Randomized phase IIB trial of BLP25 liposome vaccine in stage IIIB and IV non-small-cell lung cancer.
OBJECTIVE
To evaluate the effect of BLP25 liposome vaccine (L-BLP25) on survival and toxicity in patients with stage IIIB and IV non-small-cell lung cancer (NSCLC). Secondary objectives included health-related quality of life (QOL) and immune responses elicited by L-BLP25.


METHODS
Patients with an Eastern Cooperative Oncology Group performance status of 0 to 2 and stable or responding stage IIIB or IV NSCLC after any first-line chemotherapy were prestratified by stage and randomly assigned to either L-BLP25 plus best supportive care (BSC) or BSC alone. Patients in the L-BLP25 arm received a single intravenous dose of cyclophosphamide 300 mg/m2 followed by eight weekly subcutaneous immunizations with L-BLP25 (1,000 microg). Subsequent immunizations were administered at 6-week intervals.


RESULTS
The survival results indicate a median survival time of 4.4 months longer for patients randomly assigned to the L-BLP25 arm (88 patients) compared with patients assigned to the BSC arm (83 patients; adjusted hazard ratio [HR] = 0.739; 95% CI, 0.509 to 1.073; P = .112). The greatest effect was observed in stage IIIB locoregional (LR) patients, for whom the median survival time for the L-BLP25 arm has not yet been reached compared with 13.3 months for the BSC arm (adjusted HR = 0.524; 95% CI, 0.261 to 1.052; P = .069). No significant toxicity was observed. QOL was maintained longer in patients on the L-BLP25 arm.


CONCLUSIONS
L-BLP25 maintenance therapy in patients with advanced NSCLC is feasible with minimal toxicity. The survival difference of 4.4 months observed with the vaccine did not reach statistical significance. In the subgroup of patients with stage IIIB LR disease, a strong trend in 2-year survival in favor of L-BLP25 was observed.
Butts
Charles
C
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada. charlesb@cancerboard.ab.ca
Murray
Nevin
N
Maksymiuk
Andrew
A
Goss
Glenwood
G
Marshall
Ernie
E
Soulières
Denis
D
Cormier
Yvon
Y
Ellis
Peter
P
Price
Allan
A
Sawhney
Ravinder
R
Davis
Mary
M
Mansi
Janine
J
Smith
Colum
C
Vergidis
Dimitrios
D
Ellis
Paul
P
MacNeil
Mary
M
Palmer
Martin
M
D000368:Aged; D019496:Cancer Vaccines / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D016001:Confidence Intervals; D005260:Female; D006801:Humans; D008081:Liposomes; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011336:Probability; D011379:Prognosis; D016016:Proportional Hazards Models; D012016:Reference Values; D018570:Risk Assessment; D016879:Salvage Therapy; D016019:Survival Analysis; D016896:Treatment Outcome
D019496:Cancer Vaccines; D008081:Liposomes