Journal of Bone Oncology最新文献

{"title":"Post-treatment late and long-term effects in bone sarcoma: A scoping review","authors":"Kaainat Khan ,&nbsp;Kathleen Kane ,&nbsp;Zoe Davison ,&nbsp;Darrell Green","doi":"10.1016/j.jbo.2025.100671","DOIUrl":"10.1016/j.jbo.2025.100671","url":null,"abstract":"<div><div>Despite the fact that chemotherapy for bone sarcomas (e.g. Ewing sarcoma, osteosarcoma) has well-reported toxicities and that surgical intervention is frequently life altering, follow-up care to monitor for late and long-term effects beyond that of oncological surveillance in former patients is variable. Anecdotal evidence suggests that inconsistent follow-up means some former bone sarcoma patients are left to cope with post-treatment late and long-term effects with limited support. Here, we performed a scoping review to provide a more empirical identification of the knowledge gaps and to provide an overview of the peer reviewed academic literature reporting the late and long-term effects of treatment for bone sarcoma. JBI Scoping Review Network guidelines for charting, analysis and data extraction were followed. Literature searches were conducted in Medline (Ovid), Cochrane CENTRAL, EMBASE (Ovid), CINAHL, PsycINFO, Proquest and Web of Science (Clarivate Analytics) from March 2024 to September 2024. Paper titles and abstracts were screened by two independent reviewers followed by full text analysis by the lead researcher. Seventy-four peer reviewed articles were included in the analysis. Most studies were of a retrospective study design, some up to 20 years of follow-up and included chemotherapy, surgery and sometimes radiotherapy as the treatment modality. Our analysis identified secondary malignancies, cardio- and nephrotoxicity, lower bone mineral density and microarchitectural deterioration, cancer related fatigue and motor neuropathies as the major physical late and long-term effects requiring dedicated follow-up. In some cases, follow-up may need to span decades, especially given the increasing population of former patients. Our results form the evidence-based foundations for future work that might include late and long-term effect follow-up service mapping exercises and expanded clinical recommendations.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"52 ","pages":"Article 100671"},"PeriodicalIF":3.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143687979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Faster R-CNN model for target recognition and diagnosis of scapular fractures","authors":"Qiong Fang ,&nbsp;Anhong Jiang ,&nbsp;Meimei Liu ,&nbsp;Sen Zhao","doi":"10.1016/j.jbo.2025.100664","DOIUrl":"10.1016/j.jbo.2025.100664","url":null,"abstract":"<div><h3>Objective</h3><div>This study aims to establish a diagnostic model for scapular fractures using a convolutional neural network (CNN) and to discuss the clinical advantages of this model in diagnosing such complex conditions.</div></div><div><h3>Methods</h3><div>Computed tomography (CT) images of 90 patients with scapular fractures were collected. A faster R-CNN-based recognition model was developed and compared with manual diagnosis. External validation was conducted to evaluate the model’s accuracy, sensitivity, specificity, positive predictive value, and negative predictive value.</div></div><div><h3>Results</h3><div>The CNN model, when combined with medical expert interpretation, demonstrated significantly higher specificity and positive predictive value compared to orthopedist-independent interpretation and algorithm-independent prediction (P &lt; 0.05). The area under the curve (AUC) value of the combined approach was significantly higher than that of orthopedist-independent interpretation and algorithm-independent prediction groups, with statistically significant differences (P &lt; 0.05). The accuracy of the CNN algorithm model combined with orthopedist interpretation was 97.78 %, significantly higher than orthopedist-independent interpretation (82.95 %) and CNN algorithm-independent prediction (92.05 %) (P &lt; 0.05).</div></div><div><h3>Conclusions</h3><div>The CNN-based recognition model for scapular fractures can assist clinicians in improving their diagnostic accuracy and precision in identifying such fractures on CT images.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"51 ","pages":"Article 100664"},"PeriodicalIF":3.