Clinical Division of Oncology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.
Comprehensive Cancer Center, Vienna, Austria.
Cancer Chemother Pharmacol. 2020 Jul;86(1):109-115. doi: 10.1007/s00280-020-04094-0. Epub 2020 Jun 18.
Therapeutic options are limited for advanced, metastatic biliary tract cancer. The pivotal NAPOLI-1 trial demonstrated the superior clinical benefit of nanoliposomal irinotecan (Nal-IRI) in gemcitabine-pretreated patients with metastatic pancreatic ductal adenocarcinoma; however, the antitumor activity of Nal-IRI in biliary tract cancer is unknown. This is the first report describing the efficacy of Nal-IRI in biliary tract cancer.
In this multicenter retrospective cohort analysis, we identified patients with metastatic biliary tract adenocarcinoma who were treated with Nal-IRI in combination with 5-fluorouracil and folinic acid following tumor progression under standard therapy at one of the study centers between May 2016 and January 2019. We assessed disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
There were 14 patients; the median age at the time of diagnosis and the median age at the initiation of Nal-IRI were 59.3 and 60.0 years, respectively. Nal-IRI in combination with 5-fluorouracil and folinic acid was administered as second-, third-, fourth-, and fifth-line treatment in 6 (43%), 5 (36%), 2 (14%), and 1 (7%) patient with metastatic disease, respectively. The objective DCR with Nal-IRI was 50% (7/14 patients). Six patients (43%) had partial response, and one patient (7%) had stable disease. Progressive disease was observed in seven patients. The median PFS and median OS following Nal-IRI initiation were 10.6 and 24.1 months, respectively.
This retrospective analysis provides the first evidence that Nal-IRI might exhibit a clinical meaningful antitumor activity in metastatic biliary tract cancer.
对于晚期转移性胆道癌，治疗选择有限。NAPOLI-1 关键试验表明，纳米脂质体伊立替康（Nal-IRI）在吉西他滨预处理的转移性胰腺导管腺癌患者中具有更好的临床获益；然而，Nal-IRI 在胆道癌中的抗肿瘤活性尚不清楚。这是首次报道 Nal-IRI 在胆道癌中的疗效。
在这项多中心回顾性队列分析中，我们在研究中心之一，在标准治疗下肿瘤进展后，鉴定了 2016 年 5 月至 2019 年 1 月期间接受 Nal-IRI 联合 5-氟尿嘧啶和亚叶酸治疗的转移性胆道腺癌患者。我们评估了疾病控制率（DCR）、无进展生存期（PFS）和总生存期（OS）。
共有 14 名患者；诊断时的中位年龄和开始接受 Nal-IRI 时的中位年龄分别为 59.3 岁和 60.0 岁。Nal-IRI 联合 5-氟尿嘧啶和亚叶酸分别作为二线、三线、四线和五线治疗转移性疾病的 6（43%）、5（36%）、2（14%）和 1（7%）名患者的治疗药物。Nal-IRI 的客观 DCR 为 50%（7/14 名患者）。6 名患者（43%）有部分缓解，1 名患者（7%）有稳定的疾病。7 名患者出现疾病进展。开始接受 Nal-IRI 后，中位 PFS 和中位 OS 分别为 10.6 和 24.1 个月。
这项回顾性分析首次提供了证据表明，Nal-IRI 可能在转移性胆道癌中具有临床意义的抗肿瘤活性。
