TY - JOUR
T1 - 32P as an adjunct to standard therapy for locally advanced unresectable pancreatic cancer
T2 - A randomized trial
AU - Rosemurgy, Alexander
AU - Luzardo, German
AU - Cooper, Jennifer
AU - Bowers, Carl
AU - Zervos, Emmanuel
AU - Bloomston, Mark
AU - Al-Saadi, Sam
AU - Carroll, Robert
AU - Chheda, Hemant
AU - Carey, Larry
AU - Goldin, Steven
AU - Grundy, Shane
AU - Kudryk, Bruce
AU - Zwiebel, Bruce
AU - Black, Thomas
AU - Briggs, John
AU - Chervenick, Paul
N1 - Funding Information:
Funded by a grant from Mallinckrodt, Inc., St. Louis, MO.
PY - 2008/4
Y1 - 2008/4
N2 - 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.
AB - 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.
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U2 - 10.1007/s11605-007-0430-6
DO - 10.1007/s11605-007-0430-6
M3 - Article
C2 - 18266048
AN - SCOPUS:40849105030
SN - 1091-255X
VL - 12
SP - 682
EP - 688
JO - Journal of Gastrointestinal Surgery
JF - Journal of Gastrointestinal Surgery
IS - 4
ER -