Phase iii study of adjuvant vaccination with Bec2/bacille calmette-guerin in responding patients with limited-disease small-cell lung cancer (european organisation for research and treatment of cancer 08971-08971B; Silva study)
Identifieur interne : 00A508 ( Main/Exploration ); précédent : 00A507; suivant : 00A509Phase iii study of adjuvant vaccination with Bec2/bacille calmette-guerin in responding patients with limited-disease small-cell lung cancer (european organisation for research and treatment of cancer 08971-08971B; Silva study)
Auteurs : Giuseppe Giaccone [Pays-Bas, Belgique, Espagne, États-Unis, Australie, France, Suisse, République tchèque] ; Channa Debruyne ; Enriqueta Felip ; Paul B. Chapman ; Stefan C. Grant ; Michael Millward ; Luc Thiberville ; Giannicola D'Addario ; Corneel Coens ; Lisa S. Rome ; Petr Zatloukal ; Oriol Masso ; Catherine LegrandSource :
- Journal of clinical oncology [ 0732-183X ] ; 2005.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Adjuvant, Vaccination, Homme, Recherche.
English descriptors
- KwdEn :
Abstract
Purpose Bec2 is an anti-idiotypic antibody that mimics GD3, a ganglioside that is expressed on the surface of tumor cells and is of neuroectodermal origin. We assessed whether Bec2/bacille Calmette-Guerin (BCG) vaccination prolongs survival in patients with limited-disease small-cell lung cancer (SCLC) after a major response to chemotherapy and chest radiation Patients and Methods Patients were randomly assigned to receive five vaccinations of Bec2 (2 5 mg)/BCG vaccine or follow-up Vaccination was given over a 10-week period The sample size was targeted to detect an increase in median survival of 40% after random assignment, and stratification was by performance status, response, and institution Quality of life was assessed by using the European Organisation for Research and Treatment of Cancer instrument. Humoral response was assessed in patients who received vaccination Results A total of 515 patients were randomly assigned The primary toxicities of vaccination were transient skin ulcerations and mild flu-like symptoms. There was no improvement in survival, progression-free survival, or quality of life in the vaccination arm. Median survival from randomization was 16.4 and 14.3 months in the observation and vaccination arms (P = .28), respectively Among vaccinated patients, a trend toward prolonged survival was observed in those (one third) who developed a humoral response (P = .085). Multivariate analysis showed a positive impact on survival by prior treatment with concomitant chemoradiotherapy, prophylactic cranial irradiation, female sex, low lactate dehydrogenase, and normal platelets Conclusion Vaccination with Bec2/BCG has no impact on outcome of patients with limited-disease SCLC responding to combined-modality treatment. Vaccination strategies in SCLC may still be warranted using vaccines that produce a better immunologic response.
Affiliations:
- Australie, Belgique, Espagne, France, Pays-Bas, République tchèque, Suisse, États-Unis
- Bohême centrale, Catalogne, Hollande-Septentrionale, Région de Bruxelles-Capitale
- Amsterdam, Barcelone, Bruxelles, Prague
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- to stream Main, to step Merge: 00B106
- to stream Main, to step Curation: 00A508
Le document en format XML
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Chapman</name></author><author><name sortKey="Grant, Stefan C" sort="Grant, Stefan C" uniqKey="Grant S" first="Stefan C." last="Grant">Stefan C. Grant</name></author><author><name sortKey="Millward, Michael" sort="Millward, Michael" uniqKey="Millward M" first="Michael" last="Millward">Michael Millward</name></author><author><name sortKey="Thiberville, Luc" sort="Thiberville, Luc" uniqKey="Thiberville L" first="Luc" last="Thiberville">Luc Thiberville</name></author><author><name sortKey="D Addario, Giannicola" sort="D Addario, Giannicola" uniqKey="D Addario G" first="Giannicola" last="D'Addario">Giannicola D'Addario</name></author><author><name sortKey="Coens, Corneel" sort="Coens, Corneel" uniqKey="Coens C" first="Corneel" last="Coens">Corneel Coens</name></author><author><name sortKey="Rome, Lisa S" sort="Rome, Lisa S" uniqKey="Rome L" first="Lisa S." last="Rome">Lisa S. Rome</name></author><author><name sortKey="Zatloukal, Petr" sort="Zatloukal, Petr" uniqKey="Zatloukal P" first="Petr" last="Zatloukal">Petr Zatloukal</name></author><author><name sortKey="Masso, Oriol" sort="Masso, Oriol" uniqKey="Masso O" first="Oriol" last="Masso">Oriol Masso</name></author><author><name sortKey="Legrand, Catherine" sort="Legrand, Catherine" uniqKey="Legrand C" first="Catherine" last="Legrand">Catherine Legrand</name></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2005">2005</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvant</term><term>BCG</term><term>Bonchopulmonary small cell carcinoma</term><term>Cancerology</term><term>Europe</term><term>Human</term><term>Lung cancer</term><term>Malignant tumor</term><term>Phase III trial</term><term>Research</term><term>Treatment</term><term>Vaccination</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term><term>Traitement</term><term>Adjuvant</term><term>Carcinome