713P - Activity, Efficacy and Safety of Nab-Paclitaxel (Nab-P) and Gemcitabine (G) in Advanced Pancreatic Cancer (Apdac) Elderly Patients

Abstract

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.