Esophagus to Small Intestine
J Clin Oncol. 2024;42(2):146–56
Effect of hyperthermic intraperitoneal chemotherapy on cytoreductive surgery in gastric cancer with synchronous peritoneal metastases: The Phase 3 GASTRIPEC-I trial
Purpose: In patients with peritoneal metastasis (PM) from gastric cancer (GC), chemotherapy is the treatment of choice. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) are still being debated. This randomized, controlled, open-label, multicenter phase 3 trial explored the impact on overall survival (OS) of HIPEC after CRS. Patients and methods: Adult patients with GC and histologically proven PM were randomly assigned (1:1) to perioperative chemotherapy and CRS alone (CRS-A) or CRS plus HIPEC (CRS+H). HIPEC comprised mitomycin C 15 mg/m² and cisplatin 75 mg/m² in 5 liters of saline perfused for 60 minutes at 42 °C. The primary end point was OS; secondary end points included progression-free survival (PFS), other distant metastasis-free survival (MFS), and safety. Analyses followed the intention-to-treat principle.
Results: Between March 2014 and June 2018, 105 patients were randomly assigned (53 patients to CRS-A and 52 patients to CRS+H). The trial stopped prematurely because of slow recruitment. In 55 patients, treatment stopped before CRS mainly due to disease progression/death. Median OS was the same for both groups (CRS+H, 14.9 months [97.2% confidence interval {CI}: 8.7–17.7] vs. CRS-A, 14.9 months [97.2% CI: 7.0–19.4]; p = 0.1647). The PFS was 3.5 months (95% CI: 3.0–7.0) in the CRS-A group and 7.1 months (95% CI: 3.7–10.5; p = 0.047) in the CRS+H group. The CRS+H group showed better MFS (10.2 months [95% CI: 7.7–14.7] vs. CRS-A, 9.2 months [95% CI: 6.8–11.5]; p = 0.0286). The incidence of grade ≥ 3 adverse events was similar between groups (CRS-A, 38.1% vs. CRS+H, 43.6%; p = 0.79).
Conclusion: This study showed no difference in overall survival between cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) (CRS+H) and CRS alone. Progression-free survival and metastasis-free survival were significantly better in the CRS+H group, which needs further exploration. HIPEC did not increase adverse events.
DOI: 10.1200/jco.22.02867