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. - Archive ouverte HAL Access content directly
Journal Articles European Journal of Cancer Year : 2008

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.

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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 (2.5mg)/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.

Dates and versions

inserm-00467793 , version 1 (29-03-2010)

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Andrew Bottomley, Channa Debruyne, Enriqueta Felip, Michael Millward, Luc Thiberville, et al.. 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.. European Journal of Cancer, 2008, 44 (15), pp.2178-84. ⟨10.1016/j.ejca.2008.06.036⟩. ⟨inserm-00467793⟩
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