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 : 001A17 ( PascalFrancis/Curation ); précédent : 001A16; suivant : 001A18Phase 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.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">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)</title><author><name sortKey="Giaccone, Giuseppe" sort="Giaccone, Giuseppe" uniqKey="Giaccone G" first="Giuseppe" last="Giaccone">Giuseppe Giaccone</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Vnje Universiteit Medical Center</s1><s2>Amsterdam</s2><s3>NLD</s3></inist:fA14><country>Pays-Bas</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>EORTC Data Center</s1><s2>Brussels</s2><s3>BEL</s3></inist:fA14><country>Belgique</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Vail d'Hebron University Hospital</s1><s2>Barcelona</s2><s3>ESP</s3></inist:fA14><country>Espagne</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Memorial Sloan- Kettering Cancer Center</s1><s2>New York, NY</s2><s3>USA</s3></inist:fA14><country>États-Unis</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>School of Medicine and Pharmacology, Sir Charles Gairdner Hospital</s1><s2>Perth</s2><s3>AUS</s3></inist:fA14><country>Australie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Clinique Pneumologique, Rouen University Hospital</s1><s3>FRA</s3></inist:fA14><country>France</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s2>Kantonsspital, St Gallen</s2><s3>CHE</s3></inist:fA14><country>Suisse</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>VA Connecticut Cancer Center</s1><s2>West Haven, CT</s2><s3>USA</s3></inist:fA14><country>États-Unis</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Charles University, Faculty Hospital Bulovka and Postgraduate Medical School</s1><s2>Prague</s2><s3>CZE</s3></inist:fA14><country>République tchèque</country></affiliation></author><author><name sortKey="Debruyne, Channa" sort="Debruyne, Channa" uniqKey="Debruyne C" first="Channa" last="Debruyne">Channa Debruyne</name></author><author><name sortKey="Felip, Enriqueta" sort="Felip, Enriqueta" uniqKey="Felip E" first="Enriqueta" last="Felip">Enriqueta Felip</name></author><author><name sortKey="Chapman, Paul B" sort="Chapman, Paul B" uniqKey="Chapman P" first="Paul B." last="Chapman">Paul B. 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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><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0732-183X</s0></fA01><fA03 i2="1"><s0>J. clin. oncol.</s0></fA03><fA05><s2>23</s2></fA05><fA06><s2>28</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>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)</s1></fA08><fA11 i1="01" i2="1"><s1>GIACCONE (Giuseppe)</s1></fA11><fA11 i1="02" i2="1"><s1>DEBRUYNE (Channa)</s1></fA11><fA11 i1="03" i2="1"><s1>FELIP (Enriqueta)</s1></fA11><fA11 i1="04" i2="1"><s1>CHAPMAN (Paul B.)</s1></fA11><fA11 i1="05" i2="1"><s1>GRANT (Stefan C.)</s1></fA11><fA11 i1="06" i2="1"><s1>MILLWARD (Michael)</s1></fA11><fA11 i1="07" i2="1"><s1>THIBERVILLE (Luc)</s1></fA11><fA11 i1="08" i2="1"><s1>D'ADDARIO (Giannicola)</s1></fA11><fA11 i1="09" i2="1"><s1>COENS (Corneel)</s1></fA11><fA11 i1="10" i2="1"><s1>ROME (Lisa S.)</s1></fA11><fA11 i1="11" i2="1"><s1>ZATLOUKAL (Petr)</s1></fA11><fA11 i1="12" i2="1"><s1>MASSO (Oriol)</s1></fA11><fA11 i1="13" i2="1"><s1>LEGRAND (Catherine)</s1></fA11><fA14 i1="01"><s1>Vnje Universiteit Medical Center</s1><s2>Amsterdam</s2><s3>NLD</s3></fA14><fA14 i1="02"><s1>EORTC Data Center</s1><s2>Brussels</s2><s3>BEL</s3></fA14><fA14 i1="03"><s1>Vail d'Hebron University Hospital</s1><s2>Barcelona</s2><s3>ESP</s3></fA14><fA14 i1="04"><s1>Memorial Sloan- Kettering Cancer Center</s1><s2>New York, NY</s2><s3>USA</s3></fA14><fA14 i1="05"><s1>School of Medicine and Pharmacology, Sir Charles Gairdner Hospital</s1><s2>Perth</s2><s3>AUS</s3></fA14><fA14 i1="06"><s1>Clinique Pneumologique, Rouen University Hospital</s1><s3>FRA</s3></fA14><fA14 i1="07"><s2>Kantonsspital, St Gallen</s2><s3>CHE</s3></fA14><fA14 i1="08"><s1>VA Connecticut Cancer Center</s1><s2>West Haven, CT</s2><s3>USA</s3></fA14><fA14 i1="09"><s1>Charles University, Faculty Hospital Bulovka and Postgraduate Medical School</s1><s2>Prague</s2><s3>CZE</s3></fA14><fA20><s1>6854-6864</s1></fA20><fA21><s1>2005</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20094</s2><s5>354000131942050090</s5></fA43><fA44><s0>0000</s0><s1>© 2005 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>46 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>05-0481277</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Journal of clinical oncology</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B04</s0></fC02><fC02 i1="02" i2="X"><s0>002B11A</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Essai clinique phase III</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Phase III trial</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Ensayo clínico fase III</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Traitement</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Treatment</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Tratamiento</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Adjuvant</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Adjuvant</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Coadyuvante</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Carcinome petite cellule bronchopulmonaire</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Bonchopulmonary small cell carcinoma</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Carcinoma pequeňa célula bronchopulmonar</s0><s2>NM</s2><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>BCG</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>BCG</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>BCG</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Vaccination</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Vaccination</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Vacunación</s0><s5>06</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Tumeur maligne</s0><s5>07</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Malignant tumor</s0><s5>07</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Tumor maligno</s0><s5>07</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Homme</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Human</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Hombre</s0><s5>08</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Cancer du poumon</s0><s2>NM</s2><s5>09</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Lung cancer</s0><s2>NM</s2><s5>09</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Cáncer del pulmón</s0><s2>NM</s2><s5>09</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Europe</s0><s2>NG</s2><s5>11</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Europe</s0><s2>NG</s2><s5>11</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Europa</s0><s2>NG</s2><s5>11</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Recherche</s0><s5>12</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Research</s0><s5>12</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Investigación</s0><s5>12</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Cancérologie</s0><s5>17</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Cancerology</s0><s5>17</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Cancerología</s0><s5>17</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Appareil respiratoire pathologie</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Respiratory disease</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Aparato respiratorio patología</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Bronche pathologie</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Bronchus disease</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Bronquio patología</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Poumon pathologie</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Lung disease</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Pulmón patología</s0><s5>39</s5></fC07><fN21><s1>339</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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|texte= 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)
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