1. Patients with stage 3 epithelial ovarian cancer treated with hyperthermic intraperitoneal chemotherapy (HIPEC) in addition to cytoreductive surgery and neoadjuvant chemotherapy experienced increased overall and recurrence-free survival compared to those treated with surgery and chemotherapy alone.
2. No difference in grade 3 or 4 adverse side effects were observed between HIPEC and non-HIPEC treated patients.
Evidence Rating: 1 (Excellent)
Study Rundown: Ovarian cancer has high rates of mortality as it is often diagnosed in late stages with spread to the peritoneal surface. In addition to surgery, chemotherapy performed via both intraperitoneal and intravenous approaches can reduce cancer burden and prolong overall survival. Logistical challenges of intraperitoneal chemotherapy delivery have hampered its uptake into clinical use, necessitating the need for strong evidence of its effectiveness. This study evaluates HIPEC, designed to increase local penetration and chemotherapy efficacy, in addition to cytoreductive surgery and neoadjuvant chemotherapy in a phase 3 randomized trial. The primary end-point of recurrence-free survival and secondary endpoints of overall survival both showed improvements in HIPEC treated patients. Rates of serious adverse events were similar between the two groups.
This study provides strong evidence for the use of HIPEC in eligible advanced stage ovarian cancer patients. Strengths include its multicenter randomized design and thorough adverse event characterization, and a limitation is little detail of additional treatment costs associated with HIPEC.
In-Depth [randomized controlled trial]: This randomized controlled trial conducted between 2007 and 2016 enrolled 245 patients at multiple sites in the Netherlands and Belgium. Eligible patients had stage 3 epithelial ovarian, fallopian tube, or peritoneal cancer requiring chemotherapy either before surgery or after and incomplete surgery. All patients received 3 cycles of neoadjuvant chemotherapy with carboplatin and paclitaxel. Randomization occurred prior to cytoreductive surgery resulting in no visible disease. HIPEC treated patients received saline heated to 40 degrees Celsius and perfusion with cisplatin. Following surgery, patients received 3 cycles of chemotherapy. Patients were followed for a median of 4.7 years, during which recurrence was detected with imaging and/or CA-125 levels. Disease recurrence as a primary end point occurred in 89% and 81% of the surgery and HIPEC groups, respectively (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.50 to 0.87; p = 0.003). Probability of recurrence-free survival at 3 years was 8% and 17% in the surgery and HIPEC groups, respectively. Death occurred in 62% of the surgery group and 50% of the HIPEC group (HR, 0.67; 95% CI, 0.48 to 0.94; p = 0.02). Median overall survival was 33.9 months in the surgery group and 45.7 months in the HIPEC group. Median length of surgery was 192 minutes in the surgery group and 338 minutes in the HIPEC group. Grade 3 or 4 adverse events were reported in 25% and 27% of surgery and HIPEC group patients, respectively (p = 0.76).
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