复发性宫颈癌是一种危及生命的疾病，当一线联合治疗后出现疾病进展时，可用的治疗选择有限。我们进行了一项 tisotumab vedotin 作为二线或三线治疗的 3 期、多国、开放标签试验患有复发性或转移性宫颈癌的患者。患者以 1:1 的比例随机分配接受 tisotumab vedotin 单药治疗（每 3 周每公斤体重 2.0 mg）或研究者选择的化疗（托泊替康、长春瑞滨、吉西他滨、伊立替康或培美曲塞）。主要终点是总生存期。共有 502 名患者接受了随机分组（253 名患者被分配至 tisotumab vedotin 组，249 名患者被分配至化疗组）；这些群体在人口和疾病特征方面相似。 tisotumab vedotin 组的中位总生存期显着长于化疗组（11.5 个月 [95% 置信区间 {CI}，9.8 至 14.9] 对比 9.5 个月 [95% CI，7.9 至 10.7]），结果与化疗相比，tisotumab vedotin 的死亡风险降低了 30%（风险比，0.70；95% CI，0.54 至 0.89；双侧 P = 0.004）。 tisotumab vedotin 组的中位无进展生存期为 4.2 个月（95% CI，4.0 至 4.4），化疗组为 2.9 个月（95% CI，2.6 至 3.1）（风险比，0.67；95% CI，0.54 至 0.82；2单侧 P<0.001）。经证实的客观缓解率，tisotumab vedotin 组为 17.8%，化疗组为 5.2%（比值比，4.0；95% CI，2.1 至 7.6；双侧 P<0.001）。 tisotumab vedotin 组中总共 98.4% 的患者和化疗组中 99.2% 的患者在治疗期间（定义为从第 1 剂的第 1 天到最后一次剂量后 30 天的期间）发生了至少一种不良事件。 ; 3 级或以上事件的发生率分别为 52.0% 和 62.3%。共有14.8%的患者因毒性作用停止了tisotumab vedotin治疗。 在复发性宫颈癌患者中，使用tisotumab vedotin二线或三线治疗的疗效明显优于化疗。 （由 Genmab 和 Seagen 资助[被辉瑞收购]；innovaTV 301 ClinicalTrials.gov 编号，NCT04697628。）。版权所有 © 2024 马萨诸塞州医学会。

Recurrent cervical cancer is a life-threatening disease, with limited treatment options available when disease progression occurs after first-line combination therapy.We conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in patients with recurrent or metastatic cervical cancer. Patients were randomly assigned, in a 1:1 ratio, to receive tisotumab vedotin monotherapy (2.0 mg per kilogram of body weight every 3 weeks) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival.A total of 502 patients underwent randomization (253 were assigned to the tisotumab vedotin group and 249 to the chemotherapy group); the groups were similar with respect to demographic and disease characteristics. The median overall survival was significantly longer in the tisotumab vedotin group than in the chemotherapy group (11.5 months [95% confidence interval {CI}, 9.8 to 14.9] vs. 9.5 months [95% CI, 7.9 to 10.7]), results that represented a 30% lower risk of death with tisotumab vedotin than with chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 to 0.89; two-sided P = 0.004). The median progression-free survival was 4.2 months (95% CI, 4.0 to 4.4) with tisotumab vedotin and 2.9 months (95% CI, 2.6 to 3.1) with chemotherapy (hazard ratio, 0.67; 95% CI, 0.54 to 0.82; two-sided P<0.001). The confirmed objective response rate was 17.8% in the tisotumab vedotin group and 5.2% in the chemotherapy group (odds ratio, 4.0; 95% CI, 2.1 to 7.6; two-sided P<0.001). A total of 98.4% of patients in the tisotumab vedotin group and 99.2% in the chemotherapy group had at least one adverse event that occurred during the treatment period (defined as the period from day 1 of dose 1 until 30 days after the last dose); grade 3 or greater events occurred in 52.0% and 62.3%, respectively. A total of 14.8% of patients stopped tisotumab vedotin treatment because of toxic effects.In patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy. (Funded by Genmab and Seagen [acquired by Pfizer]; innovaTV 301 ClinicalTrials.gov number, NCT04697628.).Copyright © 2024 Massachusetts Medical Society.