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Modified irinotecan and infusional 5-fluorouracil (mFOLFIRI) in patients with refractory advanced pancreas cancer (APC): a single-institution experience

机译:改良的伊立替康和输注的5-氟尿嘧啶(mFOLFIRI)在难治性晚期胰腺癌(APC)患者中的应用:单机构经验

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摘要

Pancreatic adenocarcinoma is the fourth leading cause of cancer death. Recently, MM-398 (nanoliposomal irinotecan) was shown to be associated with significant improvement in outcome measures with acceptable toxicities when combined with 5-fluorouracil (5-FU)/leucovorin (LV) compared to 5-FU/LV alone in patients failing one line of gemcitabine-based therapy. There is a paucity of data evaluating the role of irinotecan in combination with 5FU in advanced pancreas cancer (APC). We performed a retrospective analysis of all patients who received mFOLFIRI (minus bolus 5FU and LV). All patients with metastatic disease who had failed at least one line of gemcitabine-based therapy prior to receiving mFOLFIRI were included in this study. Descriptive statistics were used to assess the continuous variables and adverse events (AEs), and Kaplan–Meier methods were used to calculate the median progression-free survival (PFS) and overall survival (OS). Forty patients were included in this analysis. Patients received 1–5 lines of prior therapy (25 % with more than 3 lines of prior therapy). The mean age at diagnosis was 60, and 98 % had ECOG of 1. The mean CA 19-9 at the start of therapy was 33,169 U/ml. The median PFS was 2.59 months [95 % confidence interval (CI) (1.90, 3.54)], and OS was 4.75 months [95 % CI (3.14, 8.98)]. The most common AEs included fatigue (98 %), neuropathy (83 %), anorexia (68 %), nausea (60 %) and constipation (55 %). Grade 3 toxicities included fatigue (13 %) and rash (3 %). There were no observed grade 4 toxicities. In this single-institution retrospective analysis, mFOLFIRI was found to be both tolerable and relatively effective in a heavily pretreated patient population with APC. Future prospective studies should consider evaluating the role of mFOLFIRI in refractory APC.
机译:胰腺腺癌是癌症死亡的第四大主要原因。最近,与单独使用5-FU / LV的患者相比,与单独使用5-FU / LV的患者相比,与5-氟尿嘧啶(5-FU)/亚叶酸(LV)联合使用时,MM-398(纳米脂质体伊立替康)可显着改善预后,并具有可接受的毒性一线基于吉西他滨的疗法。缺乏数据评估伊立替康联合5FU在晚期胰腺癌(APC)中的作用。我们对所有接受mFOLFIRI(减去5FU和LV推注)的患者进行了回顾性分析。所有接受转移性疾病的患者在接受mFOLFIRI之前至少一项基于吉西他滨的治疗均无效。描述性统计用于评估连续变量和不良事件(AE),Kaplan–Meier方法用于计算中位数无进展生存期(PFS)和总体生存期(OS)。该分析包括40名患者。患者接受1至5线的先前治疗(25%的患者接受3线以上的先前治疗)。诊断时的平均年龄为60岁,ECOG为1 98%。治疗开始时的平均CA 19-9为33,169 U / ml。 PFS中位数为2.59个月[95%置信区间(CI)(1.90,3.54)],而OS为4.75个月[95%CI(3.14,8.98)]。最常见的不良事件包括疲劳(98%),神经病(83%),厌食症(68%),恶心(60%)和便秘(55%)。 3级毒性包括疲劳(13%)和皮疹(3%)。没有观察到4级毒性。在这一单一机构的回顾性分析中,发现在经过大量预处理的APC患者中,mFOLFIRI既可耐受,又相对有效。未来的前瞻性研究应考虑评估mFOLFIRI在难治性APC中的作用。

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