Advanced intrahepatic cholangiocarcinoma: post-hoc analysis of the ABC-01, -02 and -03 clinical trials
Hubner, Richard A
McNamara, Mairead G
Valle, Juan W
AffiliationDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester
MetadataShow full item record
AbstractBACKGROUND: The incidence of intrahepatic cholangiocarcinoma (iCCA) is increasing. The aim was to provide reference survival data for patients with advanced iCCA treated with first-line cisplatin-gemcitabine chemotherapy (current standard of care). METHODS: Individual data from patients with iCCA recruited into the prospective, randomised Advanced Biliary tract Cancer (ABC)-01, -02 and -03 studies were retrieved. The prevalence and survival of liver-only iCCA was also assessed. Survival analysis was performed using univariate and multivariable Cox Regression. All statistical tests were two-sided. RESULTS: Of 534 patients recruited into the ABC-01, -02 and -03 studies, 109 (20.4%) had iCCA. Most patients (n?=?86; 78.9%) had metastatic disease at the time of recruitment; 52 patients (47.7%) had liver-only disease. Following randomisation, 66 (60.6%) iCCA patients received cisplatin/gemcitabine. The median progression-free (PFS) and overall survival (OS) was 8.4 months (95%confdence interval [CI] = 5.9-8.9) and 15.4 months (95%CI = 11.1-17.9), respectively. Of these 66 patients, 34 patients (51.5%) had liver-only disease. Following chemotherapy, 30 (45.5%) and 21 (31.8%) were progression free at 3 and 6 months from chemotherapy commencement, respectively. Median OS for patients with liver-only iCCA at diagnosis, and after 3 and 6 months of chemotherapy was 16.7 months (95% confidence interval [CI] = 8.7-20.2), 17.9 (95%CI = 11.7-20.9) and 18.9 (95%CI = 16.7-25.9) months, respectively. Multivariable analysis confirmed that iCCA had a longer OS compared to other non-iCCA BTCs (hazard ratio = 0.58, 95%CI = 0.35-0.95; p-value = 0.03); liver-only iCCA patients also showed longer OS even though findings did not reach statistical significance (hazard ratio = 0.65, 95%CI = 0.36-1.19; p-value = 0.16). CONCLUSIONS: Patients diagnosed with advanced iCCA have a better OS compared to other BTCs; similar trend was identified for patients diagnosed with liver-only iCCA. These findings are to be considered for future clinical trial design.
CitationLamarca A, Ross P, Wasan HS, Hubner RA, McNamara MG, Lopes A, et al. Advanced intrahepatic cholangiocarcinoma: post-hoc analysis of the ABC-01, -02 and -03 clinical trials. J Natl Cancer Inst. 2019.
JournalJournal of the National Cancer Institute
- Cisplatin and gemcitabine for advanced biliary tract cancer: a meta-analysis of two randomised trials.
- Authors: Valle JW, Furuse J, Jitlal M, Beare S, Mizuno N, Wasan H, Bridgewater J, Okusaka T
- Issue date: 2014 Feb
- Prognostic factors for progression-free and overall survival in advanced biliary tract cancer.
- Authors: Bridgewater J, Lopes A, Wasan H, Malka D, Jensen L, Okusaka T, Knox J, Wagner D, Cunningham D, Shannon J, Goldstein D, Moehler M, Bekaii-Saab T, McNamara MG, Valle JW
- Issue date: 2016 Jan
- Chemotherapy for inoperable advanced or metastatic cholangiocarcinoma: retrospective analysis of 78 cases in a single center over four years.
- Authors: Pracht M, Le Roux G, Sulpice L, Mesbah H, Manfredi S, Audrain O, Boudjema K, Raoul JL, Boucher E
- Issue date: 2012
- Impact of adjuvant chemotherapy on survival in patients with intrahepatic cholangiocarcinoma: a multi-institutional analysis.
- Authors: Reames BN, Bagante F, Ejaz A, Spolverato G, Ruzzenente A, Weiss M, Alexandrescu S, Marques HP, Aldrighetti L, Maithel SK, Pulitano C, Bauer TW, Shen F, Poultsides GA, Soubrane O, Martel G, Koerkamp BG, Guglielmi A, Itaru E, Pawlik TM
- Issue date: 2017 Oct
- Second-line chemotherapy in advanced biliary cancers: A retrospective, multicenter analysis of outcomes.
- Authors: Lowery MA, Goff LW, Keenan BP, Jordan E, Wang R, Bocobo AG, Chou JF, O'Reilly EM, Harding JJ, Kemeny N, Capanu M, Griffin AC, McGuire J, Venook AP, Abou-Alfa GK, Kelley RK
- Issue date: 2019 Dec 15