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Radiotherapy after prostatectomy increased PFS in pT3 prostate cancer

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Radiotherapy given after radical prostatectomy increased biochemical PFS by 18% after five years among men with pT3 disease, according to data from a randomized trial. These results support data from two previously published studies: the EORTC trial 229111 and a 2006 SWOG trial.

“The question of whether adjuvant radiotherapy should now be the standard of care for these patients remains,” Ian M. Thompson, Jr., MD, department of urology, University of Texas Health Science Center in San Antonio, wrote in an accompanying editorial.

According to Thompson, the answer remains elusive because results from the SWOG trial were only recently reported and results from EORTC are still pending. In addition, some experts believe salvage radiotherapy may be equivalent to adjuvant radiotherapy. Thompson also wrote that patients should be made aware of the consistent results regarding adjuvant radiotherapy, but should also be educated on the dangers of drawing conclusions from clinical series.

The study included 268 patients with pT3 prostate cancer who had undetectable PSA after radical prostatectomy. Patients were randomly assigned to immediate postoperative radiotherapy (n=114) or wait-and-see (n=159). The primary endpoint was biochemical PFS.

After five years, patients assigned to radiotherapy had higher biochemical PFS compared with those assigned to wait-and-see (72% vs. 54%; HR=0.53). The researchers did not investigate local relapse due to the risk for false positive results on digital rectal palpation.

Four patients assigned to radiotherapy and five assigned to wait-and-see had distant metastases. Death occurred among five patients assigned to radiotherapy and eight assigned to wait-and-see. According to the researchers, longer follow-up is needed to assess the effects of metastatic free survival and OS.

In a univariate analysis, Gleason score >6 and <7, PSA before prostatectomy, tumor stage and positive surgical margins were predictors of outcome. One grade-3 toxicity occurred in the bladder and no grade-4 events were recorded. The rate for both grade-3 and -4 toxicities was 0.3%.

Wiegel. J Clin Oncol. 2009;doi:10.1200/JCO.2008.18.9563