Citation: World Journal of Surgical Oncology. 16(1):191, 2018 Sep 19..Journal: World journal of surgical oncology.Published: ; 2018ISSN: 1477-7819.Full author list: Engellau J; Seeger L; Grimer R; Henshaw R; Gelderblom H; Choy E; Chawla S; Reichardt P; O'Neal M; Feng A; Jacobs I; Roberts ZJ; Braun A; Bach BA.UI/PMID: 30231890.Subject(s): Adult | *Antineoplastic Agents/tu [Therapeutic Use] | *Bone Neoplasms/dg [Diagnostic Imaging] | *Bone Neoplasms/dt [Drug Therapy] | Clinical Trials, Phase II as Topic | *Denosumab/tu [Therapeutic Use] | Female | *Giant Cell Tumor of Bone/dg [Diagnostic Imaging] | *Giant Cell Tumor of Bone/dt [Drug Therapy] | Humans | Male | Prognosis | Retrospective Studies | Treatment OutcomeInstitution(s): MedStar Washington Hospital CenterDepartment(s): Orthopedic OncologyActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1186/s12957-018-1478-3 (Click here)ORCID: Engellau, Jacob http://orcid.org/0000-0003-4424-5985 (Click here)Abbreviated citation: World J Surg Oncol. 16(1):191, 2018 Sep 19.Local Holdings: Available online through MWHC library: 2003 - present.Abstract: 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.Abstract: 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).Abstract: 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.Abstract: 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.Abstract: TRIAL REGISTRATION: ClinicalTrials.gov Clinical Trials Registry NCT00396279 (retrospectively registered November 6, 2006) and NCT00680992 (retrospectively registered May 20, 2008).