Denosumab Induces Tumor Reduction and Bone Formation in Patients with Giant-Cell Tumor of Bone
Identifieur interne : 001216 ( PascalFrancis/Checkpoint ); précédent : 001215; suivant : 001217Denosumab Induces Tumor Reduction and Bone Formation in Patients with Giant-Cell Tumor of Bone
Auteurs : Daniel G. Branstetter [États-Unis] ; Scott D. Nelson [États-Unis] ; J. Carlos Manivel [États-Unis] ; Jean-Yves Blay [France] ; Sant Chawla [États-Unis] ; David M. Thomas [Australie] ; Susie Jun [États-Unis] ; Ira Jacobs [États-Unis]Source :
- Clinical cancer research [ 1078-0432 ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
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Abstract
Purpose: Giant-cell tumor of bone (GCTB) is a locally aggressive, benign osteolytic tumor in which bone destruction is mediated by RANK ligand (RANKL). The RANKL inhibitor denosumab is being investigated for treatment of GCTB. We describe histologic analyses of GCTB tumor samples from a phase II study of denosumab in GCTB. Experimental Design: Adult patients with recurrent or unresectable GCTB received subcutaneous denosumab 120 mg every 4 weeks (with additional doses on days 8 and 15). The primary histologic efficacy endpoint was the proportion of patients who had a 90% or more elimination of giant cells from their tumor. Baseline and on-study specimens were also evaluated for overall tumor morphology and expression of RANK and RANKL. Results: Baseline tumor samples were typically composed of densely cellular proliferative RANKL-positive tumor stromal cells, RANK-positive rounded mononuclear cells, abundant RANK-positive tumor giant cells, and areas of scant de novo osteoid matrix and woven bone. In on-study samples from 20 of 20 patients (100%), a decrease of 90% or more in tumor giant cells and a reduction in tumor stromal cells were observed. In these analyses, thirteen patients (65%) had an increased proportion of dense fibro-osseous tissue and/or new woven bone, replacing areas of proliferative RANKL-positive stromal cells. Conclusions: Denosumab treatment of patients with GCTB significantly reduced or eliminated RANK-positive tumor giant cells. Denosumab also reduced the relative content of proliferative, densely cellular tumor stromal cells, replacing them with nonproliferative, differentiated, densely woven new bone. Denosumab continues to be studied as a potential treatment for GCTB.
Affiliations:
- Australie, France, États-Unis
- Auvergne-Rhône-Alpes, Californie, Minnesota, Rhône-Alpes, Washington (État)
- Lyon
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Nelson</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>University of California</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Manivel, J Carlos" sort="Manivel, J Carlos" uniqKey="Manivel J" first="J. Carlos" last="Manivel">J. Carlos Manivel</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>University of Minnesota</s1><s2>Minneapolis, Minnesota</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Blay, Jean Yves" sort="Blay, Jean Yves" uniqKey="Blay J" first="Jean-Yves" last="Blay">Jean-Yves Blay</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>University Claude Bernard Lyon I and Hôpital Edouard Heriot</s1><s2>Lyon</s2><s3>FRA</s3><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Chawla, Sant" sort="Chawla, Sant" uniqKey="Chawla S" first="Sant" last="Chawla">Sant Chawla</name><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Sarcoma Oncology Center, Santa Monica</s1><s2>California</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Thomas, David M" sort="Thomas, David M" uniqKey="Thomas D" first="David M." last="Thomas">David M. 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Branstetter</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Amgen Inc</s1><s2>Seattle, Washington</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Nelson, Scott D" sort="Nelson, Scott D" uniqKey="Nelson S" first="Scott D." last="Nelson">Scott D. Nelson</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>University of California</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Manivel, J Carlos" sort="Manivel, J Carlos" uniqKey="Manivel J" first="J. Carlos" last="Manivel">J. Carlos Manivel</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>University of Minnesota</s1><s2>Minneapolis, Minnesota</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Blay, Jean Yves" sort="Blay, Jean Yves" uniqKey="Blay J" first="Jean-Yves" last="Blay">Jean-Yves Blay</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>University Claude Bernard Lyon I and Hôpital Edouard Heriot</s1><s2>Lyon</s2><s3>FRA</s3><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Chawla, Sant" sort="Chawla, Sant" uniqKey="Chawla S" first="Sant" last="Chawla">Sant Chawla</name><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Sarcoma Oncology Center, Santa Monica</s1><s2>California</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Thomas, David M" sort="Thomas, David M" uniqKey="Thomas D" first="David M." last="Thomas">David M. Thomas</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Peter MacCallum Cancer Centre, East Melbourne</s1><s2>Victoria</s2><s3>AUS</s3><sZ>6 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Jun, Susie" sort="Jun, Susie" uniqKey="Jun S" first="Susie" last="Jun">Susie Jun</name><affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Amgen Inc., Thousand Oaks</s1><s2>California</s2><s3>USA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Jacobs, Ira" sort="Jacobs, Ira" uniqKey="Jacobs I" first="Ira" last="Jacobs">Ira Jacobs</name><affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Amgen Inc., Thousand Oaks</s1><s2>California</s2><s3>USA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Clinical cancer research</title><title level="j" type="abbreviated">Clin. cancer res.