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RogerC Offline OP
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http://abcnews.go.com/Health/HPV-vaccine-prevent-cancer-recurrence/story?id=16013281#.T4hQOb_hc3J

"The human papillomavirus (HPV) vaccine has been touted as a way to prevent cervical cancer and genital warts, but a new study suggests the vaccine may also prevent women diagnosed with precancers from developing recurrences.

Researchers randomly assigned more than 1,350 women diagnosed with genital warts or certain precancerous conditions to receive either three injections of the HPV vaccine or a placebo. The women were followed for about four years.

Women who received the vaccine had 46.2 percent lower risk of developing another HPV-related disease after treatment for their genital warts or their precancerous condition."


First, the study subjects did not actually have cancer, they had precancerous conditions. Without treatment, 30-50% of dysplasia progress to cervical cancer. The study points to 46.2% decrease in recurrence... of further HPV precancerous growths, not cancer (right?). As HPV-related oral cancer survivors, progression to cancer has already been established in us. Second, say a new study focuses on cervical cancer survivors, HPV SCC cervical cancer does not necessarily behave the same as HPV SCC oral cancer.
That said, the current study does present scientific validation that something is happening to the virus in those women who receive the vaccine. And it seems from a few forums I visit, there are some H&N survivors who have decided to get it.

My doctor is willing to give it to me but it is not covered in any way where I live. Cost is $550. Fortunately, I can afford it. Clinical benefit unknown.

Thoughts? Would you consider it?






FNAB Dx SCC left lymph Sept2/11 (age 43), left tonsillectomy Sept21/11 confirmed primary. T1N2bM0. 35 IMRT both sides Oct17-Dec12/11. Cisplatin week 1,4,7. Non-smoker, non-drinker, p16+.
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Did I miss something here? From what I read, this article is only talking about other cancers. I did not see OC mentioned at all, unless I missed something.

For those who are HPV+ oral cancer survivors, their risk of a recurrence is already much less than that of patients who are non HPV. The Guardisil shot has been effective in helping to prevent HPV+ 16 and 18 which are the 2 that cause most cancers. There are still many other strains out there that it does not protect you against.

If I were you I would ask the doctor who suggested this to you exactly how they thought it would help an HPV+ oral cancer survivor. Does getting the shot change you from being HPV+ to HPV-?

Hope to hear from Brian (our HPV expert) on this one.


Christine
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Your interpretation of this work is right on. I am going to the NIH/NCI on May 18th to argue alongside Dr. Gillison for a federally funded trial of the vaccines on head and neck cancers. Merck isn't interested in pursuing this - their experience so far (due to their bungled marketing of the cervical cancer use) is less than they would have hoped, and this is a 10 million dollar effort, which they do not wish to fund. GSK has shown interest in a combined private sector, federal, and non profit (OCF) funding group effort to get the answers that we need.

The science community for the most part is a big believer in the vaccines potential in oral. But since the cervix and the oropharynx are not apples and apples, there are a lot of unknowns. Given the low incidence of clinical issues from getting the vaccine, there is little down side except for the cost. Having said that, recurrences in the HPV+ group are very low compared to tobacco carcinogenesis in NEVER smokers ( not non smokers who smoked at some period of their life).

Please note that in the last two weeks we have put a number of stories about the vaccine on the OCF news feed. One about Merck's marketing failures, another about adverse events (almost none), this time being reported outside the FDA reporting system, which confirms what we knew from the FDA collection of data, that there are no more adverse events in this vaccinated group than in an unvaccinated part of the population.

I am pretty far out from my HPV+ diagnosis and treatment in December of 97. I have had many issues, but recurrence of an HPV+ squamous cell carcinoma has not been one of them.


Brian, stage 4 oral cancer survivor. OCF Founder and Director. The first responsibility of a leader is to define reality. The last is to say thank you. In between, the leader is a servant.
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RogerC Offline OP
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Hi Christine, you are correct. There is no reference in the study to oral cancer. The subject title here is my own question. And I'm wondering what people's thoughts are on it since there seems to be HPV+ oral cancer survivors out there going ahead and getting the vaccine.

