Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

Stage III epithelial ovarian cancer with CR, PR or SD after 3 cycles of neoadjuvant carboplatin+paclitaxel

245

First-line

Open-Label, Randomized

RFS, OS, evaluated per RECIST or CA125

CarboPt+Pac+HIPEC vs CarboPt+Pac+Placebo:

RFS: 14.3 vs 10.7 months, HR: 0.63 (0.48-0.83, p=0.0008)
OS: 44.9 vs 33.3 months, HR: 0.70 (0.53-0.92, p=0.011)

Exploratory analysis, BRCA/HRD status:
BRCA MUT: RFS: HR: 1.25 (0.48-3.29)
BRCA WT/HRD+: RFS: HR: 0.44 (0.21-0.91)
BRCA WT/HRD-: RFS: HR: 0.82 (0.48-1.42)

CarboPt+Pac+HIPEC vs CarboPt+Pac+Placebo:
Serious AE:
Grade 3-4 AE: overall (27 vs 25%)

Among patients with stage III ovarian cancer, the addition of HIPEC to interval cytoreductive surgery resulted in longer RFS and OS than surgery alone and did not show higher rates of side effects

van Driel WJ et al. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med (2018) 18;378(3):230-240
https://pubmed.ncbi.nlm.nih.gov/29342393/

Koole SN et al. Effect of HIPEC according to HRD/BRCAwt genomic profile in stage III ovarian cancer: Results from the phase III OVHIPEC trial. Int J Cancer (2022) 151(8):1394-1404
https://pubmed.ncbi.nlm.nih.gov/35583992/

Lot Aronson S et al. Cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy in patients with advanced ovarian cancer (OVHIPEC-1): final survival analysis of a randomised, controlled, phase 3 trial. Lancet Oncol (2023) 24(10):1109-1118
https://pubmed.ncbi.nlm.nih.gov/37708912/