Taking Action Against Cervical Cancer Through Early Detection and Vaccination

Coordinator:
Welcome and thank you for standing by. At this time all parties are on a listen-only mode until the question and answer session of today’s conference. At that time if you’d like to ask a question, please press star one. Today’s conference is also being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the meeting over to Miss Leticia Davila. You may begin.

Leticia Davila:
Thank you Troy. Good afternoon. I’m Leticia Davila and I’m representing the Clinician Outreach and Communication Activity (COCA) with the Healthcare Preparedness Activity at the Centers for Disease Control and Prevention. I am delighted to welcome you to today’s COCA webinar, Taking Action Against Cervical Cancer Through Early Detection and Vaccination. We are pleased to have with us today Dr. Mona Saraiya, Dr. George Sawaya, and Dr. Francisco Garcia. They will discuss clinical features of cervical cancer and vaccination recommendations and cervical cancer screening recommendations.

COCA is excited to partner with CDC Vital Signs to present an update and call to action on cervical cancer in the United States. For more information about Vital Signs, please visit www.cdc.gov/vitalsigns. You may participate in today’s presentation by audio only or via webinar. The webinar link can be found on our COCA website at emergency.cdc.gov/coca. Click on COCA calls. The webinar link is located under the call-in number and call passcode.

At the conclusion of today’s session, the participant will be able to describe the epidemiology, natural history and clinical features of cervical cancer, discuss current recommendations and rationale for HPV vaccination and cervical cancer screening in the US and identify opportunities for screening and vaccination and share evidence-based practices for clinicians and health departments.

In compliance with continuing education requirements, CDC, our planners, presenters and their spouses/partners wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services or commercial supporters. Planners had reviewed content to ensure there is no bias. The presentation will not include any discussion of the unlabeled use of a product or products under investigational use. CDC does not accept commercial support.

At the end of the presentation, you will have the opportunity to ask the presenters questions. On the phone dialing *1 will put you in the queue for questions. You may submit questions through the webinar system at any time during the presentation by selecting the Q&A tab at the top of the webinar screen and typing in your question.

Our first presenter, Dr. Mona Saraiya is a medical officer and the associate director in the Division of Cancer Prevention and Control’s Office of International Cancer Control. Dr. Saraiya’s main areas of expertise involve skin cancer epidemiology and cervical cancer screening.

Our second presenter is Dr. George Sawaya. He’s a practicing obstetrician-gynecologist and serves as the director of the San Francisco General Hospital Colposcopy Clinic. His main research involves all major aspects of cervical cancer screening including the optimal age to begin screening, age to end screening, screening periodicity and screening technologies.

Our final presenter, Dr. Francisco Garcia is a director of the Pima County Health Department in Tucson, Arizona. His research in clinical expertise is in the area of premalignant cervical disease and human papillomavirus infection affecting the female lower genital tract and the evaluation of new technologies and therapeutics for cervical cancer precursors.

Again the PowerPoint slide set and the webinar link are available on our COCA webpage at emergency.cdc.gov/coca. At this time, please welcome Dr. Saraiya.

Dr. Mona Saraiya:
Thank you. Good afternoon. It’s my pleasure to give an overview today on our work in cervical cancer. I’ll present a quick glance at our Vital Signs MMWR looking at three national data sets for cervical cancer such as incidence, mortality and screening and also give an overview background of HPV vaccination.

Our main message for the Vital Signs, which was published in early November, is that cervical cancer is largely preventable and that no woman should die of cervical cancer. Yet, our sobering statistics show that around 12,000 women develop and 4,000 women die of this disease each year. Unlike other cancers, we have preventive measures with screening and vaccinations for as many as 93% of cervical cancers could be prevented based on modeling studies. Yet, in 2012, we found eight million women in the US had not been screened for cervical cancer at all or within the last five years.

For this MMWR, we examined screening patterns using the Behavioral Risk Factor Surveillance System for 2012 and examined the percentage of women who had not been screened in the past five years, including women who have never been screened.

We examined the US Cancer Statistics from 2007 to 2011 to determine incidence rates by state, region, and the US and then we also examined the National Vital Statistics from 2007 to 2011 to look at death rates by state, region, and the US.

There were eight million women who had not been screened for cervical cancer in the past five years. Of these, almost half are never screened. There were disparities when looking at barriers including 23% of women who had not been screened, did not have health insurance and 25% of women not screened, but did not have a regular healthcare provider. Additionally, older women and Pacific Islanders were more likely to be inadequately screened.