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143550088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of ADC histogram analysis for predicting of postoperative recurrence in aggressive spinal tumors","authors":"Qizheng Wang ,&nbsp;Yongye Chen ,&nbsp;Guangjin Zhou ,&nbsp;Tongyu Wang ,&nbsp;Jingchao Fang ,&nbsp;Ke Liu ,&nbsp;Siyuan Qin ,&nbsp;Weili Zhao ,&nbsp;Dapeng Hao ,&nbsp;Ning Lang","doi":"10.1016/j.jbo.2025.100666","DOIUrl":"10.1016/j.jbo.2025.100666","url":null,"abstract":"<div><h3>Background</h3><div>Risk stratification of spinal tumors is a major unmet clinical need for personalized therapy.</div></div><div><h3>Purpose</h3><div>To explore the feasibility of pretreatment whole-lesion apparent diffusion coefficient (ADC) histogram in predicting local recurrence of aggressive spinal tumors.</div></div><div><h3>Methods</h3><div>119 aggressive spinal tumor patients (median age, 40; range, 13–74  years) confirmed by pathological findings with a mean follow-up of 36 months were enrolled and divided into the recurrence and non-recurrence group. The histogram metrics of whole-lesion, including the maximum, mean, kurtosis, skewness, entropy, and percentiles (10th, 25th, 50th, 75th, 95th) ADC values, were evaluated and take the average. Fractal dimension (FD) was assessed in the three orthogonal directions and take maximum. Clinical and general imaging features were used to construct an alternative prognostic model for comparison. Variables with statistical differences would be included in stepwise logistic regression analysis.</div></div><div><h3>Results</h3><div>As for the clinical model, Enneking staging (odds ratio [OR]: 3.572; <em>P</em> = 0.04) and vertebral compression (OR: 4.302; <em>P</em> = 0.002) were independent predictors of recurrence. There was no statistical difference in FD between the two groups (<em>P</em> = 0.623). Among the ADC histogram parameters compared, skewness, maximum, and mean ADC values were independent risk factors and constructed ADC histogram prediction models. The ADC histogram model (AUC = 0.871) and the combined model (AUC = 0.884) performed better than the clinical prediction model (AUC = 0.704) with <em>P</em>-values of 0.004 and 0.001, respectively.</div></div><div><h3>Conclusion</h3><div>Prediction models based on the ADC histogram analysis might represent serviceable instruments for the aggressive spinal tumors.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"51 ","pages":"Article 100666"},"PeriodicalIF":3.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143394627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mechanistic insights into bone destruction in multiple myeloma: Cellular and molecular perspectives","authors":"Oxana Lungu ,&nbsp;Denise Toscani ,&nbsp;Nicola Giuliani","doi":"10.1016/j.jbo.2025.100668","DOIUrl":"10.1016/j.jbo.2025.100668","url":null,"abstract":"<div><div>Multiple myeloma (MM) is a hematological malignancy that leads to significant bone destruction, resulting in debilitating pain and skeletal-related events. The pathophysiology of osteolytic bone destruction in MM involves complex interactions between malignant plasma cells (PCs) and the bone marrow (BM) microenvironment. This review aims to provide a comprehensive synthesis of the cellular and molecular pathways underlying MM-associated bone disease. We discuss the role of osteoclast (OC), osteoblast (OB), osteocytes, along with the complex interactions between immune cells and the BM microenvironment in shaping disease progression. Additionally, we explore the molecular signaling pathways involved in bone disease as well as the influence of inflammatory cytokines, and the role of the metabolic alterations that characterize the MM BM. We also explore novel therapeutic strategies targeting these pathways to improve clinical outcomes. Understanding these mechanisms is crucial for the development of more effective treatments to prevent bone damage in MM patients.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"51 ","pages":"Article 100668"},"PeriodicalIF":3.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143550087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative analysis of aggressiveness in giant cell tumor of bone between upper and lower extremities: A systematic review and meta-analysis","authors":"Rhyan Darma Saputra ,&nbsp;Dita Anggara Kusuma ,&nbsp;Fathih Kaldani ,&nbsp;Khoirul Fahmi","doi":"10.1016/j.jbo.2025.100663","DOIUrl":"10.1016/j.jbo.2025.100663","url":null,"abstract":"<div><h3>Background and Objective</h3><div>Giant cell tumor of bone (GCTB) is among the most prevalent benign primary bone tumors, characterized by its potential for aggressive local recurrence, soft tissue invasion, and, though rare, lung metastasis. Emerging evidence suggests unique behavioral patterns of GCTB in extremities. This study seeks to rigorously compare the aggressiveness of GCTB in the upper versus lower extremities, centering on recurrence rates.