OBJECTIVES: To demonstrate the validity of our analysis techniques utilizing real-world data to assess and compare the effectiveness of two chemotherapy regimens that have not been directly compared in randomized clinical trials: FOLFIRINOX (combined leucovorin calcium, fluorouracil, irinotecan and oxaliplatin) and gemcitabine plus nab-paclitaxel for first line metastatic pancreatic cancer.

METHODS: Our proprietary detection algorithm identifies attributes of chemotherapy regimens in a large population of individual patients in US medical claims and pharmacy prescription fill data. Key attributes examined: chemotherapeutic agents, duration, timing, and associations to preceding and following treatments.

With a cohort of 17k pancreatic cancer patients treated either with FOLFIRINOX or gemcitabine/nab-paclitaxel as first line therapy in the last 5 years, we identified a subset of 2439 metastatic patients aged 50+ at the time of the first line starting date, who completed first line treatment prior to December 31^st, 2021.

Using medical claims made through June 30^th, 2022, a death surrogate event was estimated as last medical event of any type prior to the observation end date. Overall Survival (OS) analysis was made using the Kaplan-Meier method. The cohort was split by chemotherapy regimen.

RESULTS: The analysis demonstrates survival benefit of FOLFIRNOX over gemcitabine/nab-paclitaxel:

FOLFIRINOX 12.5 months vs gemcitabine plus nab-paclitaxel 10.25 months. Comparable outcomes can be found in publications based on the results of randomized clinical trials, separately for each chemotherapy regimen, and retrospective analyzes.

CONCLUSIONS: Survival benefit was shown in patients with metastatic pancreatic cancer treated with FOLFIRNOX over gemcitabine/nab-paclitaxel. Our proprietary detection algorithm identifies attributes of chemotherapy regimens in claims data and can be used to provide insights into oncology treatment regimens in large populations of oncology patients, which is especially important when comparative analyzes of clinical effectiveness are limited.