Quality of life in men treated with antiandrogen therapy with or without radiation therapy

In December 2008 we reported the results of  the effects of endocrine treatment with or without radiotherapy on mortality, as studied in the SPCG-7/SFUO-3 trial. In patients who received both treatments, prostate cancer-specific mortality was halved, relative to that in patients who received endocrine treatment alone. The same group of researchers have now published data for patient-reported symptoms and quality of life after 4 years in the SPCG-7/SFUO-3 study.

In the current publication, Fransson et al. provide quality-of-life information from 872/875 eligible men (99 percent) with locally advanced prostate cancer who were randomly assigned to 3 months of total androgen blockade (with leuprolide acetate + flutamide) followed by continuous endocrine treatment with flutamide alone (439 patients) or the same hormonal treatment with the addition of radiotherapy 3 months after randomization (436 patients). All patients were enrolled between 1996 and 2002. Prospective outcomes included patient-reported symptoms and quality of life assessed with questionnaires from baseline to 4 years after randomization.

The findings reported by the authors are as follows:

  • 78 percent of the patients had clinical stage T3 disease.
  • 438/439 men assigned to the endocrine treatment and 434/436 men assigned to endocrine treatment plus radiotherapy completed at least one questionnaire.
  • Missing data at baseline and during follow-up was equally distributed between groups.
  • At 4 years of follow-up
    • 64/353 patients on combined therapy (18 percent) and 39/337 on endocrine therapy only (12 percent) had moderate to severe urinary bother
    • 16/355 patients on combined therapy (4 percent) and 5/338 on endocrine treatment alone (2 percent) had pain while urinating.
    • 37/350 patients in the combined treatment group (11 percent) and 23/335  in the endocrine-only group (7 percent) had overall bother from all bowel symptoms.
    • 281/332 patients in the combined treatment group (85 percent) and 227/313 in the endocrine-only group (72 percent) had erectile dysfunction.
  • Quality of life at 4 years was similar, with the exception of decreased social function in patients receiving endocrine treatment plus radiotherapy.

The authors interpret these data as follows: “Although addition of radiotherapy to endocrine treatment significantly increased some treatment-related symptoms, none were serious. Given the substantial survival benefit of combined treatment, the increase of symptoms seems acceptable and has little extra effect on quality of life after 4 years compared with endocrine treatment alone.”

This report should be read in conjunction with the prior report by Widmark et al. As we have commented previously, the form of androgen deprivation therapy used in this trial after the first 3 months of treatment (flutamide alone) would not be considered as the normal standard of hormonal care in the USA today. Whether there would be significant impact in application of the premise behind this trial if one used either long-term bicalutamide therapy or long-term LHRH therapy to replace the long-term flutamide, we obviously cannot tell.

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