Gemcitabine/nabpaclitaxel is a polychemotherapy regimen currently used to treat metastatic pancreatic cancer patients with a good performance status (PS). Gemcitabine/nabpaclitaxel significantly improves overall survival (OS) and progression free survival (PFS), but few data are available in elderly patients. Therefore, we carried out a retrospective analysis to evaluate efficacy and safety profile of this combination in a cohort of elderly patients.
All cases of metastatic pancreatic adenocarcinoma in patients over 70 years old treated at our Department between 2014 and 2016 with gemcitabine/nab-paclitaxel were retrospectively reviewed. The primary objective was to evaluate the safety and efficacy of this regimen in the elderly population.
Forty-six patients with a median age of 73 years (range: 70-79) were included in this analysis: males: 19 (41%); PS2: 6 (13%); primary location: head 26 (57%); biliary stent:14 (30%); previous surgery: 5 (11%); adjuvant CT 5 (11%). Overall response rate (ORR) was 33.3%; median progression-free survival (PFS) was 7 mo (95% CI 5.89-9.10) and median overall survival (OS) was 12 mo (95% CI 10.7-16.13). Treatment was well tolerated. No grade 4 toxicity was reported. Grade 3 toxicity included neutropenia in 5 pts (10%), peripheral neuropathy in 2 pts (4.3%), thrombocytopenia in 2 pts (4%), diarrhea in 3 pts (6.5%), nausea and vomiting in 1 pt (2.1%), and fatigue in 2 pts (4.3%). No significant difference in terms of efficacy and safety was recorded with a cohort of 50 pts under 70 years of age: ORR: 36.6%; median PFS 6.7 mo (95% CI 5.966-8.034), and median OS 10.5 mo (95% CI 7.864-12.136). Finally, pain control was achieved in 15 of 24 patients (62.5%) with a performance status improvement of 10% according to the Karnofsky scale.
Although pancreatic cancer mostly affects elderly people, clinical trials often include few elderly pts. These data suggest that combination of gemcitabine plus nab-paclitaxel is effective and safe in an unselected population of elderly pts showing no differences in outcome between older patients and younger patients treated with this combination.
Clinical trial identification
Legal entity responsible for the study
University of Campania Luigi Vanvitelli
All authors have declared no conflicts of interest.