JoVE - Journal of Visualized Experiments
JoVE Visualize
Contact Us

Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study

  • 0Department of Surgical Oncology, University Hospital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France; Department of Surgical Oncology, University Hospital Gustave Roussy, Villejuif, France.
The Lancet. Oncology +

|

July 28, 2020

|

July 28, 2020

View abstract on PubMed

Summary

This summary is machine-generated.

Systematic second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) did not improve disease-free survival for high-risk colorectal cancer patients. Standard surveillance is adequate and effective for monitoring these patients.

Area Of Science

  • Oncology
  • Surgical Oncology
  • Gastroenterology

Background

  • Colorectal peritoneal metastases pose a significant risk to patient survival.
  • Early diagnosis and treatment are crucial for improving outcomes.
  • Identifying patients at high risk is essential for targeted interventions.

Purpose Of The Study

  • To compare the survival benefit of systematic second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) versus surveillance in patients at high risk for colorectal peritoneal metastases.
  • To evaluate the efficacy of HIPEC in conjunction with surgery for preventing disease recurrence.

Main Methods

  • An open-label, randomized phase 3 study involving 150 patients across 23 French hospitals.
  • Patients were stratified and randomly assigned to either surveillance or second-look surgery with HIPEC (oxaliplatin-based or mitomycin-based).
  • The primary outcome was 3-year disease-free survival, analyzed by intention to treat.

Main Results

  • After a median follow-up of 50.8 months, 3-year disease-free survival was 53% in the surveillance group versus 44% in the second-look surgery group (HR 0.97, 95% CI 0.61-1.56).
  • No treatment-related deaths occurred.
  • Grade 3-4 complications were reported in 41% of patients undergoing second-look surgery, primarily intra-abdominal and hematological adverse events.

Conclusions

  • Systematic second-look surgery plus HIPEC did not demonstrate an improvement in disease-free survival compared to standard surveillance.
  • Current surveillance strategies appear adequate and effective for managing patients at high risk of colorectal peritoneal metastases.
  • Further research may be needed to identify optimal treatment strategies for this patient population.