Radiotherapy averts progression after radical prostatectomy.
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 impressive had all patients in the radiotherapy arm actually received radiotherapy, said Dr. Thomas Wiegel, a radiation oncologist at the University of Ulm (Germany) Hospital.
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 level, 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.
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 2-109 months.
BY JANE SALODOF MACNEIL
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|Author:||MacNeil, Jane Salodof|
|Publication:||Internal Medicine News|
|Article Type:||Clinical report|
|Date:||Aug 15, 2007|
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