van Driel WJ, et al. - The target of this paper was to examine if the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery would improve outcomes among patients who were receiving neoadjuvant chemotherapy for stage III epithelial ovarian cancer. Longer recurrence-free survival and overall survival were reported due to the addition of HIPEC to interval cytoreductive surgery when compared to surgery alone. Additionally, it did not exhibit higher rates of side effects.

Methods

• The scheme of this research was a multicenter, open-label, phase 3 trial.
• Researchers enrolled 245 patients who had at least stable disease after three cycles of carboplatin (area under the curve of 5 to 6 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area).
• Candidates were allocated to undergo interval cytoreductive surgery either with or without administration of HIPEC with cisplatin (100 mg per square meter).
• This randomization was carried out at the time of surgery in cases in which surgery that would result in no visible disease (complete cytoreduction) or surgery after which one or more residual tumors measuring 10 mm or less in diameter remain (optimal cytoreduction) was deemed to be feasible.
• During this study, 3 additional cycles of carboplatin and paclitaxel were administered postoperatively.
• Recurrence-free survival was included as the primary end point.
• Overall survival and the side-effect profile served as pivotal secondary end points.

Results

• The occurrence of disease recurrence events or death were reported in 110 of the 123 patients (89%) who underwent cytoreductive surgery without HIPEC (surgery group) and in 99 of the 122 patients (81%) who underwent cytoreductive surgery with HIPEC (surgery-plus-HIPEC group) (hazard ratio for disease recurrence or death, 0.66; 95% confidence interval [CI], 0.50 to 0.87; P=0.003).
• As per the results, the median recurrence-free survival was determined to be 10.7 months in the surgery group and 14.2 months in the surgery-plus-HIPEC group.
• Death was reported in 76 patients (62%) in the surgery group and 61 patients (50%) in the surgery-plus-HIPEC group (hazard ratio, 0.67; 95% CI, 0.48 to 0.94; P=0.02) at a median follow-up of 4.7 years.
• Researchers revealed that the median overall survival was 33.9 months in the surgery group and 45.7 months in the surgery-plus-HIPEC group.
• Both groups illustrated a similar percentage of patients who had adverse events of grade 3 or 4 (25% in the surgery group and 27% in the surgery-plus-HIPEC group, P=0.76).