A randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance: Korean Gynecologic Oncology Group (KGOG 3067)/SOCCER-P trial.

Jung-Yun Lee; Hyun-Woong Cho; Jae-Weon Kim; Jeong-Yeol Park; Yoo Young Lee; Myong Cheol Lim; Sung-Jong Lee; Kyung-Jin Min; Jae Yun Song; Kyung Jin Eoh; Kwang Beom Lee; Min Kyu Kim; Seung-Hyuk Shim; Yong Il Ji; Yong-Joong Song

Background: Although recent two phase 3 randomized controlled trials showed survival benefit of secondary cytoreductive surgery in first relapsed ovarian cancer, the patients who received PARP inhibitor (PARPi) as first-line maintenance which is thought as standard treatment nowadays were not included in these trials. Therefore, there is a significant need for optimal strategy including secondary cytoreductive surgery in patients whose cancer progresses while using a PARPi. The aim of SOCCER-P is to find out whether secondary cytoreductive surgery is beneficial in patients who have progressed on PARPi maintenance. Methods: The SOCCER-P is a multicenter, investigator-initiated, randomized phase II trial of secondary cytoreductive surgery in patients with first relapsed ovarian cancer who have progressed on PARPi. This trial included patients with the first recurrence of platinum-sensitive ovarian cancer who had a treatment free interval from last platinum dose (TFIp) 6 months and progressed on PARPi maintenance. Patients who are considered likely to be completely resected according to the international model (AGO or iMODEL) or based on a consensus between the surgeon and designated radiologist are eligible for this study. A total of 124 subjects are randomly assigned to undergo secondary cytoreductive surgery and subsequent platinum-based chemotherapy plus or minus bevacizumab, or to receive platinum-based chemotherapy plus or minus bevacizumab alone. The primary endpoints were progression-free survival. A one-sided log-rank test with an overall sample size of 124 subjects (62 in the control group and 62 in the treatment group) achieves 80.1% power at a 0.100 significance level to detect a hazard ratio of 0.6500.

CYTOREDUCTIVE surgery; GYNECOLOGIC oncology; OVARIAN cancer; POLY(ADP-ribose) polymerase; LOG-rank test; CA 125 test

Journal of Gynecologic Oncology, 2024, Vol 35, p21

2005-0380

Academic Journal

10.3802/jgo.2024.35.S2.P3