Comparative Effectiveness of nab-Paclitaxel Plus Gemcitabine vs FOLFIRINOX in Metastatic Pancreatic Cancer: A Retrospective Nationwide Chart Review in the United States

Abstract

Introduction: nab-Paclitaxel plus gemcitabine (nab-P + G) and FOLFIRINOX (FFX) are among the most common first-line (1L) therapies for metastatic adenocarcinoma of the pancreas (MPAC), but real-world data on their comparative effectiveness are limited.

Methods: This retrospective cohort study compared the efficacy and safety of 1L nab-P + G versus FFX, overall and under specific treatment sequences. Medical records were reviewed by 215 US physicians who provided information on MPAC patients who initiated 1L therapy with nab-P + G or FFX between April 1, 2015 and December 31, 2015. Study outcomes were overall survival (OS) and tolerability. OS was compared using Kaplan-Meier curves and adjusted Cox proportional hazards models.

Results: In total, 654 medical records were reviewed, including those of 337 and 317 patients initiated on nab-P + G and FFX as 1L MPAC therapy, respectively. nab-P + G-initiated patients were older, less likely to have ECOG ≤ 1, and had more comorbidities than FFX-initiated patients. Median OS (mOS) was 12.1 and 13.8 months for nab-P + G- and FFX-initiated patients, respectively (HR = 0.99, P = 0.96). Among patients with ECOG ≤ 1, mOS was 14.1 and 13.7 months, respectively (HR = 1.00, P = 0.99). Among patients with 1L nab-P + G and FFX, 36.1% and 41.3% received 2L therapy and experienced mOS of 16.3 and 16.6 months, respectively (HR = 1.04, P = 0.76). The rates of diarrhea, fatigue, mucositis, and nausea and vomiting were significantly higher in the FFX than nab-P + G cohort.

Conclusion: The real-world survival was similar between patients receiving 1L nab-P + G or FFX both overall and among patients who received active 2L treatments. In addition, nab-P + G was associated with significantly lower rates of common AEs compared with FFX.

Funding: Celgene.

Keywords: Adverse events; FOLFIRINOX; Metastatic adenocarcinoma of the pancreas; Real-world evidence; Survival analysis; nab-Paclitaxel.

Figures

Fig. 1

Survival curves for OS by 1L therapy. nab-P + G, nanoparticle albumin-bound paclitaxel/gemcitabine; FFX FOLFIRINOX, 1L first-line

Fig. 2

Treatment sequences. The inner cycle depicts the 1L treatment; the outer cycle depicts the 2L treatment. nab-P + G, nanoparticle albumin-bound paclitaxel/gemcitabine; FFX, FOLFIRINOX; 5-FU based w/Nal-IRI, fluorouracil (5-FU) based regimen with nanoliposomal irinotecan; 5-FU based w/o Nal-IRI, fluorouracil (5-FU) based regimen without nanoliposomal irinotecan; G based w/ABR, gemcitabine-based regimen with nanoparticle albumin-bound paclitaxel; G based w/o ABR, gemcitabine-based regimen without nanoparticle albumin-bound paclitaxel; Hospice or SC only, hospice or supportive care only; Other, other drug (active) treatment; 1L, first-line

Fig. 3

Survival curves for OS by treatment sequence. nab-P + G, nanoparticle albumin-bound paclitaxel/gemcitabine; FFX FOLFIRINOX, 2L second-line