BACKGROUND AND PURPOSE:

• The most effective treatment for ovarian cancer, often diagnosed at advanced stage, is surgery followed by 6 cycles of chemotherapy
  • Another option is surgical cytoreduction after 3 cycles of chemotherapy
• There may be benefit to hyperthermic intraperitoneal chemotherapy (HIPEC) delivered during surgery
  • Hyperthermia causes apoptosis and direct cytotoxic effects aside from other positive cancer treatment attributes
• Willamien et al. (NEJM, 2018) studied whether the addition of HIPEC to interval cytoreductive surgery would improve outcomes in women with stage III epithelial ovarian cancer

METHODS:

• Randomized Multicenter, open-label, phase 3 controlled trial
• Participants
  • Patients with least stable disease after three cycles chemotherapy
  • Unfavorable prognostic stage III ovarian cancer
    • ineligible for primary cytoreduction because of extensive abdominal disease
  • Patients were randomized to the following groups
    • Interval cytoreductive surgery with HIPEC with cisplatin (100 mg per square meter)
    • Interval cytoreductive surgery without HIPEC
  • Three additional cycles of carboplatin and paclitaxel were administered postoperatively
  • Primary end point
    • Recurrence-free survival
  • Secondary end points:
    • Overall survival | Side-effect profile

RESULTS:

• 245 patients were included in the study
• There were significantly higher rates of disease recurrence or death in the non-HIPEC group (89%) compared to the HIPEC group (81%)
  • Hazard ratio for disease recurrence or death, 0.66; 95% CI, 0.50 to 0.87 (P=0.003)
• Median recurrence-free survival was 10.7 months in the non-HIPEC group vs 14.2 months in the HIPEC group
• At a median follow-up of 4.7 years significantly fewer patients in HIPEC group had died (62%), compared to non-HIPEC (50%)
  • Hazard ratio, 0.67; 95% CI, 0.48 to 0.94 (P=0.02)
• Median overall survival was 33.9 months in the non-HIPEC group and 45.7 months in the HIPEC group
• Adverse events of grade 3 or 4 was similar in the non-HIPEC group (25%) and HIPEC group (27%); (P=0.76)

CONCLUSION:

• This efficacy data suggests that adding HIPEC to interval cytoreductive surgery resulted in longer recurrence-free survival and overall survival in women with stage III epithelial ovarian cancer
• HIPEC group median overall survival was 12 months longer and median recurrence-free survival was 3.5 months longer
• Authors conclude that “HIPEC plus complete or optimal interval cytoreductive surgery resulted in longer survival than cytoreductive surgery alone”

Learn More – Primary Sources:

Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer

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