Abstract 1530P
Background
Gemcitabine/nab-Paclitaxel (GN) and (modified) FOLFIRINOX are standard first-line treatment options for advanced pancreatic ductal adenocarcinoma (PDAC), but no randomized head-to-head comparison between these treatments currently exists.
Methods
We thus conducted a propensity score (PS) analysis of overall (OS) and progression-free survival (PFS) outcomes in a tri-center cohort of PDAC patients treated with either GN or (m)FOLFIRINOX.
Results
Four-hundred-fifty-five patients were included (table). In unadjusted analysis, both OS and PFS were highly similar in the GN group (n=297) and (m)FOLFIRINOX group (n=158). In detail, median-, 1-year, and 2-year OS estimates were 10.1 months, 42%, and 18% in the GN group, as compared to 11.2 months, 45%, and 12% in the (m)FOLFIRINOX group, respectively (log-rank p=0.783). In terms of PFS, median (4.6 vs. 4.8 months), 6-month (40% vs. 43%), and 1-year (9% vs. 9%) estimates were also highly comparable (log-rank p=0.717). However, patients in the (m)FOLFIRINOX group were significantly younger, less comorbid, had a lower prevalence of myocardial infarction, and a better ECOG performance status. These imbalances in confounders were removed by weighting the data with the PS. In PS analysis of survival outcomes, OS and PFS remained comparable between the two treatment groups. In detail, PS-weighted median-, 1-year, and 2-year OS estimates were 10.1 months, 42%, and 18% in the GN group, as compared to 10.1 months, 40%, and 13% in the (m)FOLFIRINOX group (PS-weighted log-rank p=0.449). PS-weighted median (4.6 vs. 4.4 months), 6-month (41% vs. 35%), and 1-year (7% vs. 7%) PFS estimates did again not differ (PS-weighted log-rank p=0.329). Table: 1530P
Baseline characteristics
| Variable | GN (n=297) | (m)FOLFIRINOX (n=158) | p |
| Age (years) | 70 [62-74] | 63 [53-67] | <0.0001 |
| Female sex | 123 (41%) | 64 (41%) | 0.851 |
| Charleson Comorbidity Index | 9 [8-10] | 8 [7-9] | <0.0001 |
| Myocardial infarction | 23 (8%) | 4 (3%) | 0.035 |
| ECOG: 0 | 87 (30%) | 99 (63%) | <0.0001 |
| Tumor location: Pancreatic head | 175 (61%) | 74 (50%) | 0.024 |
| Primary palliative setting | 242 (81%) | 140 (89%) | 0.033 |
| Surgery of primary tumor | 65 (22%) | 18 (11%) | 0.006 |
| Prior adjuvant chemotherapy | 44 (15%) | 14 (9%) | 0.085 |
| Tumor extent: Metastatic | 231 (78%) | 121 (77%) | 0.282 |
| CA 19-9 (U/mL) | 959 [74-6390] | 1555 [135-12278] | 0.117 |
Data are medians [25th-75th percentile] or absolute frequencies (%).
Conclusions
In this propensity score analysis of advanced PDAC patients undergoing 1st-line combination chemotherapy with GN or (m)FOLFIRINOX, OS and PFS did not differ between these two treatments.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
R. Greil: Honoraria (self), Advisory/Consultancy: Celgene. A. Gerger: Honoraria (self), Advisory/Consultancy: Celgene. All other authors have declared no conflicts of interest.