- Second-look surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) offers no advantage over surveillance in 3-year disease-free survival in patients with colorectal cancer (CRC) at high risk for peritoneal metastases.
Why this matters
- Results from previous prospective, nonrandomized trials suggested that second-look surgery with HIPEC could prolong survival.
- Phase 3 randomized controlled trial (PROPHYLOCHIP–PRODIGE 15).
- After 6 months of adjuvant therapy with no disease recurrence, 150 patients were assigned to surveillance or second-look surgery plus oxaliplatin-HIPEC (oxaliplatin 460 mg/m2 or oxaliplatin 300 mg/m2 plus irinotecan 200 mg/m2, plus intravenous fluorouracil 400 mg/m2) or mitomycin-HIPEC (mitomycin 35 mg/m2) alone in case of neuropathy.
- Patients had primary CRC with synchronous and localized colorectal peritoneal metastases removed during tumor resection, resected ovarian metastases, or a perforated tumor.
- Funding: French National Cancer Institute.
- Median follow-up, 50.8 months.
- 3-year disease-free survival was similar in surveillance vs surgery (53% vs 44%: HR, 0.97; P=.82).
- OS was similar in the 2 groups.
- Grade 3-4 complications occurred in 41% of the second-look surgery group, most commonly intra-abdominal adverse events (hemorrhage, digestive leakage; 17%) and hematological adverse events (18%).
- Study centers specialized in peritoneal disease, which may have led to earlier diagnosis and improved survival in the surveillance group.