This figure - Cervical Cancer Incidence Rates - presents the incidence rates by state for 2011. As you will see on the map, DC has the highest incidence rate of approximately 13.7 per 100,000 women while New Hampshire has a lowest rate of 4.5 per 100,000 women and note that the darker colors indicating higher incidence rates are in the Southern region.

The next slide is of the figure showing the cervical cancer death rates by the states for 2011 and here you’ll see West Virginia has the highest death rate of 4.8 per 100,000 while Minnesota has the lowest rate at 1.2 per 100,000. Again the darker colors are noted in the Southern states.

Overall, we’ve reported that for screening in 2012, the range of not being screened by a state was 6.9 or - hold on. We noticed that the screening by state was 6.9 to 18.7 and the southern states have the highest percentage of women not screened. There were over 62,000 women that were diagnosed with cervical cancer from 2007 to 2011 and overall there was a 1.9% annual percent decrease per year over this time with the South having the highest incidence rate at 8.5 per 100,000 women.

Over 19,000 women died of cervical cancer over this time period and their rates remain stable at 2.3 per 100,000. The South had a rate of 2.7 per 100,000 - the highest. The next slide is looking at cervical deaths in the US. We see in this graph from 1975 to 2000 there were dramatic decreases to cervical cancer and this is mostly due to the widespread use of the Pap test. However, from 2007 to 2011 the death rates have remained stable.

When we look at its national surveys to look at screening trends, we found a decrease in screening from 2000 to 2010. We believe the real key to moving the mark on cervical cancer is to reach those women who are not screened because we know that over half of cervical cancers in the US are among women who have never or rarely been screened.

So what can be done to address cervical cancer? Doctors, nurses and health systems can help women understand what screening types are best for them and when they should get screened. We know from CDC literature that many women don’t know what a Pap test is or feel like a Pap test screens for more than just cervical cancer.

Doctors, nurses and systems can also screen or refer all women as recommended at any visit, make sure that patients get their screening results and the right follow-up care quickly, use healthcare systems like reminder recall systems to help doctors, nurses and patients remember when screening and HPV vaccinations are due and strongly recommend that preteens and teens get vaccinated against HPV.

Now, I’m briefly going to be talking about HPV and some basics about HPV vaccine. So HPV is a family of more than 120 closely-related DNA viruses that are identified as types. HPV infection is restricted to the epithelium and is somewhat shielded from the immune system. Both humoral and cellular responses have been identified but not all those that are infected have a detectable immune response.

HPV types differ in their tendency to infect cutaneous, mucosal, or genital epithelium. There’s approximately 40 types found in the genital tract and these are groups as high list for oncogenic types including 16 and 18. Persistent infections with these types can result in cancers including cervical, other anogenital cancers and oral pharyngeal cancers as well as low grade cervical disease.

The low-risk or non-oncogenic types, such as six and eleven, can cause anogenital warts as well as laryngeal papillomas and low-grade cervical disease. HPV infections are very common. Almost all sexually active persons will acquire HPV in the US and it’s estimated there are about 79 million infected persons with 14 million new infections per year. It’s acquired around the time after sexual experience and 40% are infected within two years of onset sexual activity.

The infection is usually transient and not associated with symptoms. An infection with one type of HPV is not necessarily protective against infection with other types and cancer is a very rare outcome of those common infections and requires persistent infection with high-risk types.

I notice that my slides are not moving. Okay. Excuse me. I apologize. We are now on this slide called the evolution of HPV recommendations in the US. There have been an evolution of HPV vaccines recommended in the US over the last seven years based on available data and new licensures and indications. And this slide basically shows how the quadrivalent vaccine was first licensed in June of 2006 when the ACIP recommended this vaccine for routine use in females 11 or 12 years of age and through age 26 for those who are not previously vaccinated.

In October of 2009, the bivalent vaccine with licensed for use and the recommendations for females changed to either quadrivalent or bivalent vaccine. In October of 2009, the quadrivalent HPV vaccine was licensed for males to prevent genital warts and at this time, ACIP recommended that males may be given the vaccine to prevent genital warts.

From 2009 to 2011, more data became available to consider revised recommendations for men including efficacy for prevention of anal cancer. In October of 2011, the ACIP recommended quadrivalent vaccine be routinely given for males age 11 or 12 years and through age 21.

