Hot flushes in prostatic cancer patients during androgen deprivation therapy with monthly degarelix or leuprolide
Résumé
The aim of the study was to compare the onset, incidence rate, frequency and intensity of hot flushes during androgen deprivation therapy with a GnRH blocker versus an agonist using data from a pivotal Phase 3 trial. Six hundred ten prostate cancer patients received either monthly degarelix (sc, 240 mg/80 mg, n=207, or 240/160 mg, n=202) or leuprolide (im, 7.5 mg, n=201) for 12 months. Data on hot flushes was collected as self-reported adverse events and in a subgroup of 254 patients with daily electronic diaries. The onset of hot flushes was faster on degarelix versus leuprolide. Median daily hot flush scores were larger in degarelix-treated patients during the first 3 month, but showed no differences over the 12 months. Incidence rates during the first 3 months were 17% (degarelix 240/80 mg and leuprolide) and 22% (degarelix 240/160 mg). Subsequently, rates dropped below 6%, whilst prevalence rates remained constant. Body weight and heart rate at baseline were independent predictors of hot flushes (p<0.05). Except for a more rapid onset with the GnRH antagonist, there were no major differences in the pattern of hot flushes between treatments. Weight control may help to minimise the incidence of hot flushes.
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