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首页> 外文期刊>Clinical colorectal cancer >Aflibercept Plus FOLFIRI in the Real-life Setting: Safety and Quality of Life Data From the Italian Patient Cohort of the Aflibercept Safety and Quality-of-Life Program Study
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Aflibercept Plus FOLFIRI in the Real-life Setting: Safety and Quality of Life Data From the Italian Patient Cohort of the Aflibercept Safety and Quality-of-Life Program Study

机译：Aflibercept Plus Folfiri在现实生活中的环境：来自意大利病人队列的安全性和质量，AFLibercept安全和生活质量计划研究

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BackgroundAflibercept combined with FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) as second-line treatment of metastatic colorectal cancer (mCRC) significantly improved survival compared with FOLFIRI alone in the pivotal VELOUR (aflibercept vs. placebo in combination with irinotecan and 5-fluorouracil in the treatment of patients with metastatic colorectal cancer after failure of an oxaliplatin-based regimen) trial. No quality-of-life assessment was performed in VELOUR; therefore, the ASQoP (Aflibercept Safety and Quality-of-Life Program) trial was designed to capture the safety and health-related quality of life (HRQL). Patients and MethodsASQoP was an international, open-label, single-arm trial evaluating the safety and HRQL of aflibercept combined with FOLFIRI administered in a real-life setting to 781 patients with mCRC, pretreated with an oxaliplatin-based regimen with or without bevacizumab. The Italian subset of ASQoP enrolled 200 patients from 28 institutions. The primary endpoint was safety; HRQL was a secondary endpoint, assessed by validated questionnaires (European quality of life 5-dimension instrument 3-level; European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30, version 3; and EORTC-CR29) at baseline, during treatment, and at the end of treatment. ResultsThe median age of the Italian ASQoP population was 63 years; the median number of aflibercept and FOLFIRI cycles was 7. Treatment-emergent adverse events were reported in 97.5% of patients. Hypertension (28.5%), neutropenia (27.5%; from laboratory data), asthenic conditions (20.0%), diarrhea (17.0%), and stomatitis (13.0%) were the most frequent (incidence,?≥ 5%) grade 3/4 toxicities. One toxic death occurred during the study period due to sepsis, without neutropenic complications. No significant worsening of HRQL was shown during treatment. ConclusionAflibercept combined with FOLFIRI was well tolerated when administered as second-line treatment for patients with mCRC in a real-life setting. It did not affect HRQL and showed similar rates of treatment-emergent adverse events as those observed in the VELOUR trial. No new safety signals were identified.
机译：Backgroundaflibribercept与Folfiri（叶酸，5-氟尿嘧啶，伊替替康）作为转移性结肠直肠癌（MCRC）的二线治疗与单独的枢轴丝绒中单独的Folfiri相比显着提高了存活率（Aflibercept与伊替替康和5-氟尿嘧啶组合。在奥沙利铂的方案失败后治疗转移性结肠直肠癌患者的试验。没有在Velor中进行寿命质量评估;因此，ASQOP（AFLibercept安全和寿命质量计划）试验旨在捕捉安全和健康的生活质量（HRQL）。患者和方法是一种国际，开放标签，单臂试验，评估AFLIBSCEPT的安全性和HRQL与MFRC中的781名患者组合的FOLFIRI联合，用基于Okaliplatin的方案有或没有Bevacizumab进行预处理。意大利ASQOP子集注册了28个机构的200名患者。主要终点是安全; HRQL是一个辅助终点，通过经过验证的问卷评估（欧洲生命质量5-Vimension internamet 3-Level;欧洲研究和治疗组织癌症质量问卷核心30，版本3;和EORTC-CR29）在基线，期间治疗，并在治疗结束时。结果的意大利ASQOP人口的中位年龄为63岁; AfliBercept和Folfiri循环的中位数为7. 97.5％的患者报告治疗 - 紧急不良事件。高血压（28.5％），中性粒细胞病（27.5％;来自实验室数据），哮喘的条件（20.0％），腹泻（17.0％）和口腔炎（13.0％）是最常见的（发病率，？≥5％）3级/ 4毒性。由于败血症，在研究期间发生了一种毒性死亡，没有中性并发症。在治疗期间显示了HRQL的显着恶化。结案，当在现实生活中的MCRC患者的第二线治疗时，与FOLFIRI相结合的结合耐受性。它没有影响HRQL，并且显示出类似的治疗急性不良事件率，因为在Velor试验中观察到的速度。没有确定新的安全信号。

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