gastrointestinal tumours, non-colorectal

Annals of Oncology 25 (Supplement 4): iv210–iv253, 2014
doi:10.1093/annonc/mdu334.75
gastrointestinal tumours,
non-colorectal
690P
CLINICAL IMPACT OF FOLFIRINOX DOSE/SCHEDULE
MODIFICATIONS (MFOLFORINOX) AND ADDITIONAL
SUPPORTIVE MEASURES IN THE MANAGEMENT OF
PANCREATIC CANCER (PDAC) PATIENTS (PTS)
abstracts
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.
Table: 690P
N. of Pts (%)
Pts
Median age (range)
M/F
ECOG PS 0 1 2 na
T location head body-tail
Stage I-II III IV
Biliary Stent
Biliopancreatic derivation
Folfirinox schedule classic (group 1) modified
(group 2)
Locoregional treatment for inoperable disease
Second line chemotherapy
270
59 yrs (37-76)
146 (54) / 124 (46)
189 (70) 75 (28) 7 (1) 3 (1)
132 (49) 138 (51)
21 (8) 86 (32) 163 (60)
57 (21)
31 (12)
82 (30) 188 (70)
36 (13)
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.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
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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
1
Medical Oncology, Regina Elena National Cancer Institute, Roma, ITALY
2
Biostatistics, Regina Elena National Cancer Institute, Roma, ITALY
3
Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo
Roma", Verona, ITALY
4
Oncology, Polo Oncologico - Azienda Ospedaliero-Universitaria Pisana - Istituto
Toscano Tumori, Pisa, ITALY
5
Medical Oncology, AOU Ospedali Riuniti Ancona Università Politecnica delle
Marche, Ancona, ITALY
6
Medical Oncology Unit, Ospedale ’Sacro Cuore di Gesù’ Fatebenefratelli,
Benevento, ITALY
7
Oncology Department, Fondazione Poliambulanza, Brescia, ITALY
8
Medical Oncology, USL 10 Firenze, Florence, ITALY
9
Dipartimento Di Medicina Clinica E Biotecnologie A, AOU Ospedali Riuniti Ancona
Università Politecnica delle Marche, Ancona, ITALY
10
Dept. of Oncology-presidio Ospedaliero, Azienda Ospedaliero Univesitaria
Pisana, Pisa, ITALY
11
Oncologia Medica, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo
Roma", Verona, ITALY
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.

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