32 P as an Adjunct to Standard Therapy for Locally Advanced Unresectable Pancreatic Cancer: A Randomized Trial

This prospective randomized trial was undertaken to determine the added efficacy of 32 P in treating locally advanced unresectable pancreatic cancer. Thirty patients with biopsy proven locally advanced unresectable adenocarcinoma of the pancreas were assessable after receiving 5-fluorouracil and radiation therapy with or without 32 P, followed by gemcitabine. Intratumoral 32 P dose was determined by tumor size and volume and was administered at months 0, 1, 2, 6, 7, and 8. Tumor cross-sectional area and liquefaction were determined at intervals by computed tomography scan. Tumor liquefaction occurred in 78% of patients receiving 32 P and in 8% of patients not receiving 32 P, although tumor cross-sectional area did not decrease. Serious adverse events occurred more often per patient for patients receiving 32 P (4.2 ± 3.1 vs. 1.8 ± 1.9; p = 0.03) leading to more hospitalizations. Death was because of disease progression (23 patients), gastrointenstinal hemorrhage (4 patients), and stroke (1 patient). One patient not receiving 32 P and one receiving 32 P are alive at 28 and 13 months, respectively. 32 P did not prolong survival (7.4 ± 5.5 months with 32 P vs. 11.5 ± 8.0 months without 32 P, p = 0.16). 32 P promoted tumor liquefaction, but did not decrease tumor size. Intratumoral 32 P was associated with more serious adverse events and did not improve survival for locally advanced unresectable pancreatic cancer.