Moderate hypofractionation in intermediate and high risk, localized prostate cancer: Health-related quality of life from the randomized, phase 3 HYPRO trial
Mené sur 697 patients atteints d'un cancer de la prostate à risque intermédiaire ou élevé de récidive, cet essai de phase III évalue, du point de vue de la survenue à 3 ans de symptômes urinaires, de symptômes gastro-intestinaux et de symptômes liés au traitement anti-androgénique ainsi que du point de vue de la fonction et de l'activité sexuelles, la non infériorité d'une radiothérapie hypofractionnée par rapport à une radiothérapie conventionnelle
Purpose : The phase 3 HYPRO trial compared hypofractionated radiotherapy with conventionally fractionated radiotherapy in patients with localized prostate cancer. Similar 5-year relapse-free survival rates were achieved, whereas non-inferiority of hypofractionation was not confirmed for genitourinary and gastrointestinal toxicity. Here, we present the secondary trial endpoint on patient-reported quality of life. Methods and Materials : A total of 820 patients with intermediate or high-risk prostate cancer were randomized to hypofractionation (19 fractions of 3.4 Gy) or conventional fractionation (39 fractions of 2.0 Gy). Quality of life was measured using the validated EORTC-QLQ PR25 questionnaire. Subscales (score range 0-100) on urinary symptoms, gastrointestinal symptoms, androgen deprivation therapy-related symptoms, sexual function, and sexual activity were analyzed. Changes from baseline of at least 5 points were considered clinically relevant. Inferiority of hypofractionation for separate subscales was rejected if the mean difference in 3-year incidence of clinically relevant deterioration between treatments was <8.0%. Results : A total of 697 men were eligible for this quality of life analysis. Baseline characteristics were comparable between both groups. At 3-year follow-up, the incidence of clinically relevant deterioration of urinary symptoms was 33% for both treatments (difference 0.49% in favor of conventional fractionation, 90% CI: -7.20%- 8.18%), whereas such deterioration of gastrointestinal symptoms was reported in 38% for hypofractionation versus 36% for conventional fractionation (2.03% in favor of conventional fractionation, 90% CI: -6.18%- 10.23%). Therefore, we could not demonstrate non-inferiority of hypofractionation for genitourinary and gastrointestinal quality-of-life. For all other subscales, non-inferiority of hypofractionation was demonstrated. Conclusions : Non-inferiority of the hypofractionated treatment was not demonstrated for genitourinary and gastrointestinal quality of life, and therefore we cannot rule out that relevant differences may exist between both treatments. Non-inferiority of hypofractionation was demonstrated for androgen-deprivation therapy-related symptoms, sexual activity and sexual function.