I did not speak directly to my GP, I spoke with his clerk or nurse and she said he was okay with me receiving it. I take it as he is not giving me any resistance. I can't really speak for him, but I don't think he will offer any explanation of how the vaccine might help because I am the one asking for it, and there is no research to explain it as an oral treatment.

My guess is there are questions, observations and assumptions being made to extrapolate it to preventing HPV+ oral SCC recurrence. Why is there a reduction in future cervical dysplasia in those women who receive the vaccine? Is the vaccine acting as an immune booster to help clear it like what most people can do naturally? If it does have the ability to help eliminate viral load in those already positive, perhaps it can also prevent future oral dysplasia or precursors to oral SCC caused by HPV. The assumption being that HPV+ cervical changes are similar in behaviour to HPV+ oral changes.

I think it helps that HPV is not a robust virus and most people can get rid of it on their own. In contrast, people do not normally clear Hepatitis B, so giving them the Hep B vaccine is unlikely to boost their immune system into clearing it.

Unfortunately, this novel approach will not work on someone who is immunocompromised. The HPV vaccine is not technically doing the work, rather it's the person's immune response to it.




FNAB Dx SCC left lymph Sept2/11 (age 43), left tonsillectomy Sept21/11 confirmed primary. T1N2bM0. 35 IMRT both sides Oct17-Dec12/11. Cisplatin week 1,4,7. Non-smoker, non-drinker, p16+.
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RE: consideration of HPV vaccine.

I asked this question of our radiation oncologist this time last year, after the first all clear PET.

Remembering there are no data to suggest any benefits whatsoever once infected with HPV, I asked the RO what his thoughts were. His response was skeptical as to the value, but was ok for both Alex and I to take the course if we really wanted to.

He rightly pointed out that I had likely been exposed to HPV already and my body had reacted "normally" and was doing what it was supposed to by clearing the virus. The protective effect would likely be pointless as my body seemed capable of identifying and clearing the virus.

His attitude towards Alex having the shot was slightly different with his argument being that the vaccine was designed to be preventative and there was no evidence that it could assist in clearing the virus once infected. In Alex's case it was a bit like shutting the gate after the horse had bolted.

Having said all that, I have heard of anecdotal evidence that the vaccine is capable of assisting in erradication of the virus after a person has been infected. This is NOT proven, or even accepted in the scientific community.

I am lucky enough to be good friends with the person responsible for Gardasil in Australia. In Australia, the company responsible is not Merck and they have done a great job of educating and making the vaccine available. Uptake here has been extremely good, with none of the stigma and politics that appears to have limited access or use in the US. Alex and I have been offered the vaccine for free ($220 per shot otherwise). Whilst we seriously considered it, we have decided not to go ahead - mainly due to lack of data and possibly being too little, too late. That Alex could not face another round of any sort of treatment had its part to play as well.


Karen
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Dx March 2010 51yrs. Unresectable. HPV+ve
Tx Chemo x 3+1 cycles(cisplatin,docetaxel,5FU)- complete May 31
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I told this board 4 or 5 years ago that Dr Anna Giuliano, a HPV researcher from Moffitt, told me that even at my advanced age if I were single she would advise me of getting the vaccine. We traveled and spoke many times together re HPV including appearing before the CDC on behalf of the OCF on the male version of the Gardasil vaccination.


David

Age 58 at Dx, HPV16+ SCC, Stage IV BOT+2 nodes, non smoker, casual drinker, exercise nut, Cisplatin x 3 & concurrent IMRT x 35,(70 Gy), no surgery, no Peg, Tx at Moffitt over Aug 06. Jun 07, back to riding my bike 100 miles a wk. Now doing 12 Spin classes and 60 outdoor miles per wk. Nov 13 completed Hilly Century ride for Cancer, 104 miles, 1st Place in my age group. Apr 2014 & 15, Spun for 9 straight hrs to raise $$ for YMCA's Livestrong Program. Certified Spin Instructor Jun 2014.
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So here is the study that has caused everyone to talk about this. It has a list of what I think are the conclusions/takeaways at the end if you just want to skip to that.

