Neoadjuvant gemcitabine, docetaxel, and capecitabine followed by gemcitabine and capecitabine/radiation therapy and surgery in locally advanced, unresectable pancreatic adenocarcinoma

BACKGROUND This prospective study was undertaken to assess toxicity, resectability, and survival in pancreatic adenocarcinoma patients presenting with locally advanced, unresectable disease treated with neoadjuvant gemcitabine, docetaxel, and capecitabine (GTX) and gemcitabine and capecitabine (GX)/radiation therapy (RT). METHODS All patients presenting to the Pancreas Center were evaluated for eligibility. Forty‐five patients (mean age, 64 years; range, 44‐83 years)—34 patients deemed unresectable because of arterial involvement and 11 patients deemed unresectable because of extensive venous involvement—were treated with 6 cycles of GTX. Those with arterial involvement were treated with GX/RT after chemotherapy. RESULTS The GTX and GX/RT treatments were tolerated with the expected drug‐related toxicities. There were no bowel perforations, cases of pancreatitis, or delayed strictures. Among those with arterial involvement, 29 underwent subsequent resection, with 20 (69%) achieving R0 resections. All 11 patients with venous‐only involvement underwent resection, with 8 achieving R0 resections and 3 achieving complete pathologic responses. For the arterial arm, the 1‐year survival rate was 71% (24 of 34 patients), and the median survival was 29 months (95% confidence interval, 21‐38 months). Thirteen patients (38%) have not relapsed (range, 5‐49+ months). For the venous arm, the median survival has not been reached at more than 42 months. Six patients (55%) in the venous arm did not experience recurrence (range, 6.2‐42+ months). CONCLUSIONS GTX plus GX/RT is an effective neoadjuvant regimen that can be safely administered to patients up to at least the age of 83 years. It is associated with a high response rate, a high rate of R0 resections, and prolonged overall survival. Cancer 2015;121:673–680. © 2014 American Cancer Society. Gemcitabine, docetaxel, and capecitabine followed by gemcitabine and capecitabine/radiation therapy can downstage more than 85% of patients with locally advanced pancreatic cancer so that more than 60% can achieve an R0 resection. This neoadjuvant regimen leads to a median survival greater than 29 months in those with arterial involvement, with more than 23% alive and disease‐free beyond 32 months.