HIPEC May Benefit Certain Patients With Metastatic Gastric Cancer

Hyperthermic intraperitoneal chemotherapy (HIPEC) may benefit certain patients with gastric cancer and peritoneal metastases, according to researchers.

They found that adding HIPEC to cytoreductive surgery (CRS) and perioperative chemotherapy did not improve overall survival (OS) among all patients who received it, but HIPEC did improve OS in patients who had no macroscopic residual disease after CRS.

HIPEC also improved progression-free survival (PFS) and other distant metastases-free survival (MFS) in the overall trial population.

These results, from the phase 3 GASTROPEC-I trial (ClinicalTrials.gov Identifier: NCT02158988), were published in the Journal of Clinical Oncology.

The trial included 105 adults with gastric cancer and peritoneal metastases who were randomly assigned to receive perioperative chemotherapy and CRS or perioperative chemotherapy plus CRS and HIPEC.

The CRS-chemotherapy arm included 53 patients, and the HIPEC arm included 52 patients. However, 39 patients in the CRS-chemotherapy arm and 36 in the HIPEC arm were treated per protocol.

The primary endpoint, OS, was similar between the treatments arms both overall and in the per-protocol population. In the entire cohort, the median OS was 14.9 months in both arms (P =.1647). In the per-protocol cohort, the median OS was 13.2 months in the CRS-chemotherapy arm and 13.9 months in the HIPEC arm (P =.1353).

On the other hand, PFS and other distant MFS were improved in the HIPEC arm both in the overall study population and in the per-protocol population.

In the entire cohort, the median PFS was 3.5 months in the CRS-chemotherapy arm and 7.1 months in the HIPEC arm (P =.0472). The median PFS was the same in the per-protocol cohort — 3.5 months and 7.1 months, respectively (P =.0089).

In the entire cohort, the median other distant MFS was 9.2 months in the CRS-chemotherapy arm and 10.2 months in the HIPEC arm (P =.0286). In the per-protocol cohort, the median other distant MFS was 7.0 months and 9.0 months, respectively (P =.0034).

The researchers also conducted a planned subgroup analysis of 35 patients with no macroscopic residual disease after CRS — 16 of whom were in the CRS-chemotherapy arm and 19 of whom were in the HIPEC arm. The median OS was significantly improved with HIPEC in this group (P =.043).

“The addition of HIPEC significantly prolonged PFS and MFS but only showed an OS benefit in the subgroup of patients in whom a complete CRS could be performed,” the researchers wrote. “HIPEC shows benefit in a highly selected subgroup.”

The safety analysis included 50 patients in the CRS-chemotherapy arm and 50 in the HIPEC arm. The rate of grade 3-4 adverse events (AEs) was 76.0% in the CRS-chemotherapy arm and 84.0% in the HIPEC arm.

The rate of treatment-related AEs was 24.0% in the CRS-chemotherapy arm and 34.0% in the HIPEC arm. There were no fatal treatment-related AEs in the CRS-chemotherapy arm, but there were 2 in the HIPEC arm.

“Hyperthermic intraperitoneal chemotherapy has a debated role in advanced gastrointestinal cancers,” Eileen M. O’Reilly, MD, associate editor of the Journal of Clinical Oncology, wrote in a comment.

“The data from this randomized study inform that hyperthermic intraperitoneal chemotherapy following debulking surgery confers a palliative benefit in patients with metastatic GC [gastric cancer] with peritoneal metastases, with a subset having more durable benefit. The debate continues.”

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Rau B, Lang H, Koenigsrainer A, et al. Effect of hyperthermic intraperitoneal chemotherapy on cytoreductive surgery in gastric cancer with synchronous peritoneal metastases: The phase III GASTRIPEC-I trial. J Clin Oncol. Published online October 31, 2023. doi:10.1200/JCO.22.02867

This article originally appeared on Cancer Therapy Advisor