</div></div><div><h3>Method</h3><div>This systematic review and meta-analysis, conducted in accordance with PRISMA guidelines, sourced data from MEDLINE/PubMed, Cochrane, Scopus, CINAHL/EBSCO, and reference lists of pertinent studies. Two independent reviewers screened studies, with discrepancies resolved by discussion. Eligible studies included a minimum of 10 participants. Data extraction and analysis were performed by an additional team of two researchers.</div></div><div><h3>Results</h3><div>Out of 1,283 studies spanning from 1984 to 2023, 30 met eligibility, encompassing 2,672 participants. The mean age was 32.77 ± 12.99 years, with an average follow-up of 75.53 ± 65.88 months. GCTB predominantly affected the lower extremities, accounting for 1,937 cases. Notably, comparisons of aggressiveness between upper and lower extremity GCTB revealed no statistically significant difference (OR = 1.10, p = 0.56 for Surgery Group; OR = 1.16, p = 0.45 for Local Adjuvant Group; and OR = 1.71, p = 0.32 for Drug/Denosumab Group).</div></div><div><h3>Conclusion</h3><div>This analysis underscores the lower extremities as the primary site for GCTB but finds no significant difference in aggressiveness between upper and lower extremities. These findings challenge assumptions about GCTB behavior based on tumor location and highlight the need for further investigation to fully elucidate the complex biology of extremity GCTB.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"51 ","pages":"Article 100663"},"PeriodicalIF":3.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143394628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Molecular pathological insights into tumorigenesis and progression of giant cell tumor of bone","authors":"Yibing Yao ,&nbsp;Victor Kwan Min Lee ,&nbsp;Ee Sin Chen","doi":"10.1016/j.jbo.2025.100665","DOIUrl":"10.1016/j.jbo.2025.100665","url":null,"abstract":"<div><div>Giant cell tumor of bone (GCTB) is a primary bone tumor that typically exhibits benign histological appearance and clinical behavior in most cases, with local aggressiveness and rare metastasis. It predominantly affects individuals in the young adult age group. It is characterized by the presence of multinucleated osteoclastic giant cells and a stromal population of neoplastic cells. A key hallmark for GCTB pathogenesis is the G34W genetic mutation in the histone H3.3 gene, which is restricted to the population of cancerous stromal cells and is absent in osteoclasts and their progenitor cells. This review presents a comprehensive overview of the pathology of GCTB, including its histopathological characteristics, cytological features, histopathological variants, and their clinical relevance. We also discuss recent insights into genetic alterations in relation to the molecular pathways implicated in GCTB. A summary of the current understanding of GCTB pathology will update the knowledge base to guide the diagnosis and management of this unique bone tumor.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"51 ","pages":"Article 100665"},"PeriodicalIF":3.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143487723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The METTL3/TGF-β1 signaling axis promotes osteosarcoma progression by inducing MSC differentiation into CAFs via m6A modification","authors":"Jin Qi ,&nbsp;Sihang Liu ,&nbsp;Baomin Wu ,&nbsp;Gang Xue","doi":"10.1016/j.jbo.2025.100662","DOIUrl":"10.1016/j.jbo.2025.100662","url":null,"abstract":"<div><div>Osteosarcoma, a prevalent and aggressive skeletal malignancy, significantly impacts the prognosis of individuals, particularly young patients. Current treatments, including surgery and chemotherapy, often prove inadequate for advanced osteosarcoma with metastasis. This study investigates the role of the METTL3/TGF-β1 signaling axis in promoting osteosarcoma progression by inducing mesenchymal stem cells (MSCs) to differentiate into cancer-associated fibroblasts (CAFs). Utilizing co-culture technology, we demonstrated that osteosarcoma cells secrete TGF-β1, which is crucial for MSC differentiation into CAFs, as evidenced by the increased expression of CAF markers α-SMA, FSP-1, and FAP. Additionally, METTL3 was found to enhance the stability and expression of TGF-β1 mRNA through m⁶A modification, thereby facilitating the differentiation process of MSCs. <em>In vivo</em> xenograft experiments further confirmed that the METTL3/TGF-β1 axis significantly promotes tumor growth in osteosarcoma by mediating the differentiation of MSCs into CAFs. These findings provide new insights into the molecular mechanisms underlying osteosarcoma progression and highlight potential therapeutic targets for treating advanced stages of this malignancy.