CLINICAL CONTEXT

Both the quadrivalent and bivalent human papillomavirus (HPV) vaccines are highly effective in preventing cervical intraepithelial neoplasia grade II to III or adenocarcinoma in situ in women not infected with the relevant HPV type before vaccination. However, the effect of the HPV quadrivalent vaccine on disease progression and future risk for disease in women with precancer or cervical disease is not known.

This study involves women who have been vaccinated with the quadrivalent HPV vaccine and who have received cervical surgery or have been diagnosed with genital warts or vulvar disease. The study authors examined the effect of the vaccine on disease progression and future risk for HPV-related disease.

STUDY SYNOPSIS AND PERSPECTIVE

HPV vaccination substantially reduced the risk for subsequent HPV disease in women who already had 1 bout of HPV-related disease, according to a study published online March 27 in BMJ.

"These are, to our knowledge, the first results in vaccinated women who have undergone treatment for HPV-related disease," write the authors, headed by Elmar Joura, MD, from the Medical University of Vienna in Austria.

The data come from a subgroup of women who participated in trials of the quadrivalent HPV vaccine Gardasil (Merck & Co).

Women who had HPV infection at the time of vaccination and who developed cervical, vulvar, or vaginal HPV disease had a substantially reduced risk of developing subsequent HPV-related disease after the first definitive treatment.

HPV vaccination substantially reduced the risk for subsequent HPV disease � not only that caused by the 4 viral strains in the quadrivalent vaccine (HPV subtypes 6, 11, 16, and 18), but also that caused by other strains of HPV-related disease.

This study "reinforces much of what we already know about the protective properties of the quadrivalent vaccine, including cross-protection against nonvaccine HPV types and vaccine benefit despite HPV exposure," writes Jane Kim, assistant professor of health decision science at Harvard School of Public Health, Boston, Massachusetts, in an accompanying editorial.

Subgroup of Women

The study analyzed data collected from 2 large company-sponsored placebo-controlled trials of Gardasil, known as FUTURE I and FUTURE II. Together, they involved 17,622 women 15 to 26 years of age who were randomized to receive 3 doses of the quadrivalent HPV vaccine or placebo. They were subsequently followed for approximately 4 years.

The analysis focused on a subgroup of 2054 women who participated in these trials and who were subsequently treated for cervical, vulval, or vaginal disease.

More than half of this subgroup (1350 women) underwent cervical surgery (which included any method used to treat cervical disease) � 763 from the placebo group and 587 from the vaccine group.

The researchers calculate that the incidence of any subsequent HPV-related disease in the cervix was 6.6 in the vaccine group and 12.2 in the placebo group � a reduction of 46.2% with vaccination.

When only high-grade disease of the cervix was considered, this reduction is even greater; vaccination reduced the risk for any subsequent high-grade disease of the cervix by 64.9%.

The remaining women in the subgroup (229 in the vaccine group and 475 in the placebo group) were subsequently diagnosed with either genital warts or vulvar or vaginal intraepithelial neoplasia. Here, the incidence of any subsequent HPV-related disease was 20.1 in the vaccine group and 31.0 in the placebo group � a reduction of 35.2% with vaccination.

This was primarily driven by a reduction in the incidence of genital warts (63% reduction after vaccination), the authors note.

In all cases, the reduction was for all subtypes of HPV-related disease, including strains of HPV virus that were not included in the vaccine.

New Findings Welcome

These findings are "welcome," Dr. Kim writes.

This study "moves us closer to understanding the full scope of benefits from HPV vaccination by showing for the first time that vaccine protection against disease can endure beyond the management of HPV-related disease in women already vaccinated," she adds.

However, Dr. Kim takes issue with some of the conclusions drawn by the authors.

This study corroborates previous findings that the benefits of vaccination are not limited to the primary target group of young sexually na�ve girls, Dr. Kim explains. The findings highlight the importance of vaccinating at an early age, when exposure to HPV is minimal, to maximize protection against all HPV types targeted by the vaccine.

