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Adjuvant RT after RP: no survival benefit to date

Posted Sep 28 2008 5:40pm

Morgan et al. have just published a meta-analysis of data from randomized, controlled clinical trials comparing adjuvant external beam radiotherapy (EBRT) to active surveillance in treatment of men with pT3 disease or positive surgical margins following first-line radical prostatectomy (RP). Their analysis confirms that, to date, adjuvant EBRT has not demonstrated an improvement in overall survival compared with active surveillance in this patient group.

Adjuvant RT does, however, significantly improve biochemical progression-free survival (bPFS) in this patient group, and does not seem to be associated with excess severe late toxicity.

Patients who are initially treated with RP, and who are found to have cancer extending beyond the prostate capsule (pT3 disease) or positive surgical margins after pathological examination of the RP specimen, are known to be at risk for progressive disease. However, the optimal postoperative management of such patients is not known. The most commonly used treatment alternatives for these patients at this time include adjuvant external beam radiotherapy (EBRT) and active surveillance.

The meta-analysis of available data from randomized controlled trials (RCTs) compared adjuvant EBRT after RP to active surveillance in the immediate post-surgical timeframe — with therapies held in reserve for salvage — in prostate cancer patients with pT3 or positive surgical margins or both. The primary outcome of interest was overall survival.

Three RCTs that included a total of 1,743 patients satisfied the eligibility criteria. Two trials reported data on overall survival. The meta-analysis showed no significant improvement associated with adjuvant EBRT (p = 0.52). All trials reported data on biochemical progression-free survival (bPFS). In this case the meta-analysis showed that adjuvant RT significantly improved bPFS (p < 0.00001). One of the three trials also provided comparative graded toxicity data; there were no significant differences between arms in severe (grade 3) gastrointestinal or genitourinary toxicity at 5 years.

Although the analysis by Morgan et al. confirms that adjuvant EBRT has not demonstrated an improvement in overall survival compared with active surveillance in this patient group to date, the authors also note that longer follow-up from completed RCTs is required to accurately assess this outcome.

Filed under: Management, Treatment

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