TY - JOUR
T1 - Androgen deprivation with radiation therapy compared with radiation therapy alone for locally advanced prostatic carcinoma
T2 - a randomized comparative trial of the radiation therapy oncology group
AU - Pilepich, Miljenko V.
AU - Sause, William T.
AU - Shipley, William U.
AU - Krall, John M.
AU - Lawton, Colleen A.
AU - Grignon, David
AU - Al-Sarraf, Muhyi
AU - Abrams, Ross A.
AU - Caplan, Richard
AU - John, Madhu J.
AU - Rotman, Marvin
AU - Cox, James D.
AU - Doggett, R. L.Scotte
AU - Rubin, Philip
AU - Soloway, Mark S.
PY - 1995/4
Y1 - 1995/4
N2 - Objectives: Androgen deprivation therapy before and during radiation therapy could, by reducing tumor volume, increase local tumor control, disease-free survival, and overall survival in patients with locally advanced adenocarcinomas of the prostate. Methods: In a randomized controlled clinical trial, patients with large T2, T3, and T4 prostate tumors, but no evidence of osseous metastasis, were randomized to receive goserelin 3.6 mg subcutaneously every 4 weeks and flutamide 250 mg orally three times daily 2 months before and during the radiation therapy course (Arm I) compared with radiation therapy alone (Arm II). Pelvic irradiation was administered with 1.8 to 2.0 Gy per day to a total dose of 45 ± 1 Gy followed by a boost to the prostate target volume to a total dose of 65 to 70 Gy. Results: Of 471 randomized patients, 456 were evaluable, 226 on Arm I and 230 on Arm II. With a median potential follow-up of 4.5 years, the cumulative incidence of local progression at 5 years was 46% in Arm I and 71% in Arm II (P < 0.001). The 5-year incidence of distant metastasis on Arms I and II was 34% and 41 %, respectively (P = 0.09). Progression-free survival rates including normal prostate-specific antigen (PSA) levels for 396 patients with at least one PSA recorded were 36% in Arm I and 15% in Arm II at 5 years (P < 0.001 ). At this time, no significant difference in overall survival could be detected (P = 0.7). Conclusions: Short-term androgen deprivation with radiation therapy results in a marked increase in local control and disease-free survival compared with pelvic irradiation alone in patients with locally advanced carcinoma of the prostate. Long-term surveillance is required to assess effects on overall survival.
AB - Objectives: Androgen deprivation therapy before and during radiation therapy could, by reducing tumor volume, increase local tumor control, disease-free survival, and overall survival in patients with locally advanced adenocarcinomas of the prostate. Methods: In a randomized controlled clinical trial, patients with large T2, T3, and T4 prostate tumors, but no evidence of osseous metastasis, were randomized to receive goserelin 3.6 mg subcutaneously every 4 weeks and flutamide 250 mg orally three times daily 2 months before and during the radiation therapy course (Arm I) compared with radiation therapy alone (Arm II). Pelvic irradiation was administered with 1.8 to 2.0 Gy per day to a total dose of 45 ± 1 Gy followed by a boost to the prostate target volume to a total dose of 65 to 70 Gy. Results: Of 471 randomized patients, 456 were evaluable, 226 on Arm I and 230 on Arm II. With a median potential follow-up of 4.5 years, the cumulative incidence of local progression at 5 years was 46% in Arm I and 71% in Arm II (P < 0.001). The 5-year incidence of distant metastasis on Arms I and II was 34% and 41 %, respectively (P = 0.09). Progression-free survival rates including normal prostate-specific antigen (PSA) levels for 396 patients with at least one PSA recorded were 36% in Arm I and 15% in Arm II at 5 years (P < 0.001 ). At this time, no significant difference in overall survival could be detected (P = 0.7). Conclusions: Short-term androgen deprivation with radiation therapy results in a marked increase in local control and disease-free survival compared with pelvic irradiation alone in patients with locally advanced carcinoma of the prostate. Long-term surveillance is required to assess effects on overall survival.
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U2 - 10.1016/S0090-4295(99)80053-3
DO - 10.1016/S0090-4295(99)80053-3
M3 - Article
C2 - 7716842
AN - SCOPUS:0028880521
SN - 0090-4295
VL - 45
SP - 616
EP - 623
JO - Urology
JF - Urology
IS - 4
ER -