Ovarian Cancer Program, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
J Gynecol Oncol. 2020 May;31(3):e61. doi: 10.3802/jgo.2020.31.e61.
In China, secondary cytoreductive surgery (SCR) has been widely used in ovarian cancer (OC) over the past two decades. Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open. The preliminary data from our pre-SOC1 phase II study showed that selected patients with second relapse who never received SCR at recurrence may still benefit from surgery. Moreover, poly(ADP-ribose) polymerase inhibitors (PARPi) maintenance now has been a standard care for platinum sensitive relapsed OC. To our knowledge, no published or ongoing trial is trying to answer the question if patient can benefit from a potentially complete resection combined with PARPi maintenance in OC patients with secondary recurrence.
SOC-3 is a multi-center, open, randomized, controlled, phase II trial of SCR followed by chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance in patients with platinum-sensitive second relapsed OC who never received SCR at recurrence. To guarantee surgical quality, if the sites had no experience of participating in any OC-related surgical trials, the number of recurrent lesions evaluated by central-reviewed positron emission tomography-computed tomography image shouldn't be more than 3. Eligible patients are randomly assigned in a 1:1 ratio to receive either SCR followed by 6 cycles of platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone. Patients who undergo at least 4 cycles of chemotherapy and must be, in the opinion of the investigator, without disease progression, will be assigned niraparib maintenance. Major inclusion criteria are secondary relapsed OC with a platinum-free interval of no less than 6 months and a possibly complete resection. Major exclusion criteria are borderline tumors and non-epithelial ovarian malignancies, received debulking surgery at recurrence and impossible to complete resection. The sample size is 96 patients. Primary endpoint is 12-month non-progression rate.
ClinicalTrials.gov Identifier: NCT03983226.
在中国，过去二十年来，卵巢癌（OC）的二次细胞减灭术（SCR）已被广泛应用。尽管 Gynecologic Oncology Group-0213 试验并未显示其对首次复发患者的总体生存获益，但患者选择和后续靶向治疗效果的问题仍未解决。我们在 SOC1 前阶段 II 研究中的初步数据表明，从未在复发时接受过 SCR 的第二次复发患者中，选择合适的患者进行手术仍可能从中获益。此外，聚 ADP-核糖聚合酶抑制剂（PARPi）维持治疗现已成为铂类敏感复发性 OC 的标准治疗方法。据我们所知，目前尚无已发表或正在进行的试验试图回答 OC 患者二次复发时，潜在完全切除联合 PARPi 维持治疗是否能使患者获益的问题。
SOC-3 是一项多中心、开放、随机、对照的 II 期试验，研究对象为从未在复发时接受过 SCR 的铂类敏感二次复发 OC 患者，这些患者接受 SCR 后再接受化疗和尼拉帕利维持治疗，或接受化疗和尼拉帕利维持治疗。为了保证手术质量，如果研究中心无参与任何 OC 相关手术试验的经验，则由中心审查的正电子发射断层扫描-计算机断层扫描图像评估的复发病灶数不应超过 3 个。符合条件的患者以 1:1 的比例随机分配接受 SCR 后接受 6 个周期的铂类为基础的化疗和尼拉帕利维持治疗，或单独接受 6 个周期的铂类为基础的化疗和尼拉帕利维持治疗。至少接受 4 个周期化疗且根据研究者的判断没有疾病进展的患者，将接受尼拉帕利维持治疗。主要纳入标准为铂类无进展间期不少于 6 个月的二次复发 OC，且可能完全切除。主要排除标准为交界性肿瘤和非上皮性卵巢恶性肿瘤、复发时接受过减瘤手术且无法完全切除的患者。样本量为 96 例。主要终点为 12 个月无进展率。
ClinicalTrials.gov 标识符：NCT03983226。
