ABSTRACT
BACKGROUND: Neoadjuvant chemotherapy can facilitate pancreatic resection in patients with initially unresectable pancreatic cancer (PC). We report the results of a phase II trial of gemcitabine-oxaliplatin neoadjuvant chemotherapy for patients with locally advanced, nonmetastatic PC. METHODS: A prospective, phase II clinical trial using neoadjuvant chemotherapy, consisting of gemcitabine (900 mg/m(2)) and oxaliplatin (60 mg/m(2)) given as intravenous infusion once a week at day 1 of each treatment cycle (NeoGemOx protocol). Patients received 6-9 cycles of chemotherapy. Those patients with sufficient tumor regression subsequently underwent pancreatic resection and were followed postoperatively to assess long-term survival. RESULTS: A total of 33 patients were eligible and were included in the intent-to-treat and evaluable population. On centralized review of the imaging studies, 18 patients had unresectable disease at inclusion, and 15 patients had borderline resectable PC. Eventually, 13 patients (39%) had a curative resection after neoadjuvant therapy. The R0 resection rate was 69%. Median overall survival of patients who underwent tumor resection was 22 months (95% confidence interval [CI], 14-30) compared with 12 months (95% CI, 9-15) for those without resection (P = .046). The median recurrence-free survival rate after resection was 10 months (95% CI, 4-17). CONCLUSION: Neoadjuvant gemcitabine plus oxaliplatin is well tolerated and safe. Substantive tumor regression occurs in some patients with locally advanced PC treated with this neoadjuvant protocol, offering the potential for curative resection and improvement in overall survival. Additional studies involving the NeoGemOx protocol should be considered to further evaluate the safety and efficacy of this combination.
