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长春氟宁治疗复发性尿路上皮膀胱癌:希腊泌尿生殖系统癌症小组的真实世界证据

Treatment of relapsed urothelial bladder cancer with vinflunine: real-world evidence by the Hellenic Genitourinary Cancer Group.

作者信息

Pistamaltzian Nikolaos, Tzannis Kimon, Pissanidou Vassiliki, Peroukidis Stavros, Milaki Georgia, Karavasilis Vasilis, Mitsogiannis Iraklis, Varkarakis Ioannis, Papatsoris Athanasios, Dellis Athanasios, Adamakis Ioannis, Stravodimos Konstantinos, Molyva Dimitra, Athanasiadis Ilias, Androulakis Nikos, Andreadis Charalambos, Kalofonos Charalambos, Mitropoulos Dionisios, Deliveliotis Charalambos, Constantinides Constantinos, Dimopoulos Meletios A, Bamias Aristotelis

机构信息

aSecond Oncology Department, MITERA Hospital, Maroussi bDepartment of Clinical Therapeutics, Medical School cSecond University Urological Clinic, Sismanoglio General Hospital dFirst University Urological Clinic, Laiko General Hospital, University of Athens, Athens eOncology University Clinic, General Hospital of Thessaloniki Papageorgiou fThird Oncology Clinic, Theagenio Cancer Hospital of Thessaloniki, Thessaloniki gOncology University Clinic, Patras University Hospital, Patras hOncology Unit, Venizeleio General Hospital, Heraklion, Greece.

出版信息

Anticancer Drugs. 2016 Jan;27(1):48-53. doi: 10.1097/CAD.0000000000000297.

Abstract

Relapsed urothelial cancer represents an unmet medical need. Vinflunine is a third-generation antimicrotubuline inhibitor and is currently the only approved drug for second-line treatment across the European Union. We conducted a retrospective analysis assessing the efficacy and safety of vinflunine in 71 Greek patients with relapsed urothelial cancer who were treated between 2005 and 2014. An overall 84% of our patients received vinflunine as second-line treatment, 77% had a performance status of Eastern Cooperative Oncology Group scale 0 or 1, and 30% had liver metastasis at the time of vinflunine administration. A median of four cycles of vinflunine were administered (range 1-16). The most common reported adverse events were constipation, fatigue, and anemia. Median progression-free survival was 6.2 months (95% confidence interval: 4.4-8.8) and overall survival was 11.9 months (95% confidence interval: 7.4-21). Two patients (3%) achieved a complete remission, seven a partial remission (10%), and 22 (31%) had stable disease according to an intention-to-treat analysis. Hemoglobin level less than 10 g/dl and Eastern Cooperative Oncology Group performance status greater than 1 were independent adverse prognostic factors. Stratification according to the Bellmunt risk model was also associated with progression-free survival and overall survival in our population. Vinflunine appears to be a safe and effective treatment modality for relapsed urothelial cancer. More effective therapies and more accurate prognostic algorithms should be sought.

摘要

复发性尿路上皮癌是一种尚未满足的医疗需求。长春氟宁是一种第三代抗微管蛋白抑制剂,目前是欧盟唯一批准用于二线治疗的药物。我们进行了一项回顾性分析,评估了2005年至2014年间接受治疗的71例希腊复发性尿路上皮癌患者使用长春氟宁的疗效和安全性。我们的患者中,总体84%接受长春氟宁作为二线治疗,77%的东部肿瘤协作组体能状态为0或1,30%在使用长春氟宁时发生肝转移。长春氟宁的给药周期中位数为4个周期(范围1 - 16)。报告的最常见不良事件为便秘、疲劳和贫血。无进展生存期的中位数为6.2个月(95%置信区间:4.4 - 8.8),总生存期为11.9个月(95%置信区间:7.4 - 21)。根据意向性分析,2例患者(3%)实现完全缓解,7例部分缓解(10%),22例(31%)病情稳定。血红蛋白水平低于10 g/dl和东部肿瘤协作组体能状态大于1是独立的不良预后因素。根据贝尔蒙特风险模型进行分层也与我们研究人群的无进展生存期和总生存期相关。长春氟宁似乎是复发性尿路上皮癌一种安全有效的治疗方式。应寻求更有效的治疗方法和更准确的预后算法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e17/4885529/d70fcf8f8352/cad-27-48-g003.jpg

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