Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States; Sarah Cannon Research Institute, Nashville, TN, United States.
University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium.
Gynecol Oncol. 2024 Jun;185:186-193. doi: 10.1016/j.ygyno.2024.01.045. Epub 2024 Mar 5.
Evaluate the antitumor activity and safety profile of the triplet combination of mirvetuximab soravtansine (MIRV), carboplatin, and bevacizumab in recurrent, platinum-sensitive ovarian cancer.
Participants with recurrent, platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer (1-2 prior lines of therapy) received MIRV (6 mg/kg adjusted ideal body weight), carboplatin (AUC5), and bevacizumab (15 mg/kg) once every 3 weeks. Carboplatin could be discontinued after 6 cycles per investigator discretion; continuation of MIRV+bevacizumab as maintenance therapy was permitted. Eligibility included folate receptor alpha (FRα) expression by immunohistochemistry (≥50% of cells with ≥2+ intensity; PS2+ scoring); prior bevacizumab was allowed. Tumor response, duration of response (DOR), progression-free survival (PFS), and adverse events (AEs) were assessed.
Forty-one participants received triplet therapy, with a median of 6, 12, and 13 cycles of carboplatin, MIRV, and bevacizumab, respectively. The confirmed objective response rate was 83% (9 complete and 25 partial responses). The median DOR was 10.9 months; median PFS was 13.5 months. AEs (any grade) occurred as expected, based on each agent's safety profile; most common were diarrhea (83%), nausea (76%), fatigue (73%), thrombocytopenia (71%), and blurred vision (68%). Most cases were mild to moderate (grade ≤2), except for thrombocytopenia, for which most drug-related discontinuations occurred, and neutropenia.
This triplet regimen (MIRV+carboplatin+bevacizumab) was highly active, with a tolerable AE profile in participants with recurrent, platinum-sensitive, FRα-expressing ovarian cancer. Thrombocytopenia was the primary cause of dose modifications. These outcomes compare favorably to historical data reported for platinum-based chemotherapy plus bevacizumab regimens in similar patient populations.
评估 mirvetuximab soravtansine（MIRV）、卡铂和贝伐珠单抗三联疗法在复发性铂敏感卵巢癌中的抗肿瘤活性和安全性。
入组患者为复发性铂敏感的上皮性卵巢癌、输卵管癌或原发性腹膜癌（1-2 线治疗），接受 MIRV（6mg/kg 理想体重调整剂量）、卡铂（AUC5）和贝伐珠单抗（15mg/kg）每 3 周一次。根据研究者的判断，卡铂可在 6 个周期后停药；允许继续使用 MIRV+贝伐珠单抗维持治疗。入组标准包括免疫组织化学检测到叶酸受体α（FRα）表达（≥50%细胞 2+以上强度；PS2+评分）；允许使用过贝伐珠单抗。评估肿瘤反应、反应持续时间（DOR）、无进展生存期（PFS）和不良事件（AE）。
41 名患者接受了三联治疗，卡铂、MIRV 和贝伐珠单抗的中位周期数分别为 6、12 和 13。确认的客观缓解率为 83%（9 例完全缓解和 25 例部分缓解）。DOR 中位数为 10.9 个月；中位 PFS 为 13.5 个月。AE（任何级别）与各药物的安全性特征相符；最常见的是腹泻（83%）、恶心（76%）、疲劳（73%）、血小板减少（71%）和视力模糊（68%）。大多数为轻至中度（1-2 级），除血小板减少症外，大多数与药物相关的停药事件和中性粒细胞减少症发生于此。
该三联方案（MIRV+卡铂+贝伐珠单抗）在 FRα 表达的复发性铂敏感卵巢癌患者中具有高活性和可耐受的 AE 特征。血小板减少症是剂量调整的主要原因。这些结果与类似患者人群中铂类化疗加贝伐珠单抗方案的历史数据相比具有优势。
