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-125 Brachytherapy Demonstrates Long-term Biochemical and Local Control

Emma Hitt, PhD

April 28, 2003 (Chicago) - In patients with T1-T2 prostate cancer treated with I-125 brachytherapy, a delivered dose of 160 Gy demonstrates high rates of biochemical and local control over a median six-year follow-up, according to the findings of a new study presented here at the annual meeting of the American Urological Association.
Nelson N. Stone, MD, from the Department of Urology at Mount Sinai School of Medicine in New York City, and colleagues evaluated 279 men, of which 64 (23%) also had six months of hormonal therapy (HT). About two thirds of the patients agreed to biopsy at least two years after implant and then yearly if the biopsy was positive or if prostate-specific antigen (PSA) levels had risen.
Median patient age was 67 years (range, 42-82 years). Overall, slightly more than half of the patients were considered low risk based on their PSA levels and Gleason scores. Initial PSA was 10 ng/mL or less in 202 patients and more than 10 ng/mL in 77 patients. Gleason score was 6 or lower in 272 patients (97.5%) and stage was T2a or lower in 198 patients (71%).
Of the 279 patients, 49 (17.6%) experienced a failure, defined as three consecutive rises in PSA levels, indicating a 10-year freedom-from-failure (FFF) rate of 78%.
Nonfailing patients had a median PSA level of 0.1 ng/mL or less. The only significant variables in treatment success were D90 dose (P < .001) and risk group (P = .01). For doses lower than 140 Gy and 120 Gy, the relative risk of PSA failure was 5.4 (P = .002) and 9.3 (P < .001), respectively.
In the 185 patients who underwent biopsy, 166 (90%) had a negative biopsy. In these patients, FFF was 85% compared with 21% for those with a positive biopsy (P < .001). Patients with a D90 dose of at least 160 Gy had positive biopsy rate of 4.6% compared with 13.6% for those with a lower dose (P < .001).
Patients receiving a dose less than 120 Gy had a 30% likelihood of a positive biopsy result. Those receiving a dose of 140 Gy and 120 Gy were five times and eight times more likely than those receiving a higher dose to have a positive biopsy, respectively (P < .001 for both doses).
Univariate analysis found that patients receiving a dose of at least 160 Gy had a 93% chance of FFF and a 95.4% likelihood of local control, Dr. Stone and colleagues conclude. In addition, low-risk patients (P < .001) and those patients receiving HT (P < .013) were significantly more likely to have FFF than those who were not.
According to Dr. Stone, this is only the second paper that presents 10-year results on brachytherapy, and the first ever study that presents 10-year data on the newer real-time method of seed implantation rather than the older preplanned method.
"It is the dose delivered that is the most highly predictive of biochemical freedom from failure - there was a huge difference in outcome based on the delivered dose," Dr. Stone said during a press conference. He noted that the optimal dose of 160 Gy observed in his study is higher than the American Brachytherapy Society's recommendation of 145 Gy.
"This is a very important study," said Thomas W. Brady, MD, a urologist in private practice in Reno, Nevada, and chair of the AUA's public media relations committee. "For the first time we are getting 10-year figures for seed implantation in the prostate, and the results are as good as or better than those for radical prostatectomy," he told Medscape.
According to Dr. Brady, the decision between radical prostatectomy and brachytherapy will be a personal choice made in consultation with a physician. However, many younger patients are choosing brachytherapy because of less risk of erectile dysfunction, urinary incontinence, and an easier recovery compared with radical prostatectomy.
"The incidence of patients having brachytherapy has risen dramatically in recent years," he noted, "whereas fewer patients are undergoing radical prostatectomy."
AUA 98th Annual Meeting: Abstract 100111. Presented April 30, 2003.