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Other HPV Cancers

Federal Committee Ponders HPV Vaccines and Anal Cancer

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Man and Woman in Black and White

In late 2010 the Food and Drug Administration approved Merck’s Gardasil® HPV vaccine to prevent anal cancers in males and females. The American Cancer Society (ACS) estimates there about 5,200 new cases (with approximately 700 deaths) each year in the U.S. Women are affected more than men, although men who have sex with men are at higher risk for anal cancers.

Current recommendations issued by the Advisory Committee on Immunization Practices (ACIP) - the body that advises federal health officials on vaccine-preventable diseases- call for permissive use of HPV vaccines (at a health care provider’s discretion) in males to prevent genital warts. Many public health observers are now speculating on what the potential impact the anal cancer indication may have on future ACIP guidance: the two ACIP meetings held so far in 2011 included a number of discussions about HPV vaccines and anal cancer, including cost-effectiveness and policy considerations for HPV vaccine in males.

More discussions, and possibly a vote on updated guidance, will likely occur at the next ACIP meeting October 25-26, 2011.


Anal Cancer Primer

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In late 2010 the FDA green-lighted use of Merck’s Gardasil® vaccine for the prevention of anal cancers in males and females ages 9-26. The new indication put a spotlight on a disease that had already gathered more attention following Farrah Fawcett’s death from anal cancer in 2009.

What is anal cancer?
Most anal cancers are squamous cell carcinomas that develop in the anal canal (the passage linking the lower intestine to the outside of our bodies). Squamous cells are tough, flat cells that are part of the epidermis (the top most layer of skin).

The American Cancer Society (ACS) estimates there about 5,200 new cases (with approximately 700 deaths) each year in the U.S. Women are affected more than men, although men who have sex with men (MSM) are at high risk for anal cancers.

Signs and Symptoms:

  • Bleeding, itching, discharge, or pain with the anus or rectum (symptoms can mimic those found with hemorrhoids)
  • Lumps or bumps in the anus
  • Swollen glands in the groin or anus
  • Change in stools or bowl movements (going more or less often)
  • Not all cases involve symptoms, or symptoms might be minor

What are risk factors for anal cancer?

  • Infection with high-risk HPV types
  • Having a weakened immune system (for example, being HIV positive or a transplant patient)
  • Anal sex
  • A history of having cervical or vaginal cancer
  • Smoking

What is the link between HPV and anal cancer?
As with cervical cancer, high-risk types of HPV are found in most anal cancers. HPV produces proteins that are able to ‘turn off” other proteins that the immune system uses to suppress and clear tumor cells. Hampering the immune response in this way is a key part in allowing cells to become abnormal and progress along to cancer.

Transmission of HPV to the anal canal is usually (but not always) by anal sex. Since HPV is acquired through skin-to-skin contact with an area that contains the virus, penetration is not necessary for transmission to occur. But fingers and sex toys are also possible routes of introducing HPV to the anus, especially when HPV-related lesions are present in the genital or perianal area. Females and gay men are not the only ones at risk: It’s not uncommon for anal HPV to be detected in men who report no history of sexual contact with other men, and in women who have never had anal intercourse.

Screening tests
Anal cytology (Pap tests): Anal Pap tests involve taking cell samples from the anal canal which are then viewed under microscope and examined for abnormalities. Much like cervical cytology, anal Paps seek to detect abnormal cell changes or lesions of the epithelium (surface of the skin), ideally before cancer develops. Precancerous anal lesions are referred to as anal intraepithelial neoplasia (AIN) or anal squamous intraepithelial lesion (ASIL). Depending on their severity, size, and risk to progress to cancer, lesions can be classified as either low-grade or high-grade.

Follow-up for patients with abnormal cell changes detected is high resolution anoscopy (HRA). A procedure similar to cervical colposcopy, HRA uses a special microscope to examine the anal area. Any suspicious lesions detected are biopsied.

Low-grade lesions are often monitored, while high-grade lesions may either be monitored or treated. Treatment for anal cancer includes:

  • Surgery
  • Radiation therapy
  • Chemotherapy
  • Combination therapy (radiation and chemotherapy used in tandem)


  • One HPV vaccine, Gardasil®, is approved for the prevention of anal cancers in males and females ages 9-26.
  • Practice safer sex such as using condoms. Condoms aren’t 100% effective at preventing HPV transmission, but using them consistently and correctly can reduce the risk of acquiring the virus.
  • Stop smoking.
  • Anal Pap tests for those with risk factors for anal cancer (see What are risk factors for anal cancer above).

American Society of Colon & Rectal Surgeons: Anal Cancer
American Cancer Society: Detailed Guide to Anal Cancer
Richard Ortoski, DO and Christine Kell, PhD. Anal Cancer and Screening Guidelines for Human Papillomavirus in Men. Journal of the American Osteopathic Association, March 2011.
111(S2), 3, S35-S43.
UCSF AIDS Research Institute. Anal Cancer In Gay and Bisexual Men


Oral Cancer Rates Up Sharply Since 1970s

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Data presented at the February meeting of the American Association for the Advancement of Science (AAAS) and reported in numerous media outlets provide more evidence of the link between HPV, oral sex, and the development of some oral cancers.

