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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 : 004686 ( PascalFrancis/Corpus ); précédent : 004685; suivant : 004687

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)

Auteurs : Giuseppe Giaccone ; 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 Legrand

Source :

RBID : Pascal:05-0481277

Descripteurs français

English descriptors

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

pA  
A01 01  1    @0 0732-183X
A03   1    @0 J. clin. oncol.
A05       @2 23
A06       @2 28
A08 01  1  ENG  @1 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)
A11 01  1    @1 GIACCONE (Giuseppe)
A11 02  1    @1 DEBRUYNE (Channa)
A11 03  1    @1 FELIP (Enriqueta)
A11 04  1    @1 CHAPMAN (Paul B.)
A11 05  1    @1 GRANT (Stefan C.)
A11 06  1    @1 MILLWARD (Michael)
A11 07  1    @1 THIBERVILLE (Luc)
A11 08  1    @1 D'ADDARIO (Giannicola)
A11 09  1    @1 COENS (Corneel)
A11 10  1    @1 ROME (Lisa S.)
A11 11  1    @1 ZATLOUKAL (Petr)
A11 12  1    @1 MASSO (Oriol)
A11 13  1    @1 LEGRAND (Catherine)
A14 01      @1 Vnje Universiteit Medical Center @2 Amsterdam @3 NLD
A14 02      @1 EORTC Data Center @2 Brussels @3 BEL
A14 03      @1 Vail d'Hebron University Hospital @2 Barcelona @3 ESP
A14 04      @1 Memorial Sloan- Kettering Cancer Center @2 New York, NY @3 USA
A14 05      @1 School of Medicine and Pharmacology, Sir Charles Gairdner Hospital @2 Perth @3 AUS
A14 06      @1 Clinique Pneumologique, Rouen University Hospital @3 FRA
A14 07      @2 Kantonsspital, St Gallen @3 CHE
A14 08      @1 VA Connecticut Cancer Center @2 West Haven, CT @3 USA
A14 09      @1 Charles University, Faculty Hospital Bulovka and Postgraduate Medical School @2 Prague @3 CZE
A20       @1 6854-6864
A21       @1 2005
A23 01      @0 ENG
A43 01      @1 INIST @2 20094 @5 354000131942050090
A44       @0 0000 @1 © 2005 INIST-CNRS. All rights reserved.
A45       @0 46 ref.
A47 01  1    @0 05-0481277
A60       @1 P
A61       @0 A
A64 01  1    @0 Journal of clinical oncology
A66 01      @0 USA
C01 01    ENG  @0 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.
C02 01  X    @0 002B04
C02 02  X    @0 002B11A
C03 01  X  FRE  @0 Essai clinique phase III @5 01
C03 01  X  ENG  @0 Phase III trial @5 01
C03 01  X  SPA  @0 Ensayo clínico fase III @5 01
C03 02  X  FRE  @0 Traitement @5 02
C03 02  X  ENG  @0 Treatment @5 02
C03 02  X  SPA  @0 Tratamiento @5 02
C03 03  X  FRE  @0 Adjuvant @5 03
C03 03  X  ENG  @0 Adjuvant @5 03
C03 03  X  SPA  @0 Coadyuvante @5 03
C03 04  X  FRE  @0 Carcinome petite cellule bronchopulmonaire @2 NM @5 04
C03 04  X  ENG  @0 Bonchopulmonary small cell carcinoma @2 NM @5 04
C03 04  X  SPA  @0 Carcinoma pequeňa célula bronchopulmonar @2 NM @5 04
C03 05  X  FRE  @0 BCG @5 05
C03 05  X  ENG  @0 BCG @5 05
C03 05  X  SPA  @0 BCG @5 05
C03 06  X  FRE  @0 Vaccination @5 06
C03 06  X  ENG  @0 Vaccination @5 06
C03 06  X  SPA  @0 Vacunación @5 06
C03 07  X  FRE  @0 Tumeur maligne @5 07
C03 07  X  ENG  @0 Malignant tumor @5 07
C03 07  X  SPA  @0 Tumor maligno @5 07
C03 08  X  FRE  @0 Homme @5 08
C03 08  X  ENG  @0 Human @5 08
C03 08  X  SPA  @0 Hombre @5 08
C03 09  X  FRE  @0 Cancer du poumon @2 NM @5 09
C03 09  X  ENG  @0 Lung cancer @2 NM @5 09
C03 09  X  SPA  @0 Cáncer del pulmón @2 NM @5 09
C03 10  X  FRE  @0 Europe @2 NG @5 11
C03 10  X  ENG  @0 Europe @2 NG @5 11
C03 10  X  SPA  @0 Europa @2 NG @5 11
C03 11  X  FRE  @0 Recherche @5 12
C03 11  X  ENG  @0 Research @5 12
C03 11  X  SPA  @0 Investigación @5 12
C03 12  X  FRE  @0 Cancérologie @5 17
C03 12  X  ENG  @0 Cancerology @5 17
C03 12  X  SPA  @0 Cancerología @5 17
C07 01  X  FRE  @0 Appareil respiratoire pathologie @5 37
C07 01  X  ENG  @0 Respiratory disease @5 37
C07 01  X  SPA  @0 Aparato respiratorio patología @5 37
C07 02  X  FRE  @0 Bronche pathologie @5 38
C07 02  X  ENG  @0 Bronchus disease @5 38
C07 02  X  SPA  @0 Bronquio patología @5 38
C07 03  X  FRE  @0 Poumon pathologie @5 39
C07 03  X  ENG  @0 Lung disease @5 39
C07 03  X  SPA  @0 Pulmón patología @5 39
N21       @1 339
N44 01      @1 OTO
N82       @1 OTO

