Real-world analysis of treatment patterns examining nab-Paclitaxel plus Gemcitabine (nab-P+G) versus FOLFIRINOX (FFX) in first-line (1L) treatment (tx) of metastatic pancreatic adenocarcinoma (MPAC) in a U.S. community oncology setting.

Authors

Fadi S. Braiteh

Fadi S. Braiteh

Comprehensive Cancer Centers of Nevada, Las Vegas, NV

Fadi S. Braiteh , Manish Patel , Monika Parisi , Quanhong Ni , Si yeon Park , Claudio Faria

Organizations

Comprehensive Cancer Centers of Nevada, Las Vegas, NV, Celgene, Summit, NJ, Celgene Corporation, Summit, NJ, The Ohio State University, Columbus, OH

Research Funding

Pharmaceutical/Biotech Company

Background: In independent phase III trials, both nab-P + G and FFX demonstrated significantly better OS, PFS, and ORR than G alone as 1L tx for MPAC. Limited real-world data exist on the effectiveness of and treatment patterns associated with nab-P + G vs FFX for 1L tx of patients (pts) with MPAC, supporting the need for the current study. Methods: A retrospective cohort study was performed using fully de-identified data from a nationally representative electronic medical record platform of 1,300 community oncologists. Pts diagnosed with MPAC between 9/10/13 and 10/6/14 and received either nab-P+G or FFX as 1L tx were included. We calculated median time to treatment discontinuation (TTD) and estimated survival (ES), proxy for OS, using the Kaplan Meier method. We also assessed incidence of adverse events (AEs), utilization of supportive care, and incidence of regimen modifications and dose delays across the two groups. Lastly, we explored outcomes associated with sequencing 1L and 2L therapy. Results: 202 pts met eligibility criteria (nab-P+G, n = 122; FFX, n = 80). Pts on nab-P+G were older than pts on FFX (mean age 67.0 vs 61.4; p < 0.01), but other baseline characteristics were comparable. TTD (3.4 vs 3.8 mos) and ES (8.6 vs 8.6 mos) were not statistically different for nab-P+G and FFX, respectively. FFX pts had a higher incidence of overall AEs vs nab-P + G pts (95% vs 84%), and utilized significantly more G-CSF (39% of pts on FFX vs 8% on nab-P + G received prophylactic G-CSF), but nab-P + G pts require significantly more ESA. Fewer pts in the nab-P+G group required a regimen modification (10.7% v 27.5%) and dose delay (39.3% v 73.8%) compared to FFX pts. For nab-P+G pts who moved to a 5-FU based 2nd line regimen (n = 25), the median ES was 12.7 mos compared to 9.3 mos (p = 0.48) for FFX pts who switched to a G based 2nd line regimen (n = 41). Conclusions: TTD and ES for pts with MPAC did not differ significantly between nab-P+G and FFX. Fewer nab-P+G pts required regimen modifications and dose delays compared to FFX pts. Pts who received 1st-line nab-P + G followed by a 5-FU-based 2nd-line therapy had a longer ES.

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Health Services Research and Quality of Care

Track

Health Services Research and Quality of Care

Sub Track

Outcomes

Clinical Trial Registration Number

NCT01962103

Citation

J Clin Oncol 34, 2016 (suppl; abstr e18130)

DOI

10.1200/JCO.2016.34.15_suppl.e18130

Abstract #

e18130

Abstract Disclosures