Head and neck cancers include those of the oral cavity, and most HPV-related head and neck cancers are of the oropharynx (tongue, soft palate, and tonsils). Tobacco and alcohol use is strongly linked to these diseases, but “high risk” HPV is increasingly found to play a role, perhaps accounting for half or more of oropharyngeal cancers in the U.S. At the AAAS meeting, Ohio State University researcher Dr. Maura Gillison said oral cancers increased 225% in the U.S. from the mid-1970s through 2007.

Earlier research by Gypsyamber D’Souza, Ph.D., and colleagues demonstrated that oral sex is a risk for cancers of the oropharynx. In a study published in the Journal of Infectious Diseases in 2009, she and her team found the risk of oral HPV infection grew as the number of oral sex partners increased. HPV was detected most often in the oral cavity of those who had six or more oral sex partners in the previous 12 months.

There are two HPV vaccines (Gardasil® and Cervarix®) on the market, and both are effective against the HPV types most commonly found with cervical cancers (Gardasil® also prevents infection with the types of HPV that typically cause genital warts). One of the HPV types linked with cervical cancers (and covered by both vaccines), HPV 16, is also common in HPV-related head and neck tumors, leading many experts to call for more research to evaluate the potential of the vaccines in preventing these diseases.

While the spate of research linking HPV to some oropharyngeal cancers might seem alarming, it’s important to note these diseases are actually uncommon. The American Cancer Society estimates about 26,000 new cases occur each year in the U.S. (a figure that’s been decreasing in recent decades), with fewer than 6,000 related deaths.

G D’Souza, Y Agrawal, J Halpern, S Bodison, M Gillison. Oral Sexual Behaviors Associated with Prevalent Oral Human Papillomavirus Infection. Journal of Infectious Diseases, 2009. 199 (9): 1263-69.


HPV and Anal Cancer Foundation

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“Every cancer patient deserves resources, support and hope, including those with anal cancer. Through The Foundation for HPV and Anal Cancer, we want to give other patients and their families the guidance, the information and the chance for saving a loved one’s life that we did not have.”

Anal cancer has been in the news over the past year, beginning with the actress Farrah Fawcett’s death from the disease in 2009 and, more recently, gaining exposure when the Food and Drug Administration (FDA) expanded the indication of Merck’s HPV vaccine, Gardasil, to include anal cancer prevention.

While anal cancer is not particularly common – the American Cancer Society estimates approximately 5,200 new cases annually – rates of the disease have been climbing in recent years. As with cervical cancer, almost all cases of anal cancer are linked with high-risk types of HPV. Unlike cervical cancer, though, anal cancer screenings are not common-place, and there’s even debate among experts about how effective anal Pap tests are in detecting and preventing the disease.

With any cancer, the impact is felt by both the patient and their family. Justine, Tristan and Camille Almada experienced this when their mother, Paulette Crowther, was diagnosed with advanced stage IV anal cancer in the spring of 2008. Despite juggling the demands of their own busy lives, the siblings were their mother’s primary care givers until her death in April 2010. Fueled in part by their frustration over the lack of resources and information available for anal cancer patients and their families, they established the non-profit Foundation for HPV and Anal Cancer shortly after their mother’s passing.

Tell us about your mother, and the experiences that led you to start your Foundation.
Justine, Tristan, and Camille: Mom was 51 when she was diagnosed, and we went through a two-year experience with her before she died in April 2010. We were a close family and remained with her at every step. As we were going through this with her, we became really frustrated that we struggled to find information about anal cancer and that the disease is perceived in a negative way.

We were very strong advocates while mom was alive and did a lot of research and we learned a great deal, so after she died we decided quickly that we needed to share what we learned with others. The question was, how do we do that? We decided to start an organization that focuses on anal cancer and HPV and that first is a place for people to go who are looking for information and support about the disease.

How do you find time to do this?
The three of us have full-time jobs and lives and we work on it in our free time, which is late into the night…it takes a lot of time, but this is something we’re really passionate about. We want to provide help, support and options to other families and survivors who are going through this, so that’s driving us and helps us find time.

Talk about what it was like to be a care-giver for your mom?
Seeing our mom suffer was an incredible challenge but we loved her so much, she was the most wonderful mother. On day one we fell into a routine where someone was with her at every single chemo appointment, every PET scan, and every radiation treatment. At the end in the hospital, she did a long stay and we were there every single night, at least one of us, sometimes all. We just lived on cafeteria food and hospital chairs and would stay up all night, but it was nothing compared to what she was going through. We were trying everything to help her get better and it was the least we could do for her being such a wonderful mom. Even though she did not survive despite our desperate attempts to save her, it brought us incredible pride to provide for her in every way we possibly could.

We hope through our foundation we can help other care-givers ease the burden a little bit. If there were better resources then the whole thing might have been easier for our family.

