AustralieFrV1, Main, Exploration, bibRecord, 008A06

Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer

Identifieur interne : 008A06 ( Main/Exploration ); précédent : 008A05; suivant : 008A07

Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer

Auteurs : Andrew Bottomley [Belgique] ; Channa Debruyne [Belgique] ; Enriqueta Felip [Espagne] ; Michael Millward [Australie] ; Luc Thiberville [France] ; Giannicola D'Addario [Suisse] ; Lisa Rome [États-Unis] ; Petr Zatloukal [République tchèque] ; Corneel Coens [Belgique] ; Giuseppe Giaccone [États-Unis]

Source :

European journal of cancer : (1990) [ 0959-8049 ] ; 2008.

RBID : Pascal:08-0531815

Descripteurs français

Pascal (Inist)
- Essai clinique phase III, Symptomatologie, Qualité de vie, Carcinome à petites cellules bronchopulmonaire, International, Randomisation, Traitement, Vaccination, Prévention, BCG, Homme, Cancer du poumon, Cancérologie.
Wicri :
- topic : Vaccination, Homme.

English descriptors

KwdEn :
- BCG, Bonchopulmonary small cell carcinoma, Cancerology, Human, International, Lung cancer, Phase III trial, Prevention, Quality of life, Randomization, Symptomatology, Treatment, Vaccination.

Abstract

Aims: This study reports the symptom and HRQOL results in which standard treatment was compared to standard therapy plus Bec2, an anti-idiotypic antibody that mimics GD3, a ganglioside antigen. Methods: Five hundred and fifteen LD SCLC patients were randomised to receive five vaccinations of Bec2 (2.5 mg)/BCG vaccine arm (VA) or an observational arm (OA) administered over a 10-week period. Survival was the primary end-point; HRQOL was a secondary end-point, assessed using the EORTC QLQ-C30/LC 13. Results: There was no improvement in survival or progression-free survival in the vaccination arm. At baseline patients in both arms demonstrated significantly impaired scores on the global QOL scale, when compared to a normative population. However, HRQOL and symptom scores between the two treatment arms were not statistically different at any time point. Conclusion: We found no benefits to patient HRQOL by additional vaccination with Bec2/BCG to LD SCLC for patients who have been undergoing standard therapy.

Affiliations:

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Le document en format XML

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<term>International</term>
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<term>Phase III trial</term>
<term>Prevention</term>
<term>Quality of life</term>
<term>Randomization</term>
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<term>International</term>
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<term>Traitement</term>
<term>Vaccination</term>
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<front><div type="abstract" xml:lang="en">Aims: This study reports the symptom and HRQOL results in which standard treatment was compared to standard therapy plus Bec2, an anti-idiotypic antibody that mimics GD3, a ganglioside antigen. Methods: Five hundred and fifteen LD SCLC patients were randomised to receive five vaccinations of Bec2 (2.5 mg)/BCG vaccine arm (VA) or an observational arm (OA) administered over a 10-week period. Survival was the primary end-point; HRQOL was a secondary end-point, assessed using the EORTC QLQ-C30/LC 13. Results: There was no improvement in survival or progression-free survival in the vaccination arm. At baseline patients in both arms demonstrated significantly impaired scores on the global QOL scale, when compared to a normative population. However, HRQOL and symptom scores between the two treatment arms were not statistically different at any time point. Conclusion: We found no benefits to patient HRQOL by additional vaccination with Bec2/BCG to LD SCLC for patients who have been undergoing standard therapy.</div>
</front>
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Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer

Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri