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Journal of Cancer Research and Clinical Oncology

, Volume 137, Issue 9, pp 1337–1342 | Cite as

Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial

  • Charles Butts
  • Andrew Maksymiuk
  • Glenwood Goss
  • Denis Soulières
  • Ernie Marshall
  • Yvon Cormier
  • Peter M. Ellis
  • Allan Price
  • Ravinder Sawhney
  • Frank Beier
  • Martin Falk
  • Nevin Murray
Original Paper

Abstract

Purpose

To present an updated survival analysis of an open-label, parallel-group, phase IIB trial of BLP25 liposome vaccine (L-BLP25) in patients with stage IIIB or IV non-small-cell lung cancer (NSCLC).

Methods

Patients were randomized to either L-BLP25 plus best supportive care (BSC) or BSC alone. Patients in the L-BLP25 arm received subcutaneous vaccinations of L-BLP25 930 μg weekly for 8 weeks, followed by maintenance vaccinations at 6-week intervals.

Results

Median survival time was 4.2 months longer in patients receiving L-BLP25 plus BSC (n = 88) than in those receiving BSC alone (n = 83; 17.2 months vs. 13.0 months, respectively; hazard ratio [HR] 0.745, 95% confidence interval [CI] 0.533–1.042). The 3-year survival rate was 31% in patients receiving L-BLP25 plus BSC and 17% in those receiving BSC (P = 0.035). In the stratified subset of patients with stage IIIB loco-regional (LR) disease, median survival time was 17.3 months longer in patients receiving L-BLP25 plus BSC (n = 35) than in those receiving BSC (n = 30; 30.6 months vs. 13.3 months, respectively; HR 0.548, 95% CI 0.301–0.999). In this subgroup, 3-year survival was 49% in patients receiving L-BLP25 plus BSC and 27% in those receiving BSC (P = 0.070).

Conclusions

Confirming the initial results, further follow-up continues to show that survival time for patients with stage IIIB/IV NSCLC was longer with L-BLP25 plus BSC compared with BSC alone, with the greatest difference seen in patients with stage IIIB LR disease.

Keywords

Survival Non-small-cell lung cancer Therapeutic cancer vaccine L-BLP25 MUC1 

Notes

Acknowledgments

This trial was supported by Biomira Inc., Edmonton, Canada, in collaboration with Merck KGaA, Darmstadt, Germany. The authors take full responsibility for the content of this publication. Editorial assistance, including drafting and revision of the manuscript as directed by the authors, was provided by Ian Faulkner, International Medical Press, funded by Merck KGaA, Darmstadt, Germany.

Conflict of interest

Frank Beier is employed as a Senior Biostatistician at Merck KGaA in Darmstadt. Martin Falk is an employee of Merck KGaA. Charles Butts has provided consultancy and served on Speakers' Bureaux for Merck Serono.

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Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Charles Butts
    • 1
  • Andrew Maksymiuk
    • 2
  • Glenwood Goss
    • 3
  • Denis Soulières
    • 4
  • Ernie Marshall
    • 5
  • Yvon Cormier
    • 6
  • Peter M. Ellis
    • 7
  • Allan Price
    • 8
  • Ravinder Sawhney
    • 9
  • Frank Beier
    • 10
  • Martin Falk
    • 10
  • Nevin Murray
    • 11
  1. 1.Cross Cancer InstituteEdmontonCanada
  2. 2.CancerCare ManitobaWinnipegCanada
  3. 3.The Ottawa Hospital Cancer CentreOttawaCanada
  4. 4.Centre Hospitalier de l’Université de MontrealMontrealCanada
  5. 5.Clatterbridge Centre for OncologyBebingtonUK
  6. 6.Universite LavalSainte-FoyCanada
  7. 7.Juravinski Cancer CentreHamiltonCanada
  8. 8.Western General HospitalEdinburghUK
  9. 9.Fraser Valley Cancer CentreSurreyCanada
  10. 10.Merck KGaADarmstadtGermany
  11. 11.Vancouver Cancer CentreVancouverCanada

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