Targeting, toxicity, and efficacy of 2-step, pretargeted radioimmunotherapy using a chimeric bispecific antibody and 131I-labeled bivalent hapten in a phase I optimization clinical trial.
Identifieur interne : 002875 ( Main/Exploration ); précédent : 002874; suivant : 002876Targeting, toxicity, and efficacy of 2-step, pretargeted radioimmunotherapy using a chimeric bispecific antibody and 131I-labeled bivalent hapten in a phase I optimization clinical trial.
Auteurs : RBID : pubmed:16455630English descriptors
- KwdEn :
- Adult, Aged, Antibodies, Bispecific (administration & dosage), Antibodies, Bispecific (adverse effects), Antibodies, Monoclonal (administration & dosage), Antibodies, Monoclonal (adverse effects), Dose Fractionation, Female, Haptens (administration & dosage), Haptens (adverse effects), Humans, Iodine Radioisotopes (administration & dosage), Iodine Radioisotopes (adverse effects), Male, Middle Aged, Radiation Injuries (diagnosis), Radiation Injuries (etiology), Radioimmunotherapy (adverse effects), Radioimmunotherapy (methods), Radiopharmaceuticals (administration & dosage), Radiopharmaceuticals (adverse effects), Radiotherapy Dosage, Risk Assessment (methods), Thyroid Neoplasms (diagnosis), Thyroid Neoplasms (radiotherapy), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antibodies, Bispecific, Antibodies, Monoclonal, Haptens, Iodine Radioisotopes, Radiopharmaceuticals.
- chemical , adverse effects : Antibodies, Bispecific, Antibodies, Monoclonal, Haptens, Iodine Radioisotopes, Radiopharmaceuticals.
- adverse effects : Radioimmunotherapy.
- diagnosis : Radiation Injuries, Thyroid Neoplasms.
- etiology : Radiation Injuries.
- methods : Radioimmunotherapy, Risk Assessment.
- radiotherapy : Thyroid Neoplasms.
- Adult, Aged, Dose Fractionation, Female, Humans, Male, Middle Aged, Radiotherapy Dosage, Treatment Outcome.
Abstract
Safety, targeting, and antitumor efficacy of pretargeted radioimmunotherapy using anti-carcinoembryonic antigen (CEA) hMN-14 x m734 bispecific antibody (BsmAb) and 131I-di-diethylenetriamine pentaacetic acid (DTPA)-indium hapten were evaluated in a phase I study performed on patients with CEA-expressing tumors.
PubMed: 16455630
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Targeting, toxicity, and efficacy of 2-step, pretargeted radioimmunotherapy using a chimeric bispecific antibody and 131I-labeled bivalent hapten in a phase I optimization clinical trial.</title><author><name sortKey="Kraeber Bodere, Francoise" uniqKey="Kraeber Bodere F">Françoise Kraeber-Bodéré</name><affiliation wicri:level="1"><nlm:affiliation>Nuclear Medicine Department, René Gauducheau Cancer Center, Nantes, France. francoise.bodere@chu-nantes.fr</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Nuclear Medicine Department, René Gauducheau Cancer Center, Nantes</wicri:regionArea><placeName><region type="région">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Rousseau, Caroline" uniqKey="Rousseau C">Caroline Rousseau</name></author><author><name sortKey="Bodet Milin, Caroline" uniqKey="Bodet Milin C">Caroline Bodet-Milin</name></author><author><name sortKey="Ferrer, Ludovic" uniqKey="Ferrer L">Ludovic Ferrer</name></author><author><name sortKey="Faivre Chauvet, Alain" uniqKey="Faivre Chauvet A">Alain Faivre-Chauvet</name></author><author><name sortKey="Campion, Loic" uniqKey="Campion L">Loïc Campion</name></author><author><name sortKey="Vuillez, Jean Philippe" uniqKey="Vuillez J">Jean-Philippe Vuillez</name></author><author><name sortKey="Devillers, Anne" uniqKey="Devillers A">Anne Devillers</name></author><author><name sortKey="Chang, Chien Hsing" uniqKey="Chang C">Chien-Hsing Chang</name></author><author><name sortKey="Goldenberg, David M" uniqKey="Goldenberg D">David M Goldenberg</name></author><author><name sortKey="Chatal, Jean Francois" uniqKey="Chatal J">Jean-François Chatal</name></author><author><name sortKey="Barbet, Jacques" uniqKey="Barbet J">Jacques Barbet</name></author></titleStmt><publicationStmt><date when="2006">2006</date><idno type="RBID">pubmed:16455630</idno><idno type="pmid">16455630</idno><idno type="wicri:Area/Main/Corpus">002C60</idno><idno type="wicri:Area/Main/Curation">002C60</idno><idno type="wicri:Area/Main/Exploration">002875</idno></publicationStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antibodies, Bispecific (administration & dosage)</term><term>Antibodies, Bispecific (adverse effects)</term><term>Antibodies, Monoclonal (administration & dosage)</term><term>Antibodies, Monoclonal (adverse effects)</term><term>Dose Fractionation</term><term>Female</term><term>Haptens (administration & dosage)</term><term>Haptens (adverse effects)</term><term>Humans</term><term>Iodine Radioisotopes (administration & dosage)</term><term>Iodine Radioisotopes (adverse effects)</term><term>Male</term><term>Middle Aged</term><term>Radiation Injuries (diagnosis)</term><term>Radiation Injuries (etiology)</term><term>Radioimmunotherapy (adverse effects)</term><term>Radioimmunotherapy (methods)</term><term>Radiopharmaceuticals (administration & dosage)</term><term>Radiopharmaceuticals (adverse effects)</term><term>Radiotherapy Dosage</term><term>Risk Assessment (methods)</term><term>Thyroid Neoplasms (diagnosis)</term><term>Thyroid Neoplasms (radiotherapy)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Bispecific</term><term>Antibodies, Monoclonal</term><term>Haptens</term><term>Iodine Radioisotopes</term><term>Radiopharmaceuticals</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Bispecific</term><term>Antibodies, Monoclonal</term><term>Haptens</term><term>Iodine Radioisotopes</term><term>Radiopharmaceuticals</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Radioimmunotherapy</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Radiation Injuries</term><term>Thyroid Neoplasms</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Radiation Injuries</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Radioimmunotherapy</term><term>Risk Assessment</term></keywords><keywords scheme="MESH" qualifier="radiotherapy" xml:lang="en"><term>Thyroid Neoplasms</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Dose Fractionation</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Radiotherapy Dosage</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Safety, targeting, and antitumor efficacy of pretargeted radioimmunotherapy using anti-carcinoembryonic antigen (CEA) hMN-14 x m734 bispecific antibody (BsmAb) and 131I-di-diethylenetriamine pentaacetic acid (DTPA)-indium hapten were evaluated in a phase I study performed on patients with CEA-expressing tumors.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">16455630</PMID><DateCreated><Year>2006</Year><Month>02</Month><Day>03</Day></DateCreated><DateCompleted><Year>2006</Year><Month>11</Month><Day>24</Day></DateCompleted><Article PubModel="Print"><Journal><ISSN IssnType="Print">0161-5505</ISSN><JournalIssue CitedMedium="Print"><Volume>47</Volume><Issue>2</Issue><PubDate><Year>2006</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Journal of nuclear medicine : official publication, Society of Nuclear Medicine</Title><ISOAbbreviation>J. Nucl. Med.</ISOAbbreviation></Journal><ArticleTitle>Targeting, toxicity, and efficacy of 2-step, pretargeted radioimmunotherapy using a chimeric bispecific antibody and 131I-labeled bivalent hapten in a phase I optimization clinical trial.</ArticleTitle><Pagination><MedlinePgn>247-55</MedlinePgn></Pagination><Abstract><AbstractText Label="UNLABELLED">Safety, targeting, and antitumor efficacy of pretargeted radioimmunotherapy using anti-carcinoembryonic antigen (CEA) hMN-14 x m734 bispecific antibody (BsmAb) and 131I-di-diethylenetriamine pentaacetic acid (DTPA)-indium hapten were evaluated in a phase I study performed on patients with CEA-expressing tumors.