As reported in the Journal of Clinical Oncology by Rau et al, the German phase III GASTRIPEC-I trial showed no improvement in overall survival with the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to cytoreductive surgery in patients with gastric cancer and synchronous peritoneal metastases. However, the addition of HIPEC was associated with improved progression-free and distant metastasis–free survival.
Study Details
In the open-label multicenter trial, 105 patients were randomly assigned between March 2014 and June 2018 to receive perioperative chemotherapy plus cytoreductive surgery alone (n = 53) or cytoreductive surgery with HIPEC (n = 52). HIPEC consisted of mitomycin at 15 mg/m2 and cisplatin at 75 mg/m2 in 5 L of saline perfused for 60 minutes at 42°C.
Trial recruitment was stopped early due to slow patient accrual. The primary endpoint was overall survival in the intent-to-treat population.
Key Findings
A total of 11 patients (21.2%) in the cytoreductive surgery/HIPEC group and 13 (24.5%) in the cytoreductive surgery group had unresectable tumors due to disease progression. Cytoreductive surgery with the goal of complete cytoreduction was possible in 28 patients (53.8%) in the cytoreductive surgery/HIPEC group and 22 patients (41.5%) in the cytoreductive surgery group.
Median overall survival was 14.9 months (97.2% confidence interval [CI] = 8.7–17.7 months) in the cytoreductive surgery/HIPEC group vs 14.9 months (97.2% CI = 7.0–19.4 months) in the cytoreductive surgery group (P = .1647). Rates at 1, 2, and 3 years were 58.2% vs 60.5%, 25.5% vs 15.4%, and 13.6% vs 0.0%, respectively.
Median progression-free survival was 7.1 months (95% CI = 3.7–10.5 months) in the cytoreductive surgery/HIPEC group vs 3.5 months (95% CI = 3.0–7.0 months) in the cytoreductive surgery group (P = .047). Rates at 1, 2, and 3 years were 21.4% vs 17.8%, 10.7% vs 0.0%, and 10.7% vs 0.0%, respectively.
Median distant metastasis–free survival was 10.2 months (95% CI = 7.7–14.7 months) in the cytoreductive surgery/HIPEC group vs 9.2 months (95% CI = 6.8–11.5 months) in the cytoreductive surgery group (P = .0286). Rates at 1, 2, and 3 years were 42.6% vs 31.3%, 17.7% vs 0.0%, and 13.3% vs 0.0%, respectively.
Grade ≥ 3 adverse events occurred in 43.6% of the cytoreductive surgery/HIPEC group vs 38.1% of the cytoreductive surgery group (P = .79).
The investigators concluded, “This study showed no overall survival difference between cytoreductive surgery plus HIPEC and cytoreductive surgery alone. Progression-free survival and metastasis-free survival were significantly better in the cytoreductive surgery plus HIPEC group, which needs further exploration. HIPEC did not increase [rates of] adverse events.”
Beate Rau, MD, PhD, MBA, of the Department of Surgery, Charité-Universitätsmedizin Berlin, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by German Cancer Aid. For full disclosures of the study authors, visit ascopubs.org.
