P-141 - Combined versus sequential adjuvant therapy of biliary tract cancer: what is the best option?

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anticancer agents
Hepatobiliary Cancers
Biological Therapy
Presenter A. Cassano
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors A. Cassano1, G.C. Mattiucci2, E. Cerchiaro2, V.P. Di Noia2, L. De Filippo1, R. Autorino1, V. Dadduzio2, S. Rossi3, F. Ardito4, F. Giuliante5, M. Basso3, V. Valentini2, C. Barone3
  • 1Medical Oncology - Catholic University of Sacred Heart - Rome, Rome/IT
  • 2Catholic University of Sacred Heart - Rome, Roma/IT
  • 3Catholic University of Sacred Heart - Rome, Rome/IT
  • 4Hepato-Biliary Surgery Unit - Catholic University of Sacred Heart - Rome, Rome/IT
  • 5Hepato-Biliary Surgery Unit - Catholic University of Sacred Heart - Rome, Roma/IT



Biliary tract cancers (BTC) are composed by an heterogeneous and rare group of malignant tumors with poor prognosis. Surgical resection is the only potentially curative treatment. Currently, the standard of the adjuvant therapy is not yet defined due to the low number of pts and the few phase II-III available studies. The objective of this single retrospective center study is to compare the addition of CT to concurrent chemoradiation therapy (CT-CCRT) in an integrated model versus concurrent chemoradiation therapy (CCRT) alone in adjuvant setting.


We reviewed clinical data about 123 pts with intra and extra-hepatic BTC treated with radical resection followed by adjuvant therapy from 2003 to 2013 at our institution. We compared the group of pts treated with adjuvant FOLFOX 6 schedule for 3 cycles followed by RT with 5-FU or Gem and further 3 cycles of FOLFOX (CT-CCRT) with pts treated with the same RT associated with Gem or 5-FU (CCRT).


Complete follow-up was available in 80 pts. Forty seven pts had intrahepatic and 33 pts had extra-hepatic adenocarcinoma. Thirty eight pts received CT-CCRT and 42 received only CCRT. Median OS was 33 months in the CT-CCRT group compared to 25 months in the CCRT group (p = 0.04). Median DFS was 25 and 21 months in the CT-CCRT and CCRT group, respectively (p = 0.03). Survival benefit of CT-CCRT over CCRT was observed in positive lymph nodes and R1 resection group (microscopically positive margins) (p= 0.01).


Our study, although the small sample size, suggests that the CT-CCRT could represent a better option for patients submitted to radical surgery for BTCs in terms of OS and DFS. High risk patients, with nodal disease and R1 resection, seem to obtain the major benefit from this approach of therapy. Nevertheless, further randomized trials studies are needed.