Preliminary quality-of-life outcomes for SWOG-9346: Intermittent androgen deprivation in patients with hormone-sensitive metastatic prostate cancer (HSM1PC)—Phase III.

4571 Background: The relative quality of life (QOL) for patients with newly diagnosed, metastatic prostate cancer, treated with intermittent androgen deprivation (IAD) has been assumed and hypothesized, yet never compared in a well-powered randomized trial (RT) to continuous androgen deprivation (CAD). SWOG-9346 provided such a RT in which to test QOL differences between CAD and IAD in men with metastatic prostate cancer. Methods: Patients were randomized to CAD or IAD. Patients completed the SWOG QOL Questionnaire (SF-20/SF-36, Symptom Distress Scale, treatment-specific symptoms, global QOL) at randomization and months (mo) 3, 9, and 15 post-randomization. Five QOL change scores at one time point (mo 3) were designated as primary for the QOL endpoint and are reported in this abstract: impotence, libido, energy/vitality (E/V), physical function (PF), and emotional function (EF). Significance level was adjusted for 5 comparisons (used p=0.01). Results: 615 patients in the CAD arm and 633 in the IAD arm completed the QOL questionnaire at baseline. Change between baseline and 3 months differed for the two arms with CAD reporting statistically significantly more impotence and less libido than IAD. EF was also slightly better for the IAD arm. Conclusions: These results indicate better sexual function in men receiving IAD versus CAD through post-randomization month 3. Additional benefits for IAD may include better PF, E/V and EF. Ongoing analyses will address the role of missing data, additional follow-up assessments, and resumption of therapy in the IAD arm. [Table: see text]