Malignancy in giant cell tumor of bone: analysis of an open-label phase 2 study of denosumab View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2021-01-22

AUTHORS

Emanuela Palmerini, Leanne L. Seeger, Marco Gambarotti, Alberto Righi, Peter Reichardt, Susan Bukata, Jean-Yves Blay, Tian Dai, Danielle Jandial, Piero Picci

ABSTRACT

BackgroundGiant cell tumor of bone (GCTB) is a rare osteoclastogenic stromal tumor. GCTB can rarely undergo malignant transformation. This post hoc analysis evaluated and classified malignancies in patients with GCTB who received denosumab.MethodsThis analysis was conducted on patients with pathologically confirmed GCTB and measurable active disease treated with denosumab 120 mg subcutaneously once every 4 weeks, with loading doses on study days 8 and 15, as part of a phase 2, open-label, multicenter study. We identified potential cases of malignancy related to GCTB through an independent multidisciplinary review or medical history, associated imaging or histopathologic reports, and disease course. The findings were summarized and no statistical analysis was performed.ResultsTwenty of five hundred twenty-six patients (3.8%) who received at least one dose of denosumab were misdiagnosed with GCTB that was later discovered to be malignancies: five primary malignant GCTB, five secondary malignant GCTB, four sarcomatous transformations, and six patients with other malignancies (giant cell-rich osteosarcoma, undifferentiated pleomorphic sarcoma, spindle cell sarcoma, osteogenic sarcoma, phosphaturic mesenchymal tumor of mixed connective tissue type, and fibrosarcoma/malignant fibrous histiocytoma). Many malignancies were present before denosumab was initiated (8 definitive cases, 7 likely cases), excluding potential involvement of denosumab in these cases. Signs associated with potential misdiagnoses of GCTB included poor mineralization with denosumab treatment, rapid relapse in pain, or a failure of the typical dramatic improvement in pain normally observed with denosumab.ConclusionsAlthough rare, GCTB can undergo malignant transformation, and rates in this study were consistent with previous reports. Signs of poor mineralization or lack of response to denosumab treatment may warrant close monitoring.Trial registrationclinicaltrials.gov, (NCT00680992). Registered May 20, 2008. More... »

PAGES

89

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URI

http://scigraph.springernature.com/pub.10.1186/s12885-020-07739-8

DOI

http://dx.doi.org/10.1186/s12885-020-07739-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1134796044

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/33482769


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32 schema:description BackgroundGiant cell tumor of bone (GCTB) is a rare osteoclastogenic stromal tumor. GCTB can rarely undergo malignant transformation. This post hoc analysis evaluated and classified malignancies in patients with GCTB who received denosumab.MethodsThis analysis was conducted on patients with pathologically confirmed GCTB and measurable active disease treated with denosumab 120 mg subcutaneously once every 4 weeks, with loading doses on study days 8 and 15, as part of a phase 2, open-label, multicenter study. We identified potential cases of malignancy related to GCTB through an independent multidisciplinary review or medical history, associated imaging or histopathologic reports, and disease course. The findings were summarized and no statistical analysis was performed.ResultsTwenty of five hundred twenty-six patients (3.8%) who received at least one dose of denosumab were misdiagnosed with GCTB that was later discovered to be malignancies: five primary malignant GCTB, five secondary malignant GCTB, four sarcomatous transformations, and six patients with other malignancies (giant cell-rich osteosarcoma, undifferentiated pleomorphic sarcoma, spindle cell sarcoma, osteogenic sarcoma, phosphaturic mesenchymal tumor of mixed connective tissue type, and fibrosarcoma/malignant fibrous histiocytoma). Many malignancies were present before denosumab was initiated (8 definitive cases, 7 likely cases), excluding potential involvement of denosumab in these cases. Signs associated with potential misdiagnoses of GCTB included poor mineralization with denosumab treatment, rapid relapse in pain, or a failure of the typical dramatic improvement in pain normally observed with denosumab.ConclusionsAlthough rare, GCTB can undergo malignant transformation, and rates in this study were consistent with previous reports. Signs of poor mineralization or lack of response to denosumab treatment may warrant close monitoring.Trial registrationclinicaltrials.gov, (NCT00680992). Registered May 20, 2008.
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38 schema:keywords BackgroundGiant cell tumors
39 ConclusionsAlthough
40 GCTB
41 MethodsThis analysis
42 ResultsTwenty
43 active disease
44 analysis
45 bone
46 cases
47 cell tumors
48 close monitoring
49 course
50 day 8
51 denosumab
52 denosumab 120
53 denosumab treatment
54 disease
55 disease course
56 dose
57 dose of denosumab
58 doses
59 dramatic improvement
60 failure
61 findings
62 giant cell tumor
63 histopathologic reports
64 history
65 imaging
66 improvement
67 involvement
68 lack
69 lack of response
70 malignancy
71 malignant GCTB
72 malignant transformation
73 medical history
74 mineralization
75 misdiagnoses
76 monitoring
77 multicenter study
78 multidisciplinary review
79 open-label phase 2 study
80 pain
81 part
82 patients
83 phase 2
84 phase 2 study
85 poor mineralization
86 post
87 potential cases
88 potential involvement
89 potential misdiagnoses
90 previous reports
91 primary malignant GCTB
92 rapid relapse
93 rate
94 relapse
95 report
96 response
97 review
98 sarcomatous transformation
99 secondary malignant GCTB
100 signs
101 statistical analysis
102 stromal tumors
103 study
104 study day 8
105 transformation
106 treatment
107 tumors
108 weeks
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