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"51 ","pages":"Article 100662"},"PeriodicalIF":3.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic Innovations: Advances in imaging techniques for diagnosis and follow-up of multiple myeloma","authors":"M. Talarico ,&nbsp;S. Barbato ,&nbsp;A. Cattabriga ,&nbsp;I. Sacchetti ,&nbsp;E. Manzato ,&nbsp;R. Restuccia ,&nbsp;S. Masci ,&nbsp;F. Bigi ,&nbsp;M. Puppi ,&nbsp;M. Iezza ,&nbsp;I. Rizzello ,&nbsp;K. Mancuso ,&nbsp;L. Pantani ,&nbsp;P. Tacchetti ,&nbsp;C. Nanni ,&nbsp;M. Cavo ,&nbsp;E. Zamagni","doi":"10.1016/j.jbo.2025.100669","DOIUrl":"10.1016/j.jbo.2025.100669","url":null,"abstract":"<div><h3>Introduction</h3><div>The International Myeloma Working Group (IMWG) defines myeloma related bone disease (MBD) as a diagnostic criterion for symptomatic multiple myeloma (MM) as the presence of osteolytic lesions ≥ 5 mm or more than one focal lesion (FL) ≥ 5 mm by magnetic resonance imaging (MRI). Whole-body low-dose CT (WBLDCT) is recommended as the first-choice imaging technique for the diagnosis of MBD with ¹⁸F-fluorodeoxyglucose-positron emission tomography/CT (¹⁸F-FDG-PET/CT) being considered a possible alternative at staging, whereas use of MRI studies is recommended in cases without myeloma-defining events (MDEs) in order to exclude the presence of FLs. Furthermore, use of ¹⁸F-FDG-PET/CT is recommended in response assessment, to be integrated with hematologic response and bone marrow minimal residual disease (MRD).</div></div><div><h3>Areas covered</h3><div>In this paper, we review novel functional imaging techniques in MM, particularly focusing on their advantages, limits, applications and comparisons with ¹⁸F-FDG-PET/CT or other standardized imaging techniques.</div></div><div><h3>Conclusions</h3><div>Combining both morphological and functional imaging, ¹⁸F-FDG-PET/CT is currently considered a standard imaging technique in MM for staging (despite false positive or negative results) and response assessment. The introduction of novel functional imaging techniques, as whole-body diffusion-weighted magnetic resonance imaging (WB-DWI-MRI), or novel PET tracers might be useful in overcoming these limits. Future studies will give more information on the complementarity of these imaging techniques or whether one of them might become a new gold standard in MM.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"51 ","pages":"Article 100669"},"PeriodicalIF":3.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143563646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of myosteatosis on prognosis in multiple myeloma patients: A subgroup analysis of 182 cases and development of a nomogram","authors":"Jun-Peng Liu ,&nbsp;Xing-Chen Yao ,&nbsp;Ming Shi ,&nbsp;Zi-Yu Xu ,&nbsp;Yue Wu ,&nbsp;Xiang-Jun Shi ,&nbsp;Meng Li ,&nbsp;Xin-Ru Du","doi":"10.1016/j.jbo.2025.100670","DOIUrl":"10.1016/j.jbo.2025.100670","url":null,"abstract":"<div><h3>Background</h3><div>This study aims to explore the prognostic value of myosteatosis in multiple myeloma (MM) and to analyze the factors influencing myosteatosis.</div></div><div><h3>Methods</h3><div>A retrospective analysis was conducted on 182 patients treated for MM at our institution from 2009 to 2020 who underwent MRI examinations. The fatty infiltration rate (FIR) of the erector spinae and multifidus muscles at the L3 level was measured to assess the degree of myosteatosis. Patients were grouped based on fracture presence and median FIR, and group differences were compared, with P &lt; 0.05 considered statistically significant. Survival and fractures were used as prognostic indicators, and regression analysis was performed to determine the impact of FIR on these outcomes in MM patients. The factors influencing FIR were analyzed, and the relationship between myosteatosis and MM prognosis was further analyzed within its sensitive subgroups. Finally, a nomogram based on FIR was established and validated.