Department of Obstetrics and Gynecology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, South Korea.
Department of Obstetrics and Gynecology, Seoul National University, Seoul, South Korea.
Int J Gynecol Cancer. 2024 Nov 4;34(11):1809-1812. doi: 10.1136/ijgc-2024-005838.
Although two recent phase III randomized controlled trials showed survival benefits of undergoing secondary cytoreductive surgery for an initial relapse of ovarian cancer, patients who received a poly-ADP ribose polymerase inhibitor (PARPi) as the first-line maintenance treatment, which is currently the standard treatment for advanced ovarian cancer, were not included in those trials. Therefore, determining an optimal treatment strategy, including secondary cytoreductive surgery, in patients whose cancer progresses even with PARPi treatment, is needed.
To determine whether secondary cytoreductive surgery is beneficial in patients who have progressed on PARPi maintenance treatment.
Secondary cytoreductive surgery followed by chemotherapy is superior to chemotherapy alone for patients who have progressed on PARPi maintenance treatment.
The SOCCER-P study is a multicenter randomized phase II clinical trial. Patients who meet the eligibility criteria will be randomized to either undergo secondary cytoreductive surgery and subsequent platinum-based chemotherapy plus or minus bevacizumab, or to receive platinum-based chemotherapy plus or minus bevacizumab alone. Patients randomly allocated to the surgery group will undergo secondary cytoreductive surgery followed by six cycles of a physician's choice of platinum-based chemotherapy once they have recovered from surgery.
MAJOR INCLUSION/EXCLUSION CRITERIA: The major inclusion criteria are as follows: first recurrence of disease with treatment-free interval from last platinum dose (TFIp) ≥6 months and progression during PARPi maintenance or treatment-free interval from last PARPi therapy (TFI) <3 months. The major exclusion criteria are as follows: >1 line of prior chemotherapy, TFIp <6 months, and radiological signs suggesting metastases not accessible to surgical removal (complete resection is deemed not possible).
Progression-free survival.
124 patients.
Accrual completion approximately the end of 2026 and the results are expected after 2 years of follow-up in 2029.
NCT05704621.
尽管最近两项 III 期随机对照试验显示，对于初始复发性卵巢癌患者进行二次细胞减灭术可带来生存获益，但这些试验未纳入接受聚 ADP 核糖聚合酶抑制剂（PARPi）作为一线维持治疗的患者，而 PARPi 目前是晚期卵巢癌的标准治疗。因此，需要确定在接受 PARPi 维持治疗后癌症进展的患者中，包括二次细胞减灭术在内的最佳治疗策略。
确定在 PARPi 维持治疗进展的患者中，二次细胞减灭术是否有益。
对于在 PARPi 维持治疗中进展的患者，二次细胞减灭术联合化疗优于单纯化疗。
SOCCER-P 研究是一项多中心随机 II 期临床试验。符合入选标准的患者将被随机分配至行二次细胞减灭术及随后的铂类为基础的化疗加或不加贝伐珠单抗，或单纯接受铂类为基础的化疗加或不加贝伐珠单抗。随机分配至手术组的患者将在手术恢复后，接受 6 个周期的医生选择的铂类为基础的化疗。
主要纳入/排除标准：主要纳入标准为：末次铂类剂量无治疗间期（TFIp）≥6 个月的疾病首次复发，且在 PARPi 维持治疗或末次 PARPi 治疗的无治疗间期（TFI）<3 个月时进展。主要排除标准为：既往接受过≥1 线化疗，TFIp<6 个月，以及影像学提示无法手术切除的转移灶（完全切除被认为不可能）。
无进展生存期。
124 例患者。
预计 2026 年底完成入组，2029 年随访 2 年后报告结果。
NCT05704621。
