Gemcitabine plus nab-paclitaxel for advanced pancreatic cancer after first-line FOLFIRINOX: Single institution retrospective review of efficacy and toxicity

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.