690P - Clinical impact of FOLFIRINOX dose/schedule modifications (mFOLFORINOX) and additional supportive measures in the management of pancreatic cancer (...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Supportive Care
Pancreatic Cancer
Presenter Vanja Vaccaro
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors V. Vaccaro1, I. Sperduti2, D. Melisi3, E. Bria3, E. Vasile4, M. Santoni5, G. Giordano6, P. Bertocchi7, E. Lucchini3, M.S. Pino8, A. Gelibter1, C. Garufi1, M. Zeuli1, A. Zaniboni7, A. Febbraro6, S. Cascinu9, A. Falcone10, G. Tortora11, F. Cognetti1, M. Milella1
  • 1Medical Oncology, Regina Elena National Cancer Institute, 00144 - Roma/IT
  • 2Biostatistics, Regina Elena National Cancer Institute, 00144 - Roma/IT
  • 3Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo Roma", 37134 - Verona/IT
  • 4Oncology, Polo Oncologico - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT
  • 5Medical Oncology, AOU Ospedali Riuniti Ancona Università Politecnica delle Marche, 60126 - Ancona/IT
  • 6Medical Oncology Unit, Ospedale 'Sacro Cuore di Gesù' Fatebenefratelli, Benevento/IT
  • 7Oncology Department, Fondazione Poliambulanza, IT-25124 - Brescia/IT
  • 8Medical Oncology, USL 10 Firenze, 50012 - Firenze/IT
  • 9Dipartimento Di Medicina Clinica E Biotecnologie A, AOU Ospedali Riuniti Ancona Università Politecnica delle Marche, 60126 - Ancona/IT
  • 10Dept. Of Oncology-presidio Ospedaliero, Azienda Ospedaliero Univesitaria Pisana, IT-56100 - Pisa/IT
  • 11Oncologia Medica, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo Roma", 37134 - Verona/IT

Abstract

Aim

FOLFIRINOX has proven effective in advanced PDAC. In order to overcome toxicity issues, dose/schedule modifications and additional supportive measures are being considered.

Methods

We reviewed the clinical charts of 270 PDAC pts receiving classic FOLFIRINOX (group 1) or mFOLFIRINOX (group 2) at 7 Italian Institutions.

Results

Patient characteristics are shown in the table. Fifty seven pts/590 cycles and 213 pts/1127 cycles were available for analysis in groups 1 and 2, respectively. Overall toxicity was mild; significant differences in G2-4 toxicities between the two groups: asthenia (10% vs 6%, p = 0.001), diarrhea (7% vs 4%, p = 0.01), and thrombocytopenia (4% vs 0.5%, p < 0.00001), favouring group 2, and neutropenia (5% vs 12%, p < 0.0001), favouring group 1. G-CSF was used more frequently in group 1 (80% vs 36%, p < 0.0001). Dose delays were comparable between the two groups; dose reductions were more common in group 2 (39% vs 28%, p < 0.00001). No differences in the complete control of nausea/vomiting at cycle 1 (no N/V) with or without aprepitant were observed (50% vs 45%, respectively). The presence of a biliary stent did not appear to significantly worsen toxicity. ORR and disease control rate (DCR: PR + SD) were 39% and 61%, respectively, without significant differences between the two groups. Median PFS was 7 mos in both groups. Median OS, however, was significantly longer in group 2 (18 vs 12 mos, respectively; p = 0.04), mostly due to a better performance of mFOLFIRINOX in PS0 pts.

N. of Pts (%)
Pts 270
Median age (range) 59 yrs (37-76)
M/F 146 (54) / 124 (46)
ECOG PS 0 1 2 na 189 (70) 75 (28) 7 (1) 3 (1)
T location head body-tail 132 (49) 138 (51)
Stage I-II III IV 21 (8) 86 (32) 163 (60)
Biliary Stent 57 (21)
Biliopancreatic derivation 31 (12)
Folfirinox schedule classic (group 1) modified (group 2) 82 (30) 188 (70)
Locoregional treatment for inoperable disease 36 (13)
Second line chemotherapy 120 (44)

Conclusions

FOLFIRINOX/mFOLFIRINOX are well tolerated and easily manageable on an outpatient basis and can be safely used in pts carrying biliary stents. Differences in toxicity and efficacy with modified schedules deserve further investigation.

Disclosure

All authors have declared no conflicts of interest.