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首页> 外文期刊>Journal of Oncological Sciences >Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patients
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Experience from Turkish centers participating in the Early Access Program (EAP): Preliminary real-world safety data of nivolumab (nivo) combined with ipilimumab (ipi) in pre-treated advanced melanoma patients

机译：来自土耳其参与早期访问计划（EAP）的中心的经验：在接受过治疗的晚期黑色素瘤患者中，nivolumab（nivo）联合ipilimumab（ipi）的初步真实世界安全性数据

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ObjectiveWe aimed to evaluate the safety of nivolumab?+?ipilimumab (nivo?+?ipi) in advanced melanoma patients who had relapsed after ≥1 line of systemic treatment in a real-world setting.MethodsAdult patients with advanced melanoma who had progressed after ≥1 line of systemic treatment were eligible for nivo 1?mg/kg?+?ipi 3?mg/kg Q3W?×?4, followed by nivo 3?mg/kg Q2W until progression, or unacceptable toxicity for up to 24 months in the Early Access Program (EAP) in Turkey. Treatment-related adverse events (TRAEs) were recorded and analyzed.ResultsForty patients who received at least one dose of nivo?+?ipi were included. Median number of doses (Nivo?+?ipi and nivo alone) were 4 with a median follow-up of 19 weeks. Thirty patients (75%) were alive and 24 patients (60%) were on treatment. TRAEs of any grade and grade 3–4 occurred in 53% and 20% of the patients, respectively. One patient died due to TRAEs (colitis and diarrhea) after the second dose of nivo?+?ipi. Median times to onset and resolution of TRAEs were 6 and 3 weeks, respectively. Eleven patients (28%) discontinued treatment for reasons other than TRAEs. TRAEs of any grade led to discontinuation in 5 patients (13%). Most of the TRAEs were reversible when managed with available guidelines.DiscussionSafety profile of N?+?I was found to be consistent with early reports. Increased experience with the management of TRAEs of immunotherapies, short follow-up and ≥2 line real-world setting may account for lower TRAEs rates. Long-term follow is needed.
机译：目的我们旨在评估在现实世界中≥1行系统治疗后复发的晚期黑色素瘤患者中nivolumab？+？ipilimumab（nivo？+？ipi）的安全性。 1线全身性治疗符合条件的是尼古丁1？mg / kg？+？ipi 3？mg / kg Q3W？×？4，随后是尼古丁3？mg / kg Q2W，直到进展，或在24个月内出现不可接受的毒性。土耳其的抢先体验计划（EAP）。记录并分析与治疗相关的不良事件（TRAE）。结果包括40例接受至少一剂nivo？+？ipi的患者。中位剂量数（仅Nivo？+？ipi和nivo）为4，中位随访时间为19周。有30名患者（75％）存活，有24名患者（60％）正在接受治疗。 53％和20％的患者分别发生任何级别和3-4级的TRAE。在第二剂nivo？+？ipi后，一名患者因TRAE（结肠炎和腹泻）死亡。 TRAEs发作的中位数时间和缓解时间分别为6周和3周。 11名患者（28％）因TRAE以外的原因而中止了治疗。任何级别的TRAE均导致5例患者停药（13％）。如果按照可用的指南进行管理，大多数TRAE都是可逆的。发现N ++ I的讨论安全性与早期报道一致。免疫疗法的TRAE的管理经验增加，短期随访和≥2行真实环境设置可能是导致TRAE发生率降低的原因。需要长期跟踪。

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