Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Gynecology & Gynecologic Oncology, Evangelische Kliniken Essen-Mitte, Essen, Germany.
Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Gynecol Oncol. 2024 Jul;186:104-109. doi: 10.1016/j.ygyno.2024.03.006. Epub 2024 Apr 18.
To compare oncologic outcomes of secondary cytoreductive surgery (SCS) before and after FDA approval of Poly(ADP-ribose) polymerase inhibitor (PARPi) and bevacizumab maintenance therapies for platinum-sensitive recurrent ovarian cancer (PS-ROC).
Patients who underwent SCS for first recurrence of PS-ROC from 1/1/2013-1/1/2020 were identified. Exclusion criteria included prior chemotherapy for recurrence, bowel obstruction procedures, and palliative surgery. Data were dichotomized pre/post 1/2017, relative to FDA approval of PARPi and bevacizumab maintenance for ROC. Second progression-free survival (PFS2), the primary endpoint, was estimated using Kaplan-Meier method.
Overall, 245 patients underwent SCS-131 (53%) pre- and 114 (47%) post-approval. Most patients had high-grade serous tumors (83% and 90%, respectively; p = 0.13). Deleterious BRCA1/2 alterations were identified in 27% (32/120) and 28% (32/113) of tested patients, respectively (p = 0.88). Disease-free intervals pre- and post-approval were: 6-12 months, 16% and 18%; 12-30 months, 56% and 59%; and >30 months, 28% and 24%, respectively (p = 0.73). Overall, 85% and 86% of patients, respectively, achieved complete gross resection (CGR; p > 0.99). PARPi maintenance use increased from 3.8% to 27% (p < 0.001) following approval, and bevacizumab from 1.5% to 12% (p < 0.001). Median PFS2 was 19 and 20.1 months, respectively. In the post group, 1-year PFS2 rate was 84.5% (95% CI, 75.7-90.4%) for patients with CGR vs 56.2% (95% CI, 29.5-76.2%) for those with residual disease; 3-year PFS2 rates were 31.3% (95% CI, 21.6-41.4%) and 12.5% (95% CI, 2.1-32.8%), respectively (p = 0.001).
CGR during SCS is associated with improved PFS2 compared to suboptimal resection. Prospective randomized trials are warranted to elucidate the role of SCS as more therapeutics become available.
比较 FDA 批准聚（ADP-核糖）聚合酶抑制剂（PARPi）和贝伐单抗维持治疗用于铂敏感复发性卵巢癌（PS-ROC）前后辅助细胞减灭术（SCS）的肿瘤学结局。
本研究纳入了 2013 年 1 月 1 日至 2020 年 1 月 1 日期间因 PS-ROC 首次复发而接受 SCS 的患者。排除标准包括复发前的化疗、肠梗阻手术和姑息性手术。数据以 2017 年 1 月为界，分为 FDA 批准 PARPi 和贝伐单抗维持治疗 ROC 前后。次要无进展生存期（PFS2）为主要终点，采用 Kaplan-Meier 法估计。
共有 245 例患者接受了 SCS-131（53%）前和 114 例（47%）后。大多数患者为高级别浆液性肿瘤（分别为 83%和 90%；p=0.13）。分别有 27%（32/120）和 28%（32/113）的患者检测到有害 BRCA1/2 改变，差异无统计学意义（p=0.88）。SCS 前和后的无疾病间隔分别为：6-12 个月，16%和 18%；12-30 个月，56%和 59%；30 个月以上，28%和 24%，差异无统计学意义（p=0.73）。总体而言，分别有 85%和 86%的患者实现了完全肉眼肿瘤切除（CGR；p>0.99）。PARPi 维持治疗的使用率分别从批准前的 3.8%和 1.5%增加到 27%（p<0.001）和 12%（p<0.001）。中位 PFS2 分别为 19 和 20.1 个月。在后一组中，CGR 患者的 1 年 PFS2 率为 84.5%（95%CI，75.7-90.4%），而残留疾病患者为 56.2%（95%CI，29.5-76.2%）；3 年 PFS2 率分别为 31.3%（95%CI，21.6-41.4%）和 12.5%（95%CI，2.1-32.8%），差异有统计学意义（p=0.001）。
与非最佳切除相比，SCS 期间的 CGR 与 PFS2 改善相关。需要前瞻性随机试验来阐明 SCS 的作用，因为更多的治疗方法正在出现。
