P-182 Multicenter real-world data of treatment with NALIRI plus 5FU/LV in advanced Spanish pancreatic cancer

Pancreatic cancer is a tumor with a high lethality rate and an increasing incidence in Europe and Spain. There are limited treatment alternatives in metastatic disease after progression to a first line treatment. Advanced pancreatic cancer cases, treated with NALIRI plus 5FU/LV as second (2L) or third line (3L) therapy between 2017 and 2020 in 14 Spanish centers were retrospectively and consecutively collected. Primary endpoint were median overall survival (OS) and median overall survival from diagnosis of metastatic disease (metOS). Secondary objectives included survival rate at 6 and 12 months since treatment initiation, progression-free survival (PFS) and PFS rate at 6 and 12 months, overall disease control rate (DCR) and DCR (CR, PR or SD) in patients previously treated with irinotecan, impact on the patient's baseline functional status after treatment and grade III/IV toxicity. Two hundred patients were included. Eighty-seven percent of patients were treated in second line. OS was 7.2 months (95%CI 6.2-8.3). metOS was 17.4 months (95% CI 15.2-19.7). Six-month and 12-month OS rates were 58.1% (CI95% 51.1-65) and 28.9% (CI95% 22.5-35.4), respectively. Median PFS was 3.7 months (CI95% 2.6-4.7) and the 6- and 12-month PFS rate were 37.6% (CI95% 30.9-44.4) and 15.3% (CI95% 10.2-20.3). DCR was achieved in 70 patient in the overall population and was similar in the subgroup of patients who had received prior irinotecan (35%). Median number of cycles to response were 5 cycles. 16.5% of patients presented worsening related to treatment, 78.5% stabilized their clinical situation and 5.1% improved clinically. Toxicity grade III/IV was observed in 35% of patients (diarrhea 14.5% and asthenia 10.5% were the most frequent). Real-world data of unselected patients treated with NALIRI plus 5FU/LV confirm the efficacy results of NAPOLI-1 trial with an overall survival of 7.2 months and a high 12-months survival rate (28.9%) with a manageable toxicity profile.