713P - Activity, efficacy and safety of nab-paclitaxel (Nab-P) and gemcitabine (G) in advanced pancreatic cancer (APDAC) elderly patients

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Geriatric Oncology
Pancreatic Cancer
Presenter Guido Giordano
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors G. Giordano1, D. Melisi2, M. Milella3, A. Zaniboni4, E. Vasile5, V. Zagonel6, E. Giommoni7, L. Maiorino8, M. Santoni9, V. Vaccaro3, P. Bertocchi4, F. Bergamo10, G. Musettini11, E. Lucchini2, S. Cascinu9, A. Febbraro1
  • 1Medical Oncology Unit, Ospedale "Sacro Cuore di Gesù" Fatebenefratelli, 82100 - Benevento/IT
  • 2Medical Oncology, Azienda Ospedaliera Universitaria Integrata, University of Verona, Verona, Italy, Verona/IT
  • 3Medical Oncology, Regina Elena National Cancer Institute, 00144 - Roma/IT
  • 4Medical Oncology, Casa di Cura Poliambulanza, Brescia/IT
  • 5Medical Oncology, Ospedale S. Chiara - Azienda Ospedaliero-Universitaria Pisana Istituto Toscano Tumori, Pisa, Italy, Pisa/IT
  • 6Medical Oncology 1, Istituto Oncologico Veneto IOV, IRCCS, 35100 - Padova/IT
  • 7Medical Oncology 1, Azienda Ospedaliera Universitaria Careggi, IT-50139 - Firenze/IT
  • 8Oncology Unit, Ospedale San Gennaro dei Poveri, Napoli/IT
  • 9Medical Oncology, AOU Ospedali Riuniti Ancona Università Politecnica delle Marche, 60126 - Ancona/IT
  • 10Medical Oncology 1, Istituto Oncologico Veneto IOV-IRCCS, IT-35128 - Padova/IT
  • 11Medical Oncology Unit, Ospedale S. Chiara - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT

Abstract

Aim

Nab-P and G combination represents a standard of care in APDAC first line therapy (CT) and it seems to be active and effective also in pretreated pts. Activity, efficacy and safety of Nab-P + G have not been established in elderly patients and clinical trials on APDAC treatment contain fewer elderly patients compared with everyday clinical practice. Aim of our retrospective analysis is to investigate outcomes and toxicities of elderly pts treated with Nab-P + G.

Methods

61 APDAC pts aged ≥65 receiving Nab-P 125 mg/m2 and G 1000 mg/m2 on days 1,8 and 15 of a 28 day cycle as first (39 pts, 64%) or further (22 pts, 36%) line of CT were included in our analysis for activity (Disease Control Rate, DCR: Stable Disease + Partial Response + Complete Response, SD + PR + CR), efficacy (Progression Free Survival, PFS and Overall Survival, OS) and safety. OS and PFS were estimated with Kaplan-Meyer method with 95% CI. Univariate and multivariate analysis were performed using Cox-regression model.

Results

61 pts, median age 69 (range 65-83; 48% pts ≥70 years) and ECOG Performance Status of 0/1/2: 24/26/11 respectively, were included in our analysis. 44 pts (72%) had liver metastases, 21 (34.4%) had multiple metastatic sites and biliary stent was present in 10 pts (16.4%). 14 SD, 9 PR (DCR: 59%) were observed in first line CT pts and 9 SD, 2 PR (DCR 50%) were recorded in pretreated pts. Median PFS was 6 months (mo) (95% CI 3.9-8.1) and 3.5 mo (95% CI 1.6-5.4) in first line and pretreated pts, with median OS of 9.5 (95% CI 7.3-11.7) and 6 mo (95% CI 4.2-7.8) in first line and pretreated pts respectively. Age ≥70 was not significantly associated to PFS and OS at univariate and multivariate analysis. Treatment was well tolerate with no G4 events, 15 (24.5%) G3 neutropenia, 6 (9.8%) G3 thrombocytopenia, 2 (3.2%) G3 anemia, 8 (13%) G3 fatigue, 4 (6.6%) G3 diarrhea and neurotoxicity. Dose reduction was needed in 18 (29.5%) pts. No significative differences in toxicity profile and dose reductions were observed in ≥70 years pts.

Conclusions

These data show that APDAC elderly pts may benefit from Nab-P and G combination as well as younger population both in terms of responses and survival, in first line CT as well as further lines, experiencing a low toxicity profile.

Disclosure

All authors have declared no conflicts of interest.