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Advanced intrahepatic cholangiocarcinoma: post-hoc analysis of the ABC-01, -02 and -03 clinical trials
Lamarca, Angela Ross, P Wasan, H Hubner, Richard A McNamara, Mairead G Lopes, A Manoharan, Prakash Palmer, D Bridgewater, J Valle, Juan W
Lamarca, Angela
Ross, P
Wasan, H
Hubner, Richard A
McNamara, Mairead G
Lopes, A
Manoharan, Prakash
Palmer, D
Bridgewater, J
Valle, Juan W
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Abstract
BACKGROUND:
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.
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Date
2019
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Citation
Lamarca 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.