Predictors of Overall Survival (OS) and Time to Next Treatment (TTNT) in Real-World Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Patients Who Received First-Line (1L) Folfirinox (FFX) or Gemcitabine + Nab-paclitaxel (GnP)

Author(s)

Dennen S1, Silver M1, Cockrum P2, Kim GP3
1Genesis Research, Hoboken, NJ, USA, 2Ipsen, Fort Worth, TX, USA, 3University of Florida Health Cancer Center, Gainesville, FL, USA

Presentation Documents

OBJECTIVES: Using real-world data, we assessed OS and TTNT between 1L FFX and GnP and assessed factors associated with these outcomes.

METHODS: This retrospective observational study utilized the Ontada Clinical Data View: Pancreatic Cancer database. The study included adult mPDAC patients diagnosed November 2018–November 2022 treated with 1L FFX or GnP ≤90 days after metastatic diagnosis. Kaplan-Meier (KM) analyses assessed unadjusted OS and TTNT, while Cox proportional hazards models adjusted these outcomes for patient age, race, sex, treatment year, baseline BSA and ECOG, and baseline lab values (SA, bilirubin, AST/ALT, ALP, CA 19-9, and WBC count).

RESULTS: 2,911 mPDAC patients met inclusion criteria. 42% were treated with 1L FFX and 58% with 1L GnP. Unadjusted median OS for FFX vs. GnP was 10.0 (95% CI:9.0–11.3) vs. 7.6 months (95% CI:7.1–8.5) (p<.001). Unadjusted median TTNT for FFX vs. GnP was 5.6 (95% CI:5.3–6.0) vs. 5.3 months (95% CI:5.1–5.6) (p=.175). In adjusted analyses, the hazard ratios (HRs) of OS and TTNT were lower for FFX vs. GnP (HR:0.71, 95% CI:0.63–0.79; HR:0.88, 95% CI:0.80–0.98, respectively). Significant predictors of lower OS were abnormal SA (HR:1.39, 95% CI:1.24–1.57), ALP (HR:1.47, 95% CI:1.29–1.68), and CA 19-9 (HR:1.20, 95% CI:1.01–1.42). Compared to a baseline ECOG=0, OS was lower for ECOG=1 (HR:1.20, 95% CI:1.02–1.40) and 2–3 (HR:1.59, 95% CI:1.28–1.97). Significant predictors of lower TTNT were male sex (HR:1.13; 95% CI:1.02–1.26), and abnormal SA (HR:1.28, 95% CI:1.15–1.43) and ALP (HR:1.29, 95% CI:1.15–1.45). Compared to baseline ECOG=0, TTNT was lower for ECOG=1 (HR:1.21; 95% CI:1.05–1.40) and 2–3 (HR:1.42; 95% CI:1.16–1.73).

CONCLUSIONS: 1L GnP was associated with lower OS and marginally lower TTNT relative to FFX. Abnormal SA, ALP, and higher ECOG score predicted inferior outcomes.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA

Value in Health, Volume 27, Issue 6, S1 (June 2024)

Code

CO32

Topic

Clinical Outcomes, Study Approaches

Topic Subcategory

Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy, Electronic Medical & Health Records

Disease

Oncology

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