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Poster display session

5058 - Actionable molecular alterations in advanced biliary tract carcinomas: preliminary data from the ProfiLER program (NCT01774409)


09 Sep 2017


Poster display session


Philippe Cassier


Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369


P. Cassier1, C. de la Fouchardiere1, P. Guibert1, D. Pissaloux2, C. Pacaux1, C. Terret1, L. Eberst1, M. Sarabi1, V. Attignon2, Q. Wang3, V. Corset4, D. Perol4, J. Blay1, F. Desseigne1

Author affiliations

  • 1 Department Of Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 2 Département De Recherche Translationnelle, Centre Léon Bérard, 69008 - Lyon/FR
  • 3 Recherche Translationnelle, Centre Léon Bérard, 69008 - Lyon/FR
  • 4 Département De Recherche Clinique, Centre Léon Bérard, 69008 - Lyon/FR


Abstract 5058


Patients (pts) with advanced biliary tract cancers (BTC) have poor prognosis and limited therapeutic option. The objectives were to characterize tumor genomic alterations for patients diagnosed with BTC enrolled in the ProfiLER program and identify actionable targets.


The ProfiLER program is a multicentric prospective molecular profiling trial in patients with advanced cancers. DNA extracted from either archival or freshly collected tumor samples was analyzed by targeted exon sequencing (NGS) of 59 cancer related genes and whole genome array comparative genomic hybridization (CGH). Genomic profiles were discussed at a dedicated molecular tumor board (MTB) for recommendation of molecularly targeted agents (MTA) when applicable.


Of 2184 included pts in the ProfiLER program, 45 pts diagnosed with advanced BTC (intrahepatic cholangiocarcinoma – ICC, n = 32; vesicular carcinoma, n = 7; main biliary duct, n = 5; primary was unknown for one pt) were included between March 2013 to April 2017. Median age was 61 (range 35-78) years, and 21 pts (47%) were women. The median time from inclusion to MTB discussion was 12 (range 3-99) weeks. NGS was feasible for 31 pts (69%) and CGH for 24 (53%), both analyses were available for 22 (49%) and at least one analysis was available for 34 (75%) pts. 19 pts (56% of 34 analyzed pts) had at least one actionable alteration: CDKN2A homozygous deletion (n = 8), MDM2 amplification (n = 3) and PDGFRA amplification (n = 5) were the only recurrent alterations. Among 31 pts with NGS data, 7 had TP53 mutations, 4 had KRAS mutations while none had BRAF mutations. Four pts received MTA based on the alteration identified (CDK4/6 inhibitor for CDK4 amplification, ERBB2 inhibitor for a ERBB2 mutation, EGFR inhibitor for EGFR mutation and mTOR inhibitor for homozygous TSC2 deletion), progressive disease was the best response in all pts.


CGH and NGS identified actionable alterations in 56% of pts with BTC for whom analyses could be performed. However, the analyses were both feasible in only 49% of patients due to the use of archival biopsy samples in most cases.

Clinical trial identification


Legal entity responsible for the study

Centre Léon Bérard


LYric (DGOS-INCa-4664), Bpifrance Financement abounded by European Community (E8983 – PREDICTIV)


P. Cassier: Research funding: Astrazeneca, Roche/Genentech, Bayer, Novartis, Celgene, Blueprint, Lilly, Toray, MSD, Merck Serono, Transgene. Honoraria: Amgen, Astrazeneca, Elsalys. C. de la Fouchardiere: Research funding: Amgen, Astrazeneca, Eisai, Exelixis, Lilly, MSD, Taiho. C. Terret: Research funding: Roche/Genentech, Novartis. D. Perol: Honoraria: Lilly, Roche, Janssen, Celgene. J-Y. Blay: Research funding: Roche/Genentech, Novartis, Lilly, Amgen, Astrazeneca, Bayer, Eisai, Epizyme, Five Prime, GSK, Janssen, Daiichi Sankyo. F. Desseigne: Research funding: Merck Serono. All other authors have declared no conflicts of interest.

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