[SUN-261] Prevalence and Impact of Hypogonadism in Cancer Patients with Muscle Wasting in a Phase IIb Enobosarm Trial

Adrian S Dobs, Shontelle T Dodson, Mary Ann Johnston, Michael L Hancock, Ronald A Morton, Mitchell S Steiner. Johns Hopkins University, Baltimore, MD; GTx, Inc, Memphis, TN.

Background
Hypogonadism has been associated with weight loss and poor outcomes in cancer patients. Up to 50% of males with advanced cancer are hypogonadal at presentation or during the course of treatment. Wasting in cancer patients has also been associated with a decline in physical function and performance status and has major public health significance. We conducted a Phase IIb, randomized, double blind, placebo controlled, multi-center study to evaluate the effect of enobosarm on muscle wasting and physical function in cancer patients.
Methods
Patients (n=159) were randomized to oral enobosarm (1 or 3 mg) or placebo daily for 16 wks. Patients were males >45 y and postmenopausal females, had ≥2% weight loss in the 6 mths prior to randomization, BMI <35 and either NSCLC, colorectal cancer, non-Hodgkin's lymphoma, chronic lymphocytic leukemia or breast cancer. We report on the incidence and impact of hypogonadism (T<300 ng/dL) in this population.
Results
Baseline testosterone levels were available for 93 of 103 men. 60% of male patients were hypogonadal at randomization. Distribution of hypogonadism was similar across cancers; however hypogonadal men were less likely to complete the study. Baseline T levels were positively correlated with weight loss (r=0.32, P=0.002,) with hypogonadal men demonstrating greater weight loss in the previous six months (median, -9.5%). Baseline physical function as measured by stair climb power was higher among eugonadal males compared to hypogonadal males (84.5 watts vs 70.6 watts; P=0.016). Enobosarm significantly improved physical function in this population regardless of baseline gonadal status (hypogonadal: 18.7%, P=0.0061; eugonadal: 13.2%, P=0.0032). The magnitude of improvement was greater in hypogonadal men.
Conclusions
Hypogonadism is common in male cancer patients and is correlated with weight loss and diminished physical function. In this randomized, placebo controlled trial, enobosarm improved physical function in both hypogonadal and eugonadal men despite poorer baseline physical function in hypogonadal patients. These data provide evidence that enobosarm may play an important role in the management of cancer related muscle wasting.

Disclosures: ASD: Investigator, Aeterna-Zentaris. STD: Employee, GTx, Inc. MAJ: Employee, GTx, Inc. MLH: Employee, GTx, Inc. RAM: Employee, GTx, Inc. MSS: Employee, GTx, Inc.

Date: Sunday, June 24, 2012
Session Info: POSTER SESSION: Neoplasia of Endocrine Tissues (1:30 PM-3:30 PM)
Presentation Time: 1:30 pm
Room: Expo

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