</div></div><div><h3>Results</h3><div>Significant differences were observed between the fracture and non-fracture groups in lactate dehydrogenase, serum phosphorus, visual analogue scale, oswestry disability index and FIR (P &lt; 0.05). When patients were grouped based on the median FIR (28.89 %), there were significant differences in age, sex, body mass index (BMI), red blood cell (RBC) count, hemoglobin, hematocrit, albumin, visual analogue scale, oswestry disability index, and fracture incidence (P &lt; 0.05). Univariate COX regression analysis indicated that myosteatosis had no significant impact on survival prognosis in MM patients (HR = 0.999, P = 0.852), with a log-rank test P value of 0.11 when grouped by the cut-off FIR value of 33.67 %. Multivariate logistic regression indicated that FIR is an independent predictor of fractures (OR = 1.054, P = 0.000). Multivariate linear regression revealed that age, sex, RBC count, and BMI are independent factors influencing FIR (P &lt; 0.05). When not grouped, FIR’s prediction of fractures showed no significant interaction with age, sex, RBC count, or BMI (P for interaction &gt; 0.05). In subgroups with BMI ≥ 25 kg/m² or RBC count &gt; 3.68 × 10^12/L, FIR lost its predictive significance for fractures. The FIR nomogram model had a C-index of 0.777, and the calibration curve, decision curve analysis, and clinical impact curve all validated its effectiveness.</div></div><div><h3>Conclusions</h3><div>Myosteatosis characterized by FIR is not a reliable predictor of survival in MM patients but is effective in predicting fractures and is closely related to back pain and functional impairment. FIR is significantly associated with age, sex, RBC count, and BMI.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"51 ","pages":"Article 100670"},"PeriodicalIF":3.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143621301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva®) in patients with bone metastasis from solid tumors","authors":"Mingchuan Zhao ,&nbsp;Xichun Hu ,&nbsp;Pengpeng Zhuang ,&nbsp;Aiping Zeng ,&nbsp;Yan Yu ,&nbsp;Zhendong Chen ,&nbsp;Hongmei Sun ,&nbsp;Weihua Yang ,&nbsp;Lili Sheng ,&nbsp;Peijian Peng ,&nbsp;Jingfen Wang ,&nbsp;Tienan Yi ,&nbsp;Minghong Bi ,&nbsp;Huaqiu Shi ,&nbsp;Mingli Ni ,&nbsp;Xiumei Dai ,&nbsp;Changlu Hu ,&nbsp;Hongjie Xu ,&nbsp;Dongqing Lv ,&nbsp;Qingshan Li ,&nbsp;Changlin Dou","doi":"10.1016/j.jbo.2025.100661","DOIUrl":"10.1016/j.jbo.2025.100661","url":null,"abstract":"<div><h3>Introduction</h3><div>Denosumab (Xgeva®) is a standard treatment for the prevention of skeletal-related events (SREs) in patients with bone metastases (BM). This trial was designed to assess the equivalence of LY01011 to denosumab in terms of efficacy and safety.</div></div><div><h3>Materials and methods</h3><div>Eligible patients with BM from solid tumors were randomized at a 1:1 ratio to receive 120 mg of LY01011 or 120 mg of denosumab subcutaneously every four weeks during a 12-week double-blind treatment period, and then all enrolled patients continued to receive LY01011 until week 53. The primary endpoint was the natural logarithm of change of the urinary N-terminal crosslinked telopeptide of type I collagen level normalized to the urine creatinine level (uNTX/uCr) at week 13 from baseline. Other endpoints included the uNTX/uCr ratio, serum bone-specific alkaline phosphatase level alteration, status of anti-drug antibodies and neutralizing antibodies, adverse events and SREs.</div></div><div><h3>Results</h3><div>850 eligible patients were randomized into the LY01011 group (n = 424) or the denosumab group (n = 426). The least-squares means (SEs) of the natural logarithms of the changes in the uNTX/uCr ratios at week 13 from baseline were −1.810 (0.0404) in the LY01011 group and −1.791 (0.0406) in the denosumab group. The LSM difference [90 % CI] between two arms was −0.019 [-0.110, 0.073] within the equivalence margins (−0.135, 0.135) and met the predetermined primary endpoint. The AEs, ADAs and the PK data showed no statistically significant difference.</div></div><div><h3>Conclusions</h3><div>This study demonstrated the equivalent efficacy and safety of LY01011 to denosumab in patients with BM.</div></div>","PeriodicalId":48806,"journal":{"name":"Journal of Bone Oncology","volume":"51 ","pages":"Article 100661"},"PeriodicalIF":3.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143332852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}