Assessment of denosumab treatment effects and imaging response in patients with giant cell tumor of bone.

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Citation: World Journal of Surgical Oncology. 16(1):191, 2018 Sep 19.PMID: 30231890Institution: MedStar Washington Hospital CenterDepartment: Orthopedic OncologyForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Antineoplastic Agents/tu [Therapeutic Use] | *Bone Neoplasms/dg [Diagnostic Imaging] | *Bone Neoplasms/dt [Drug Therapy] | *Denosumab/tu [Therapeutic Use] | *Giant Cell Tumor of Bone/dg [Diagnostic Imaging] | *Giant Cell Tumor of Bone/dt [Drug Therapy] | Adult | Clinical Trials, Phase II as Topic | Female | Humans | Male | Prognosis | Retrospective Studies | Treatment OutcomeYear: 2018Local holdings: Available online through MWHC library: 2003 - presentISSN:
  • 1477-7819
Name of journal: World journal of surgical oncologyAbstract: BACKGROUND: Denosumab has been shown to reduce tumor size and progression, reform mineralized bone, and increase intralesional bone density in patients with giant cell tumor of bone (GCTB); however, radiologic assessment of tumors in bone is challenging. The study objective was to assess tumor response to denosumab using three different imaging parameters in a prespecified analysis in patients with GCTB from two phase 2 studies.CONCLUSION: Modified PET scan criteria and ICDS criteria indicate that most patients show responses and higher benefit rates than modified RECIST, and therefore may be useful for early assessment of response to denosumab.METHODS: The studies enrolled adults and adolescents (skeletally mature and at least 12 years of age) with radiographically measurable GCTB that were given denosumab 120 mg every 4 weeks, with additional doses on days 8 and 15 of cycle 1. The proportion of patients with an objective tumor response was assessed using either Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST), European Organisation for Research and Treatment of Cancer response criteria (positron emission tomography [PET] scan criteria), or inverse Choi density/size (ICDS) criteria. Target lesions were measured by computed tomography or magnetic resonance imaging (both studies), PET (study 2 only), or plain film radiograph (study 2 only).RESULTS: Most patients (71.6%) had an objective tumor response by at least one response criteria. Per RECIST, 25.1% of patients had a response; per PET scan criteria, 96.2% had a response; per ICDS, 76.1% had a response. 68.5% had an objective tumor response >= 24 weeks. Using any criteria, crude incidence of response ranged from 56% (vertebrae/skull) to 91% (lung/soft tissue), and 98.2% had tumor control >= 24 weeks. Reduced PET avidity appeared to be an early sign of response to denosumab treatment.TRIAL REGISTRATION: ClinicalTrials.gov Clinical Trials Registry NCT00396279 (retrospectively registered November 6, 2006) and NCT00680992 (retrospectively registered May 20, 2008).All authors: Bach BA, Braun A, Chawla S, Choy E, Engellau J, Feng A, Gelderblom H, Grimer R, Henshaw R, Jacobs I, O'Neal M, Reichardt P, Roberts ZJ, Seeger LFiscal year: FY2019Digital Object Identifier: ORCID: Date added to catalog: 2018-09-28
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 30231890 Available 30231890

Available online through MWHC library: 2003 - present

BACKGROUND: Denosumab has been shown to reduce tumor size and progression, reform mineralized bone, and increase intralesional bone density in patients with giant cell tumor of bone (GCTB); however, radiologic assessment of tumors in bone is challenging. The study objective was to assess tumor response to denosumab using three different imaging parameters in a prespecified analysis in patients with GCTB from two phase 2 studies.

CONCLUSION: Modified PET scan criteria and ICDS criteria indicate that most patients show responses and higher benefit rates than modified RECIST, and therefore may be useful for early assessment of response to denosumab.

METHODS: The studies enrolled adults and adolescents (skeletally mature and at least 12 years of age) with radiographically measurable GCTB that were given denosumab 120 mg every 4 weeks, with additional doses on days 8 and 15 of cycle 1. The proportion of patients with an objective tumor response was assessed using either Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST), European Organisation for Research and Treatment of Cancer response criteria (positron emission tomography [PET] scan criteria), or inverse Choi density/size (ICDS) criteria. Target lesions were measured by computed tomography or magnetic resonance imaging (both studies), PET (study 2 only), or plain film radiograph (study 2 only).

RESULTS: Most patients (71.6%) had an objective tumor response by at least one response criteria. Per RECIST, 25.1% of patients had a response; per PET scan criteria, 96.2% had a response; per ICDS, 76.1% had a response. 68.5% had an objective tumor response >= 24 weeks. Using any criteria, crude incidence of response ranged from 56% (vertebrae/skull) to 91% (lung/soft tissue), and 98.2% had tumor control >= 24 weeks. Reduced PET avidity appeared to be an early sign of response to denosumab treatment.

TRIAL REGISTRATION: ClinicalTrials.gov Clinical Trials Registry NCT00396279 (retrospectively registered November 6, 2006) and NCT00680992 (retrospectively registered May 20, 2008).

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