Article Text
Abstract
Introduction/Background Hyperthermic intraperitoneal chemotherapy (HIPEC) during cytoreductive surgery has emerged to achieve a higher concentration of chemotherapeutic agents and treat micro-metastases on peritoneal surfaces. At advanced staged ovarian cancer treated with neoadjuvant chemotherapy, HIPEC during interval cytoreductive surgery with cisplatin 75–100mg/m2 increases progression-free survival and overall survival (OVHIPEC-01 and KOVHIPEC-01). In chemotherapy-naïve ovarian cancer patients, survival benefit is not identified with HIPEC (KOVHIPEC-01). And the meta-analysis revealed the survival benefit after recent exposure of chemotherapy. In ovarian cancer, HIPEC is thought to overcome chemotherapy resistance.
Methodology This trial (KOVHIPEC-02) is currently actively enrolling, a multicenter, open-label, 1:1 randomized, phase III trial that will enroll 140 patients in platinum-resistant recurrent epithelial ovarian cancer. The trial is registered on ClinicalTrials.gov (NCT05316181). The first patient was enrolled Apr 07, 2022. The experimental arm will receive HIPEC followed by standard chemotherapy, and the control arm will receive standard chemotherapy without HIPEC until disease progression. If patients are assigned to the HIPEC group, the HIPEC procedure is carried out using the open or closed technique, infusing 41.5–42.0°C doxorubicin 35mg/m2 and mitomycin 15mg/m2. Enrolled patients will receive physician-choice non-platinum compound systemic chemotherapy until progression. The primary objective of the trial is to evaluate progression-free survival (PFS) between the HIPEC group and the control group. Secondary objectives are overall survival (OS), cancer-specific survival, safety, and quality of life according to whether HIPEC was performed during surgery in patients with platinum-resistant recurrent ovarian cancer. Assuming that the enrollment period is three years and the follow-up period is two years, the total number of events required is 121. Based on the log-rank test, the total number of subjects required to prove HR 0.6 with a two-sided alpha of 0.05 and 80% power is 126. One hundred forty patients are finally studied, considering 10% drop-out.
Results N/A
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Disclosures MCL reported having a consulting or advisory role for AstraZeneca, Boryung, CKD Pharm, Genexine, Hospicare, GI Innovation, and Takeda and receiving research funding from AbbVie, Amgen, Astellas, AstraZeneca, BeiGene, Cellid, CKD Pharm, Clovis, Eisai, Genexine, GSK, Incyte, Merck, MSD, OncoQuest, Pfizer, and Roche outside the submitted work.