Changes in body composition and lipid profile in prostate cancer patients without bone metastases given Degarelix treatment: the BLADE prospective cohort study

Abstract

Background Luteinizing hormone-releasing hormone (LHRH)-agonists in prostate cancer (PCa) patients induce sarcopenic obesity. The effect of LHRH-antagonist on body composition has never been explored. We evaluated changes in fat (FBM) and lean body mass (LBM) in PCa patients undergoing Degarelix. Methods This is a single-center prospective study, enrolling 29 non-metastatic PCa patients eligible to LHRH-antagonist from 2017 to 2019. All patients received monthly subcutaneous injection of Degarelix for 12 months. Changes in FBM and LBM between baseline and 12-month Degarelix, as measured by dual-energy x-ray absorptiometry, were the co-primary endpoints. Secondary endpoints were changes in serum lipids, glucose profile and follicle-stimulating hormone (FSH). Appendicular lean mass index (ALMI) and ALMI/FBM ratio were assessed as post-hoc analyses. Linear mixed models with random intercept tested for estimated least squared means differences (EMD). Results FBM significantly increased after 12 months (EMD +2920.7, +13.8%, p < 0.001), whereas LBM remained stable (EMD −187.1, −0.3%, p = 0.8). No differences occurred in lipid profile. Glycated hemoglobin significantly increased and serum FSH significantly decreased. A significant inverse relationship was found between serum FSH and ALMI/FBM ratio after 12 month ( r = −0.44, p = 0.02). Conclusions The BLADE study prospectively evaluated changes in body composition after LHRH-antagonist. LHRH-antagonist therapy is associated to an increased risk of obesity and diabetes, but lean body mass and serum lipids are not affected. This may represent an additional evidence supporting the reduced cardiovascular risk associated with LHRH-antagonist. The role of FSH in influencing sarcopenic obesity in PCa after androgen deprivation deserves to be further explored.

Effect of Body Composition Change during Neoadjuvant Chemotherapy for Esophageal Squamous Cell Carcinoma

“…However, the effects of NAC only on body composition abnormalities and the prognostic impact of changes during NAC in patients with esophageal cancer remain unclear. It has been reported that androgen deprivation therapy, a prostate cancer treatment, causes body composition changes such as weight, fat gain, and muscle mass loss approximately 3-6 months after the start of treatment due to adverse effects [30,31]. These changes in body composition are known to cause sarcopenic obesity [32], which is associated with an increased risk of lipid disorders, insulin resistance, and cardiovascular events [33].…”

Early results of PRO-EPI: PROspective multicenter observational study on elective pelvic nodes irradiation in patients with intermediate/high/very high-risk non-metastatic prostate cancer submitted to radical, adjuvant, or salvage radiotherapy with or without concomitant androgen deprivation therapy

“…The limits of this study must be as well acknowledged. First, this represents only a preliminary analysis, as long-term data are awaited to define the impact of different treatment modalities and techniques on clinical outcomes and late toxicities [including, e.g., the metabolic effects of ADT ( 34 )].…”

Relationship between circulating FSH levels and body composition and bone health in patients with prostate cancer who undergo androgen deprivation therapy. The BLADE study

“…Male patients with histologically confirmed PC without bone metastasis at bone scintigraphy, judged eligible to ADT according to current guidelines recommendations (Cornford et al 2017;Mottet et al 2017) after a multidisciplinary discussion, were enrolled. Eligibility criteria have been published elsewhere (Palumbo, et al 2021). Degarelix was administered as a subcutaneous injection with a starting dose of 240 mg, followed by a maintenance dose of 80 mg every 28 days.…”

“…We recently conducted the BLADE study (Bone mineraL mAss Dexa dEgarelix), a prospective phase IV study designed to obtain explorative information on dual-energy x-ray absorptiometry (DXA) measurement changes in lean body mass (LBM) and fat body mass (FBM) in patients with non-metastatic PC treated with degarelix. Data on changes in total LBM and FBM and on the impact of degarelix on BMD and bone turnover markers were recently published (Palumbo et al 2021;Palumbo et al 2022).…”