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    北京市朝阳区桓兴肿瘤医院

    中国医学科学院肿瘤医院紧密型医联体

    肿瘤专科医协体

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    桓兴医讯 在晚期程序性死亡配体1阳性宫颈癌中派姆单抗的安全性和

    作者:南南和北北 来源:北京市朝阳区桓兴肿瘤医院
    字号: + - 14
    美国《临床肿瘤杂志》2017年11月2日在线先发
    在晚期程序性死亡配体1阳性宫颈癌中派姆单抗的安全性和有效性:来自Ib期KEYNOTE-028试验的结果
    目的
    KEYNOTE-028试验(ClinicalTrials.gov网站注册号:NCT02054806)旨在在程序性死亡配体1阳性的20种晚期实体瘤队列中评价派姆单抗(pembrolizumab)的安全性和有效性。在此,我们对晚期宫颈癌患者队列结果予以报告。
    方法
    患者用派姆单抗(pembrolizumab)10mg/kg、每2周一次治疗,直至24个月,前6个月每8周评价一次缓解情况,以后每12个月评价一次。主要终点为总缓解率,按照“实体瘤疗效评价标准1.1版”由研究人员评价总缓解率,安全性为一项次要终点。
    结果
    24名患者入组到宫颈癌队列,中位年龄为42岁(26-62岁),22名患者既往接受过放射治疗,15名针对晚期肿瘤,接受过包括贝伐单抗在内的2线或2线以上的治疗。在数据锁定日,中位随访期为11.0月(1.3-32.2个月)。总缓解率为17%(95%CI,5%-37%),4名患者(17%)获得了确定性的部分缓解,3名(13%)稳定?;竦貌糠只航獾恼?名患者缓解的中位时间为5.4个月(4.1-7.5个月)。18名患者(75%)经历了治疗相关性不良事件(AEs),≥10%的患者只是出现了皮疹(n=5,21%)和发热(n=4,17%)。5名患者经历了3级治疗相关性不良事件,未观察到4级治疗相关性不良事件或死亡。
    结论
    在程序性死亡配体1阳性的晚期宫颈癌患者中,派姆单抗(pembrolizumab)显示出有抗肿瘤活性,所展现出的安全性与在其它类型的肿瘤中所见到的安全性一致。
    北京市朝阳区桓兴肿瘤医院 桓兴医讯编译组 南南和北北
    2017年11月20日 星期一




    Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1–Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial
    Purpose
    The KEYNOTE-028 trial (ClinicalTrials.gov identifier: NCT02054806) was designed to assess the safety and efficacy of pembrolizumab in 20 programmed death ligand 1–positive, advanced solid tumor cohorts. Here, we present the results from the cohort of patients with advanced cervical cancer.
    Methods
    Patients were treated with pembrolizumab 10 mg/kg every 2 weeks for up to 24 months. Response was assessed every 8 weeks for the first 6 months and every 12 weeks thereafter. The primary end point was overall response rate per Response Evaluation Criteria in Solid Tumors, version 1.1, by investigator review. Safety was a secondary end point.
    Results
    Twenty-four patients were enrolled in the cervical cancer cohort. The median age was 42 years (range, 26 to 62 years), 22 patients (92%) had received prior radiation therapy, and 15 patients (63%) had received two or more lines of therapy, including bevacizumab (10 of 24 patients), for advanced disease. At the data cutoff, median follow-up duration was 11.0 months (range, 1.3 to 32.2 months). Overall response rate was 17% (95% CI, 5% to 37%); four patients (17%) achieved a confirmed partial response, and three patients (13%) had stable disease. Median duration of response for the four patients who achieved a partial response was 5.4 months (4.1 to 7.5 months). Treatment related adverse events (AEs) were experienced by 18 patients (75%); only rash (n = 5; 21%) and pyrexia (n = 4; 17%) and occurred in ≥ 10% of patients. Five patients experienced grade 3 treatment-related AEs. No grade 4 treatment-related AEs or deaths were observed.
    Conclusion
    In patients with programmed death ligand 1–positive advanced cervical cancer, pembrolizumab demonstrated antitumor activity and exhibited a safety profile consistent with that seen in other tumor types.
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