RETRACTED: Denosumab versus zoledronic acid in cases of surgically unsalvageable giant cell tumor of bone: A randomized clinical trial

Li, Shenglong; Chen, Peng; Yang, Q.

doi:10.1016/j.jbo.2019.100217

Cited by 13 publications

(11 citation statements)

References 23 publications

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“…Despite the encouraging results, a few questions still exit. First, consensus regarding denosumab treatment dose and duration has not been reached, with published reports describing widely varying denosumab treatment durations. Second, very few studies have exclusively evaluated the combination regime of “neoadjuvant” denosumab with surgery without postoperative denosumab use, especially for those unresectable or recurrent GCTB.…”

Section: Introductionmentioning

confidence: 99%

Short‐term Preoperative Denosumab With Surgery in Unresectable or Recurrent Giant Cell Tumor of Bone

Zhang

et al. 2019

Orthopaedic Surgery

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Objective: The purpose of this retrospective study was to evaluate the clinical and oncological results of combination treatment of short-term preoperative denosumab (the receptor activator of nuclear factor kappa-B ligand inhibitor) with surgery in unresectable or recurrent cases of giant cell tumor of the bone (GCTB).Methods: Between 2016 and 2018, 11 eligible patients (1 man, 10 women, mean age 38.1 years) with grade 3 GCTB were treated with a combination of short-term (six doses) preoperative denosumab and surgery in a single institution. The clinical, radiological, and pathological alteration after the denosumab treatment were compared. The oncological results of the combination therapy were also recorded. Meanwhile, adverse effects or complications of denosumab, if any, were reported.Results: The median follow-up time after surgical procedure was 30 months (range 13-45 months). After 3-4 denosumab injections, pain relief was observed in all patients. In two spine patients, the neurological status improved after four doses of treatment. Intraoperatively, the margin of the tumor became clear and the intensity of the tumor increased while the blood supply around and within the lesion decreased. Within the lesion, the typically soft and loose tissue were replaced by the tough and dense fibro-osseous tissue. The mean diameter of the lesion before and after treatment was 61.55 AE 22.49 mm and 51.81 AE 21.12 mm, respectively, and the T-score was 1.02 (P = 0.32). Variable calcification was observed at the periphery and within the lesion. A total of three patients experienced local recurrence in this study. In the resection group, only one extremity patient had soft tissue recurrence that was treated with en-bloc excision. In the curettage group, two of three sacral tumor patients had local occurrence. Both refused re-operation and restarted the monthly denosumab injection thereafter, and the lesions remained stable at the final follow up. Finally, no adverse effects or complications related to denosumab treatment were found.Conclusion: For the unresectable or recurrent GCTB cases, short-term (six doses) preoperative use of denosumab improved clinical symptoms, decreased the tumor size, and increased the tumor density. The changes in tumors, in turn, simplified the tumor removal manipulation and, subsequently, decreased the local recurrence for the resection surgery. For the curettage, the denosumab-induced changes had mixed impacts, and shorter term (fewer than six doses) usage may be more appropriate. Our six-dose regime was deemed safe, while the safety of long-term use remains unknown.

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Section: Introductionmentioning

confidence: 99%

Short‐term Preoperative Denosumab With Surgery in Unresectable or Recurrent Giant Cell Tumor of Bone

Zhang

et al. 2019

Orthopaedic Surgery

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“…Balke et al [28] reported a series of 12 patients with metastatic GCTB who had a stable disease following bisphosphonate treatment. Li et al [64] conducted a randomized study comparing the e cacy and safety of denosumab and zoledronic acid treatment in patients with surgically unsalvageable GCTB, including GCTB of the sacrum and spine, and multifocal tumor including lung metastases. In their study, 29 of 125 patients who were administered denosumab had lung metastasis, compared to 25 of 125 patients who were administered zoledronic acid.…”

