In an Italian phase III trial (HORSE; MITO-18) reported in Journal of Clinical Oncology, Fagotti et al found that the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to secondary cytoreductive surgery without neoadjuvant chemotherapy did not improve progression-free survival vs no HIPEC in platinum-sensitive recurrent epithelial ovarian cancer.
Study Details
The multicenter trial enrolled 167 patients between 2012 and January 2019. Patients with a platinum-free interval of more than 6 months and residual tumor ≤ 0.25 cm after secondary cytoreductive surgery were randomly assigned at the time of surgery to receive HIPEC consisting of cisplatin at 75 mg/m2 for 60 minutes at 41.5°C at the end of surgery (n = 82) or no HIPEC (n = 85). All patients received adjuvant chemotherapy. The primary endpoint was progression-free survival.
Key Findings
Median follow-up was 83 months (interquartile range = 64–102 months). Median progression-free survival was 23 months (95% confidence interval [CI] = 17–29 months) with surgery alone vs 25 months (95% CI = 18–32 months) with surgery plus HIPEC (hazard ratio [HR] = 1.02, 95% CI = 0.73–1.42, P = .91). The rate at 2 years was 47.3% vs 51.1%. Totals of 78 patients in the surgery group and 81 in the surgery-plus-HIPEC group received at least three cycles of adjuvant chemotherapy.
Median postrecurrence survival was 101 months (95% CI = 51–151 months) with surgery alone vs 91.0 months (95% CI = 79–103 months) with surgery plus HIPEC (P = .40). The likelihood of postrecurrence survival at 5 years was 61.6% (95% CI = 50.8%–72.4%) in the surgery group vs 75.9% (95% CI = 66.5%–85.3%) in the surgery-plus-HIPEC group.
Grade 3 or 4 adverse events occurred in 6 patients (7.1%) in the surgery group and 10 patients (12.2%) in the surgery-plus-HIPEC group (P = .26). No deaths within 30 or 90 days after surgery were observed in either group. Late postoperative complications occurred in 8.2% vs 6.1% of patients (P = .83).
The investigators concluded: “The addition of HIPEC to complete or nearly complete primary [secondary cytoreductive surgery] did not confer a benefit in terms of [progression-free survival] in patients with platinum-sensitive peritoneal recurrence.”
Anna Fagotti, MD, PhD, of the Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was reported by the Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome. For full disclosures of the study authors, visit ascopubs.org.
