Phase 1 Radioimmunotherapy Study with Lutetium 177-labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma
Identifieur interne : 000748 ( Main/Repository ); précédent : 000747; suivant : 000749Phase 1 Radioimmunotherapy Study with Lutetium 177-labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma
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Abstract
Background: Patients with metastatic clear cell renal cell carcinoma (ccRCC) have a dismal prognosis. Therefore, new and less toxic treatments are needed. Objective: We determined the maximum tolerated dose (MTD) and potential therapeutic efficacy of multiple infusions of lutetium 177 (177Lu)-girentuximab (cG250) on various dose levels in a phase 1 trial in patients with progressive metastasized ccRCC. Design, setting, and participants: In this uncontrolled case series in 23 patients with progressive ccRCC metastases, cG250 accumulation was verified by diagnostic indium 111-cG250 imaging. Patients then received a high-activity dose of 177Lu-cG250. Intervention: Groups of three patients received 177Lu-cG250, starting at a dose level of 1110 MBq/m2 177Lu-cG250, with dose increments of 370 MBq/m2 per group. In the absence of persistent toxicity, progressive disease, and accelerated blood clearance, patients were eligible for retreatment after 3 mo with 75% of the previous activity dose. Patients could receive a total of three treatment cycles. Outcome measurements and statistical analysis: Determination of the MTD was the primary and therapeutic efficacy was the secondary outcome measurement of the study. Results and limitations: The MTD was 2405 MBq/m2 because higher doses resulted in dose-limiting myelotoxicity. Some patients received second (13 of 23 [56%]) and third (4 of 23 [17%]) treatment cycles. Most patients (17 of 23 [74%]) demonstrated stable disease 3 mo after the first treatment, and one patient showed a partial response that lasted for 9 mo. Mean growth of target tumor lesions was reduced from 40.4% (95% confidence interval [CI], ±17.0) during the last 3 mo before study entry to 5.5% (95% CI, ±5.3; p < 0.001) at 3 mo after the first treatment cycle. No major nonhematologic side effects were observed. Conclusions: 177Lu-cG250 radioimmunotherapy in metastatic ccRCC patients is well tolerated at an activity dose level as high as 2405 MBq/m2 (MTD). Radioimmunotherapy with 177Lu-cG250 may stabilize previously progressive metastatic ccRCC.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Phase 1 Radioimmunotherapy Study with Lutetium 177-labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma</title><author><name sortKey="Stillebroer, Alexander B" uniqKey="Stillebroer A">Alexander B. Stillebroer</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Urology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Nuclear Medicine, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation></author><author><name sortKey="Boerman, Otto C" uniqKey="Boerman O">Otto C. Boerman</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Nuclear Medicine, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation></author><author><name sortKey="Desar, Ingrid M E" uniqKey="Desar I">Ingrid M. E. Desar</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Medical Oncology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation></author><author><name sortKey="Boers Sonderen, Marije J" uniqKey="Boers Sonderen M">Marije J. Boers-Sonderen</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Medical Oncology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation></author><author><name sortKey="Herpen, Carla M L Van" uniqKey="Herpen C">Carla M. L. Van Herpen</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Medical Oncology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation></author><author><name sortKey="Langenhuijsen, Johannes F" uniqKey="Langenhuijsen J">Johannes F. Langenhuijsen</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Urology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation></author><author><name sortKey="Smith Jones, Peter M" uniqKey="Smith Jones P">Peter M. Smith-Jones</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Nuclear Medicine, Memorial Sloan-Kettering Cancer Center</s1><s2>New York, NY</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>New York, NY</wicri:noRegion></affiliation></author><author><name sortKey="Oosterwijk, Egbert" uniqKey="Oosterwijk E">Egbert Oosterwijk</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Urology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation></author><author><name sortKey="Oyen, Wim J G" uniqKey="Oyen W">Wim J. G. Oyen</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Nuclear Medicine, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>9 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation></author><author><name sortKey="Mulders, Peter F A" uniqKey="Mulders P">Peter F. A. Mulders</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Urology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>Pays-Bas</country><wicri:noRegion>Nijmegen</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="inist">13-0286984</idno><date when="2013">2013</date><idno type="stanalyst">PASCAL 13-0286984 INIST</idno><idno type="RBID">Pascal:13-0286984</idno><idno type="wicri:Area/Main/Corpus">000855</idno><idno type="wicri:Area/Main/Repository">000748</idno></publicationStmt><seriesStmt><idno type="ISSN">0302-2838</idno><title level="j" type="abbreviated">Eur. urol.