Randomized, Multicenter, Phase II Study of CO-101 Versus Gemcitabine in Patients With Metastatic Pancreatic Ductal Adenocarcinoma: Including a Prospective Evaluation of the Role of hENT1 in Gemcitabine or CO-101 Sensitivity
作者： Elizabeth Poplin , Harpreet Wasan , Lindsey Rolfe , Mitch Raponi , Tone Ikdahl
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摘要: Purpose Gemcitabine requires transporter proteins to cross cell membranes. Low expression of human equilibrative nucleoside transporter-1 (hENT1) may result in gemcitabine resistance pancreatic ductal adenocarcinoma (PDAC). CO-101, a lipid-drug conjugate gemcitabine, was rationally designed enter cells independently hENT1. We conducted randomized controlled trial determine whether CO-101 improved survival versus patients with metastatic PDAC (mPDAC) low The study also tested the hypothesis that is more active mPDAC tumors high hENT1 expression. Patients and Methods were randomly assigned or after providing metastasis sample for blinded assessment. An immunohistochemistry test measuring tumor developed. To dichotomize population, an cutoff value defined using primary samples from adjuvant trial, high/low applied. end po...
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