau was not involved in the study.