NeoGemTax: gemcitabine and docetaxel as neoadjuvant treatment for locally advanced nonmetastasized pancreatic cancer.

ABSTRACT

BACKGROUND: About 30% of patients with pancreatic cancer suffer from locally advanced nonmetastatic carcinoma at the time of diagnosis. We conducted a prospective phase II clinical trial using neoadjuvant chemotherapy, consisting of gemcitabine and docetaxel, to assess the rate of complete radical resection and overall survival. METHODS: Gemcitabine (900 mg/m2) and docetaxel (35 mg/m2) were given on days 1, 8, and 15 of a 28-day cycle. Two cycles were administered for a preoperative treatment duration of 8 weeks. Patients experiencing tumor regression or stable disease and improved performance status subsequently underwent surgical exploration and pancreatic resection, if feasible. All patients were followed postoperatively to assess long-term survival. RESULTS: A total of 25 patients were eligible and included in the intent-to-treat and evaluable population. Thirteen patients had unresectable disease at inclusion and 12 patients had borderline resectable pancreatic cancer. Finally, 8 of 25 (32%) patients underwent resection after neoadjuvant chemotherapy; 7 (87%) of these patients had R0 resection. The median overall survival of patients who underwent resection was 16 months (95% confidence interval [CI], 8-24 months) compared to 12 months (95% CI, 8-16 months) for those without resection (p=0.276). The median recurrence-free survival rate after resection was 12 months (95% CI, 2-21 months). CONCLUSIONS: NeoGemTax was safe and resection was feasible in a number of patients after systemic neoadjuvant treatment. Further randomized clinical trials are needed to identify novel multimodal regimens that would be able to increase the percentage of patients undergoing curative pancreatic cancer surgery despite advanced tumor stage at the time of diagnosis.