The next slide – I’m unable to go forward? - there - okay - shows the HPV - the vaccine is recommended for both male and females age 11 to 12. Catch-up is for 13 to 20 years for males and 13 to 26 for females and they may vaccinate age nine to ten for both males and females. And vaccination is recommended for gay and bisexual men and men with compromised immune systems if they did not get fully vaccinated before the ages of 22 to 26.

For females, as I mentioned before, the vaccine can be used for girls for prevention of cervical cancer. It’s a quadrivalent vaccine also provides protection against infection with HPV causing vaginal, vulvar and anal cancer, as well as genital warts.

Boys need the HPV vaccine as well and many parents don’t understand that boys can get cancer and disease caused by HPV and again here are the recommendations. For the ACIP recommendation schedule for three doses - for the 3-doses series in zero, one to two months, and six months for all other vaccines. The minimum intervals for both vaccines is four weeks between the first and second dose, 12 weeks between the second and third dose, and 24 weeks between the first and third doses. However, the minimal intervals between doses should not be used for routine vaccinations.

There are almost no situations where a compressed or accelerated schedule is needed. And recall that the vaccine can be started as early as nine years of age.

A question we’re often asked is, “How long will the protection be provided by the HPV vaccine?”. Studies show that the vaccine is long lasting. In 2010, a review of the vaccine was conducted regarding a long-term protection against cervical infections with the HPV virus. At that time, vaccine were shown to provide cervical protection against persistent HPV infection for up to eight years and now we have information that that’s up to ten.

More will be known about the total duration of protection as research continues, but at this time there’s no evidence of waning immunity such as has been seen with other vaccines. And this information will be updated as the additional duration of protection data become available.

I wanted to end with this last slide that talks about HPV vaccine and cancer prevention. This is - these next three slides highlight that CDC has a newer campaign about HPV vaccine highlighting the cancer aspect and the enormous amount of materials that are available on the website for both providers and women and the public. These were based on research of parents and caregivers showing how to frame the HPV vaccine as safe, effective and like any other adolescent HPV vaccine. Thank you very much for your time. And now I’d like to introduce you to Dr. George Sawaya.

Dr. George Sawaya:
Thank you Mona. So I’m going to talk about updates and cervical cancer screening and Mona did a great job about talking about what we can do in terms of primary prevention of HPV infection and I’m going to spend a bit of time talking about the downstream effects of an HPV infection. Let me start with the next slide - from virus to cancer.

As Mona mentioned, HPV certainly is an important if not vital and necessary component of getting cervical cancer and but of course many women are exposed to HPV and many of those exposures do not lead to cervical cancer. Some of them lead to changes that are minimal on the cervix that have a very high natural resolution rate and other changes if not detected and treated have the potential to turn into cervical cancer.

Our next slide shows the precancerous lesions that are caused by HPV. These are cervical intraepithelial neoplasia and these are graded - just to refresh everyone’s memory - on a scale from one to three. CIN 1 indicates an active HPV infection. This has a high spontaneous resolution rate and treatment is discouraged in women with simply this diagnosis.

There are some potential indications for women with continued CIN on the cervix - CIN 1 where the option of treatment may be entertained but generally these are not treated lesions. CIN 2 is the most - is a more severe lesion. Most of these lesions are treated, but we know that about 40% of these lesions will resolve over a six month period and certainly if we treated all women with CIN 2, we would be over-treating a substantial portion of women.

Current guidelines suggest that treatment may be deferred in young women with a diagnosis of CIN 2. CIN 3 is the most proximal cancer precursor and all recommendations are that that lesion be treated. We also do find some precancerous lesions for glandular or non-squamous carcinomas such as abnormal carcinoma in situ. These are rare but important lesions for us to detect. We can go to the next slide.

When we talk about treating precancerous lesions we have three main modalities. The first is destroying the abnormal cervical changes and this is by either freezing with a very cold probe. That’s called cryotherapy - or by vaporizing these lesions with a laser. The other way of treating precancerous lesions is through a - excisional procedures. The most commonly employed are LEEP which stands for Loop Excisional Electrosurgical Procedure or a cone biopsy which is done in the operating room.

Of course the ultimate treatment for dysplasia is hysterectomy, which is removal of the cervix and we - it’s certainly not a first line treatment for dysplasia, but it can be offered to patients who have a recurrent high grade lesions of the cervix after treatment.

