The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to complete cytoreductive surgery significantly improves overall survival in patients with platinum-sensitive, late-relapsing epithelial ovarian cancer, according to results from the phase III CHIPOR trial.
The open-label, multicenter CHIPOR trial, conducted across 31 hospitals and cancer centers in France, Belgium, Spain, and Canada, enrolled 415 patients with a first relapse of epithelial ovarian cancer at least 6 months after completing first-line platinum-based chemotherapy. Patients were randomized 1:1 to undergo complete cytoreductive surgery with (n = 207) or without (n = 208) HIPEC. The HIPEC regimen consisted of a 60-minute infusion of 75 mg/m2 of cisplatin in 2 L/m2 of serum at 41°C ± 1°C.
The primary endpoint was overall survival in the intention-to-treat population. After a median follow-up of 6.2 years, HIPEC significantly improved overall survival (stratified hazard ratio = 0.73, 95% confidence interval [CI] = 0.56–0.96; P = .024). The median overall survival was 54.3 months (95% CI = 41.9–61.7 months) with HIPEC plus surgery, compared to 45.8 months (95% CI = 38.9–54.2 months) with surgery alone.
Safety and Tolerability
Grade 3 or higher adverse events within 60 days after surgery were more frequent in the HIPEC group (49%) compared to the surgery-alone group (27%). The most common adverse events in the HIPEC group included anemia (23% vs 14%), hepatotoxicity (11% vs 9%), electrolyte disturbance (14% vs 1%), and renal failure (10% vs 1%). Three patients died within 60 days of cytoreductive surgery, all of whom were in the surgery-alone group.
Expert Commentary
"CHIPOR provides robust evidence that hyperthermic intraperitoneal chemotherapy improves overall survival in patients undergoing complete cytoreductive surgery for platinum-sensitive recurrent ovarian cancer," the investigators concluded. They also noted that while toxicity was increased with HIPEC, there was no detectable detrimental effect on quality of life or increase in pain in the immediate postoperative period. The investigators recommend that HIPEC should be administered in specialist centers with experience in preventing and managing toxicities and with access to prophylactic thiosulfate.
Jean-Marc Classe, MD, of Institut de Cancérologie de l'Ouest, Saint Herblain, France, is the corresponding author of the article published in The Lancet Oncology.
