A multicenter review of gemcitabine, docetaxel, and capecitabine (GTX) in patients with advanced pancreatic adenocarcinoma.

Abstract

e14580 Background: Combination chemotherapy provides modest benefit in patients with advanced pancreatic adenocarcinoma over single agent gemcitabine. Recent studies have suggested that new regimens that included taxanes may be active in this disease. One of the more promising regimens combines gemcitabine with docetaxel and capecitabine (GTX) reporting a median survival of greater than 1 year. We were interested in confirming these observations in our patient population. Methods: We performed a multicenter review of all patients with pathologically confirmed locally advanced or metastatic pancreatic adenocarcinoma who received treatment with GTX. Results: Clinical outcomes on 70 patients (36 locally advanced and 34 metastatic pancreatic adenocarcinoma) were collected. Patients had a mean age of 60.6 (range 39-81) and ECOG performance 0-1. Forty-seven percent of patients were deceased at time of this review. GTX was delivered every 21 days (gemcitabine 750 mg/m2 fixed dose rate D4 and D11, docetaxel 30 mg/m2 D4 and D11, capecitabine 1,000 mg bid D1-14) and used as the first-line therapy in 66% of cases. Median overall survival from the time of GTX initiation was 12.4 months, which improved to 14.3 months when used as a first-line regimen; one-year survival was 53% and 61% respectively. In patients with metastatic disease the median overall survival was 12.4 months with a one-year survival of 55%. More than half of patients with metastatic disease had at least a 50% drop in CA19-9. Response rate by RECIST criteria at one institution showed a 24.3% objective response rate (CR + PR) with one complete response, and the majority (70%) of patients exhibiting stable disease. Grade 3-4 hematological toxicities were neutropenia 40%, thrombocytopenia 12.5% and anemia 10%. Hospital admissions were required in 33% (23/70) of the patients while receiving GTX. There were no deaths attributed to toxicity from this regimen. Conclusions: GTX has a promising survival benefit of greater than 1 year in patients with advanced pancreatic adenocarcinoma when compared to studies using single agent gemcitabine or other combination chemotherapies. Randomized controlled studies in pancreatic cancer with GTX are warranted. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Concordia, Roche Concordia Bristol-Myers Squibb, Concordia, Genentech, Lilly