Phase II study of nab-paclitaxel/gemcitabine (NabP-Gem) alternating with FOLFIRI as 1st line therapy ( Rx) in patients (pts) with metastatic pancreatic cancer (mPC).

作者：Vincent J. Picozzi, Joseph L. Leach, Tim Larson, Carol Y. Nishikubo, Stephen Patrick Anthony, Bruce Shih-Li Lin, Vanessa Bolejack, Amy C. Stoll, Daniel D. Von Hoff, Ramesh K. Ramanathan · 发表于：Journal of Clinical Oncology · 年份：2015 · DOI：10.1200/jco.2015.33.15_suppl.e15277 · 被引用次数：1 · 研究领域：Cancer Genomics and Diagnostics、Cancer Treatment and Pharmacology、Pancreatic and Hepatic Oncology Research

e15277 Background: NabP-Gem and FOLFIRINOX are standard mPC regimens.The optimal sequence is unknown.This phase II study evaluated the feasibility of NabP-Gem alternating with FOLFIRI as 1stline Rx for untreated mPC. Methods: Eligibility criteria included: 1) diagnosis untreated mPC, 2) ECOG PS 0-1 and 3) adequate organ function. Pts received Nab-P (125 mg/m2) and Gem (1000 mg/ m2) weekly x 3 every 4 weeks (wks) for 8 wks, alternating with FOLFIRI (irinotecan 180 mg/m2, folinic acid 400mg/m2, 5FU 2400 mg/m2over 46 hrs) x 4 for 8 wks. Rx continued in alternating fashion unless disease progression/toxicity for 48 wks, followed by Rx per investigator discretion, including “molecular guidance” as able. Primary study endpoint was overall survival (OS) with the goal to increase 1 year (yr) OS to > 70%, (n = 30, 95% CI +/- 20%). Results: The study accrued 27 pts. Median pt age 65 yrs. 1 pt withdrew consent prior to Rx. 14/26 (54%) pts experienced grade > 3 all cause adverse events during Rx including 15% grade ≥ 4 infections (1 grade 5) and 15% grade ≥ 4 neutropenia. 13/26 (50%) pts initiated FOLFIRI with stable/responding disease and acceptable Nab P-Gem toxicity after 8 weeks . The remaining 13 pts experienced disease progression (6 pts), NabP-Gem drug toxicity (3 pts), early death (2 pts) or other (2 pts). ORR by RECIST was 36% (8/22 evaluable pts). Of pts with elevated CA 19.9, median decline was 62%; 40% had > 90% decline. For all pts, current median follow up is 12.3 months (m...