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Radiotherapy has modest impact on quality of life when added to ADT
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The addition of radiotherapy to androgen deprivation therapy significantly improved OS with only minor and temporary negative effects on health-related quality of life in patients with locally advanced prostate cancer, according to the results of a phase 3 trial.
Michael D. Brundage, MD, MSc, director of the division of cancer care and epidemiology at the Cancer Research Institute at Queen’s University in Kingston, Ontario, and colleagues conducted the randomized, phase 3 NCIC CTG PR3/MRC PR07 trial to assess the addition of radiotherapy to ADT in men with locally advanced prostate cancer.
A previous interim analysis of the trial showed that the addition of radiotherapy to ADT significantly improved OS and disease-specific survival rates, according to study background. However, radiotherapy can result in known toxicities that impact health-related quality of life.
The original analysis included 1,205 patients (78% aged older than 65 years). The researchers randomly assigned patients to receive ADT alone (n = 602) or with radiotherapy (n = 603). The majority of trial patients had stage III (83%) or stage IV (5%) disease, and 78% of patients had an ECOG score of 0.
Patients completed the European Organization for Research and Treatment of Cancer Care questionnaire and a prostate cancer-specific checklist or the Functional Assessment of Cancer Therapy–Prostate questionnaire as part of the study’s health-related quality-of-life analyses at baseline and every 6 months. Researchers observed mean changes from baseline scores for five function domains and nine symptom domains relevant to ADT and radiotherapy.
Eighty-eight percent of patients (n = 1,028) completed the baseline questionnaires.
At the first 6-month interval, radiation therapy demonstrated a significant impact on the mean scores for bowel symptoms (P = .02), diarrhea (P < .001), urinary function (P = .003) and erectile dysfunction (P = .008).
However, researchers did not observe significant differences between the treatment arms in any domain at the 3-year interval.
When researchers evaluated symptoms that improved, stabilized, or worsened at any point from baseline, they found men who received radiation reported significantly worse symptoms for diarrhea and bowel symptoms at some point during treatment. In both arms, a large proportion of patients reported improved urinary symptoms at some point during treatment.
Results of linear mixed modeling to assess the effect of time on mean score changes did not demonstrate any significant differences between the treatment arms in any domain. However, patients in both arms experienced deterioration over time for the Functional Assessment of Cancer Therapy–Prostate total score, treatment index outcome and physical and functional well-being.
Despite high compliance, the researchers acknowledged the likelihood that missing data may result in potential bias toward underestimating the impact of treatment on symptoms.
“We conclude that the health-related quality-of-life findings from PR3/PR07 illustrate clear evidence of the negative impact on bladder and bowel domains, but in most men, this impact was transient, in that health-related quality-of-life scores returned to levels seen in patients receiving only ADT," Brundage and colleagues concluded. “The adverse impact of radiotherapy overall was modest and temporary and, in our view, not of sufficient magnitude to offset the clear disease-specific and OS benefits conferred by curative radiotherapy in this setting.” – by Cameron Kelsall
Disclosure: Brundage reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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