Regional targeting chemoimmunotherapy in patients undergoing pancreatic resection in an advanced stage of their disease: a prospective randomized study.

Abstract

To evaluate in a prospective randomized study the long-term results of adjuvant locoregional chemoimmunotherapy in a number of patients with stage III pancreatic duct cancer who underwent pancreatic resection between November 1993 and October 2000. One hundred twenty-eight patients were divided into three groups. Group A (n = 40) patients had surgical resection alone. Group B (n = 45) patients had, using a side arterial branch of the jejunal artery, an arterial catheter advanced under fluoroscopic control into the superior mesenteric artery. Group B patients also received adjuvant chemotherapy. Group C (n = 43) patients had the same kind of arterial catheter and received as an adjuvant treatment locoregional chemoimmunotherapy. During the initial surgical exploration, all patients underwent pancreatic resection. Pancreatic resection involved a standard technique of extended duodenopancreatectomy with regional lymphadenectomy and was carried out in all patients by the first author. At the end of intervention, all patients were randomly assigned to the above-mentioned groups. Randomization was based mainly on histologic evidence of the stage of the disease. The 2- and 5-year survival rates were 29% and 0% for group A, 52% and 10% for group B, and 65% and 18% for group C. The respective percentages for disease-free survival were 20% and 0% for group A, 35% and 7% for group B, and 58% and 11% for group C. Since statistical differences among groups were observed from the second and third years, the study was interrupted early for ethical reasons. When applied regionally, combined chemoimmunotherapy is simple, safe, and effective. This type of therapy offers substantial advantages in terms of prolonging overall survival and improving disease-free survival compared to surgical resection alone or to surgical resection and adjuvant regional chemotherapy.