</title><title level="j" type="main">European urology</title></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Carbonate dehydratase</term><term>Carcinoma</term><term>Grawitz tumor</term><term>Human</term><term>Immunoradiotherapy</term><term>Kidney cancer</term><term>Lutetium</term><term>Monoclonal antibody</term><term>Nephrology</term><term>Phase I trial</term><term>Treatment</term><term>Urology</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase I</term><term>Immunoradiothérapie</term><term>Lutétium</term><term>Cancer rein</term><term>Carbonate dehydratase</term><term>Anticorps monoclonal</term><term>Homme</term><term>Stade avancé</term><term>Hypernéphrome</term><term>Néphrologie</term><term>Urologie</term><term>Traitement</term><term>Carcinome</term></keywords><keywords scheme="Wicri" type="concept" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: Patients with metastatic clear cell renal cell carcinoma (ccRCC) have a dismal prognosis. Therefore, new and less toxic treatments are needed. Objective: We determined the maximum tolerated dose (MTD) and potential therapeutic efficacy of multiple infusions of lutetium 177 (<sup>177</sup>Lu)-girentuximab (cG250) on various dose levels in a phase 1 trial in patients with progressive metastasized ccRCC. Design, setting, and participants: In this uncontrolled case series in 23 patients with progressive ccRCC metastases, cG250 accumulation was verified by diagnostic indium 111-cG250 imaging. Patients then received a high-activity dose of <sup>177</sup>Lu-cG250. Intervention: Groups of three patients received <sup>177</sup>Lu-cG250, starting at a dose level of 1110 MBq/m<sup>2</sup> <sup>177</sup>Lu-cG250, with dose increments of 370 MBq/m<sup>2</sup> per group. In the absence of persistent toxicity, progressive disease, and accelerated blood clearance, patients were eligible for retreatment after 3 mo with 75% of the previous activity dose. Patients could receive a total of three treatment cycles. Outcome measurements and statistical analysis: Determination of the MTD was the primary and therapeutic efficacy was the secondary outcome measurement of the study. Results and limitations: The MTD was 2405 MBq/m<sup>2</sup> because higher doses resulted in dose-limiting myelotoxicity. Some patients received second (13 of 23 [56%]) and third (4 of 23 [17%]) treatment cycles. Most patients (17 of 23 [74%]) demonstrated stable disease 3 mo after the first treatment, and one patient showed a partial response that lasted for 9 mo. Mean growth of target tumor lesions was reduced from 40.4% (95% confidence interval [CI], ±17.0) during the last 3 mo before study entry to 5.5% (95% CI, ±5.3; p < 0.001) at 3 mo after the first treatment cycle. No major nonhematologic side effects were observed. Conclusions: <sup>177</sup>Lu-cG250 radioimmunotherapy in metastatic ccRCC patients is well tolerated at an activity dose level as high as 2405 MBq/m<sup>2</sup> (MTD). Radioimmunotherapy with <sup>177</sup>Lu-cG250 may stabilize previously progressive metastatic ccRCC.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0302-2838</s0></fA01><fA02 i1="01"><s0>EUURAV</s0></fA02><fA03 i2="1"><s0>Eur. urol.</s0></fA03><fA05><s2>64</s2></fA05><fA06><s2>3</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Phase 1 Radioimmunotherapy Study with Lutetium 177-labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients with Advanced Renal Cell Carcinoma</s1></fA08><fA11 i1="01" i2="1"><s1>STILLEBROER (Alexander B.)</s1></fA11><fA11 i1="02" i2="1"><s1>BOERMAN (Otto C.)</s1></fA11><fA11 i1="03" i2="1"><s1>DESAR (Ingrid M. E.)</s1></fA11><fA11 i1="04" i2="1"><s1>BOERS-SONDEREN (Marije J.)</s1></fA11><fA11 i1="05" i2="1"><s1>HERPEN (Carla M. L. Van)</s1></fA11><fA11 i1="06" i2="1"><s1>LANGENHUIJSEN (Johannes F.)</s1></fA11><fA11 i1="07" i2="1"><s1>SMITH-JONES (Peter M.)</s1></fA11><fA11 i1="08" i2="1"><s1>OOSTERWIJK (Egbert)</s1></fA11><fA11 i1="09" i2="1"><s1>OYEN (Wim J. G.)</s1></fA11><fA11 i1="10" i2="1"><s1>MULDERS (Peter F. A.)</s1></fA11><fA14 i1="01"><s1>Department of Urology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>6 aut.</sZ><sZ>8 aut.</sZ><sZ>10 aut.</sZ></fA14><fA14 i1="02"><s1>Department of Nuclear Medicine, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>9 aut.</sZ></fA14><fA14 i1="03"><s1>Department of Medical Oncology, Radboud University Nijmegen Medical Centre</s1><s2>Nijmegen</s2><s3>NLD</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>5 aut.