Abstract 5454
Background
FOLFIRINOX and GN have shown superior OS but with increased toxicity in fitter and younger pts vs gemcitabine. In routine practice, FOLFIRINOX is often modified at start (eg no 5FU bolus). No randomized phase III data are available and real world data are scarce.
Methods
In this observational electronic chart review data were retrospectively recorded of pts ≥18 y who completed 1L mPAC tx JUL14-JAN16. Physicians (HCPs) were recruited across different regions and settings and encouraged to enter pts in/beyond 2L. Baseline characteristics and outcomes of 1L FOLFIRINOX and GN are reported. Data are descriptive.
Results
2,565 records were completed by 225 HCPs; 500–504 from FR/GER/IT/SP/UK. Of 912 1L FOLFIRINOX pts, 18% started mFOLFIRINOX. Of 748 fFOLFIRINOX pts, 26% were later dose modified. Of 660 1L GN pts, 20% were dose modified. Compared with GN, more FOLFIRINOX pts were <65 y, male and fitter (Table). Compared with fFOLFIRINOX, more mFOLFIRINOX pts were <65 y and female. Female fFOLFIRINOX pts were a little more often dose adjusted. Of FOLFIRINOX/GN pts, 12/23% stopped further tx after 1L, 10/9% were awaiting 2L and 78/67% were in ≥ 2L. mOS/mPFS in this selected population was 15/10 mo for FOLFIRINOX and 12/7 mo for GN. mFOLFIRINOX (16/10 mo) had similar outcomes vs fFOLFIRINOX (15/10 mo). On average, 1.5 reasons were reported to stop tx. Most common for FOLFIRINOX/GN were: radiological PD (39/54%), clinical PD (24/32%), tx completed as planned (36/18%) and toxicity (13/9%). No overall benefit of continued tx by pt (8%/9%) or HCP decision (7%/7%) were noted, no differences between f/mFOLFIRINOX were seen.Table: 723P
| First-line treatment | N | % pts with dose adjustment | % pts >65 year | % female pts | % pts 0-1 ECOG Performance Score | % pts received 2L | Median OS/PFS (months) |
|---|---|---|---|---|---|---|---|
| gemcitabine+nab-paclitaxel (GN) | 660 | 20.5% | 44.8% | 43.2% | 76.5% | 67.4% | 12/7 |
| FOLFIRINOX | 912 | 23.9% | 36.3% | 87.2% | 78.1% | 15/10 | |
| mFOLFIRINOX | 164 | 6.7% | 18.3% | 41.5% | 89.0% | 78.0% | 16/10 |
| fFOLFIRINOX | 748 | 26.1% | 25.1% | 35.2% | 86.8% | 78.1% | 15/10 |
| fFOLFIRINOX modified in cycle 2/3 | 27 | 25.9% | 48.1% | 92.6% | 66.7% | ||
| fFOLFIRINOX modified in cycle 3+ | 168 | 27.4% | 41.1% | 88.1% | 77.4% | ||
| fFOLFIRINOX never modified | 553 | 24.4% | 32.7% | 86.1% | 78.9% |
Conclusions
In this large retrospective chart review, pt characteristics and outcomes for 1L mPAC f/mFOLFIRINOX tx were similar. GN had somewhat lower mOS/mPFS; however, more GN pts were >65 y, female, less fit, and less received 2L tx.
Clinical trial identification
Legal entity responsible for the study
Shire.
Funding
Shire.
Editorial Acknowledgement
Medical writing support for the preparation of this abstract was provided by Physicians World Europe GmbH, Mannheim, Germany, with financial support from Shire (previously Baxalta), Zug, Switzerland.
Disclosure
J. Taieb: Honoraria, Consulting, Speaker roles: Amgen, Roche, Merck, Celgene, Shire, Lilly, Sanofi, Sirtex, Servier. A. Carrato: Advisory boards: Roche, Merck, MSD, Baxter, Shire, Celgene, Bayer. B. Westphalen: Advisory boards: Roche, Celgene, Shire, RedHill; Research support: Roche. D. Melisi: Research funding: Shire, Incyte, Celgene; Consulting role: Eli Lilly, Shire, Baxter, Incyte. G. Prager: Advisory board, Speaker fees: Shire, Celgene, Halozyme. Å.B.C. Mellbring, F. de Jong: Employee, Stockholder: Shire. All other authors have declared no conflicts of interest.