NEW YORK (Reuters Health) - Following surgery, vaccination with virus-modified autologous tumor cells is a safe method of improving survival in patients with glioblastoma multiforme, according to the results of a pilot study reported in the November 1st issue of the Journal of Clinical Oncology.
The findings are based on a comparison of 23 patients who received the vaccine and 87 who did not. Although the main goal of the study was to determine feasibility and safety, the researchers also assessed overall and progression-free survival.
Tumor cell cultures were successfully established in roughly 90% of patients, lead author Dr. Hans Herbert Steiner, from the University of Heidelberg in Germany, and colleagues note. Vaccination was not associated with any adverse effects.
The median overall and progression-free survival periods for the vaccine group were 100 and 40 weeks, respectively. In contrast, the corresponding periods in the control group were much lower, just 49 and 26 weeks (p < 0.001 and 0.024).
Ninety-one percent of vaccinated subjects survived at least 1 year compared with only 45% of controls. Moreover, 4% of vaccinated subjects survived at least 3 years, whereas no long-term survivors were seen in the control group.
Serologic testing revealed significant increases in delayed-type hypersensitivity and numbers of tumor-specific T cells in the vaccinated group, the investigators note.
“We are aware of the fact that this pilot study has limitations regarding its patient number and the nonrandomized study design,” the authors state. “However, the results are remarkable because the treatment is well tolerated, has no major side effects, and therefore does not negatively affect the quality of life of the patients.”
Still, randomized trials are needed to rule out potential confounders, the researchers note.
Source: J Clin Oncol 2004;22:4272-4281. [ Google search on this article ]
MeSH Headings:Clinical Trials: Environment and Public Health: Epidemiologic Methods: Evaluation Studies: Health: Health Occupations: Health Services Administration: Human Activities: Mathematics: Medicine: Investigative Techniques: Physical Sciences: Population Characteristics: Preventive Medicine: Public Health: Quality of Health Care: Recombinant Proteins: Specialties, Medical: Statistics: Survival: Vaccines, Synthetic: Survival Analysis: Epidemiologic Study Characteristics: Health Care Quality, Access, and Evaluation: Health Care Evaluation Mechanisms: Disease-Free Survival: Cancer Vaccines: Analytical, Diagnostic and Therapeutic Techniques and Equipment: Anthropology, Education, Sociology and Social Phenomena: Biological Sciences: Health Care: Physical SciencesCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