The next slide is - has a lot of information, but the reason why it can all fit in one slide is that in 2012 all of the major guideline groups in the United States revised their guidelines and they all are very quite similar. This was a big benefit in terms of decreasing any confusion about how we should screen women. And so that’s why all of the guidelines now can fit comfortably on a single slide.

The groups that have made revisions in 2012 are the US Preventive Services Task Force, the American Cancer Society in partnership with the American Society for Colposcopy and Cervical Pathology and the American Society for Clinical Pathologists and the American College of Obstetricians and Gynecologists. All of these groups agree that screening should begin at the age of 21.

The Task Force actually has a specific recommendation that screening not begin before the age of 21. They give that a D recommendation indicating that the harms outweigh the benefits.

In terms of screening method and intervals, these can be classified into two age groups. Women between the ages of 21 and 65 may be screened with cytology alone every three years. There’s an alternative strategy whereby women can be screened with cytology alone every three years between the ages of 21 and 29 and then between the ages of 30 and 65, an HPV test for high risk types can be added to cytology. This is called co-testing. If co-testing is employed in that age group, it is recommended that it not be applied more often than every five years.

The age to end screening has not changed much over the last few years. All groups agree that ending - that cervical cancer screening can end at the age of 65 if women meet certain criteria and the criteria are as follows - if they have three consecutive negative cytology results or two consecutive negative cytology plus HPV tests within ten years before the cessation of screening with the most recent tests performed within five years.

So if women meet those criteria by the age of 65 then the cervical cancer screening may safely end and as a matter of fact the US Prevention Services Task Force gives screening past that age in women with these low risk criteria a D recommendation suggesting that the harms outweigh the benefits.

Screening after hysterectomy with removal of cervix is not recommended. This is generally applied to women who have not had a prior history of a precancerous lesion - a hybrid lesion CIN 2 or worse for cervical cancer. The bottom two sentences are important. These guidelines do not apply to immuno-compromised women. That includes women who are HIV positive. There are separate screening guidelines for those women, women with in utero DES exposure which is a fairly small group of women, and those with prior CIN 2 or 3 or cervical cancer as I mentioned before. It’s also important to note that vaccinated women are screened the same as unvaccinated women.

Let me go to the next slide. There are other reasons why screening may end. All of these three guideline groups all agree that screening following total hysterectomy with removal of the cervix where benign disease is not indicated as I previously mentioned and the taskforce gives a D recommendation.

ACOG had a statement in 2003 that if a woman had a prior history of CIN 2 or 3 and had a hysterectomy, the screening may end after three normal tests, but then in 2012 they revised that statement and recommended continued routine screening specified as cytology every three years for 20 years after the hysterectomy in women with that history of having a precancerous - a high grade precancerous lesion.

Let me go to the next slide entitled rationale - this is slide 38. So the rationale or the evidence underpinning all of these major aspects of the guidelines are as follows. The reason to not screen under the age of 21 is based upon the observation that cervical cancer precursors and cancers are extremely rare in women under 21. However, abnormal tests are common and you can image that’s true because as Mona said, HPV infections are very common in young women who have become sexually active.

Now there’s of course a concern given that here’s a high prevalence of HPV and a subsequent high prevalence of low grade abnormalities on the cervix that by screening that young population we will have problems with false positive testing, unnecessary invasive procedures and there is some evidence, although it’s really quite unclear, currently that some of the treatments that we - that we do on the cervix that are excisional like LEEPs or comb biopsies affect risk of preterm delivery.

The ablative procedures have not been shown to have that same effect and again I will state that the evidence behind that is quite controversial and some are contradictory.

The next bullet point is about screening every three years with cytology alone and this is based in many ways upon the natural history of cervical cancer and cervical cancer precursors. The average time from CIN 3 to cancer conversion is on average about ten years and there are concerns with annual testing or just too frequent testing that there will be a cumulative likelihood of false positive testing and a likelihood of invasive procedures, many of which may not be necessary because they don’t transpire into finding a treatable cervical cancer precursor.

Now screening every five years with cytology plus HPV testing - it was based on to some degree on a decision analysis that showed that similar benefits and harms are achieved with screening with both of these tests every five years as can be achieved with screening every three years with cytology alone.

