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Clinical Trial
. 2011 Sep;137(9):1337-42.
doi: 10.1007/s00432-011-1003-3. Epub 2011 Jul 9.

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  1 , Andrew Maksymiuk, Glenwood Goss, Denis Soulières, Ernie Marshall, Yvon Cormier, Peter M Ellis, Allan Price, Ravinder Sawhney, Frank Beier, Martin Falk, Nevin Murray
Affiliations
Clinical Trial

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 et al. J Cancer Res Clin Oncol. 2011 Sep.

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.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Overall survival in L-BLP25 and best supportive care (BSC) treatment arms after extended follow-up in a total patient group, b stage IIIB MPE/IV subgroup, and c stage IIIB LR subgroup (Survival based on Kaplan–Meier estimates) BSC best supportive care, CI confidence interval, HR hazard ratio, LR loco-regional, MPE malignant pleural effusion
Fig. 2
Fig. 2
Three-year survival rates (% patients surviving) in the total patient population, patients with stage IIIB MPE/IV disease, and patients with stage IIIB LR disease BSC best supportive care, LR loco-regional, MPE malignant pleural effusion. P-values are descriptive statistics for chi-square testing comparing 3-year survival rates with L-BLP25 and BSC
See this image and copyright information in PMC

References

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