Bergamini Marco, Dalla Volta Alberto, Palumbo Carlotta, Zamboni Stefania, Triggiani Luca, Zamparini Manuel, Laganà Marta, Rinaudo Luca, Di Meo Nunzia, Caramella Irene, Bresciani Roberto, Valcamonico Francesca, Borghetti Paolo, Guerini Andrea, Farina Davide, Antonelli Alessandro, Simeone Claudio, Mazziotti Gherardo, Berruti Alfredo
Medical Oncology Unit, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.
Division of Urology, Department of Translational Medicine, University of Eastern Piedmont, Maggiore Della Carità Hospital, Novara, Italy.
Elife. 2024 Apr 24;13:e92655. doi: 10.7554/eLife.92655.
Among its extragonadal effects, follicle-stimulating hormone (FSH) has an impact on body composition and bone metabolism. Since androgen deprivation therapy (ADT) has a profound impact on circulating FSH concentrations, this hormone could potentially be implicated in the changes of fat body mass (FBM), lean body mass (LBM), and bone fragility induced by ADT. The objective of this study is to correlate FSH serum levels with body composition parameters, bone mineral density (BMD), and bone turnover markers at baseline conditions and after 12 months of ADT.
Twenty-nine consecutive non-metastatic prostate cancer (PC) patients were enrolled from 2017 to 2019 in a phase IV study. All patients underwent administration of the luteinizing hormone-releasing hormone antagonist degarelix. FBM, LBM, and BMD were evaluated by dual-energy x-ray absorptiometry at baseline and after 12 months of ADT. FSH, alkaline phosphatase, and C-terminal telopeptide of type I collagen were assessed at baseline and after 6 and 12 months. For outcome measurements and statistical analysis, -test or sign test and Pearson or Spearman tests for continuous variables were used when indicated.
At baseline conditions, a weak, non-significant, direct relationship was found between FSH serum levels and FBM at arms ( = 0.36) and legs ( = 0.33). Conversely, a stronger correlation was observed between FSH and total FBM ( = 0.52, p = 0.006), fat mass at arms ( = 0.54, p = 0.004), and fat mass at trunk ( = 0.45, p = 0.018) assessed after 12 months. On the other hand, an inverse relationship between serum FSH and appendicular lean mass index/FBM ratio was observed ( = -0.64, p = 0.001). This is an ancillary study of a prospective trial and this is the main limitation.
FSH serum levels after ADT could have an impact on body composition, in particular on FBM. Therefore, FSH could be a promising marker to monitor the risk of sarcopenic obesity and to guide the clinicians in the tailored evaluation of body composition in PC patients undergoing ADT.
This research was partially funded by Ferring Pharmaceuticals. The funder had no role in design and conduct of the study, collection, management, analysis, and interpretation of the data and in preparation, review, or approval of the manuscript.
clinicalTrials.gov NCT03202381, EudraCT Number 2016-004210-10.
在其性腺外作用中，促卵泡生成素（FSH）对身体成分和骨代谢有影响。由于雄激素剥夺治疗（ADT）对循环FSH浓度有深远影响，这种激素可能与ADT引起的脂肪体重（FBM）、去脂体重（LBM）变化以及骨脆性有关。本研究的目的是在基线条件下以及ADT治疗12个月后，将血清FSH水平与身体成分参数、骨密度（BMD）和骨转换标志物进行关联。
2017年至2019年，连续29例非转移性前列腺癌（PC）患者被纳入一项IV期研究。所有患者均接受促性腺激素释放激素拮抗剂地加瑞克治疗。在基线和ADT治疗12个月后，通过双能X线吸收法评估FBM、LBM和BMD。在基线以及6个月和12个月后评估FSH、碱性磷酸酶和I型胶原C末端肽。对于结果测量和统计分析，在适当情况下使用t检验或符号检验以及连续变量的Pearson或Spearman检验。
在基线条件下，血清FSH水平与手臂（r = 0.36）和腿部（r = 0.33）的FBM之间存在微弱、无统计学意义的直接关系。相反，在12个月后评估时，FSH与总FBM（r = 0.52，p = 0.006）、手臂脂肪量（r = 0.54，p = 0.004）和躯干脂肪量（r = 0.45，p = 0.018）之间观察到更强的相关性。另一方面，观察到血清FSH与四肢去脂体重指数/FBM比值之间呈负相关（r = -0.64，p = 0.001）。这是一项前瞻性试验的辅助研究，这是主要局限性。
ADT后的血清FSH水平可能对身体成分有影响，特别是对FBM。因此，FSH可能是监测肌肉减少性肥胖风险以及指导临床医生对接受ADT的PC患者进行身体成分定制评估的一个有前景的标志物。
本研究部分由辉凌制药公司资助。资助者在研究的设计和实施、数据的收集、管理、分析和解释以及稿件的准备、审核或批准方面没有任何作用。
clinicalTrials.gov NCT03202381，欧洲临床试验数据库编号2016 - 004210 - 10。