The US Prevention Services Task Force has a bit of a different take on co-testing in these women again 30 to 65 and they suggested it be only applied to women who want to lengthen the screening interval and that’s because it’s important that we actually link then the screening intervals amongst women who are doubly negative - have a negative cytology test and a negative HPV test so that we can - so that we can capitalize on the opportunity to find low-risk women and to decrease screening frequency among them thereby minimizing the harms of over-screening.

The ACS however believes this to be a preferred strategy of a - without qualification but it’s important to note that’s based on a weak recommendation.

In terms of ending screening at age 65, some of the same things that we’ve already discussed. Cervical cancer is uncommon amongst well screened older women, but there is certainly a potential for harm due to false positive testing and invasive procedures.

I will mention and this is the next slide - slide 39 - that on the horizon there have been new tests that have been approved by FDA for use of cervical cancer screening. One is - one is a stand-alone HPV test approved by FDA as a primary screening test beginning at age 25 and the algorithm that has been proposed for the use of this test is on the slide.

As you can see, if the test is applied and a woman is negative, she would not get a Pap smear and then she would just continue to be screened with HPV testing. There are certain - if a woman is positive for HPV then a test for high risk - I should say the test for type-specific 16 and 18 can be performed and if that is positive these women go to colposcopy and if that is negative, they get cytology and then managed as is on the slide. So that is the proposal.

We - there are - this strategy is not endorsed by any major guideline group. It’s anticipated that there may be some guidance about this strategy that may appear early next year but as it states this is something new on the horizon but not in any official documents.

So I’ll end there. Thank you for your attention. I look forward to hearing any questions you have during the Q&A session.

Francisco Garcia:
Hi there. My name’s Francisco Garcia and I’m the director and chief medical officer at the Pima County Health Department - a large health jurisdiction about the size of the state of New Hampshire and that shares the longest continuous border with Mexico of any county.

I start off the presentation that way because my comments really are about how community cervical cancer prevention can look specifically in underserved communities, whether it’s a border community, whether it’s an intercity urban community, whether we’re talking about rural Appalachia that the unique challenges that impact low-resource settings within our own country are very, very place-specific, but also share a lot of commonalities.

I can tell you for instance that along the US-Mexico border, one of the things that we suffer from is a high - a relatively higher incidence of - both incidence and mortality of cervical cancer and a relatively low screening rate. And as I think about how we think about through comprehensive cervical cancer prevention, one of the things I want to make sure that I have a dialogue with my community about it how this really is a set of services and that all of these services need to be linked to each other - vaccination, screening, diagnosis, treatment, surveillance, survivorship. All of these pieces of the puzzle need to be working well.

In low-resource communities - in poor communities these often - the links where you go from one step to the other, the arrows essentially get broken for many and various reasons. And so my comments today will sort of focus on where those breaks occur.

I think for me the most important issue that has to do with cervical cancer prevention is the most important thing that we can do to improve cervical cancer in this country is to improve coverage and access. The MMWR article that was published by Vicki Benard and Mona Saraiya really kind of highlights that when we think about folks who are at risk of cervical cancer when we think about who is not getting screened. There’s an awful lot of women - 70% -- 5.6 million women, who are not screened or are under screened despite the fact that they are insured and have a healthcare provider.

And I certainly think that there are a lot of interventions that we need to sort of focus on in that particular group. In the border lands, one of the groups that we worry about is approximately 10 to 20% of folks who are uninsured and whether they are or are not hooked up with a healthcare provider becomes a major determinant of whether that person gets services.

The National Breast and Cervical Cancer Early Detection Program has really increased coverage with regards to screening. We locally continue to have some challenges with regards to the follow-up of those patients. One of the things that is really important to think about as we think about dealing with poor and low-resource settings within our own country is that they are more heterogeneous than we would like to think.

Our own work has demonstrated that the utilization of screening services is all over the place in terms of the backgrounds of individuals with Mexican-born Hispanics in a border county actually having fairly good screening rates especially in compared to US-born Hispanics. For us, that’s an opportunity for action and we’ve used that information to really inform the way that we deliver cervical cancer screening.

Part of this is tapping into existing social networks and I believe that the here is a missed opportunity that we as a public health sector may have. Figuring out how we tap into public - existing social networks becomes really, really important and a lot of people have published in this area. We have developed group education interventions that are delivered by promotoras, by community health workers essentially a lay community education model and have really shown that we’re able to not only get people to go from pre-contemplation to contemplation to action, but really to sustain that positive behavior in the long run.

