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Phase III Randomized Study of Adjuvant Radiation Therapy versus Observation in Patients with Pathologic T3 Prostate Cancer (SWOG 8794)

2005; Elsevier BV; Volume: 63; Linguagem: Inglês

10.1016/j.ijrobp.2005.07.007

1879-355X

Gregory P. Swanson, Ian M. Thompson, Catherine M. Tangen, Gary J. Miller, M. Scott Lucia, Dean A. Troyer, Jorge C. Paradelo, J. Chin, Edward M. Messing, E. Canby-Higano, J.D. Forman, David Crawford,

Urologic and reproductive health conditions

Purpose/Objective: Southwest Oncology Group Protocol 8794 was a randomized study to determine whether patients with pathologic T3 prostate cancer benefited from immediate adjuvant radiation therapy. Materials/Methods: From 1988–1995, 473 patients with pathologically determined extracapsular extension, positive margins and/or seminal vesicle involvement were randomized to radiation (60–64 Gy) versus observation. Follow up with PSA was every three months in year one, every 6 months for years 2–3 and annually thereafter. Patients were followed until death. The primary endpoint was metastasis free survival. Results: Four hundred ten patients were eligible for follow up. Median follow up was 9.7 years. Biochemical free survival (PSA <0.4 ng/ml) was significantly improved with radiation, while metastatic free survival and overall survival were non-significantly improved (table). The benefit for radiation was seen in each of the three pathologic risk groups. For patients with seminal vesicle involvement, with radiation (22 patients) 5 year bDFS was 57% and without radiation (21 patients), 22%. In the observation group, 32% subsequently received radiation. Of the 213 radiation patients, 84 (39%) subsequently were treated with androgen ablation at a median of 12.4 years and in the initial observation group, 106/210 (50%) subsequently received androgen ablation at a median of 9.9 years. At 6 weeks (during radiation), both GI and GU toxicity were significantly worse in the radiation arm. By two years, there was no significant difference in quality of life between the two groups. Tabled 1bDFS met free S survival Conclusions: Conclusions: Adjuvant radiation for pT3 disease significantly improved 5 and 10 year biochemical disease free survival and none significantly improved metastasis free and overall survival. Radiation prevented the need for androgen ablation in some patients and delayed the use by 2.5 years in the rest. Long term quality of life was not adversely affected by radiation therapy. Pathological T3 patients should be given the opportunity to receive post operative radiation.