Format Inist (serveur)

NO : PASCAL 05-0481277 INIST
ET : 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)
AU : GIACCONE (Giuseppe); DEBRUYNE (Channa); FELIP (Enriqueta); CHAPMAN (Paul B.); GRANT (Stefan C.); MILLWARD (Michael); THIBERVILLE (Luc); D'ADDARIO (Giannicola); COENS (Corneel); ROME (Lisa S.); ZATLOUKAL (Petr); MASSO (Oriol); LEGRAND (Catherine)
AF : Vnje Universiteit Medical Center/Amsterdam/Pays-Bas; EORTC Data Center/Brussels/Belgique; Vail d'Hebron University Hospital/Barcelona/Espagne; Memorial Sloan- Kettering Cancer Center/New York, NY/Etats-Unis; School of Medicine and Pharmacology, Sir Charles Gairdner Hospital/Perth/Australie; Clinique Pneumologique, Rouen University Hospital/France; Kantonsspital, St Gallen/Suisse; VA Connecticut Cancer Center/West Haven, CT/Etats-Unis; Charles University, Faculty Hospital Bulovka and Postgraduate Medical School/Prague/Tchèque, République
DT : Publication en série; Niveau analytique
SO : Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2005; Vol. 23; No. 28; Pp. 6854-6864; Bibl. 46 ref.
LA : Anglais
EA : 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.
CC : 002B04; 002B11A
FD : Essai clinique phase III; Traitement; Adjuvant; Carcinome petite cellule bronchopulmonaire; BCG; Vaccination; Tumeur maligne; Homme; Cancer du poumon; Europe; Recherche; Cancérologie
FG : Appareil respiratoire pathologie; Bronche pathologie; Poumon pathologie
ED : Phase III trial; Treatment; Adjuvant; Bonchopulmonary small cell carcinoma; BCG; Vaccination; Malignant tumor; Human; Lung cancer; Europe; Research; Cancerology
EG : Respiratory disease; Bronchus disease; Lung disease
SD : Ensayo clínico fase III; Tratamiento; Coadyuvante; Carcinoma pequeňa célula bronchopulmonar; BCG; Vacunación; Tumor maligno; Hombre; Cáncer del pulmón; Europa; Investigación; Cancerología
LO : INIST-20094.354000131942050090
ID : 05-0481277

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Pascal:05-0481277

Le document en format XML

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<term>Vaccination</term>
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<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>
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<ET>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)</ET>
<AU>GIACCONE (Giuseppe); DEBRUYNE (Channa); FELIP (Enriqueta); CHAPMAN (Paul B.); GRANT (Stefan C.); MILLWARD (Michael); THIBERVILLE (Luc); D'ADDARIO (Giannicola); COENS (Corneel); ROME (Lisa S.); ZATLOUKAL (Petr); MASSO (Oriol); LEGRAND (Catherine)</AU>
<AF>Vnje Universiteit Medical Center/Amsterdam/Pays-Bas; EORTC Data Center/Brussels/Belgique; Vail d'Hebron University Hospital/Barcelona/Espagne; Memorial Sloan- Kettering Cancer Center/New York, NY/Etats-Unis; School of Medicine and Pharmacology, Sir Charles Gairdner Hospital/Perth/Australie; Clinique Pneumologique, Rouen University Hospital/France; Kantonsspital, St Gallen/Suisse; VA Connecticut Cancer Center/West Haven, CT/Etats-Unis; Charles University, Faculty Hospital Bulovka and Postgraduate Medical School/Prague/Tchèque, République</AF>
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<EA>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.</EA>
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