Article Abstract

Dose-modified gemcitabine plus nab-paclitaxel front-line in advanced pancreatic ductal adenocarcinoma with baseline hyperbilirubinemia

Authors: Jane E. Rogers, Jonathan D. Mizrahi, Rachna T. Shroff, Douglas A. Nelson, Janet Tu, Milind M. Javle, Robert A. Wolff, Shubham Pant

Abstract

Background: Von Hoff et al. demonstrated survival improvement with gemcitabine (GEM) + nab- paclitaxel (NabP) for metastatic pancreatic ductal adenocarcinoma (PDAC) compared to GEM alone. GEM + NabP resulted in a median overall survival (OS) and progression-free survival (PFS) of 8.5 and 5.5 months, respectively. Patients with baseline hyperbilirubinemia were excluded. Primary objective was OS. Secondary objectives included time on treatment (TOT), disease control rate, dosing practices, delays/admissions, and adverse effects.
Methods: Patients with borderline resectable, locally advanced, or metastatic PDAC who initiated front- line GEM-NabP during July 01, 2013–July 01, 2017 were reviewed. Patients with a baseline total bilirubin ≥2 mg/dL were included.
Results: Twelve patients total were included. Median age was 71 years old. Median baseline total bilirubin was 2.4 mg/dL (range, 2.1–5.2 mg/dL). 58% had metastatic disease. Median doses were NabP 100 mg/m2 + GEM 600 mg/m2 IV with a fixed-dose rate infusion (10 mg/m2/min). GEM-NabP was given biweekly or 3 weeks on 1 week off. Median OS, TOT, and disease control rate were 13.9, 5.2 months, and 58%, respectively. Fifty percent of patients required a dose delay. Metastatic patients only (n=7) had median OS and TOT of 6.9 and 2.1 months, respectively. No admissions related to toxicity were found.
Conclusions: Our analysis revealed safety with NabP (median dose =100 mg/m2) + GEM (median dose =600 mg/m2 at fixed-dose rate) given predominately biweekly in patients with a baseline elevated total bilirubin (≥2 mg/dL).

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