Section: Discussionmentioning

confidence: 99%

“…In their study, 29 of 125 patients who were administered denosumab had lung metastasis, compared to 25 of 125 patients who were administered zoledronic acid. Zoledronic acid halted the progression of lung metastases as well as denosumab, with relatively manageable adverse effects [64].…”

Section: Discussionmentioning

confidence: 99%

Similar outcomes with first-line observation versus metastasectomy for bone giant cell tumor lung metastases

Tsukamoto¹,

Ciani²,

Mavrogenis³

et al. 2020

Preprint

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Background: The outcome of lung metastases in patients with giant cell tumor of bone (GCTB) varies from spontaneous regression to uncontrolled growth. To investigate whether observation is an appropriate first-line management for patients with lung metastases from GCTB, we compared the outcomes of patients initially treated with observation with those treated with metastasectomy.Methods: We retrospectively reviewed the data of 29 patients with lung metastases from histologically confirmed GCTB. The median follow-up period was 114 months. We evaluated progression-free survival, which was defined as the time from the date of occurrence of lung metastases to the date of disease progression in the observation or incomplete metastasectomy group, disease recurrence in the complete metastasectomy group, or the last follow-up.Results: Disease progression or recurrence occurred in 14 patients (48.3%). Progression-free survival did not vary significantly between the observation and metastasectomy groups (p=0.373). The number of metastasectomies was significantly higher in the initial metastasectomy group than in the observation group (p=0.017).Conclusions: Observation can be used safely as first-line management for patients with lung metastases from GCTB with an outcome similar to that of metastasectomy.

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“…Another treatment is Denosumab, which binds to RANK-L to prevent activation of osteoclasts. Although this therapeutic has successfully decreased osteoclast activity and prevented fractures, it has led to side-effects, such as hypocalcemia, jaw osteonecrosis, and tumor progression [ 265 , 266 , 267 ].…”

Section: Clinical Applications and Limitations Of Bmp-2mentioning

confidence: 99%

Bone Morphogenetic Protein-2 in Development and Bone Homeostasis

Halloran

Durbano

Nohe

2020

JDB

188

139

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Bone morphogenetic proteins (BMPs) are multi-functional growth factors belonging to the Transforming Growth Factor-Beta (TGF-β) superfamily. These proteins are essential to many developmental processes, including cardiogenesis, neurogenesis, and osteogenesis. Specifically, within the BMP family, Bone Morphogenetic Protein-2 (BMP-2) was the first BMP to be characterized and has been well-studied. BMP-2 has important roles during embryonic development, as well as bone remodeling and homeostasis in adulthood. Some of its specific functions include digit formation and activating osteogenic genes, such as Runt-Related Transcription Factor 2 (RUNX2). Because of its diverse functions and osteogenic potential, the Food and Drug Administration (FDA) approved usage of recombinant human BMP-2 (rhBMP-2) during spinal fusion surgery, tibial shaft repair, and maxillary sinus reconstructive surgery. However, shortly after initial injections of rhBMP-2, several adverse complications were reported, and alternative therapeutics have been developed to limit these side-effects. As the clinical application of BMP-2 is largely implicated in bone, we focus primarily on its role in bone. However, we also describe briefly the role of BMP-2 in development. We then focus on the structure of BMP-2, its activation and regulation signaling pathways, BMP-2 clinical applications, and limitations of using BMP-2 as a therapeutic. Further, this review explores other potential treatments that may be useful in treating bone disorders.

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RETRACTED: Denosumab versus zoledronic acid in cases of surgically unsalvageable giant cell tumor of bone: A randomized clinical trial

Cited by 13 publications

References 23 publications

Short‐term Preoperative Denosumab With Surgery in Unresectable or Recurrent Giant Cell Tumor of Bone

Short‐term Preoperative Denosumab With Surgery in Unresectable or Recurrent Giant Cell Tumor of Bone

Similar outcomes with first-line observation versus metastasectomy for bone giant cell tumor lung metastases

Bone Morphogenetic Protein-2 in Development and Bone Homeostasis

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