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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

Bottomley, Andrew;Debruyne, Channa;Felip, Enriqueta;Millward, Michael;Giaccone, Giuseppe;et.al.
(2008) European Journal of Cancer — Vol. 44, n° 15, p. 2178-2184 (2008)

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Authors
  • Bottomley, AndrewUCLouvain
    Author
  • Debruyne, ChannaUCLouvain
    Author
  • Felip, Enriqueta
    Author
  • Millward, Michael
    Author
  • Coens, CorneelUCLouvain
    Author
  • Giaccone, Giuseppe
    Author
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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 (2.5 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. (c) 2008 Elsevier Ltd. All rights reserved.
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Bottomley, A., Debruyne, C., Felip, E., Millward, M., Thiberville, L., D’Addario, G., Rome, L., Zatloukal, P., Coens, C., & Giaccone, G. (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. European Journal of Cancer, 44(15), 2178-2184. https://doi.org/10.1016/j.ejca.2008.06.036 (Original work published 2008)