Annals of Oncology 25 (Supplement 4): iv210–iv253, 2014
doi:10.1093/annonc/mdu334.103
gastrointestinal tumours,
non-colorectal
718P
NAB-PACLITAXEL (NAB-P) AND GEMCITABINE (G) IN
PRETREATED ADVANCED PANCREATIC CANCER (APDAC)
PATIENTS (PTS): A MULTICENTRE RETROSPECTIVE
ANALYSIS
abstracts
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G. Giordano1, M. Milella2, D. Melisi3, A. Zaniboni4, S. Caponi5, V. Zagonel6,
E. Giommoni7, M. Santoni8, V. Vaccaro2, P. Bertocchi4, F. Bergamo9,
E. Molinara10, G. Musettini5, E. Lucchini3, A. Febbraro1
1
Medical Oncology Unit, Ospedale ’Sacro Cuore di Gesù’ Fatebenefratelli,
Benevento, ITALY
2
Medical Oncology Unit, Regina Elena National Cancer Institute, Rome, ITALY
3
Medical Oncology, Azienda Ospedaliera Universitaria Integrata, University of
Verona, Verona, Italy, Verona, ITALY
4
Medical Oncology, Casa di Cura Poliambulanza, Brescia, ITALY
5
Medical Oncology Unit, Ospedale S. Chiara - Azienda Ospedaliero-Universitaria
Pisana - Istituto Toscano Tumori, Pisa, ITALY
6
Medical Oncology 1, Istituto Oncologico Veneto IOV, IRCCS, Padua, ITALY
7
Medical Oncology 1, Azienda Ospedaliera Careggi, Florence, ITALY
8
Medical Oncology, AOU Ospedali Riuniti Ancona Università Politecnica delle
Marche, Ancona, ITALY
9
Medical Oncology 1, Istituto Oncologico Veneto IOV-IRCCS, Padua, ITALY
10
Medical Oncology 1, Azienda Ospedaliera Universitaria Careggi, Florence, ITALY
Aim: There is no standard of care for APDAC pts who have progressed to a first line
chemotherapy (CT) and investigated drugs have shown limited activity and efficacy.
Nab-P in combination with G represents an optimal first line CT choice in APDAC
and it seems to be active in G-resistant pts.
Methods: APDAC pts who received a combination of nab-P 125 or 100 mg/m2 and G
1000 mg/m2 on days 1, 8, and 15 of a 28 day cycle as 2nd or further line of treatment
were retrospectively analyzed. We evaluated activity in terms of Stable Disease (SD),
Partial Response (PR), Complete Response (CR), efficacy (Progression-Free Survival,
PFS and Overall Survival, OS) and safety. OS and PFS were estimated with the
Kaplan-Meyer method with 95% CI. Cox-regression model was applied to the data
with a univariate and multivariate approach.
Results: 74 pts (M/F: 49/25) median age 59 (range 38-83), ECOG Performance Status
of 0/1/2: 31/33/10 respectively, were evaluated. 48 pts (64.9%) had liver metastases and
24.3% had multiple metastatic sites. Baseline CA19.9 level was >59xULN in 50% pts.
Median number of previous treatment lines was 2 (range 1-4) and 59.5% received
FOLFIRINOX/FOLFOXIRI first line CT. Nab-P + G was administered as 2nd/3rd/4th/
5th line-therapy in 35/28/10/1 pts, respectively, for a median number of 3 cycles (range
1-14). 1 CR, 16 PR and 19 SD were recorded. Median PFS was 4 months (95% CI
2.6-5.4); 3- and 6- month PFS rate were 62% and 33.8%, respectively. Median OS was 7
months (95% CI 4.3-9.7); 6- and 12-month OS were 52% and 23%, respectively. G4
neutropenia and G4 mucositis were observed in 2 and 1 pts, respectively. G3 toxicities
were represented by neutropenia (13.5%), thrombocytopenia (8%), neurotoxicity,
nausea and anemia (3%). At multivaliate analysis, first line FOLFIRINOX/FOLFOXIRI
was not significantly associated with PFS ( p = 0.556) and OS ( p = 0.70). Similarly,
number of previous treatment lines was not related to PFS and OS. CA19.9 reduction
>50% from baseline was significantly associated both to PFS and OS ( p < 0.0001).
Conclusions: Our data show that APDAC-pretreated pts may benefit from Nab-P and
G combination both in terms of PFS and OS, regardless of previous treatment number
and regimen with a mildly tolerated toxicity profile.
Disclosure: All authors have declared no conflicts of interest.