Current Fellow Spotlight
2017 AFPE Fellow, Ashley Cole, MPH, is researching the “Comparative Effectiveness and Safety of First-Line Chemotherapeutic Regimens for Unresectable Pancreatic Cancer”
Cole is completing this research project with Dr. Stacie Dusetzina at the University of North Carolina, Chapel Hill. Her project is explained below:
Pancreatic cancer ranks third among the deadliest cancers, with less than 8% of patients surviving 5 years or more. Due to a lack of clinical signs and symptoms, patients often present at an advanced stage. Consequently, over 80% of patients are diagnosed with tumors that cannot be removed with surgery, making chemotherapy a critically important treatment option.
Over the past 30 years, the prognosis for pancreatic cancer has shown the least improvement of any cancer site, in part due to lack of advances in treatment. However, in the past 5 years, 2 first-line chemotherapy regimens have emerged for the treatment of unresectable pancreatic cancer: oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) and gemcitabine and nab-paclitaxel. Both regimens have demonstrated superior overall survival to treatment with gemcitabine alone, but no clinical trials have directly compared the effectiveness or safety of these 2 options head-to-head.
The proposed study will use administrative claims data to investigate the comparative effectiveness and safety of gemcitabine/nab-paclitaxel versus FOLFIRINOX as first-line chemotherapy for unresectable pancreatic cancer. We will address the following specific aims:
Aim 1 Describe predictors of treatment for unresectable pancreatic cancer between 2013 and 2017.
Descriptive statistics will be used to characterize current practice patterns in first-line treatment of unresectable pancreatic cancer. The probability of treatment with either FOLFIRINOX or gemcitabine/nab-paclitaxel will be investigated using modified Poisson regression.
Aim 2 Compare the effectiveness of first-line treatment with gemcitabine/nab-paclitaxel versus FOLFIRINOX for unresectable pancreatic cancer.
Using predictors of treatment identified from Aim 1, overall survival will be compared between propensity-score weighted patients who receive first-line gemcitabine/nab-paclitaxel versus first-line FOLFIRINOX using Cox proportional hazards models.
Aim 3 Compare the safety of first-line treatment with gemcitabine/nab-paclitaxel versus FOLFIRINOX among for unresectable pancreatic cancer.
The incidence of adverse events will be compared between propensity-score weighted patients who receive first-line gemcitabine/nab-paclitaxel versus first-line FOLFIRINOX using Cox proportional hazards models, to account for censoring in the follow-up period.
This is the first study to directly compare the effectiveness and safety of gemcitabine/nab-paclitaxel versus FOLFIRINOX as first-line chemotherapy for patients with unresectable pancreatic cancer. Findings will directly inform treatment decisions for over 80% of patients diagnosed with this devastating disease.
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