First evidence for the antitumor activity of nanoliposomal irinotecan with 5-fluorouracil and folinic acid in metastatic biliary tract cancer.
Adenocarcinoma
/ drug therapy
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Biliary Tract Neoplasms
/ drug therapy
Deoxycytidine
/ administration & dosage
Drug Carriers
/ administration & dosage
Female
Fluorouracil
/ administration & dosage
Humans
Irinotecan
/ administration & dosage
Leucovorin
/ administration & dosage
Liposomes
/ administration & dosage
Male
Middle Aged
Nanoparticles
/ administration & dosage
Retrospective Studies
Treatment Outcome
Gemcitabine
Biliary tract cancer
Chemotherapy
Nanoliposomal irinotecan
Overall survival
Progression-free survival
Journal
Cancer chemotherapy and pharmacology
ISSN: 1432-0843
Titre abrégé: Cancer Chemother Pharmacol
Pays: Germany
ID NLM: 7806519
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
received:
20
03
2020
accepted:
03
06
2020
pubmed:
20
6
2020
medline:
20
2
2021
entrez:
20
6
2020
Statut:
ppublish
Résumé
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.
Sections du résumé
BACKGROUND
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.
METHODS
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).
RESULTS
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.
CONCLUSIONS
This retrospective analysis provides the first evidence that Nal-IRI might exhibit a clinical meaningful antitumor activity in metastatic biliary tract cancer.
Identifiants
pubmed: 32556829
doi: 10.1007/s00280-020-04094-0
pii: 10.1007/s00280-020-04094-0
pmc: PMC7338813
doi:
Substances chimiques
Drug Carriers
0
Liposomes
0
Deoxycytidine
0W860991D6
Irinotecan
7673326042
Leucovorin
Q573I9DVLP
Fluorouracil
U3P01618RT
Gemcitabine
0
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
109-115Références
Bridgewater J, Imber C (2007) New advances in the management of biliary tract cancer. HPB (Oxford) 9(2):104–111
doi: 10.1080/13651820701216216
Ciombor KK, Goff LW (2013) Advances in the management of biliary tract cancers. Clin Adv Hematol Oncol 11(1):28–34
pubmed: 23416860
pmcid: 3713630
Bridgewater JA et al (2016) Biliary tract cancer: epidemiology, radiotherapy, and molecular profiling. Am Soc Clin Oncol Educ Book 35:e194–203
doi: 10.14694/EDBK_160831
Zhao DY, Lim KH (2017) Current biologics for treatment of biliary tract cancers. J Gastrointest Oncol 8(3):430–440
doi: 10.21037/jgo.2017.05.04
Valle J et al (2010) Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362(14):1273–1281
doi: 10.1056/NEJMoa0908721
Lamarca A et al (2019) ABC-06|A randomised phase III, multi-centre, open-label study of active symptom control (ASC) alone or ASC with oxaliplatin/5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced/metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy. J Clin Oncol 37(15_suppl):4003–4003
doi: 10.1200/JCO.2019.37.15_suppl.4003
Lamarca A et al (2014) Second-line chemotherapy in advanced biliary cancer: a systematic review. Ann Oncol 25(12):2328–2338
doi: 10.1093/annonc/mdu162
Patel T (2011) Cholangiocarcinoma–controversies and challenges. Nat Rev Gastroenterol Hepatol 8(4):189–200
doi: 10.1038/nrgastro.2011.20
Sahu S, Sun W (2017) Targeted therapy in biliary tract cancers-current limitations and potentials in the future. J Gastrointest Oncol 8(2):324–336
doi: 10.21037/jgo.2016.09.16
Bragazzi MC et al (2018) New insights into cholangiocarcinoma: multiple stems and related cell lineages of origin. Ann Gastroenterol 31(1):42–55
pubmed: 29333066
Brandi G et al (2015) Genetic heterogeneity in cholangiocarcinoma: a major challenge for targeted therapies. Oncotarget 6(17):14744–14753
doi: 10.18632/oncotarget.4539
Zhang H (2016) Onivyde for the therapy of multiple solid tumors. Onco Targets Ther 9:3001–3007
doi: 10.2147/OTT.S105587
Chang TC et al (2015) Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients. Cancer Chemother Pharmacol 75(3):579–586
doi: 10.1007/s00280-014-2671-x
Woo W, Carey ET, Choi M (2019) Spotlight on liposomal irinotecan for metastatic pancreatic cancer: patient selection and perspectives. Onco Targets Ther 12:1455–1463
doi: 10.2147/OTT.S167590
Wang-Gillam A et al (2019) NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: final overall survival analysis and characteristics of long-term survivors. Eur J Cancer 108:78–87
doi: 10.1016/j.ejca.2018.12.007
Schmuck RB et al (2016) Distal bile duct carcinomas and pancreatic ductal adenocarcinomas: postulating a common tumor entity. Cancer Med 5(1):88–99
doi: 10.1002/cam4.566
Nakanuma Y, Sato Y (2014) Hilar cholangiocarcinoma is pathologically similar to pancreatic duct adenocarcinoma: suggestions of similar background and development. J Hepatobiliary Pancreat Sci 21(7):441–447
doi: 10.1002/jhbp.70
Feisthammel J et al (2007) Irinotecan with 5-FU/FA in advanced biliary tract adenocarcinomas: a multicenter phase II trial. Am J Clin Oncol 30(3):319–324
doi: 10.1097/01.coc.0000258124.72884.7a
Zheng Y et al (2018) A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin. Br J Cancer 119(3):291–295
doi: 10.1038/s41416-018-0138-2
Bhargava P et al (2003) Gemcitabine and irinotecan in locally advanced or metastatic biliary cancer: preliminary report. Oncology (Williston Park) 17(9 Suppl 8):23–26
Sanz-Altamira PM et al (2001) A phase II trial of irinotecan (CPT-11) for unresectable biliary tree carcinoma. Ann Oncol 12(4):501–504
doi: 10.1023/A:1011135014895