Trial reportAnnals of surgical oncology2015
Surgical downstaging in an open-label phase II trial of denosumab in patients with giant cell tumor of bone.
Trial report in Annals of surgical oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 96 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone
Clinical, Pathologic Characteristics and Its Mechansim of Denosumab Treated Giant Cell Tumor of Bone
Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China:Correlation Between Recurrence and Drug Withdrawl
Who cites it
96 citing papers in PubMed, 2 syntheses or guidelines pooled it, 184 citations in OpenAlex.
- Management of giant cell tumors of the distal radius: a systematic review and meta-analysis.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2023Pooled it
- Is Treatment with Denosumab Associated with Local Recurrence in Patients with Giant Cell Tumor of Bone Treated with Curettage? A Systematic Review.Clinical orthopaedics and related research · 2020Pooled it
- Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study.Nature communications · 2024Trial
- Adjuvant Zoledronic Acid in High-Risk Giant Cell Tumor of Bone: A Multicenter Randomized Phase II Trial.The oncologist · 2019Trial
- De novo osteosarcoma following prolonged denosumab treatment for giant cell tumor of bone at an anatomically distant site: a case report.Skeletal radiology · 2026Article
- Incidence of malignant transformation in giant cell tumor of bone following denosumab therapy: a systematic review and meta-analysis.Journal of bone oncology · 2026Review
- Robot-Assisted Placement of Thoracic Carbon-Fiber-Reinforced Polyetheretherketone (CFR-Peek) Pedicle Screws in the Cervical Spine for Giant Cell Tumor: Technical Note.Bioengineering (Basel, Switzerland) · 2026Article
- Giant Cell Tumor of Bone: Biology, Pathophysiology, and Histopathology in the Era of H3F3A.Biomedicines · 2026Review
- Denosumab combined with curettage after surgical dislocation of the hip in the treatment of giant cell tumors of bone in the femoral head and neck region: a single-center retrospective study.BMC musculoskeletal disorders · 2026Article
- What's new on giant cell tumor of bone.SICOT-J · 2026Article
- Treatment of Extraosseous Giant Cell Tumor of Bone and Calcitriol-Mediated Hypercalcemia With Denosumab in Paget Disease.JCEM case reports · 2025Article
- Preoperative denosumab combined with microwave ablation for joint preservation in advanced giant cell tumor of bone: a retrospective study.Journal of orthopaedic surgery and research · 2025Article
- Recurrent benign fibrous histiocytoma of the bone benefits from denosumab followed by malignant transformation: a case report.Skeletal radiology · 2024Article
- Combined preoperative denosumab and adjuvant microwave ablation for high-risk giant cell tumor of bone: a retrospective study in a single center.Journal of orthopaedic surgery and research · 2024Article
- Efficacy and safety of denosumab de‑escalation in giant cell tumor of bone.Oncology letters · 2024Article
- Current Concepts in the Treatment of Giant Cell Tumor of Bone: An Update.Current oncology (Toronto, Ont.) · 2024Review
- Denosumab induction and Zoledronic acid maintenance therapy for recurrent unresectable giant cell tumour of the distal tibia: A case report with sustained tumour control after drug withdrawal.Journal of bone oncology · 2024Article
- Sacral Nerve-Sparing Piecemeal Spondylectomy for Giant Cell Tumor of Bone in the Sacrum: Surgical Strategy and Accurate Tumor Location Identification.Spine surgery and related research · 2024Article
- Repurposing of PSMA-targeted diagnostic and therapeutic agents for the detection and treatment of giant cell tumors of bone.Frontiers in oncology · 2024Article
- Denosumab combined with microwave ablation excisional scraping for giant cell tumor of the thoracic spine: a case report and literature review.Frontiers in oncology · 2024Article
36 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 9 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSurgical resection with curative intent for giant cell tumor of bone (GCTB) may be associated with severe morbidity. This interim analysis evaluated reduction in surgical invasiveness after denosumab treatment in patients with resectable GCTB.
methodsPatients with primary or recurrent GCTB, for whom the initially planned surgery was associated with functional compromise or morbidity, received denosumab 120 mg subcutaneously every 4 weeks (additional doses on days 8 and 15 of the first cycle). Planned and actual GCTB-related surgical procedures before and after denosumab treatment were reported. Patients were followed for surgical outcome, adverse events, and recurrence following resection.
resultsOverall, 222 patients were evaluable for surgical downstaging (54 % were women; median age 34 years). Lesions (67 % primary and 33 % recurrent) were located in the axial (15 %) and appendicular skeleton (85 %). At the data cutoff date, most patients had not yet undergone surgery (n = 106; 48 %) or had a less morbid procedure (n = 84; 38 %) than originally planned. Median (interquartile range) time on denosumab was 19.5 (12.4-28.6) months for the 106 patients who had not undergone surgery and were continuing on monthly denosumab. Native joint preservation was 96 % (n = 24/25) for patients with planned joint/prosthesis replacement and 86 % (n = 30/35) for patients with planned joint resection/fusion. Of the 116 patients who had surgery (median postsurgical follow-up 13.0 [8.5-17.9] months), local recurrence occurred in 17 (15 %) patients.
conclusionFor patients with resectable GCTB, neoadjuvant denosumab therapy resulted in beneficial surgical downstaging, including either no surgery or a less morbid surgical procedure.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.