³²P 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 ³²P 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 ³²P, followed by gemcitabine. Intratumoral ³²P 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 ³²P and in 8% of patients not receiving ³²P, although tumor cross-sectional area did not decrease. Serious adverse events occurred more often per patient for patients receiving ³²P (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 ³²P and one receiving ³²P are alive at 28 and 13 months, respectively. ³²P did not prolong survival (7.4∈±∈5.5 months with ³²P vs. 11. 5∈±∈8.0 months without ³²P, p∈=∈0.16). ³²P promoted tumor liquefaction, but did not decrease tumor size. Intratumoral ³²P was associated with more serious adverse events and did not improve survival for locally advanced unresectable pancreatic cancer.