In CRC with high risk for peritoneal metastasis, no need for second-look surgery

  • Goéré D & al.
  • Lancet Oncol
  • 24 Jul 2020

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%).

Limitations

  • Study centers specialized in peritoneal disease, which may have led to earlier diagnosis and improved survival in the surveillance group.