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For patients with resectable gastric/gastroesophageal junction (GEJ) adenocarcinoma, the standard of care is surgery plus perioperative platinum-based chemotherapy
.
However, perioperative chemotherapy remains controversial for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) gastric/GEJ adenocarcinomas
.
The NEONIPIGA trial is a phase 2 study evaluating nivolumab (240 mg/2 weeks*6 times) + ipilimumab (1 mg/kg 6 weeks*2 times) neoadjuvant therapy, followed by surgery and adjuvant nivolumab (480 mg/4 weeks)
.
The primary endpoint was pathological complete response (pCR) rate
.
Between October 2019 and June 2021, a total of 32 patients with dMMR/MSI-H gastric/GEJ adenocarcinoma were recruited, with a median age of 65.
5 years (range: 40-80 years)
.
Clinical stages were cT2-T3N0 (n=9), cT2-T3N1 (n=22) and cT3N1M1 (n=1)
.
Treatment Response for Each Patient
With a median follow-up of 14.
9 months, 32 patients received neoadjuvant therapy (27 completed all courses of therapy)
.
Neoadjuvant therapy-related grade 3-4 adverse events occurred in 6 (19%) patients
.
Twenty-nine patients underwent surgery; 3 did not, with complete remission on endoscopy, no tumor biopsy, and normal computed tomography (two refused surgery and one had metastases at the time of inclusion)
.
Adverse reactions
All 29 patients achieved R0 resection, and 17 (58.
6%) achieved pathological complete remission (pathological T0N0)
.
Of the 29 patients who underwent surgery, 23 received adjuvant nivolumab
.
At the time of analysis, no patients had relapsed and one patient died (not the cause of relapse)
.
In conclusion, for patients with dMMR/MSI-H resectable gastric/gastroesophageal junction adenocarcinoma, nivolumab- and ipilimumab-based neoadjuvant therapy is feasible, with a high pathological complete response rate and no Unexpected toxicity
.
Original source:
Thierry André, et al.
Neoadjuvant Nivolumab Plus Ipilimumab and Adjuvant Nivolumab in Localized Deficient Mismatch Repair/Microsatellite Instability-High Gastric or Esophagogastric Junction Adenocarcinoma: The GERCOR NEONIPIGA Phase II Study.
Journal of Clinical Oncology.
August 13, 2022.
https:// ascopubs.
org/doi/full/10.
1200/JCO.
22.
00686
