疗效和安全性的tisotumab vedotin以前治疗的复发或转移性宫颈癌(innovaTV 204 /高格- 3023 / ENGOT-cx6):一项多中心、非盲、单臂,第二阶段的研究。
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科尔曼RL, Lorusso D, Gennigens C, Gonzalez-Martin,兰德尔•L Cibula D,隆德B, Woelber L, Pignata年代,忘记F,雷东多,Vindelov SD,陈M,哈里斯JR史密斯M, Nicacio LV,邓韩剧,Laenen, Rangwala R, Manso L,殿下,我和尚BJ, Vergote
疗效和安全性的tisotumab vedotin以前治疗的复发或转移性宫颈癌(innovaTV 204 /高格- 3023 / ENGOT-cx6):一项多中心、非盲、单臂,第二阶段的研究。
柳叶刀杂志。2021;22 (5):609 - 619。doi: 10.1016 / s1470 - 2045 (21) 00056 - 5。Epub 2021年4月9日。
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33845034 (在PubMed]
- 文摘
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背景:一些有效的二线治疗对女性存在复发或转移性宫颈癌。因此,我们的目的是评估的有效性和安全性tisotumab vedotin,组织factor-directed抗体药物共轭,患者人群。方法:多中心、非盲、单臂,第二阶段研究是做35的学术中心,医院和社区实践在欧洲和美国。研究包括18岁或以上的患者复发或转移性鳞状细胞癌,或adenosquamous宫颈癌;疾病进展与贝伐单抗或双重化疗后(如果符合当地标准);之前曾收到两个或更少的系统性方案对复发或转移性疾病;基于响应评估标准可衡量的疾病在实体肿瘤(RECIST;1.1版本);和东部有一个合作的肿瘤组0或1的性能状态。患者接受2.0毫克/公斤(200毫克)的最大tisotumab vedotin静脉注射一次3个星期,直到疾病进展(由独立审查委员会)或不可接受的毒性。 The primary endpoint was confirmed objective response rate based on RECIST (version 1.1), as assessed by the independent review committee. Activity and safety analyses were done in patients who received at least one dose of the drug. This study is ongoing with recruitment completed and is registered with ClinicalTrials.gov, NCT03438396. FINDINGS: 102 patients were enrolled between June 12, 2018, and April 11, 2019; 101 patients received at least one dose of tisotumab vedotin. Median follow-up at the time of analysis was 10.0 months (IQR 6.1-13.0). The confirmed objective response rate was 24% (95% CI 16-33), with seven (7%) complete responses and 17 (17%) partial responses. The most common treatment-related adverse events included alopecia (38 [38%] of 101 patients), epistaxis (30 [30%]), nausea (27 [27%]), conjunctivitis (26 [26%]), fatigue (26 [26%]), and dry eye (23 [23%]). Grade 3 or worse treatment-related adverse events were reported in 28 (28%) patients and included neutropenia (three [3%] patients), fatigue (two [2%]), ulcerative keratitis (two [2%]), and peripheral neuropathies (two [2%] each with sensory, motor, sensorimotor, and neuropathy peripheral). Serious treatment-related adverse events occurred in 13 (13%) patients, the most common of which included peripheral sensorimotor neuropathy (two [2%] patients) and pyrexia (two [2%]). One death due to septic shock was considered by the investigator to be related to therapy. Three deaths unrelated to treatment were reported, including one case of ileus and two unknown causes. INTERPRETATION: Tisotumab vedotin showed clinically meaningful and durable antitumour activity with a manageable and tolerable safety profile in women with previously treated recurrent or metastatic cervical cancer. Given the poor prognosis for this patient population and the low activity of current therapies in this setting, tisotumab vedotin, if approved, would represent a new treatment for women with recurrent or metastatic cervical cancer. FUNDING: Genmab, Seagen, Gynaecologic Oncology Group, and European Network of Gynaecological Oncological Trial Groups.
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