Randomized phase IIB trial of BLP25 liposome vaccine in stage IIIB and IV non-small-cell lung cancer.

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J Clin Oncol. 2005 Sep 20;23(27):6674-81.

Butts C, Murray N, Maksymiuk A, Goss G, Marshall E, Soulières D, Cormier Y, Ellis P, Price A, Sawhney R, Davis M, Mansi J, Smith C, Vergidis D, Ellis P, MacNeil M, Palmer M.
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada.

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.
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.
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.
CONCLUSION: 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.