In December 2010 the FDA approved the anal cancer indication for Gardasil® (and prior to the advisory committee’s vote in November you made a public statement to the Committee in support of the indication). What impact do you think it will have?
The expanded indication is an important step in decreasing the number of people who will be diagnosed with anal cancer and increasing the profile and awareness of the disease. It’s important to note that the US has fallen behind other developed countries in terms of vaccine uptake, and hopefully this would help remedy that. There are many organizations beyond pharmaceutical companies that are looking at how we get higher inoculation rates with the vaccine, and the expanded indication will help. The next step is getting a recommendation from the Advisory Committee on Immunization Practices (ACIP), which is where we will focus our efforts in the coming months.

Also, we think there should be a focus on the “invisible man.” Men suffer from HPV-related cancers and diseases, so it’s important to promote that HPV can cause cancer in men in many anatomical sites, including the anus. We hope this leads to higher inoculation rates for both genders.

You mentioned several times being “Frustrated by the lack of support we received during mom’s treatment.” Talk about this: What kind of support was lacking? What did you need from healthcare providers and others?
There were two components: social support and healthcare support. With social support, we tried very hard to find support groups for mom, we tried to find places where she could go and feel comfortable talking about the disease and the stigma that’s associated with the disease, but there wasn’t anything available. In terms of the health care support, it can be difficult to find doctors who understand the disease and how to treat it. Our doctors were excellent, but they needed more tools, and a place to go to find out more about the disease. For example, it’s difficult today for oncologists and physicians to find out more about anal cancer and no society exists (as there are for many other diseases), so a doctor has to do research on their own. Since anal cancer is a disease that’s not common, they really are too few resources and part of the frustration came from that.

In addition to awareness and support, your mission includes funding for research into anal and other HPV-related cancers. How will you do this?
The drug development pipeline – for any HPV-related cancer- hasn’t seen movement for some time, and treatment options are limited. A key for us is how do we get the community, including pharmaceutical companies, excited again about drug development?

We are still assessing what the best deployment of funds might be, for example, is it a research grant or a post-doctorate fellowship? What we’re doing now is to map out all the resources available to us so that our money is effective when we do give grants. In looking at some other cancers where drug development was languishing, you can see the impact private foundations have had. One example is the Multiple Myeloma Research Foundation, which was started by a survivor and has raised over $100 million. They operate much like a drug development company, except they’re not for profit and the whole mission is to ask the right questions and to see where private money can help what some scientists call the “valley of death."

To get more therapeutic choices for patients battling advanced HPV-associated cancers, we need bold research. Perhaps this means a partnership where a non-profit organization such as ours, which isn’t concerned with a financial return on research and development, takes that step and attracts pharmaceutical capital.

Apart from what we may have already covered, what are your plans for 2011?
This disease has a terribly oppressive social stigma. Our mom felt it and we feel it; sometimes when we speak to people about it, it’s difficult for them to even say the words “anal cancer.” As you know, most anal cancers are caused by HPV, a disease that at least 75% of the sexually active population will have at some point, and it affects areas of the body that everybody has! We really hope that we can give those living with anal cancer the public support and community they need. That’s an important component and one of our first steps.


Gardasil Approved to Prevent Anal Cancer

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In late December the Food and Drug Administration (FDA) expanded the indication for Merck's HPV vaccine Gardasil® for use in preventing anal precancer (known as anal intraepithelial neoplasia, or AIN) and cancer in men and women ages 9-26. FDA’s vaccine advisory subcommittee had recommended in November that the anal cancer indication be approved.

Gardasil® is currently approved for the prevention of genital warts and cervical, vaginal, and vulvar precancers and cancers in females ages 9-26. The vaccine is also licensed to prevent genital warts in males in the same age range.

The move to approve Gardasil® for anal cancer prevention was based largely on research with men who have sex with men (MSM) that found the vaccine was 77.5 % effective in preventing AIN related to the HPV types covered by the vaccine.

The new indication covers both genders despite the Merck data focusing on men. The company says this is not an issue because the disease is similar in both males and females.

Anal cancer is fairly uncommon (the American Cancer Society estimates about 5,300 new cases occur in the U.S. each year), but the CDC says the risk of the disease in gay and bisexual men is 17 times greater than heterosexual men. About 60% of anal cancers are diagnosed in females.

The FDA decision means the Advisory Committee on Immunization Practices’ (ACIP) HPV Vaccine Workgroup will then have much to mull over when considering potential recommendations for an anal cancer indication, including whether or not to endorse routine use of the vaccine with boys and young men. ACIP provides guidance to the Secretary of the Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) about the appropriate use of vaccines – including those for HPV - in the civilian population. The Committee’s next meeting is scheduled for February 2011.

Current ACIP recommendations with Gardasil® are for routine use with females ages 11-12, with catch-up vaccination for females ages 13-26 who haven’t been immunized. ACIP also supports use of Gardasil® at health care provider’s discretion with males ages 9-26.