721P - First-line treatment with FOLFIRINOX in advanced, inoperable pancreatic cancer (APDAC) patients (pts): supportive measures optimization for a safe a...

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anticancer agents
Pancreatic Cancer
Biological Therapy
Presenter Vanja Vaccaro
Authors V. Vaccaro1, E. Bria2, I. Sperduti3, F. Massari4, M.S. Pino5, E. Lucchini2, A. Gelibter1, F. Cognetti6, G. Tortora4, M. Milella7
  • 1Medical Oncology, Regina Elena National Cancer Institute, 00144 - Roma/IT
  • 2Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo Roma", 37134 - Verona/IT
  • 3Biostatistics, Regina Elena Institute, Roma/IT
  • 4Oncologia Medica, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo Roma", 37134 - Verona/IT
  • 5Medical Oncology, USL 10 Firenze, 50012 - Firenze/IT
  • 6Division Medical Oncology A, Istituto Regina Elena, IT-00144 - Roma/IT
  • 7Divisione Di Oncologia Medica A, Regina Elena National Cancer Institute, 00144 - Roma/IT



Although FOLFIRINOX has become one of the standard option for the treatment of aPDAC, tolerability and safety issues, with particular regard to hematologic toxicity and increased risk of AE in pts carrying biliary stents, may represent a barrier for the routinely adoption in clinical practice.


The clinical reports of 36 aPDAC pts undergone 1st-line FOLFIRINOX in 2 different institutions were reviewed. Toxicities, activity and efficacy were determined according to 1) primary G-CSF prophylaxis (dd 7-9-11; yes/no 21/15 pts), and 2) presence/absence biliary stent.


Pts characteristics: N°: 36; cycles: 241, M/F: 22/14; median age: 57 yrs [range 37-70]; ECOG PS 0/1: 33/3; stage III/IV: 10/26. G3/4 toxicity occurred in <1% of cycles, with the exception of G3/4 neutropenia (16.6% of pts, 3.7% of cycles); 25%-dose reduction occurred in 48/205 cycles (23%), with 3 pts stopping after 1 cycle for G3 GI toxicity in 1 pt and early PD in 2 pts. No differences according to presence/absence of biliary stent were found, in terms of G3/4 toxicities. Prophylactic G-CSF administration did not significantly change G3/4 neutropenia (5/155 [3.2%], versus 4/86 [4.6%]). Pts receiving G-CSF significantly experienced more anemia (p < 0.001) and thrombocytopenia (p = 0.009). Given the administration of PALO/aprepitant/dexamethasone, complete control of nausea/vomiting was achieved at cycle 1 in 72% (95% CI: 58-87%) and 86% (95% CI: 75-97%) of pts. Partial response and stable disease occurred in 25% and 43% of 28 evaluable pts, with a disease control rate of 68% (95% CI: 51-85%). Median PFS was 8 mos (95% CI: 6-9 mos). 61% of pts experienced a >50% reduction in CA19.9.


These data indicate that FOLFIRINOX seems to be well tolerated and easily manageable in young (<70 yrs) and fit (PS 0-1) aPDAC pts on an outpatient basis, and may be employed in pts with biliary stents. Although the routine G-CSF prophylaxis is not currently recommended, it can be considered for older/less fit/comorbid pts with aPDAC.


All authors have declared no conflicts of interest.