709P - Single-agent or doublets as second-line chemotherapy after FOLFIRINOX in patients with locally advanced or metastatic pancreatic cancer

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Pancreatic Cancer
Biological Therapy
Presenter Chiara Pellei
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors C. Pellei1, A. Bittoni1, K. Andrikou1, A. Lanese1, M. Santoni1, A. Conti1, F. Aroldi2, S. Delcuratolo3, M. Russano4, V. Vaccaro5, N. Silvestris6, M. Milella7, D. Santini4, A. Zaniboni8, S. Cascinu1
  • 1Medical Oncology, AOU Ospedali Riuniti Ancona Università Politecnica delle Marche, 60126 - Ancona/IT
  • 2Medical Oncology, Fondazione Poliambulanza, brescia/IT
  • 3Scientific Direction, National Cancer Institute "Giovanni Paolo II", bari/IT
  • 4Medical Oncology, Campus Bio-Medico di Roma, 00128 - Roma/IT
  • 5Medical Oncology, Regina Elena National Cancer Institute, 00144 - Roma/IT
  • 6Medical Oncology Unit, National Cancer Institute "Giovanni Paolo II", 70124 - bari/IT
  • 7Divisione Di Oncologia Medica A, Istituto Regina Elena, 00144 - Roma/IT
  • 8Oncology Department, Fondazione Poliambulanza, IT-25124 - Brescia/IT



FOLFIRINOX represents an active regimen in first-line treatment of advanced pancreatic adenocarcinoma (PDAC) patients (pts) with good performance status (PS). Currently, there are no accepted standard regimens in second-line therapy for patients with disease progression and data about efficacy of chemotherapy after FOLFIRINOX failure are lacking.


We retrospectively investigated clinical and laboratory characteristics (including blood count, LDH, CEA and CA19.9) of PDAC pts treated between June 2011 and April 2014 in four Italian institutions with either doublet or single agent as second-line therapy after FOLFIRINOX failure. Survival estimates were quantified using Kaplan Meier curves, and differences between groups were compared with the log-rank test.


Among 96 pts treated with FOLFIRINOX as first-line chemotherapy, 50 pts received second-line treatment (52%). Median age at diagnosis was 60 years (range 36-76); 66 pts were males (72%). PDAC was locally advanced in 15 (30%) and metastatic in 35 pts (70%). Patients who received second line single agent (gemcitabine, docetaxel or nab-paclitaxel) or doublets (gemcitabine with either abraxane, capecitabine, cisplatin or docetaxel) were 24 (48%) and 26 (52%), respectively. According to RECIST criteria, 2 pts achieved PR (4%), 10 (20%) SD for ≥9 wks and 38 (76%) PD. Median progression-free survival (PFS) was 2.7 months and median overall survival (OS) was 3.4 months. No differences were found in terms of OS (5.0 vs 3.1, p = 0.489) or PFS (4.0 vs 2.7 p = 0.182) between patients treated with single-agent or doublets as second-line. At multivariate analysis, ECOG ≥ 2 was the only independent prognostic factor for worst OS (p = 0.002) and PFS (p = 0.020).


Our findings suggest that the choice of second line therapy in patients treated with first-line FOLFIRINOX should be carefully evaluated. ECOG ≥ 2 was significantly associated with poor prognosis, while pre-treatment CA 19-9, LDH, Hb, neutrophil and platelet counts were not prognostic factors for OS, although these data should be confirmed in perspective studies.


All authors have declared no conflicts of interest.