But, there are also other missed opportunities once we get women into the screening system. It is very important to note that there is a very significant loss to follow-up at least in public sector systems. After the - after a positive screening has occurred so that both in the California public system, in Quebec or in Pima County that as many as 15% of individuals who have a significant positive cervical cytology that requires colposcopy as a diagnosis follow-up that as many as 50% of those individuals are being lost to follow-up.

Why is that important? Well, these are 50 - these are women who have already come into the screening system who have availed themselves of a screening system, but for whom the screening system has failed them because we have not been able to get those results back to those women either because of mobility or contact issues but mainly because of resource issues we believe.

There’s also another opportunity when we start thinking about vaccinations as an intervention for cancer prevention. There are other opportunities for us to really think about how we intervene. Most clinicians in general are waiting too long to have the conversation about HPV vaccination as a modality for cancer prevention both with patients and with patients’ families.

And this graphic from CDC really kind of illustrates that that by and large we are reluctant to have those conversations or to make these recommendations until women are 16 to 18 years of age. I think by and large that reflects the fact that we probably as a provider community underestimate what we think the - what we think patients and their parents think with regards to HPV vaccination and I think this is really an area that is ripe for intervention. And so how do we tap into that?

Well one of the issues is really developing reminder and recall systems both for cytology screening as well as for vaccination that when we create passive or active systems that remind providers and remind parents about moving them into - that when we create active systems of reminding parents and providers about moving them into either a screening process or a vaccination process, we really end up gaining a lot.

If we were to optimize our vaccination visits, we could go from having our current percent vaccinated coverage at least for a single dose from 47% to 91% and here is really an opportunity for us as a public health community to think about how it is that we can structure the interactions between providers, between health systems and between individuals in order to optimize coverage.

I want to go back to one of the things that to me I think is a really critical piece. There are - when we think about cervical cancer prevention, when we think about many disparities, we can sort of think about how those disparities play out in vulnerable populations - in this case low-income border populations and in resilient populations.

And one of the important things to think about with regards to this is that the disparities here probably have a lot less to do with biology because we know that the thing that makes something become a cervical pre-cancer or a cervical cancer is really, you know, high-risk HPV. It really gets at some of the contextual factors.

Those contextual factors are going to be what actually causes a woman to eventually die from cervical cancer and for us those contextual factors are really important and they may or may not be the kinds of things that we can change - immigration status, availability of services, insurance status - but we work on those and we have those in mind as we develop these important interventions.

So the challenge to all of us in the public health sector is to figure out how we can minimize these missed opportunities and I would tell you that there are five kind of lessons that we sort of carry on in our work - the first and most importantly that we have to know and understand the needs of our communities and the nuances and the heterogeneity of the communities that we serve.

The second lesson is we need to sort of tap into existing resources and for - when we deliver services to vulnerable populations, it really is about weaving a crazy quilt of resources into something that on the patient side has to look seamless.

Another really important piece that we’ve really sort of taken to heart in Southern Arizona is to try to make every single clinical encounter an opportunity to both review screening history if that’s the appropriate thing or vaccination history. And when we do that, we really start getting at how to optimize our vaccine coverage, how to optimize our screening coverage and next providing effective follow-up.

Again, when women come to us for screening, when women come to us for a vaccination, unless we really can provide the kind of follow-up that is required, we will really have missed an important opportunity. And finally and for me most importantly in our region where we’ve been able to decrease the un-insurance rate from 18% to 10% over the last year, optimizing insurance coverage becomes really important and becomes a real challenge for some of our communities. Those were the comments I wanted to share with you.

Leticia Davila:
Thank you Dr. Saraiya, Dr. Garcia and Dr. Sawaya for providing our COCA audience with such a wealth of information. We will now open up the lines for the question and answer session and also remember you can submit questions through the webinar system.

Operator, while we wait for the questions to queue up on the line, I do have a question that has come through the system and the first question is: The FDA recently approved a new HPV test. Can you tell us about when clinicians should consider using this test compared to Pap testing alone or co-testing?

Dr. Mona Saraiya:
Hi. This sounds like a great question for Dr. Sawaya.

Dr. George Sawaya:
Okay. Well I mentioned this briefly in my presentation that there are - there is this new FDA approved test for primary screening. There is no guidance yet in terms of how often that should be applied and I would suggest that people wait until we have some guidance on this clinical use before incorporating that into clinical practice.

