Bone health and body composition in prostate cancer: An italian consensus about prevention and management strategies

BackgroundIn prostate cancer (PCa), the evidence of the impact of androgen deprivation therapy (ADT) and new hormone therapies (NHT) on bone health (BH) and body composition is limited and contradictory. This is a consensus, based on Delphi method, of a multidisciplinary group of experts with the aim to produce further guidance on BH management in PCa.MethodsIn May 2023, a group of oncologists and endocrinologists with expertise in PCa and BH developed a survey made up of 37 questions and 74 statements, divided into 4 groups (non-metastatic hormone sensitive PCa, nmHSPC; metastatic hormone sensitive PCa, mHSPC; non-metastatic castration resistant PCa, nmCRPC; metastatic castration resistant PCa, mCRPC). In June 2023, 67 selected Italian experts rated their strength of agreement with each statement on a 5-point scale (an agreement ≥ 75% defined the statement as accepted).ResultsIn nmHSPC, ADT alone implies sufficient fracture risk to warrant antifracture therapy with bone target agents (BTAs) for Cancer Treatment Induced Bone Loss (CTIBL) prevention (79%). Therefore, no consensus was reached (48%) for the treatment with BTAs of patients receiving short term ADT (< 6 months). The individual fracture risk at the end of adjuvant ADT should be re-evaluated to assess the continuation of BTAs. All patients receiving active treatment for mHSPC (75%), nmCRPC (89%) and mCRPC patients without bone metastases (84%) should be treated with BTAs at the doses and schedule for CTIBL prevention. It is unnecessary both the switch to denosumab in mHSPC patients in effective treatment with bisphosphonates for previous osteoporosis (59%) and the choice of NHT on the basis of patient’s fracture risk (54%). In mCRPC patients with bone metastasis, a shift to a 12-weeks schedule in patients treated with Zoledronic acid every 4 weeks for 12-15 months (81%) can be considered. The high risk of sarcopenic obesity favours bone fragility and raises the fracture risk of the patients.ConclusionsThis consensus highlights areas lacking major agreement, like nmHSPC patients undergoing short-term ADT. Evaluation of these issues in prospective clinical trials and identification of early biomarkers of bone loss are needed.Legal entity responsible for the studyMeet-URO group and AIOM (Associazione Italiana Oncologia medica).FundingHas not received any funding.DisclosureM. Di Maio: Financial Interests, Personal, Advisory Board, Consultancy about clinical trial methodology and clinical trial results interpretation: Novartis; Financial Interests, Personal, Advisory Board, Consultancy about immunotherapy in SCLC: Roche; Financial Interests, Personal, Advisory Board, Consultancy about role and interpretation of patient-reported outcomes and quality of life in clinical trials: Takeda; Financial Interests, Personal, Advisory Board, Advisory board about the role of chemotherapy and hormonal treatment in hormone-sensitive prostate cancer: Janssen; Financial Interests, Personal, Advisory Board, Consultancy about the results obtained with lorlatinib and dacomitinib in advanced non-small cell lung cancer: Pfizer; Financial Interests, Personal, Advisory Board, Consultancy about role of osimertinib as adjuvant treatment of NSCLC: AstraZeneca; Financial Interests, Personal, Invited Speaker, Compensation for a talk and a document about role of patient-reported outcomes in clinical trials and in clinical practice, with a specific focus on lung cancer: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board, Participation in advisory boards about olaparib in pancreatic cancer, about olaparib in prostate cancer, and about immunotherapy in lung cancer: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board, Consultant for the new indication of avelumab in urothelial cancer: Merck Serono; Financial Interests, Personal, Advisory Board, Advisory board about treatment of gastric cancer: Amgen; Financial Interests, Personal, Advisory Board, Lesson for the personnel of the drug company about quality of life, patient-reported outcomes and methodological aspects of clinical trials: GSK; Financial Interests, Institutional, Research Grant, Financial support and drug supply for the Meet-URO12 trial (niraparib as maintenance treatment of urothelial carcinoma after first-line treatment with platinum-based chemotherapy): Tesaro - GSK; Financial Interests, Institutional, Local PI, Local PI of trial with tislelizumab in hepatocellular carcinoma: Beigene; Financial Interests, Institutional, Local PI, Local PI of a trial with cabozantinib and atezolizumab in advanced HCC: Exelixis; Financial Interests, Institutional, Local PI, Local PI of a trial with atezolizumab and bevacizumab in advanced HCC: Roche; Financial Interests, Institutional, Local PI, Local PI of trials with pembrolizumab in hepatocellular carcinoma: Merck Sharp & Dohme; Financial Interests, Institutional, Local PI, Local PI of a trial with sasanlimab in NMI bladder cancer: Pfizer. G. Procopio: Financial Interests, Personal, Advisory Board, consultant fees: Astellas, AstraZeneca, Amgen, Boehringer Ingelheim, Bayer, Brystol Myers Squibb, Ipsen, Janssen, Eisai, Janssen Cilag, Merck Sharp & Dohmes, Merck, Pfizer, Roche, Eli Lilly; Financial Interests, Personal, Other, workgroup: Menarini Group; Financial Interests, Institutional, Research Grant, research funding for no profit clinical trial: Ipsen, Gilead, MSD, Janssen. U. De Giorgi: Financial Interests, Personal, Advisory Board: Pfizer, BMS, MSD, Pharmamar, Astellas, Bayer, Ipsen, Novartis, EISAI, Janssen; Financial Interests, Personal, Invited Speaker: Roche, BMS, AstraZeneca, Merck; Financial Interests, Institutional, Research Grant: AstraZeneca, Sanofi, Roche. D. Santini: Financial Interests, Personal, Advisory Board, reports fee from advisory boards by AstraZeneca, Lilly, Daiichi Sankyo, Astellas, Janssen, Recordati, Gilead, Pfizer, MSD, Novartis, BMS, Roche, EISAI, Ipsen: MSD. All other authors have declared no conflicts of interest.