CRS With HIPEC Offers Better PFS, MFS for Gastric Cancer Than Chemotherapy, CRS Alone

Chemotherapy has long been the treatment of choice for patients who experience peritoneal metastasis (PM) from gastric cancer (GC). As the significance of treatments such as cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is still being determined, a phase 3 trial led by Dr. Beate Rau, of the Berlin School of Integrative Oncology, sought to determine the impact of HIPEC on overall survival (OS) in patients after undergoing CRS.

The randomized, controlled, open-label, multicenter trial enrolled 105 patients with GC and PM. Patients were randomly assigned 1:1 to receive either perioperative chemotherapy plus CRS alone (CRS-A) or CRS plus HIPEC (CRS+H). HIPEC comprised mitomycin C 15 mg/m² and cisplatin 75 mg/m² in 5 L of saline perfused for 60 minutes at 107.6°F.

Patients were assigned treatment between March 2014 and June 2018, with 53 patients receiving CRS-A and 52 receiving CRS+H. The primary end point was OS, and secondary end points included progression-free survival (PFS), other distant metastasis-free survival (MFS), and safety. The trial was stopped prematurely due to slow recruitment, and in 55 patients, treatment was stopped before CRS mainly due to disease progression or death.

The median OS was the same in both treatment groups (CRS-A, 14.9 [97.2% CI, 7.0-19.4] months vs CRS+H, 14.9 [97.2% CI, 8.7-17.7] months; P=.1647). In the CRS-A group, the PFS was 3.5 months (95% CI, 3.0-7.0), and it was 7.1 months (95% CI, 3.7-10.5; P=.047) in the CRS+H group. The CRS+H group had better MFS (10.2 months [95% CI, 7.7-14.7] vs CRS-A, 9.2 months [95% CI, 6.8-11.5]; P=.0286). The incidence of grade ≥3 adverse events (AEs) was similar between groups (CRS-A, 38.1% vs CRS+H, 43.6%; P=.79).

The study demonstrated no difference in OS between treatment with CRS-A or CRS+H, yet PFS and MFS were significantly better in the CRS+H treatment group. HIPEC was not found to increase AEs. Further exploration in future trials is needed.