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Twenty-two patients with nonmedullary thyroid carcinoma (non-MTC) (group I, 13 patients) or medullary thyroid carcinoma (MTC) (group II, 9 patients) were enrolled. These patients received a 75 mg/m2 (11 patients) or 40 mg/m2 (11 patients) dose of BsmAb and escalating activities of (131)I-di-DTPA-indium 5 d later. Toxicity and tumor response were assessed in 20 patients who received a therapeutic (>2.2 GBq) hapten dose of radioactivity.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The percentage of lesions detected by immunoscintigraphy after injection of the therapeutic dose of hapten was 70% on an anatomic-site basis. High bone uptake was relatively frequent. A transient grade I or II hepatic toxicity was observed in 5 patients (45%) injected with 75 mg/m2 of BsmAb and in 1 patient (11%) injected with 40 mg/m2. No other nonhematologic toxicity was observed. With 75 mg/m2 of BsmAb, hematologic toxicity was high: 5 cases of grade III or IV leukopenia (45%) and 5 cases of grade III or IV thrombopenia (45%). With a 40 mg/m2 dose of BsmAb, hematologic toxicity was reduced significantly: 3 cases of grade III or IV leukopenia (33%) and 1 case of grade III or IV thrombopenia (11%) (P = 0.02). Toxicity was significantly higher in MTC patients than in non-MTC patients (P = 0.019). Nine cases of tumor stabilization of 3 mo to more than 12 mo were observed (45%), 6 in the MTC group and 3 in the non-MTC group. The rate of disease stabilization was significantly higher with 75 mg/m2 of BsmAb (64%) than with 40 mg/m2 (22%) (P = 0.04). Human antimouse antibody elevation was observed in 1 patient (8%) and human antihuman antibody in 4 (33%).</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">A BsmAb dose of 40 mg/m2 and a 5-d interval appeared to be a better dose/schedule regimen, with acceptable toxicity. Under these conditions, the maximal tolerated activity was 3 GBq of 131I-di-DTPA-indium in MTC patients. In non-MTC patients, dose escalation should continue.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kraeber-Bodéré</LastName><ForeName>Françoise</ForeName><Initials>F</Initials><Affiliation>Nuclear Medicine Department, René Gauducheau Cancer Center, Nantes, France. francoise.bodere@chu-nantes.fr</Affiliation></Author><Author ValidYN="Y"><LastName>Rousseau</LastName><ForeName>Caroline</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Bodet-Milin</LastName><ForeName>Caroline</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Ferrer</LastName><ForeName>Ludovic</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Faivre-Chauvet</LastName><ForeName>Alain</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Campion</LastName><ForeName>Loïc</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Vuillez</LastName><ForeName>Jean-Philippe</ForeName><Initials>JP</Initials></Author><Author ValidYN="Y"><LastName>Devillers</LastName><ForeName>Anne</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Chang</LastName><ForeName>Chien-Hsing</ForeName><Initials>CH</Initials></Author><Author ValidYN="Y"><LastName>Goldenberg</LastName><ForeName>David M</ForeName><Initials>DM</Initials></Author><Author ValidYN="Y"><LastName>Chatal</LastName><ForeName>Jean-François</ForeName><Initials>JF</Initials></Author><Author ValidYN="Y"><LastName>Barbet</LastName><ForeName>Jacques</ForeName><Initials>J</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType>Clinical Trial, Phase I</PublicationType><PublicationType>Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Nucl Med</MedlineTA><NlmUniqueID>0217410</NlmUniqueID><ISSNLinking>0161-5505</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Antibodies, Bispecific</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Antibodies, Monoclonal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Haptens</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Iodine Radioisotopes</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance>Radiopharmaceuticals</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>J Nucl Med. 2006 Feb;47(2):196-9</RefSource><PMID Version="1">16455623</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName 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