Most important, she adds, this study examines a unique subgroup of women who were vaccinated before their first treatment for HPV-related disease. The authors suggest that these results could be generalized to women who are considering HPV vaccination after treatment for HPV-related disease, but Dr. Kim disagrees, and suggests that more data are needed.

"Only surveillance of vaccinated populations in the real world can provide clear evidence of the effectiveness of the vaccine in women who have been treated before vaccination," Dr. Kim writes. "As we await this information, it is important to emphasize to providers and decision makers that generalizations of study findings are premature."

The study was funded by Merck & Co. Dr. Joura reports receiving advisory board fees from Merck; and lecture fees from Merck, Sanofi Pasteur MSD, and GlaxoSmithKline. Several coauthors are employees of Merck & Co, and several report receiving funding from Merck and GlaxoSmithKline for HPV vaccine studies, and from other pharmaceutical companies. Dr. Kim has disclosed no relevant financial relationships.

BMJ. Published online March 27, 2012. Abstract, Editorial


STUDY HIGHLIGHTS

This is a retrospective cohort study of women in the FUTURE I and FUTURE II trials � randomized, double-blind, placebo-controlled trials testing the efficacy of the HPV quadrivalent vaccine.

The HPV quadrivalent vaccine covered HPV types 6, 11, 16, and 18.
Included in this study were women who were not pregnant, who had a lifetime number of no more than 4 sexual partners, and who had undergone either cervical surgery or were diagnosed with cervical or vulvar disease.
The studies did not include baseline HPV testing or clinical examination before randomization, so women with ongoing HPV disease were permitted.
Women were randomly assigned to receive either 3 doses of quadrivalent HPV vaccine or placebo at day 1, month 2, and month 6.
Cytology specimens were classified using the Bethesda System 2001, using ThinPrep (Cytyc; Boston, Massachusetts).

All participants were required to use contraception and were tested for pregnancy before each vaccine administration.
The outcome was the average time from diagnosis of disease to treatment of genital warts or vulvar or vaginal intraepithelial neoplasia.
The 2 trials collectively diagnosed and treated 17,622 women.
1350 women qualified for the cervical surgery, and 704 for the second (diagnosis of vulvar or vaginal disease) analysis.
Mean age was 19.7 years, two thirds were white, and from 12.9% to 21.4% were Hispanic.
More placebo recipients (n = 763) than vaccine recipients (n = 587) underwent cervical surgery for disease because of any HPV subtype.
Among women who underwent cervical surgery, more of those in the vaccine group had higher prevalence of squamous intraepithelial lesions at baseline and a higher prevalence of HPV DNA compared with placebo.
Placebo recipients were at increased risk for developing HPV-related disease.
Within 1.3 years after the vaccination, the incidence of any subsequent disease among placebo recipients was 12.2 per 100 person-years at risk, and 5.2% developed subsequent high-grade cervical, vulvar, or vaginal disease.
Compared with those who underwent surgery, those with genital warts or vulvar or vaginal intraepithelial disease were 3 times more likely to develop HPV-related disease.

During a mean of 1.2 years of follow-up, 13.0% of those with initial vulvar or vaginal disease developed high-grade cervical, vulvar, or vaginal disease.
Vaccination with the quadrivalent HPV vaccine was associated with significant reduction in risk for any subsequent HPV-related disease in women who underwent cervical surgery, irrespective of causal HPV type.
The risk reduction was 46.2% overall.
The risk reduction was 48.3% for any cervical disease, 64.9% for any high-grade cervical disease, and 63.0% for genital warts.
Vaccination was also associated with a significant reduction (79.1%) in any subsequent disease related to vaccine HPV types and with an 89.0% reduction in genital warts related to vaccine types.
After a diagnosis of genital warts or vulvar or vaginal intraepithelial neoplasia, the quadrivalent vaccine was associated with a significant reduction in risk for any HPV-related disease, regardless of HPV type.
The incidence of any HPV-related disease was 20.1 and 30.1 per 100 person-years for vaccine and placebo recipients, respectively (risk reduction, 35.2%).
For disease related to HPV vaccine types, the risk reduction was 64.4%.
The average time to first diagnosis of genital warts after vaccination was 1.4 years in the vaccine group and 2.1 years in the placebo group.
Vaccination was associated with 46.8% less recurrence of genital warts related to HPV vaccine types, but this reduction was not statistically significant.