petite cellule bronchopulmonaire</term><term>BCG</term><term>Vaccination</term><term>Tumeur maligne</term><term>Homme</term><term>Cancer du poumon</term><term>Europe</term><term>Recherche</term><term>Cancérologie</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Adjuvant</term><term>Vaccination</term><term>Homme</term><term>Recherche</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose Bec2 is an anti-idiotypic antibody that mimics GD3, a ganglioside that is expressed on the surface of tumor cells and is of neuroectodermal origin. We assessed whether Bec2/bacille Calmette-Guerin (BCG) vaccination prolongs survival in patients with limited-disease small-cell lung cancer (SCLC) after a major response to chemotherapy and chest radiation Patients and Methods Patients were randomly assigned to receive five vaccinations of Bec2 (2 5 mg)/BCG vaccine or follow-up Vaccination was given over a 10-week period The sample size was targeted to detect an increase in median survival of 40% after random assignment, and stratification was by performance status, response, and institution Quality of life was assessed by using the European Organisation for Research and Treatment of Cancer instrument. Humoral response was assessed in patients who received vaccination Results A total of 515 patients were randomly assigned The primary toxicities of vaccination were transient skin ulcerations and mild flu-like symptoms. There was no improvement in survival, progression-free survival, or quality of life in the vaccination arm. Median survival from randomization was 16.4 and 14.3 months in the observation and vaccination arms (P = .28), respectively Among vaccinated patients, a trend toward prolonged survival was observed in those (one third) who developed a humoral response (P = .085). Multivariate analysis showed a positive impact on survival by prior treatment with concomitant chemoradiotherapy, prophylactic cranial irradiation, female sex, low lactate dehydrogenase, and normal platelets Conclusion Vaccination with Bec2/BCG has no impact on outcome of patients with limited-disease SCLC responding to combined-modality treatment. Vaccination strategies in SCLC may still be warranted using vaccines that produce a better immunologic response.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Belgique</li><li>Espagne</li><li>France</li><li>Pays-Bas</li><li>République tchèque</li><li>Suisse</li><li>États-Unis</li></country><region><li>Bohême centrale</li><li>Catalogne</li><li>Hollande-Septentrionale</li><li>Région de Bruxelles-Capitale</li></region><settlement><li>Amsterdam</li><li>Barcelone</li><li>Bruxelles</li><li>Prague</li></settlement></list><tree><noCountry><name sortKey="Chapman, Paul B" sort="Chapman, Paul B" uniqKey="Chapman P" first="Paul B." last="Chapman">Paul B. Chapman</name><name sortKey="Coens, Corneel" sort="Coens, Corneel" uniqKey="Coens C" first="Corneel" last="Coens">Corneel Coens</name><name sortKey="D Addario, Giannicola" sort="D Addario, Giannicola" uniqKey="D Addario G" first="Giannicola" last="D'Addario">Giannicola D'Addario</name><name sortKey="Debruyne, Channa" sort="Debruyne, Channa" uniqKey="Debruyne C" first="Channa" last="Debruyne">Channa Debruyne</name><name sortKey="Felip, Enriqueta" sort="Felip, Enriqueta" uniqKey="Felip E" first="Enriqueta" last="Felip">Enriqueta Felip</name><name sortKey="Grant, Stefan C" sort="Grant, Stefan C" uniqKey="Grant S" first="Stefan C." last="Grant">Stefan C. Grant</name><name sortKey="Legrand, Catherine" sort="Legrand, Catherine" uniqKey="Legrand C" first="Catherine" last="Legrand">Catherine Legrand</name><name sortKey="Masso, Oriol" sort="Masso, Oriol" uniqKey="Masso O" first="Oriol" last="Masso">Oriol Masso</name><name sortKey="Millward, Michael" sort="Millward, Michael" uniqKey="Millward M" first="Michael" last="Millward">Michael Millward</name><name sortKey="Rome, Lisa S" sort="Rome, Lisa S" uniqKey="Rome L" first="Lisa S." last="Rome">Lisa S. Rome</name><name sortKey="Thiberville, Luc" sort="Thiberville, Luc" uniqKey="Thiberville L" first="Luc" last="Thiberville">Luc Thiberville</name><name sortKey="Zatloukal, Petr" sort="Zatloukal, Petr" uniqKey="Zatloukal P" first="Petr" last="Zatloukal">Petr Zatloukal</name></noCountry><country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name></region></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name></region></country><country name="Espagne"><region name="Catalogne"><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name></region></country><country name="États-Unis"><noRegion><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name></noRegion><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name></country><country name="Australie"><noRegion><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name></noRegion></country><country name="France"><noRegion><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name></noRegion></country><country name="République tchèque"><region name="Bohême centrale"><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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