Russi Alberto, Damuzzo Vera, Chiumente Marco, Pigozzo Jacopo, Cesca Marco, Chiarion-Sileni Vanna, Palozzo Angelo Claudio
a Hospital Pharmacy , Veneto Institute of Oncology - IRCCS , Padua , Italy.
b School of Hospital Pharmacy , University of Padua , Padua , Italy.
J Chemother. 2017 Aug;29(4):245-251. doi: 10.1080/1120009X.2017.1311444. Epub 2017 Apr 11.
In patients with metastatic melanoma, ipilimumab has been shown to improve long-term survival. This observational multicenter study reports clinical outcomes of 418 patients treated with second-line ipilimumab from February 2013 to August 2014. Median overall survival (OS) was 6.43 months (95%CI: 5.45-7.42; n = 300), while median progression-free survival (PFS) was 3.7 months (95%CI: 3.23-4.17; n = 188). Demographic factors, such as sex or number of previous therapies did not affect OS. Survival was shorter in patients with ECOG > 0 (Eastern Cooperative Oncology Group, Performance Status) (p < 0.001), while a longer OS was found in patients who completed all four therapy cycles (p < 0.001). Adverse events of any grade were reported for 66% of patients (mainly cutaneous and gastrointestinal), but most were low grade and easily managed. Adverse events of grades 3-4 were observed in 13% of patients. This study confirmed the efficacy and safety of this treatment in real practice.
在转移性黑色素瘤患者中，已证明伊匹单抗可改善长期生存率。这项观察性多中心研究报告了2013年2月至2014年8月期间接受二线伊匹单抗治疗的418例患者的临床结果。中位总生存期（OS）为6.43个月（95%CI：5.45 - 7.42；n = 300），而中位无进展生存期（PFS）为3.7个月（95%CI：3.23 - 4.17；n = 188）。人口统计学因素，如性别或既往治疗次数，并不影响总生存期。东部肿瘤协作组（ECOG）体能状态评分>0的患者生存期较短（p < 0.001），而完成全部四个治疗周期的患者总生存期较长（p < 0.001）。66%的患者报告了任何级别的不良事件（主要为皮肤和胃肠道不良事件），但大多数为低级别且易于处理。13%的患者观察到3 - 4级不良事件。本研究证实了该治疗方法在实际应用中的有效性和安全性。