The authors conclude that the quadrivalent HPV vaccine was associated with reduced incidence of any subsequent cervical, vaginal, or vulvar intraepithelial cancer in women previously diagnosed and treated for disease, and that this reduction was effective for both HPV vaccine and nonvaccine types.
They also note that the vaccine did not reduce progression of infection of the preexisting HPV infection in women who were already infected with HPV at the time of vaccination.

The benefits of HPV vaccine are not limited to young, sexually naive women and may be used as prophylaxis in older women with preexisting cervical, vaginal, or vulvar disease.

CLINICAL IMPLICATIONS

The quadrivalent HPV vaccine is associated with reduced risk for subsequent HPV-related disease for the vaccine and nonvaccine HPV types in women who undergo cervical surgery.

Among women with genital warts or cervical, vulvar, or vaginal disease, the quadrivalent HPV vaccine is associated with reduced future risk for vaccine and nonvaccine HPV disease.


Brian, stage 4 oral cancer survivor. OCF Founder and Director. The first responsibility of a leader is to define reality. The last is to say thank you. In between, the leader is a servant.
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RogerC Offline OP
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Thanks for posting the specifics Brian.

If I am reading right, although it is premature to speculate, and there may be unknown variables involved, a few points to me show promise:

-women who already had 1 bout of HPV disease (assumes they are HPV+)
-some type of protective immune response is occurring against future HPV disease (if not validated for recurrent SCC at this point, at least precancerous disease)
-it induces a response beyond the 4 subtypes (the response is robust and generalized)
-the response is being exhibited beyond the cervix and in other parts of the female anatomy (perhaps effective in other areas of the body with squamous cells)

The $500+ question still begs statistical significance for those who had treatment for HPV-related cancer, reproductive SCC and oral SCC.


FNAB Dx SCC left lymph Sept2/11 (age 43), left tonsillectomy Sept21/11 confirmed primary. T1N2bM0. 35 IMRT both sides Oct17-Dec12/11. Cisplatin week 1,4,7. Non-smoker, non-drinker, p16+.
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The benefits are clear in the study. WHY they exist is an unknown.

While I personally believe that even though the cervix and oropharynx are very different bits of anatomy, that this virus in each one has the same mechanism of invasion and cell domination/immortalization. Logic would dictate that the vaccines properties which interfere with the virus would be similar. But of course as always we lack a clinical model establishing proof.

The science to date, has convinced the OCF science board that fighting for boys vaccination was justified and worthwhile in oral cancers (not just genital warts), even though there was no hard clinical trial to justify it. As David has pointed out, this was accomplished by cooperating with a broad coalition of other stake holders like the HPV/Anal Cancer Foundation in arguments at the CDC. This was a big study, but conclusions about protection in head and neck recurrence is a more ambiguous issue that protection from the virus itself in a sexually/virus naive boy or girl.


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RogerC Offline OP
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I just re-read the specifics again and I'm confused now.

In the first part, it sounds like they focused on a subgroup who received the vaccine, developed HPV disease anyway, and subsequently had less recurrence than the placebo group. A generalization was made by the authors suggesting benefit of getting the vaccine after HPV disease although that is not what was in the study's methodology.

In the second part, "The studies did not include baseline HPV testing or clinical examination before randomization, so women with ongoing HPV disease were permitted." Therefore, it sounds like some of these women were indeed HPV+, yet not confirmed with any testing before receiving the vaccine.

So I'm confused. Did any of these women benefit from receiving the vaccine AFTER they were HPV+ or not?
Thanks







FNAB Dx SCC left lymph Sept2/11 (age 43), left tonsillectomy Sept21/11 confirmed primary. T1N2bM0. 35 IMRT both sides Oct17-Dec12/11. Cisplatin week 1,4,7. Non-smoker, non-drinker, p16+.
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