Gardasil gets FDA okay to fight anal cancer
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by Aimee Keenan-Greene
The Food and Drug Administration has expanded the use of the Gardasil vaccine to include prevention of anal cancer and precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18.
The vaccine will now be available for kids ages 9 through 18, and young adults up to 26 years of age.
The human papillomavirus, HPV, is a family of over 100 viruses which cause warts and tumors of the genital tract, including cancer of the cervix, according to MedicineNet. 30 types can be passed through sexual contact. HPVs produce proteins known as E5, E6, and E7. These proteins interfere with the cell functions that normally prevent excessive growth. HPV E6 interferes with the human protein p53. This protein is present in all people and acts to keep tumors from growing.
The American Cancer Society estimates 5,300 people are diagnosed with anal cancer annually in the United States, affecting more women than men. The National Cancer Institute (NCI) says 720 people a year die of anal cancer.
Anal cancer is still considered uncommon, but the incidence rate is increasing. HPV is associated with approximately 90 percent of anal cancer.
“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
Gardasil is already approved for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.
The FDA says:
"Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well."
As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide since its approval in 2006, according to the manufacturer Merck.
Anal cancer is cancer of the anus, the canal at the end of the large intestine, below the rectum, according to Butler Hospital in Providence. Cancer occurs when the cells that cover the lumen of the anus divide without control or order. A mass of tissue forms called a growth or tumor. The term cancer refers to malignant tumors, which can invade nearby tissues and spread to other parts of the body. A benign tumor does not invade or spread.
According to the NCI, risk factors for developing anal cancer, other than being infecting with HPV include:
Being over 50 years old
Having many sexual partners
Having receptive anal intercourse
Frequent anal redness, swelling, and soreness
Having anal fistulas (abnormal openings)
Smoking cigarettes
If you have any of these symptoms, the NCI says to see a doctor:
Bleeding from the anus or rectum
Pain or pressure in the area around the anus
Itching or discharge from the anus
A lump near the anus
A change in bowel habits
Testing to diagnose anal cancer may include a digital rectal examination, anoscopy, proctoscopy, endo-anal or endorectal ultrasound, and biopsy. If detected, there are several treatment options depending on the stage and placement of the cancer.
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