KEY TAKEAWAYS
- The phase 3 OVHIPEC-1 trial aimed to evaluate the addition of HIPEC to interval CRS in patients with stage III EOC who were ineligible for primary cytoreduction.
- The primary endpoint was RFS, while secondary endpoints included OS, HIPEC safety, and subsequent therapy.
- Similar recurrence rates and subsequent treatments were seen in both surgery-alone and surgery-plus-HIPEC groups after 10.1 years.
The OVHIPEC-1 trial, a randomized phase 3 study, explored the benefits of adding hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery in stage III epithelial ovarian cancer patients ineligible for primary cytoreduction. OVHIPEC-1 previously showed improved recurrence-free and overall survival after 4.7 years.
The study explored the long-term impact of HIPEC in ovarian cancer by analyzing survival outcomes and subsequent anti-cancer treatments ten years after treatment initiation.
Interval cytoreductive surgery was received by patients who underwent randomization either with or without HIPEC after completing three cycles of neo-adjuvant carboplatin and paclitaxel. The randomization occurred during surgery, aiming for either complete absence of visible disease or optimal cytoreduction with residual tumor measuring less than 10mm in diameter. Additionally, all participants were administered three extra cycles of adjuvant systemic chemotherapy. Survival analysis and comparisons of subsequent lines of therapy were conducted using stratified log-rank tests, Kaplan-Meier methods, and intention-to-treat principles.
A total of 123 patients in the surgery-alone group and 122 patients in the surgery-plus-HIPEC group were followed for a median of 10.1 years. Recurrence, progression, or death occurred in 92.7% and 89.3% of patients in the respective groups. Median recurrence-free survival was 10.7 months in the surgery group versus 14.3 months in the surgery-plus-HIPEC group (HR, 0.63; 95% CI, 0.48-0.83; stratified P<0.001). In the surgery group, 87.8% of patients have died compared to 82.0% in the surgery-plus-HIPEC group. Median overall survival was 33.3 months versus 44.9 months (HR, 0.70; 95% CI, 0.53-0.92; stratified P=0.011).
Subsequent anti-cancer therapies, including chemotherapy (platinum and non-platinum based), secondary surgery, poly (ADP-ribose) polymerase (PARP) inhibitors, and bevacizumab, were received by 84.6% and 82.0% of patients in the surgery and surgery-plus-HIPEC groups, respectively. The median number of subsequent systemic treatment lines was 2 (IQR 1-3) in both arms.
The long-term survival analysis of HIPEC in ovarian cancer confirms its benefit for patients with primary stage III epithelial ovarian cancer undergoing interval cytoreductive surgery.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.5509?af=R
Clinical Trial: https://www.clinicaltrials.gov/study/NCT00426257
Lot Aronson, Marta I. Lopez-Yurda, Simone N Koole, Jules H Schagen van Leeuwen, Henk Schreuder, Ralph Hermans, Ignace H.J.T. de Hingh, Mignon D.J.M. Van Gent, Henriëtte J.G. Arts, Maaike van Ham, Peter Van Dam, Peter Vuylsteke, Arend Aalbers, Victor Verwaal, Koen Van de Vijver, Neil K Aaronson, Gabe S. Sonke, Willemien Van Driel. DOI: 10.1200/JCO.2023.41.16_suppl.5509 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 5509-5509.
