Elbe-Klinikum Buxtehude, Buxtehude, Germany.
Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy.
J Eur Acad Dermatol Venereol. 2018 Jun;32(6):962-971. doi: 10.1111/jdv.14633. Epub 2017 Nov 8.
There is a scarcity of real-world data on treatment patterns and outcomes among advanced melanoma patients treated with immunotherapies including ipilimumab, an anti-CTLA-4 antibody approved since 2011.
To evaluate ipilimumab and postipilimumab treatment patterns and outcomes among patients with advanced melanoma in Australia, Germany, Italy and Spain, following regulatory approval.
Retrospective multicentre, multinational, observational chart review study. Data were extracted from the start of ipilimumab therapy until the end of at least 40 weeks of follow-up, or death.
Data from 371 patients (Australia, 103; Germany, 152; Italy, 76; Spain, 40) were analysed. Mean age was 65 years; 62% were male. Eastern Cooperative Oncology Group performance status (ECOG PS) was 0 or 1 for 94%. In 67%, ipilimumab was initially received as second-line or later therapy. Patients received on average 3.4 ipilimumab doses. The ipilimumab-refractory cohort comprised of 226 patients. Of these, 17% in Australia, 47% in Germany, 29% in Italy and 14% in Spain received another antimelanoma treatment after ipilimumab including chemotherapy in 26% and BRAF/other kinase inhibitors in 11%. Ipilimumab-refractory patients who received postipilimumab treatment showed a 40% reduced hazard of dying than those not receiving treatment after ipilimumab (HR 0.60; 95% CI 0.43-0.83), after adjustment for potential confounders.
During the time observed, ipilimumab was mainly used as second-line or later therapy. A significant proportion of patients received postipilimumab therapy, most of which was chemotherapy. Nevertheless, overall survival following progression on ipilimumab treatment remained poor, highlighting the need for research to develop more effective end-of-life treatment options.
目前缺乏关于免疫疗法（包括抗 CTLA-4 抗体伊匹单抗，该药于 2011 年获批）治疗晚期黑色素瘤患者的治疗模式和结局的真实世界数据。
评估澳大利亚、德国、意大利和西班牙在监管批准后，晚期黑色素瘤患者接受伊匹单抗治疗后的治疗模式和结局。
回顾性、多中心、多国观察性病历回顾研究。从伊匹单抗治疗开始到至少 40 周的随访结束或死亡，提取数据。
共纳入 371 例患者（澳大利亚 103 例、德国 152 例、意大利 76 例、西班牙 40 例）。患者的平均年龄为 65 岁，62%为男性。94%的患者东部肿瘤协作组体力状况（ECOG PS）为 0 或 1。67%的患者最初接受伊匹单抗二线或更后线治疗。患者平均接受 3.4 剂伊匹单抗。伊匹单抗耐药组包括 226 例患者。其中，澳大利亚、德国、意大利和西班牙的患者比例分别为 17%、47%、29%和 14%，在伊匹单抗治疗后接受了另一种抗黑色素瘤治疗，包括化疗（26%）和 BRAF/其他激酶抑制剂（11%）。调整潜在混杂因素后，与未接受伊匹单抗治疗的患者相比，接受伊匹单抗后治疗的伊匹单抗耐药患者的死亡风险降低了 40%（HR 0.60；95%CI 0.43-0.83）。
在观察期间，伊匹单抗主要作为二线或更后线治疗药物使用。很大一部分患者接受了伊匹单抗后的治疗，其中大部分为化疗。然而，伊匹单抗治疗进展后的总生存仍较差，这突显了需要研究开发更有效的临终治疗选择。
