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

초록

Background Although recent two phase 3 randomized controlled trials showed survival benefit of secondary cytoreductive surgery (CRS) in first relapsed ovarian cancer, the patients who received PARP inhibitor (PARPi) as first-line maintenance were not included in these trials. In addition, the treatment consensus for recurrence after PARPi has not been established because subsequent platinum-based chemotherapy is not sensitive in relapsed patients after PARPi maintenance. Therefore, there is a significant need for optimal strategy including secondary CRS in patients whose cancer progresses while using a PARPi. The aim of SOCCER-P is to find out whether secondary CRS is beneficial in patients who have progressed on PARPi maintenance. Trial design It is a multicenter, randomized phase II trial of secondary CRS in patients with relapsed ovarian cancer who have progressed on PARPi. This trial included patients with the first recurrence of platinum-sensitive ovarian cancer who had a progression-free interval of at least 6 months after the end of the last platinum-containing therapy 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. 124 subjects are randomly assigned to undergo secondary CRS and subsequent chemotherapy (carboplatin [AUC 5, day 1] plus pegylated liposomal doxorubicin [30 mg/m2, day 1] every 4 weeks) plus or minus bevacizumab (six cycles of bevacizumab [10 mg/kg, days 1 and 15] followed by maintenance bevacizumab [15 mg/kg every 3 weeks]), or to receive chemotherapy plus or minus bevacizumab alone. The primary endpoints were progression-free survival (PFS). And we also assess overall survival and PFS2 defined as the time from randomization to tumor progression on a next-line tretment or death. 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 when the hazard rate of control group is 1.05.