I think one question that was asked which is really quite critical is how does that strategy compare to all the other strategies that we have and I think that’s a critical question. We need to really understand for each strategy that is currently available or available in the future which one really maximizes benefits, minimizes harms and does it all at a reasonable cost. So I think we need to keep asking that question and push people to provide us those answers. And as currently those - it’s not quite clear how to contextualize these new strategies into that framework.

Dr. Mona Saraiya:
Dr. Garcia do you have anything to add?

Dr. Francis Garcia:
No. I couldn’t have said it better than George. That was awesome.

Leticia Davila:
Thank you. Operator?

Coordinator:
I’m showing no questions at this time but just a reminder, please press star one to ask a question.

Leticia Davila:
Thank you. The next question that we have is how are discrepant test results resolved when using co-testing, for example when a Pap test is negative but the HPV test is positive or vice versa?

Dr. Mona Saraiya:
Again, I think Dr. Sawaya had touched on this.

Dr. George Sawaya:
Yes. So currently there is guidance about how to manage those women and there are two strategies that are currently endorsed by the ASCCP as well as ACOG. The first is that these women can return in a year for both of those tests and if either is positive that they can go to colposcopy. The second strategy is to apply type-specific HPV testing. I mentioned 16 and 18. And if that is positive then the women go to colposcopy. But if it’s negative then they would return in a year for repeat co-testing: Pap plus HPV.

Leticia Davila:
Okay, thank you. We have one more. It says if the FDA screening tests covers 14 high-risk HPV types, is there a vaccination in development that covers all of the high-risk types?

Dr. Mona Saraiya:
Hi. This is Dr. Saraiya. I can answer this. There is a candidate nine-valiant HPV vaccine. Just as a review, the current HPV vaccines that are available in the United States cover two types that cause cancer – HPV-16 and 18 approximately 78% of cervical cancers can be prevented. The candidate nine-valiant HPV vaccine includes five additional HPV types - 31, 33, 45, 52 and 58 and it’s currently being reviewed by the US FDA and it’s anticipated that there might be some news in December. But, most of the cancers that are caused by HPV will be provided by the current quadrivalent vaccines - around 62%, 70% and five additional types will prevent an additional 14 to 15% of cancers caused by HPV in females.

So with every vaccine it’s important to vaccinate prior to exposure and currently CDC does not recommend that parents and healthcare providers delay HPV vaccines until the nine-valiant HPV vaccine is available because delaying can result in adolescents being exposed to HPV prior to being fully vaccinated and putting them unnecessarily at risk for cancer. And even with the current nine-valiant vaccine, there still will be some cancers that will not be covered by the HPV types or that are in the nine-valiant. Cervical cancer screening will need to continue in some fashion.

Leticia Davila:
Thank you. Operator, do we have any in the queue?

Coordinator:
I’m still showing no questions at this time.

Leticia Davila:
Okay. I do have one last one. It says Dr. Garcia could you talk a little bit more about the follow-up for women diagnosed with cervical cancer in low-resource settings? How is this done?

Dr. Francisco Garcia:
So, you know, one of the things I talked about was how do you start to weave resources within a community that has low coverage? The most important thing that we do as a public health jurisdiction is actually help people come into coverage either through Medicaid or through the federal marketplace and we really have invested lots of resources into trying to make something like that happen.

In our setting and in many settings, there will be a large percentage of individuals - a significant number of individuals - for whom those are not choices either because of immigration status, because of personal choices that individuals make because they are poor and unbanked and coverage for services for those individuals always becomes a challenge.

The National Breast and Cervical Cancer Early Detection Program resources have helped bring in a whole new set of resources into our treatment as part of the treatment component and that is administered through Medicaid programs in many states and will have whatever restrictions those Medicaid programs have. And that is largely how we get people into care.

Additionally, we’ve done very creative things in terms of partnering with our nonprofit partners - nonprofit hospitals and even with the government of the state of Senora, Mexico to get services to young women who have either pre-cancer or cancer. But it ends up being kind of a very individualized tailored approach every single time that we have a case that comes up where coverage is an issue.

Leticia Davila:
Thank you. We have another question. It says I recently had a patient who has had a hysterectomy who I performed a Pap co-testing on. It came back positive for high risk HPV. If we are cutting out the patients with no cervix for benign reasons, how can we protect these women?

Dr. Mona Saraiya:
(George) would you like to handle that one?

Dr. George Sawaya:
Yes so let me clarify. So this is a patient without a cervix who had an HPV test. Is that correct?

Leticia Davila:
Yes.

Dr. George Sawaya:
So first of all, we should not be doing HPV testing in women without a cervix. ACOG even said specifically that if we wanted to follow these women or we should follow these women after hysterectomy, but it should be with only cytology. So I think there is no guidance in terms of what to do specifically because it’s really not recommended to perform those tests in that situation.

I personally given this question and again I field questions a lot from the community that are kind of vexing in the clinical realm and I’ll just give you my opinion is that I wouldn’t respond to simply a positive HPV testing in women without a cervix. I would only respond to her having a positive Pap smear and use the traditional guidelines for (referral to colposocopy) based solely on her Pap smear result.

Dr. Francisco Garcia:
I’ll add something if I may George just from a public health perspective. We see these kinds of practices go on in our community settings and one of the things that we’ve really worked on in terms of messaging with our provider community is to talk about the kinds of resources that really are being expended in this way that really should be poured into or should be diverted to screening the unscreened.

From a public health perspective the impact of HPV testing in screening in a woman without a cervix, there’s really no public health benefit. And so we are really working hard in our jurisdiction to really work against - work with providers against this practice.

Dr. Mona Saraiya:
Excellent point.

Leticia Davila:
Thank you. Operator, do we have any more questions in the queue?

Coordinator:
We did have a question come up from (Kayla Olsen). Your line is now open.

(Kayla Olsen):
I actually sent the email and you just answered it.

Coordinator:
Alright, thank you.

Leticia Davila:
Perfect. Thank you. Are there any other questions operator?

Coordinator:
I’m showing no additional questions at this time.

Leticia Davila:
Okay, I have one last question. It says Dr. Garcia’s slides show that the clinicians are waiting too long to make HPV recommendations. Can you talk a little bit more about the tools that clinicians can use?

Dr. Francisco Garcia:
There are a variety of tools that the Centers for Disease Control have really developed that are about helping patients broach the subject with - I’m sorry - helping providers approach the subject with patients and their parents and these tools are broadly available or widely available for free on the CDC website.

I’ll tell you that the most important thing that we can do as providers of care for adolescent and pediatric age women and girls is to not be afraid to have the conversation and to really try to de-stigmatize that.

I think one of the things that we as a pediatric community and I’m not a pediatrician so I probably shouldn’t say this, but as pediatricians in general - people who provide care for children in general - have a little bit of discomfort talking about issues of sexual health and I think that is one area where we can really do some skills building to help people develop the tools to facilitate those conversations.

Dr. Mona Saraiya:
This is Dr. Saraiya. I just wanted to add that we do have a website - www.cdc.gov/vaccines/YouAreTheKey/. That has a lot of information about the materials that Dr. Garcia referenced.

Leticia Davila:
Thank you. On behalf of COCA, I would like to thank everyone for joining us today with a special thank you to Dr. Saraiya, Dr. Garcia and Dr. Sawaya. We invite you to communicate to our presenters after the webinar. If you have additional questions for today’s presenters, please email us at coca@cdc.gov. Put November 20th COCA Call in the subject line of your email and we will insure that your question is forwarded to the presenters for a response. Again that email address is coca@cdc.gov.

The recording of this call and transcript will be posted to the COCA website at emergency.cdc.gov/coca within the next few days. Free continuing education is available for this call. Those of you who participated in today’s COCA conference call and would like to receive continuing education should complete the online evaluation by December 21st 2014 using course code WC2286(SC).

For those who will complete the online evaluation between December 22nd 2014 and November 19th 2015 use course code WD2286(SC). All continuing education credits and contact hours for COCA conference calls are issued online through TCEOnline, the CDC Training and Continuing Education Online System at www.cdc.gov/tceonline.

To receive information on upcoming COCA calls, subscribe to COCA by sending an email to coca@cdc.gov and write subscribe in the subject line. Also CDC launched a Facebook page for health partners. Like our page at https://www.facebook.com/CDCHealthPartnersOutreach to receive COCA updates. Thank you again for being a part of today’s COCA webinar. Have a great day.

Coordinator:
Thank you. This now concludes today’s conference. All parties may disconnect at this time.

END