Abstract
BackgroundTherapeutic 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.MethodsIn 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).ResultsThere 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.ConclusionsThis retrospective analysis provides the first evidence that Nal-IRI might exhibit a clinical meaningful antitumor activity in metastatic biliary tract cancer.
Highlights
Biliary tract cancer (BTC) is a highly malignant and fatal cancer that arises from the biliary epithelium of the bile duct, gallbladder, and the ampulla of Vater and1 3 Vol.:(0123456789)Cancer Chemotherapy and Pharmacology (2020) 86:109–115 that there was insufficient evidence to recommend secondline chemotherapy in advanced BTC [7]
We provide the first evidence of the antitumor activity of nanoliposomal irinotecan (Nal-IRI) in combination with 5-FU and folinic acid in 14 patients with advanced and metastatic BTC after failure of the first-line gemcitabine-based chemotherapy regimen
Despite advanced disease and prior treatment, Nal-IRI achieved a disease control rate (DCR) of 50%, a median progression-free survival (PFS) of 10.6 months, and a median overall survival (OS) of 24.1 months. These results provide evidence for the antitumor activity of Nal-IRI in metastatic BTC
Summary
Biliary tract cancer (BTC) is a highly malignant and fatal cancer that arises from the biliary epithelium of the bile duct, gallbladder, and the ampulla of Vater and1 3 Vol.:(0123456789)Cancer Chemotherapy and Pharmacology (2020) 86:109–115 that there was insufficient evidence to recommend secondline chemotherapy in advanced BTC [7]. Nal-IRI at doses five times lower than those achieved with free irinotecan was shown to reach comparable local SN-38 levels within the tumor tissue, accompanied with superior antitumor activity [13, 14]. The pivotal NAPOLI-1 trial demonstrated the superior clinical benefit of nanoliposomal irinotecan (Nal-IRI) in gemcitabine-pretreated patients with metastatic pancreatic ductal adenocarcinoma; 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. Conclusions This retrospective analysis provides the first evidence that Nal-IRI might exhibit a clinical meaningful antitumor activity in metastatic biliary tract cancer
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