</sZ></fA14><fA14 i1="04"><s1>Department of Nuclear Medicine, Memorial Sloan-Kettering Cancer Center</s1><s2>New York, NY</s2><s3>USA</s3><sZ>7 aut.</sZ></fA14><fA20><s1>478-485</s1></fA20><fA21><s1>2013</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>16847</s2><s5>354000506585000240</s5></fA43><fA44><s0>0000</s0><s1>© 2013 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>29 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>13-0286984</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>European urology</s0></fA64><fA66 i1="01"><s0>GBR</s0></fA66><fC01 i1="01" l="ENG"><s0>Background: Patients with metastatic clear cell renal cell carcinoma (ccRCC) have a dismal prognosis. Therefore, new and less toxic treatments are needed. Objective: We determined the maximum tolerated dose (MTD) and potential therapeutic efficacy of multiple infusions of lutetium 177 (<sup>177</sup>Lu)-girentuximab (cG250) on various dose levels in a phase 1 trial in patients with progressive metastasized ccRCC. Design, setting, and participants: In this uncontrolled case series in 23 patients with progressive ccRCC metastases, cG250 accumulation was verified by diagnostic indium 111-cG250 imaging. Patients then received a high-activity dose of <sup>177</sup>Lu-cG250. Intervention: Groups of three patients received <sup>177</sup>Lu-cG250, starting at a dose level of 1110 MBq/m<sup>2</sup> <sup>177</sup>Lu-cG250, with dose increments of 370 MBq/m<sup>2</sup> per group. In the absence of persistent toxicity, progressive disease, and accelerated blood clearance, patients were eligible for retreatment after 3 mo with 75% of the previous activity dose. Patients could receive a total of three treatment cycles. Outcome measurements and statistical analysis: Determination of the MTD was the primary and therapeutic efficacy was the secondary outcome measurement of the study. Results and limitations: The MTD was 2405 MBq/m<sup>2</sup> because higher doses resulted in dose-limiting myelotoxicity. Some patients received second (13 of 23 [56%]) and third (4 of 23 [17%]) treatment cycles. Most patients (17 of 23 [74%]) demonstrated stable disease 3 mo after the first treatment, and one patient showed a partial response that lasted for 9 mo. Mean growth of target tumor lesions was reduced from 40.4% (95% confidence interval [CI], ±17.0) during the last 3 mo before study entry to 5.5% (95% CI, ±5.3; p < 0.001) at 3 mo after the first treatment cycle. No major nonhematologic side effects were observed. Conclusions: <sup>177</sup>Lu-cG250 radioimmunotherapy in metastatic ccRCC patients is well tolerated at an activity dose level as high as 2405 MBq/m<sup>2</sup> (MTD). Radioimmunotherapy with <sup>177</sup>Lu-cG250 may stabilize previously progressive metastatic ccRCC.</s0></fC01><fC02 i1="01" i2="X"><s0>002B14D01</s0></fC02><fC02 i1="02" i2="X"><s0>002B04C</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Essai clinique phase I</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Phase I trial</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Ensayo clínico fase I</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Immunoradiothérapie</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Immunoradiotherapy</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Inmunoradioterapia</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Lutétium</s0><s2>NC</s2><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Lutetium</s0><s2>NC</s2><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Lutecio</s0><s2>NC</s2><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Cancer rein</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Kidney 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i2="X" l="SPA"><s0>Radioterapia</s0><s5>37</s5></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Pathologie de l'appareil urinaire</s0><s5>38</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Urinary system disease</s0><s5>38</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Aparato urinario patología</s0><s5>38</s5></fC07><fC07 i1="07" i2="X" l="FRE"><s0>Pathologie du rein</s0><s5>39</s5></fC07><fC07 i1="07" i2="X" l="ENG"><s0>Kidney disease</s0><s5>39</s5></fC07><fC07 i1="07" i2="X" l="SPA"><s0>Riñón patología</s0><s5>39</s5></fC07><fC07 i1="08" i2="X" l="FRE"><s0>Tumeur maligne</s0><s2>NM</s2><s5>40</s5></fC07><fC07 i1="08" i2="X" l="ENG"><s0>Malignant tumor</s0><s2>NM</s2><s5>40</s5></fC07><fC07 i1="08" i2="X" l="SPA"><s0>Tumor maligno</s0><s2>NM</s2><s5>40</s5></fC07><fC07 i1="09" i2="X" l="FRE"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="09" i2="X" l="ENG"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="09" i2="X" l="SPA"><s0>Cáncer</s0><s2>NM</s2></fC07><fN21><s1>273</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist></record>Pour manipuler ce document sous Unix (Dilib)
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