Nab-paclitaxel (Nab-P) and gemcitabine (G) first-line chemotherapy (CT) in patients (pts) with metastatic pancreatic cancer (mPC) who relapsed after adjuvant treatment (ADJ T): A “REAL LIFE” study.

Abstract

396 Background: Nab-P and G represents a standard of care in first line mPC treatment. Only 5% of pts in Nab-P + G arm received ADJ T in the MPACT phase III trial. Accordingly, there is a lack of information about Nab-P + G benefit in this population. Aim of this analysis was to evaluate outcomes in mPC “real life” pts receiving first-line Nab-P + G after relapsing from ADJ T. Methods: Clinical records of 330 mPC pts receiving Nab-P + G with standard schedule as first line CT were retrospectively reviewed, investigating, efficacy (Progression Free Survival, PFS and Overall Survival, OS defined as time elapsed from the start of Nab-P + G to progression or death respectively) in pts treated with prior ADJ T. Analysis was then performed in ADJ T subgroup according disease free survival (DFS) cut-off ( ≤ 6 vs 6-12 vs ≥ 12 months). OS and PFS were estimated with Kaplan-Meyer method with 95% CI. Cox-regression model was applied to the data with univariate and multivariate approach. Results: At time of data analysis in the entire cohort median (m) OS was 11.3 months (95% CI 9.157-13.443); mPFS 7 months (95% CI 5.827-8.173). 90 out of 330 pts (27.3%) had received G-based ADJ T with mDFS of 29.2 months (95% CI 25.62-32.78). In the overall population at multivariate analysis, ADJ treatment was an independent prognostic factor related to better OS (HR 0.53, 95% CI 0.40-0.66; p < 0.001) and PFS (HR 0.69, 95% CI 0.49-0.89; p = 0.024). Median OS in ADJ T pts was significantly higher than pts who had not received ADJ T (15.0 vs 10.8 months respectively; p = 0.012). A similar trend in mPFS was observed in ADJ T versus non ADJ T pts (8.6 vs 6.9 months; p = 0.06). Pts with longer DFS after ADJ T showed major benefit in mOS (16.3 vs 13.1 vs 8.7 months in ≥ 12 vs 6-12 vs ≤ 6 months DFS respectively; p < 0.001). No significant differences in mPFS were observed in the three subgroups (p = 0.271). Conclusions: Nab-P + G is a standard of care also in pts treated with ADJ T. ADJ treatment is an independent prognostic factor related to better survival, maybe reflecting the effect of prior radical surgery. Pts who received G-based ADJ T may benefit of Nab-P+G combination with an increased survival in pts with longer DFS.