718P - Nab-paclitaxel (Nab-P) and gemcitabine (G) in pretreated advanced pancreatic cancer (APDAC) patients (pts): A multicentre retrospective analysis

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Guido Giordano
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors G. Giordano1, M. Milella2, D. Melisi3, A. Zaniboni4, V. Zagonel5, S. Caponi6, E. Giommoni7, M. Santoni8, V. Vaccaro2, P. Bertocchi4, F. Bergamo9, E. Molinara10, G. Musettini6, E. Lucchini3, A. Febbraro11
  • 1Medical Oncology Unit, Ospedale 'Sacro Cuore di Gesù' Fatebenefratelli, 82100 - Benevento/IT
  • 2Medical Oncology Unit, Regina Elena National Cancer Institute, Rome/IT
  • 3Medical Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy, Verona/IT
  • 4Medical Oncology, Casa di Cura Poliambulanza, Brescia/IT
  • 5Medical Oncology 1, Istituto Oncologico Veneto IOV, IRCCS, 35100 - Padova/IT
  • 6Medical Oncology Unit, Ospedale S. Chiara - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT
  • 7Medical Oncology 1, Azienda Ospedaliera Careggi, IT-50139 - Firenze/IT
  • 8Medical Oncology, AOU Ospedali Riuniti Ancona Università Politecnica delle Marche, 60126 - Ancona/IT
  • 9Medical Oncology 1, Istituto Oncologico Veneto IOV-IRCCS, IT-35128 - Padova/IT
  • 10Medical Oncology 1, Azienda Ospedaliera Universitaria Careggi, Firenze/IT
  • 11Medical Oncology Unit, Ospedale 'Sacro Cuore di Gesù' Fatebenefratelli, Benevento/IT

Abstract

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.