title: Gemcitabine plus nab-paclitaxel for advanced pancreatic cancer after first-line FOLFIRINOX: single institution retrospective review of efficacy and toxicity.
abstract: BACKGROUND
  We conducted a retrospective review of the dose, toxicity, and efficacy of second line gemcitabine plus nab-paclitaxel (G + Nab-P) after FOLFIRINOX in patients with metastatic and locally advanced unresectable pancreatic cancer.
  
  
  METHODS
  In this retrospective study, we included all patients with locally advanced unresectable or metastatic pancreatic cancer who were treated at Yale Cancer Center with G + Nab-P between 12/2011 and 12/2013 after receiving first line FOLFIRINOX. For each patient, demographics, prior therapy, doses of G + Nab-P (cumulative doses and dose intensity relative to full dose G + Nab-P), hematologic toxicities, best response by RECIST, time to treatment failure (TTF), and survival were compiled. Median TTF and overall survival (OS) were calculated by Kaplan-Meier method.
  
  
  RESULTS
  28 patients were treated with G + Nab-P after first line FOLFIRINOX. The median TTF was 12.0 weeks (range 2.0-36.0), and the median OS was 23.0 weeks (range 2.1-85.4). Five patients had a partial response (response rate 17.9 %), and 28.6 % of patients had stable disease for ≥7 weeks. A decline in CA 19-9 and CEA by >30 % was observed in 13 (46.4 %) and 11 (39.3 %) patients, respectively. The median relative dose intensities were 62.4 and 57.5 % for G and Nab-P, respectively. Grade ≥3 hematologic toxicities included neutropenia in 17.9 %, anemia in 25.0 %, and thrombocytopenia in 25.0 % of patients.
  
  
  CONCLUSIONS
  Second line G + Nab-P following FOLFIRINOX is feasible, and demonstrated modest activity and clinical benefit in advanced pancreatic cancer. The optimum sequencing and dosing of these active regimens warrants further evaluation in prospective trials.
authors.affiliation: Division of Hematology/Oncology, Stony Brook University School of Medicine, HSC T15, RM 040, Stony Brook, NY 11794-8151 USA.
authors.forename: Yue
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Smilow Cancer Center, Yale University School of Medicine, New Haven, CT 06519 USA.
authors.forename: Howard
authors.initials: H
authors.lastname: Hochster
authors.affiliation: Smilow Cancer Center, Yale University School of Medicine, New Haven, CT 06519 USA.
authors.forename: Stacey
authors.initials: S
authors.lastname: Stein
authors.affiliation: Smilow Cancer Center, Yale University School of Medicine, New Haven, CT 06519 USA.
authors.forename: Jill
authors.initials: J
authors.lastname: Lacy
keywords: FOLFIRINOX; Gemcitabine plus nab-paclitaxel; Pancreatic cancer; Second line treatment