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  • EV277/#769  Rationale and study design of the KOV-HIPEC-02r: a randomized, multicenter, open-label phase III trial of hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer

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AS10. Ovarian cancer
EV277/#769  Rationale and study design of the KOV-HIPEC-02r: a randomized, multicenter, open-label phase III trial of hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer
  1. Myong Cheol Lim1,
  2. Ji Hyun Kim1,
  3. Yoo-Young Lee2,
  4. Dae Hoon Jeong3,
  5. Chel Hun Choi2,
  6. Sung Jong Lee4,
  7. Eun-Young Park5,
  8. Jae Kyung Bae1,
  9. Uisuk Kim1,
  10. Junhwan Kim1,
  11. Jung-Yun Kim1,
  12. Taek Sang Lee6,
  13. Hye Won Jeon6,
  14. Shin Wha Lee7,
  15. Jeong-Yeol Park7,
  16. Seob Jeon8,
  17. Hyeong In Ha9,
  18. Yong Jung Song9,
  19. Ki Hyung Kim10,
  20. Hyun-Jin Roh11 and
  21. Sang-Yoon Park1
  1. 1National Cancer Center, Gynecologic Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
  2. 2Samsung Medical Center, Obstetrics and Gynecology, Seoul, Korea, Republic of
  3. 3Busan Paik Hospital, Inje University, Obstetrics and Gynecology, Busan, Korea, Republic of
  4. 4Seoul St. Mary’s Hospital, Seoul, Korea, Republic of
  5. 5National Cancer Center, Biostatistics Collaboration Team, Goyang-si, Gyeonggi-do, Korea, Republic of
  6. 6SMG-SNU Borame Medical Center, Seoul, Korea, Republic of
  7. 7Asan Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  8. 8Soonchunhyang University Cheoan Hospital, Ob and Gyn, Cheonan, Korea, Republic of
  9. 9Pusan National University Yangsan Hospital, Yangsan-si, Gyeongsangnam-do, Korea, Republic of
  10. 10Pusan National University Hospital, Department of Obstetrics and Gynecology, Pusan, Korea, Republic of
  11. 11Ulsan University Hospital, Department of Obstetrics and Gynecology, Ulsan, Korea, Republic of

Abstract

Introduction Hyperthermic intraperitoneal chemotherapy (HIPEC) administered during interval cytoreductive surgery following neoadjuvant chemotherapy has shown to increase progression-free survival (PFS) and overall survival (OS) rates, as indicated by the OV-HIPEC-01 and KOV-HIPEC-01 trials. A recent meta-analysis (Kim SI, Kim JH, et al., GO 2023) demonstrated a survival benefit associated with HIPEC, particularly after recent chemotherapy exposure. Moreover, in ovarian cancer (OC), HIPEC is suggested to be effective in overcoming chemotherapy resistance.

Methods This trial (KOV-HIPEC-02) is a multicenter, open-label, 1:1 randomized, phase III trial that will enroll 140 patients with platinum-resistant recurrent epithelial ovarian cancer (NCT05316181). After cytoreductive surgery, patients undergo the HIPEC procedure at 41.5°C, with doxorubicin at 35mg/m2 and mitomycin at 15mg/m2. Enrolled patients receive non-platinum compound systemic chemotherapy until disease progression. The primary objective is to evaluate progression-free survival (PFS) between the HIPEC group and the control group. Secondary objectives include overall survival (OS), cancer-specific survival, and safety and quality of life. Considering a 3-year enrollment period, 2-year follow-up, and a statistical power of 80%, 140 patients are needed, accounting for a 10% dropout rate. As of April 2024, 102 patients (72.8%) have been randomized.

Results There are no available results at the time of submission.

Conclusion/Implications The role of cytoreductive surgery and HIPEC in platinum-resistant recurrent ovarian cancer will be elucidated for the first time through this randomized trial (KOV-02).

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https://doi.org/10.1136/ijgc-2024-IGCS.396

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