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Randomized Phase IIB Trial of BLP25 Liposome Vaccine in Stage IIIB and IV Non–Small-Cell Lung Cancer

From the Cross Cancer Institute, Edmonton; Tom Baker Cancer Center, Calgary, Alberta; Vancouver Cancer Centre, Vancouver; Fraser Valley Cancer Centre, Surrey; Vancouver Island Cancer Center, Victoria, British Columbia; CancerCare Manitoba, Winnipeg, Manitoba; Ottawa Regional Cancer Center, Integrated Cancer Program, Ottawa; Juravinski Cancer Center, Cancer Care Ontario Regional Partner, Hamilton; Northwestern Ontario Regional Cancer Care; Thunder Bay Regional Health Science Center, Thunder Bay, Ontario; Hôpital Notre-Dame du Chum, Montreal; Hôpital Laval, Sainte-Foy, Québec City, Québec; Nova Scotia Cancer Center, Halifax, Nova Scotia; Clatterbridge Centre for Oncology, Bebington, Wirral; University of Edinburgh, Division of Oncology, Edinburgh, Scotland; St George's Hospital; and Guy's Hospital, London, England, United Kingdom

Address reprint requests to Charles Butts, MD, Cross Cancer Institute, 11560 University Avenue, Edmonton, Alberta T6G 1Z2, Canada; e-mail: charlesb{at}cancerboard.ab.ca

PURPOSE: 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 AND 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 µg). 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.

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.

Supported by Biomira Inc and Merck KGaA.

Presented in part at the 29th European Society for Medical Oncology Congress, Vienna, Austria, October 29-November 2, 2004.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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