Landmark survival analysis and impact of anatomic origin in prospective clinical trials of biliary tract cancer
Authors
McNamara, Mairead GLopes, A.
Wasan, H.
Malka, D.
Goldstein, D.
Shannon, J.
Okusaka, T.
Knox, J. J.
Wagner, A. D.
Andre, T.
Cunningham, D.
Moehler, M.
Jensen, L. H.
Koeberle, D.
Bekaii-Saab, T.
Bridgewater, J.
Valle, Juan W
Affiliation
Division of Cancer Sciences, The University of Manchester and The Christie NHS Foundation Trust, Manchester M20 4BX,Issue Date
2020
Metadata
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BACKGROUND: Inclusion of all patients with advanced biliary tract cancer (aBTC), irrespective of anatomic location, in prospective trials, is debated. Survival rates from landmark analysis offer more relevant information once patients have survived for some time. AIM: assess survival impact of BTC anatomic site origin and landmark survival (LS). PATIENTS AND METHODS: Patients enrolled into prospective first-line aBTC clinical trials were included. OS was analysed using Cox-proportional-hazard-regression; LS and 95% confidence intervals (CIs) were calculated. RESULTS: Overall: 1333 patients included (Jan 97-Dec 15); median age 63-years (range 23-85); 46%-male; 84%-ECOG-PS0/1; 25%-locally-advanced (LA), 72%-metastatic, 3%-not reported (NR); gallbladder-(GBC): 385 (29%), cholangiocarcinoma not-specified-(CCA-NS): 363 (27%), extrahepatic-(EHC): 247 (19%), intrahepatic-(IHC): 209 (16%), ampulla: 53 (4%), 76 (6%) NR. Treatment was mono-chemotherapy: 310-(23%), cisplatin/gemcitabine: 482-(36%), other combination: 520-(39%), NR: 21-(2%). Median OS: 10.2-months (95%-CI 9.6-10.9). All sites (treatment-adjusted) had decreased risk of death vs GBC: EHC-(P<.001), IHC-(P<.002), CCA-NS-(P<.003), ampulla-(P=.003). This reduced risk vs GBC was maintained in those receiving cisplatin/gemcitabine in EHC-(P<.001) and IHC-(P<.001), but not in CCA-NS-(P=.82) or ampulla-(P=.96). Probabilities of surviving an additional year given survival to 1, 2, 3, and 4 years post-trial registration were 37%, 45%, 61%, and 63% respectively. For patients who survived 1 year; those receiving combination therapy vs mono (P=.008) (acknowledging potential selection bias), and those with IHC and CCA-NS vs GBC had better LS (both P<.05). Metastatic stage vs LA was associated with shorter LS (P=.002). ECOG-PS and gender had no evidence of effect on LS (P.05Citation
M. G. McNamara, A. Lopes, H. Wasan et al. Landmark survival analysis and impact of anatomic origin in prospective clinical trials of biliary tract cancer. J Hepatol. 2020.Journal
Journal of HepatologyDOI
10.1016/j.jhep.2020.05.014PubMed ID
32446715Additional Links
https://dx.doi.org/10.1016/j.jhep.2020.05.014Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.jhep.2020.05.014
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