Journal Article

Immunotherapy with autologous tumor cell-BCG vaccine in patients with colon cancer: a prospective study of medical and economic benefits

Uyl-de Groot, C.A., Vermorken, J.B., Hanna, M.G., Pinedo, H.M., Groot, M.T., Bonsel, G.J., Verboom, P., Meijer, C.J.L.M.

2005

Overview

We have completed a multicenter, randomized controlled phase III clinical trial in Stages II and III colon cancer patients with active specific immunotherapy (ASI) using autologous tumor cells with an immunomodulating adjuvant bacillus Callmette-Guérin (BCG) vaccine (OncoVAX ®) in an adjuvant setting. In this study, patients were randomized to receive either OncoVAX ® therapy or no therapy after surgical resection of the primary tumor and stratified by stage of disease. Since the biologic essence of the effective tumor immunotherapy is the presence in the vaccine of a minimum number of viable, metabolically active, autologous tumor cells, the processing of the vaccine product, occurred within 48 h after surgery. Analysis of prognostic benefit in the pivotal phase III trial, with a 5.8 year median follow-up, showed that a beneficial effect of OncoVAX ® is statistically significant for all endpoints including recurrence-free interval, overall survival, and recurrence-free survival in Stage II colon cancer patients. Surgery alone cures approximately 65% of Stage II (Dukes B 2, B 3) colon cancer patients. In the remaining patients, OncoVAX ® in an adjuvant setting, significantly prolongs recurrence-free interval (57.1% relative risk reduction) and significantly improves 5-year overall survival and recurrence-free survival. No statistically significant prognostic benefits were achieved in Stage III (Duke's C 1–C 3) patients. A health economics assessment was performed on these results in Stage II colon cancer patients using disease-free survival and overall survival (for the entire intent-to-treat population). Cost-effectiveness, cost-utility and sensitivity analysis were applied with, cost of life years, recurrence-free life years and quality adjusted life years (QALYs) as the primary endpoints to this analysis. The perspective of the economic analysis was the current direct medical cost established by the health care providers. The introduction of new technologies often leads to additional costs. This report verified that the use of OncoVAX ® for patients with Stage II colon cancer not only has significant prognostic benefit and positive clinical outcomes, but also showed that OncoVAX ® therapy yields impressive health economics benefits.

• Publisher: Elsevier Ltd,Elsevier,Elsevier Limited
• Subject: Adult / Aged / Aged, 80 and over / Antigens / Applied microbiology / Autologous tumor cell vaccine / Bacterial diseases / BCG / BCG Vaccine - therapeutic use / Biological and medical sciences / Cancer therapies / Cancer Vaccines - economics / Cancer Vaccines - therapeutic use / Clinical trials / Colon / Colon cancer / Colonic Neoplasms - economics / Colonic Neoplasms - mortality / Colonic Neoplasms - surgery / Colonic Neoplasms - therapy / Colorectal cancer / Combined Modality Therapy / Cost-Benefit Analysis / Costs / Disease prevention / Disease-Free Survival / Economic analysis / Economics / Female / Fundamental and applied biological sciences. Psychology / Human bacterial diseases / Humans / Immunization / Immunotherapy / Immunotherapy, Active / Infectious diseases / Male / Medical sciences / Microbiology / Middle Aged / Mortality / OncoVAX ® therapy / Pharmacoeconomics / Prognosis / Prospective Studies / Sensitivity analysis / Surgery / Survival / Survival Rate / Tuberculosis and atypical mycobacterial infections / Tumors / Vaccines / Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)