Aphase III clinical trial conducted by researchers at Lehigh Valley Hospital, Allentown, Pennsylvania, found that the OncoVAX colon cancer vaccine reduced the 5-year recurrence rate of patients with stage II colon cancer patients by 61% and improved their cancer-free survival rate by 50%. The study, published in a recent issue of the Lancet, compared patients who underwent surgery alone to patients who had surgery plus the vaccine.
The vaccine was recently approved for use in The Netherlands, and the Intracel Corporation has applied for FDA approval. Side effects observed in patients treated with OncoVAX include mild flu-like symptoms, redness, and/or ulceration at the injection site.
A New Postsurgical Option
According to the American Cancer Society, colon cancer is the second leading cause of cancer death in both men and women. Of the approximately 95,600 Americans diagnosed with colon cancer in 1998, two-thirds had stage II disease.
Colon cancer patients have very few postsurgical treatment options available, said Herbert C. Hoover, md, chairman of the Department of Surgery, Lehigh Valley Hospital and professor of surgery at Penn State University, School of Medicine. If approved by FDA, the OncoVAX vaccine therapy will be a completely new treatment approach that could become standard treatment for stage II colon cancer, following surgical removal.
OncoVax is an active specific immunotherapeutic that is prepared for each patient using the patients own surgically removed tumor. The tumor is treated with enzymes to separate the tumor cells. The cells are then frozen for vaccine preparation, and, beginning 4 weeks after surgery, the patient receives four injections over a 6-month period.