</title><idno type="ISSN">1078-0432</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Clinical cancer research</title><title level="j" type="abbreviated">Clin. cancer res.</title><idno type="ISSN">1078-0432</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Bone giant cell tumor</term><term>Denosumab</term><term>Human</term><term>Malignant tumor</term><term>Osteogenesis</term><term>Patient</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Dénosumab</term><term>Tumeur maligne</term><term>Ostéogenèse</term><term>Homme</term><term>Malade</term><term>Tumeur osseuse à cellules géantes</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose: Giant-cell tumor of bone (GCTB) is a locally aggressive, benign osteolytic tumor in which bone destruction is mediated by RANK ligand (RANKL). The RANKL inhibitor denosumab is being investigated for treatment of GCTB. We describe histologic analyses of GCTB tumor samples from a phase II study of denosumab in GCTB. Experimental Design: Adult patients with recurrent or unresectable GCTB received subcutaneous denosumab 120 mg every 4 weeks (with additional doses on days 8 and 15). The primary histologic efficacy endpoint was the proportion of patients who had a 90% or more elimination of giant cells from their tumor. Baseline and on-study specimens were also evaluated for overall tumor morphology and expression of RANK and RANKL. Results: Baseline tumor samples were typically composed of densely cellular proliferative RANKL-positive tumor stromal cells, RANK-positive rounded mononuclear cells, abundant RANK-positive tumor giant cells, and areas of scant de novo osteoid matrix and woven bone. In on-study samples from 20 of 20 patients (100%), a decrease of 90% or more in tumor giant cells and a reduction in tumor stromal cells were observed. In these analyses, thirteen patients (65%) had an increased proportion of dense fibro-osseous tissue and/or new woven bone, replacing areas of proliferative RANKL-positive stromal cells. Conclusions: Denosumab treatment of patients with GCTB significantly reduced or eliminated RANK-positive tumor giant cells. Denosumab also reduced the relative content of proliferative, densely cellular tumor stromal cells, replacing them with nonproliferative, differentiated, densely woven new bone. Denosumab continues to be studied as a potential treatment for GCTB.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>1078-0432</s0></fA01><fA02 i1="01"><s0>CCREF4</s0></fA02><fA03 i2="1"><s0>Clin. cancer res.</s0></fA03><fA05><s2>18</s2></fA05><fA06><s2>16</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Denosumab Induces Tumor Reduction and Bone Formation in Patients with Giant-Cell Tumor of Bone</s1></fA08><fA11 i1="01" i2="1"><s1>BRANSTETTER (Daniel G.)</s1></fA11><fA11 i1="02" i2="1"><s1>NELSON (Scott D.)</s1></fA11><fA11 i1="03" i2="1"><s1>MANIVEL (J. Carlos)</s1></fA11><fA11 i1="04" i2="1"><s1>BLAY (Jean-Yves)</s1></fA11><fA11 i1="05" i2="1"><s1>CHAWLA (Sant)</s1></fA11><fA11 i1="06" i2="1"><s1>THOMAS (David M.)</s1></fA11><fA11 i1="07" i2="1"><s1>JUN (Susie)</s1></fA11><fA11 i1="08" i2="1"><s1>JACOBS (Ira)</s1></fA11><fA14 i1="01"><s1>Amgen Inc</s1><s2>Seattle, Washington</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>University of California</s1><s2>Los Angeles, California</s2><s3>USA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>University of Minnesota</s1><s2>Minneapolis, Minnesota</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>University Claude Bernard Lyon I and Hôpital Edouard Heriot</s1><s2>Lyon</s2><s3>FRA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Sarcoma Oncology Center, Santa Monica</s1><s2>California</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Peter MacCallum Cancer Centre, East Melbourne</s1><s2>Victoria</s2><s3>AUS</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Amgen Inc., Thousand Oaks</s1><s2>California</s2><s3>USA</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></fA14><fA20><s1>4415-4424</s1></fA20><fA21><s1>2012</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>26073</s2><s5>354000504079990240</s5></fA43><fA44><s0>0000</s0><s1>© 2012 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>50 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>12-0354416</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Clinical cancer research</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>Purpose: Giant-cell tumor of bone (GCTB) is a locally aggressive, benign osteolytic tumor in which bone destruction is mediated by RANK ligand (RANKL). The RANKL inhibitor denosumab is being investigated for treatment of GCTB. We describe histologic analyses of GCTB tumor samples from a phase II study of denosumab in GCTB. Experimental Design: Adult patients with recurrent or unresectable GCTB received subcutaneous denosumab 120 mg every 4 weeks (with additional doses on days 8 and 15). The primary histologic efficacy endpoint was the proportion of patients who had a 90% or more elimination of giant cells from their tumor. Baseline and on-study specimens were also evaluated for overall tumor morphology and expression of RANK and RANKL. Results: Baseline tumor samples were typically composed of densely cellular proliferative RANKL-positive tumor stromal cells, RANK-positive rounded mononuclear cells, abundant RANK-positive tumor giant cells, and areas of scant de novo osteoid matrix and woven bone. In on-study samples from 20 of 20 patients (100%), a decrease of 90% or more in tumor giant cells and a reduction in tumor stromal cells were observed. In these analyses, thirteen patients (65%) had an increased proportion of dense fibro-osseous tissue and/or new woven bone, replacing areas of proliferative RANKL-positive stromal cells. Conclusions: Denosumab treatment of patients with GCTB significantly reduced or eliminated RANK-positive tumor giant cells. Denosumab also reduced the relative content of proliferative, densely cellular tumor stromal cells, replacing them with nonproliferative, differentiated, densely woven new bone. Denosumab continues to be studied as a potential treatment for GCTB.</s0></fC01><fC02 i1="01" i2="X"><s0>002B02R</s0></fC02><fC02 i1="02" i2="X"><s0>002B15C</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Dénosumab</s0><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Denosumab</s0><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Denosumab</s0><s2>FR</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Tumeur maligne</s0><s2>NM</s2><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Malignant tumor</s0><s2>NM</s2><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Tumor maligno</s0><s2>NM</s2><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Ostéogenèse</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Osteogenesis</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Osteogénesis</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Homme</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Human</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Hombre</s0><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Malade</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Patient</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Enfermo</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Tumeur osseuse à cellules géantes</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Bone giant cell tumor</s0><s4>CD</s4><s5>96</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Cáncer</s0><s2>NM</s2></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Anticorps monoclonal</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Monoclonal antibody</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Anticuerpo monoclonal</s0><s5>37</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Pathologie du système ostéoarticulaire</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Diseases of the osteoarticular system</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Sistema osteoarticular patología</s0><s5>38</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Tumeur bénigne</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Benign neoplasm</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Tumor benigno</s0><s5>39</s5></fC07><fN21><s1>275</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>Australie</li><li>France</li><li>États-Unis</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Californie</li><li>Minnesota</li><li>Rhône-Alpes</li><li>Washington (État)</li></region><settlement><li>Lyon</li></settlement></list><tree><country name="États-Unis"><region name="Washington (État)"><name sortKey="Branstetter, Daniel G" sort="Branstetter, Daniel G" uniqKey="Branstetter D" first="Daniel G." last="Branstetter">Daniel G. Branstetter</name></region><name sortKey="Chawla, Sant" sort="Chawla, Sant" uniqKey="Chawla S" first="Sant" last="Chawla">Sant Chawla</name><name sortKey="Jacobs, Ira" sort="Jacobs, Ira" uniqKey="Jacobs I" first="Ira" last="Jacobs">Ira Jacobs</name><name sortKey="Jun, Susie" sort="Jun, Susie" uniqKey="Jun S" first="Susie" last="Jun">Susie Jun</name><name sortKey="Manivel, J Carlos" sort="Manivel, J Carlos" uniqKey="Manivel J" first="J. Carlos" last="Manivel">J. Carlos Manivel</name><name sortKey="Nelson, Scott D" sort="Nelson, Scott D" uniqKey="Nelson S" first="Scott D." last="Nelson">Scott D. Nelson</name></country><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Blay, Jean Yves" sort="Blay, Jean Yves" uniqKey="Blay J" first="Jean-Yves" last="Blay">Jean-Yves Blay</name></region></country><country name="Australie"><noRegion><name sortKey="Thomas, David M" sort="Thomas, David M" uniqKey="Thomas D" first="David M." last="Thomas">David M. 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