Bridging the Gap between the NAPOLI 3 Trial and Real-World Practice: Real-World Overall Survival (OS) of First-Line (1L) FOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Author(s)
George Kim, MD1, Louise Yu, MS2, Rose Chang, ScD, MS, MSPH2, Eric Maiese, PhD3, Paul Cockrum, PharmD3, Chunyi Xu, MS2, Mei Sheng Duh, ScD, MPH2.
1University of Florida/UF Health Cancer Center, Gainesville, FL, USA, 2Analysis Group, Inc., Boston, MA, USA, 3Ipsen Corp, Cambridge, MA, USA.
1University of Florida/UF Health Cancer Center, Gainesville, FL, USA, 2Analysis Group, Inc., Boston, MA, USA, 3Ipsen Corp, Cambridge, MA, USA.
Presentation Documents
OBJECTIVES: NALIRIFOX (liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin) showed significantly improved OS compared to 1L gemcitabine + nab-paclitaxel in the phase 3 NAPOLI 3 trial (NCT04083235). The median OS (95% CI) for NALIRIFOX was 11.1 (10.0, 12.1) months. However, its efficacy relative to FFX (irinotecan + 5-fluorouracil/leucovorin + oxaliplatin), another standard-of-care regimen for 1L mPDAC, has not been evaluated. To contextualize findings from NAPOLI 3 trial, this study examined OS among patients treated with 1L FFX in the real-world setting.
METHODS: Three cohorts of patients with mPDAC treated with 1L FFX were identified from the Flatiron Health database. The all-comer cohort included all adult patients with mPDAC treated with 1L FFX since January 2014. From this group, the trial-aligned cohort was defined as patients treated with 1L FFX between January 1, 2020 and July 31, 2022 (to align with the NAPOLI 3 trial’s time frame) who met the trial eligibility criteria. A subset of the trial-aligned cohort receiving the modified FFX (mFFX) regimen formed the trial-aligned mFFX cohort. OS was assessed using Kaplan-Meier analysis.
RESULTS: The all-comer cohort included 3,271 patients. The trial-aligned cohort had 219 patients, 154 (70%) of whom received mFFX. The distribution of baseline characteristics was similar across three cohorts. The mean age was 64 years, 42% of patients were female, 65% were White, 49% had an ECOG score of 1; median time from mPDAC diagnosis to FFX initiation was 3 weeks. Median OS (95% CI) was 9.0 (8.5, 9.3) months in the all-comer cohort, 9.1 (7.8, 10.9) months in the trial-aligned cohort, and 8.6 (7.3, 10.5) months in the trial-aligned mFFX cohort.
CONCLUSIONS: NALIRIFOX in the NAPOLI 3 trial had numerically higher OS compared to FFX, including mFFX, in real-world practice. Further analyses adjusting for baseline characteristics are warranted to evaluate the relative efficacy of these regimens.
METHODS: Three cohorts of patients with mPDAC treated with 1L FFX were identified from the Flatiron Health database. The all-comer cohort included all adult patients with mPDAC treated with 1L FFX since January 2014. From this group, the trial-aligned cohort was defined as patients treated with 1L FFX between January 1, 2020 and July 31, 2022 (to align with the NAPOLI 3 trial’s time frame) who met the trial eligibility criteria. A subset of the trial-aligned cohort receiving the modified FFX (mFFX) regimen formed the trial-aligned mFFX cohort. OS was assessed using Kaplan-Meier analysis.
RESULTS: The all-comer cohort included 3,271 patients. The trial-aligned cohort had 219 patients, 154 (70%) of whom received mFFX. The distribution of baseline characteristics was similar across three cohorts. The mean age was 64 years, 42% of patients were female, 65% were White, 49% had an ECOG score of 1; median time from mPDAC diagnosis to FFX initiation was 3 weeks. Median OS (95% CI) was 9.0 (8.5, 9.3) months in the all-comer cohort, 9.1 (7.8, 10.9) months in the trial-aligned cohort, and 8.6 (7.3, 10.5) months in the trial-aligned mFFX cohort.
CONCLUSIONS: NALIRIFOX in the NAPOLI 3 trial had numerically higher OS compared to FFX, including mFFX, in real-world practice. Further analyses adjusting for baseline characteristics are warranted to evaluate the relative efficacy of these regimens.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO119
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology