Surgery News - October 2007 - (Page 11)

OCTOBER 2007 • SURGERY NEWS UROLOGY 11 Continued from previous page Regardless of which specialists they consulted, fewer than 10% of men who saw a primary care provider decided on surgery. Dr. Archie Bleyer, moderator of a press briefing on patterns of care, called the study a tour de force. “The results are of concern and affect more men than not,” said Dr. Bleyer of St. Charles Medical Center, Bend, Ore. In a discussion of the study, Dr. Badrinath R. Konety, a urologist at the University of California, San Francisco, and an ACS Fellow, said it clearly showed “a differential utilization of expectant management” but also raised many questions. Expounding on the “counseling vs. consultation issue,” he said that patients may opt not to visit other specialists after consulting a urologist, but doesn’t necessarily mean they were not counseled about different options. Dr. Konety sought an explanation for the difference in “treatment vs. no treatment” by specialists consulted, and asked what the role of the rarely consulted medical oncologist should be in early prostate cancer. He also questioned what effect favorable reimbursement for intensity-modulated radiation therapy has had on treatment recommendations. Another concern, he said, was that 25% of men aged 80-85 received radiation, despite having a life expectancy of 6 years. Surgeons generally will not operate if the patient has a life expectancy of less than 10 years, he said. ■ Radiation Beneficial After Prostatectomy BY JANE SALODOF MACNEIL Else vier Global Medical Ne ws C H I C A G O — Adjuvant radiotherapy after radical prostatectomy significantly reduced biochemical progression for men with pT3 prostate cancer in a multicenter phase III trial conducted in Germany. The 385-patient study showed progression-free survival rates of 55% for men randomized to adjuvant radiotherapy versus 44% for those who were assigned to “watchful waiting” after surgery. This gap widened when 78 patients dropped out of the study in a planned exclusion because they did not reach undetectable prostate-specific antigen (PSA) levels. An intent-to-treat analysis of the remaining 307 men showed biochemical control reached 72% with adjuvant radiotherapy versus 54% with watchful waiting. The difference was highly significant with a P value of .0015, lead author Dr. Thomas Wiegel reported at the annual meeting of the American Society of Clinical Oncology. The benefit would have been even more dramatic had all patients in the radiotherapy arm actually received radiotherapy, said Dr. Thomas Wiegel, a ra- diation oncologist at the University of Ulm (Germany) Hospital. Communitybased urologists did not send 32 of 148 (22%) for adjuvant treatment despite their enrollment in the study. Nonetheless, these patients were included in the intent-to-treat comparison of 148 undetectable-PSA patients randomized to radiotherapy versus 159 comparable patients assigned to watchful waiting. It remains in dispute whether all patients should receive adjuvant radiotherapy, or whether radiotherapy should be delivered only in the presence of a rising PSA, Dr. Wiegel said. When interviewed alongside a poster reporting the trial, he was not optimistic that its findings would end the controversy over the role of adjuvant radiotherapy in pT3 prostate cancer. Adding to the debate, he said, is the emergence of ultrasensitive PSA testing capable of detecting PSA levels that were undetectable when the study was conducted. “We can’t say it [adjuvant radiotherapy] is the standard of care, but with these studies it is now really allowed,” he said, and emphasized that the new trial confirms three previous studies, which found adjuvant radiotherapy confers a 20% advantage in biochemical control. In particular, he noted that subgroup analyses of the new trial showed that patients with preoperative PSA scores greater than 10 ng/mL, all Gleason scores, and pT3 A/B tumors benefited from adjuvant radiotherapy, as did those with positive surgical margins. The trial randomized patients from April 1997 to September 2004. Outcomes were reported at a median follow-up of 55 months with a range of 2109 months. The average radiation dose for those who completed the trial was 60 Gy delivered in single 2-Gy doses five times per week. Three-dimensional conformal radiotherapy techniques were generally used, with treatment volume including the prostatic fossa and the region of the seminal vesicles basin. Patients excluded because of detectable PSA received 66 Gy of radiation. The only grade 3 toxicities reported were acute and late side effects (3% and 2%, respectively) in the bladder. Late grade 1 or grade 2 bladder events occurred in 16% of patients. Acute grade 2 rectal side effects occurred in 12% of patients, and late grade 1 or grade 2 rectal events occurred in 10%. “There were no major problems,” Dr. Wiegel said. ■ 350,000 TIMES Safety 1,2 3 Why BioGlue® has been the surgeons’ choice Strength sealants. This strength allows the surgeon to Speed BioGlue will set up in 20-30 seconds and reach hands very quickly. 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