In an MSK Team Ovary–led phase II trial reported in the Journal of Clinical Oncology, Zivanovic et al found that use of hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin during secondary cytoreduction followed by chemotherapy did not improve 24-month progression-free survival in patients with platinum-sensitive recurrent ovarian cancer.
Study Details
In the U.S. investigator-initiated, multicenter, open-label trial, 98 patients enrolled between February 2014 and November 2019 were intraoperatively randomly assigned to HIPEC with carboplatin at 800 mg/m2 (n = 49) or no HIPEC (n = 49), followed by five (HIPEC group) or six cycles (no HIPEC group) of carboplatin-based chemotherapy (investigator’s choice of carboplatin plus paclitaxel, gemcitabine, or liposomal doxorubicin). A treatment group was considered a “winner” if 17 or more of the 49 patients were without disease progression at 24 months postsurgery.
Key Findings
Complete gross resection was achieved in 82% of patients in the HIPEC group and 94% of the no-HIPEC group (P = .12). Bowel resection was performed in 37% vs 65% of patients (P = .008). No perioperative mortality was observed, and no differences between groups were observed in the use of ostomies, length of hospital stay (6 vs 5 days, P = .05), or 30-day postoperative toxicity (grade ≥ 3 in 24% vs 20%, P = .81.)
At 24 months, 8 patients (16.3%, 1-sided 90% confidence interval [CI] = 9.7%–100%) were without disease progression or death in the HIPEC group vs 12 (24.5%, 1-sided 90% CI = 16.5%–100%) in the no-HIPEC group.
Median progression-free survival was 12.3 months in the HIPEC group vs 15.7 months in the no-HIPEC group (hazard ratio [HR] = 1.54, 95% CI = 1.00–2.37, P = .05). Median overall survival was 52.5 months vs 59.7 months (HR = 1.39, 95% CI = 0.73–2.67, P = .31).
The investigators concluded, “HIPEC with carboplatin was well tolerated but did not result in superior clinical outcomes. This study does not support the use of HIPEC with carboplatin during secondary cytoreductive surgery for platinum-sensitive recurrent ovarian cancer.”
This article was published by The ASCO Post.