Lack of benefit of pelvic radiation in prostate cancer patients with a high risk of positive pelvic lymph nodes treated with high-dose radiation.

PURPOSE: The use of pelvic radiation for patients with a high risk of lymph node (LN) metastasis (>15%) remains controversial. We reviewed the data at three institutions treating patients with a combination of external-beam radiation therapy and high-dose-rate brachytherapy to address the prognostic implications of the use of the Roach formula and the benefit of pelvic treatment. METHODS AND MATERIALS: From 1986 to 2003, 1,491 patients were treated with external-beam radiation therapy and high-dose-rate brachytherapy. The Roach formula [2/3 prostate-specific antigen + (Gleason score -6) x 10] could be calculated for 1,357 patients. Group I consisted of patients having a risk of positive LN < or = 15% (n = 761), Group II had a risk >15% and < or = 30% (n = 422), and Group III had a risk of LN disease >30% (n = 174). A >15% risk of having positive LN was found in 596 patients and was used to determine the benefit of pelvic radiation. The pelvis was treated at two of the cancer centers (n = 312), whereas at the third center (n = 284) radiation therapy was delivered to the prostate and seminal vesicles alone. Average biologic effective dose was > or = 100 Gy (alphabeta = 1.2). Biochemical failure was as per the American Society for Therapeutic Radiology and Oncology definition. Statistics included the log-rank test as well as Cox univariate and multivariate analysis.
RESULTS: For all 596 patients with a positive LN risk >15%, median follow-up was 4.3 years, with a mean of 4.8 years. For all cases, median follow-up was 4 years and mean follow-up was 4.4 years. Five-year results for the three groups based on their risk of positive LN were significantly different in terms of biochemical failure (p < 0.001), clinical control (p < 0.001), disease-free survival excluding biochemical failure (p < 0.001), cause-specific survival (p < 0.001), and overall survival (p < 0.001). For all patients with a risk of positive LN >15% (n = 596), Group II (>15-30% risk), or Group III (>30% risk), no benefit was seen in the 5-year rates of clinical failure, cause-specific survival, or overall survival with pelvic radiation. In the Cox multivariate analysis for cause-specific survival, Gleason score (p = 0.009, hazard ratio [HR] 3.1), T stage (p = 0.03, HR 1.8), and year of treatment (p = 0.05, HR 1.1) were significant. A log-rank test for cause-specific survival for all patients (n = 577) by the use of pelvic radiation was not significant (p = 0.99) accounting for high-dose-rate brachytherapy dose, neoadjuvant hormones, Gleason score, prostate-specific antigen, T stage, and year of treatment as covariates.
CONCLUSIONS: The use of the Roach formula to stratify patients for clinical and biochemical outcomes is excellent. Pelvic radiation added to high prostate radiation doses did not show a clinical benefit for patients at a high risk of pelvic LN disease (>15%) selected using the Roach formula.