Summary Discussion Text

Summary Discussion

Xian Wen Jin, MD:
We have had a chance to talk about the new guidelines, and some of the implications for primary care practices.  As clinicians, I am sure we run into different clinical situations on a daily basis.  Now, I would like to ask Dr. Monk and Nancy to talk about various clinical situations in our practices, how we implement the new guidelines, and how we counsel our patients.
 
Bradley J. Monk, MD:
Maybe I can start.  As I listen to you, Nancy, I get the sense that much of the angst, the uncomfortableness of HPV testing and counseling, is about the fact that this is a sexually transmitted disease.  So, let me give you a real life scenario:  a woman comes in and says, “You know, my boyfriend cheated on me, and I need a sexually transmitted disease (STD) check.”  Is this an opportunity to integrate the new Guidelines into the STD visit?
 
Nancy Berman, MSN:
Well, absolutely not.  We really need to view HPV as pretty much a ubiquitous virus; that most everybody will be infected.  If I’\\\'m asked, “I would really like to be tested for STDs,” I explain that the STDs that we test for generally include gonorrhea, chlamydia, syphilis and HIV.  I really do not recommend HPV testing because we are not looking for a treatable infection.  We are really looking for HPV-positive women because we want to do cancer prevention strategies.
 
Bradley J. Monk, MD:
And in fact, the way the sensitivity is created, it is not designed to detect low copy numbers.
 
Nancy Berman, MSN:
Exactly.  We are looking for clinically relevant levels of HPV infection where detection limits we expect should tell us if there is an HPV infection that may lead to neoplastic change, and even cancer.
 
Bradley J. Monk, MD:
But for those other 4 STDs that you mentioned, we can treat them.  We want to know if there is just one Neisseria Gonorrhea there, then we are going to give antibiotics.  Also, the ramifications are relevant to the partner, right?  Because if the woman has - and that is why she is there in front of you – gonorrhea, then the partner has to get involved.  Does the partner have to get involved if the woman is infected with HPV?
 
Nancy Berman, MSN:
No, and it is an interesting question - and women may wonder, “If I have HPV, what about my partner?”  I think it is where we are very careful to look at what is appropriate screening.  What is appropriate for HPV disease is to know that we cannot see abnormal changes to the cervix with the naked eye, and we rely upon screening to find those women who need to be brought in for a closer evaluation.  I tell women:  on the male, HPV infection is common, and will usually go away, just as with women.  If there is an abnormality of significance on the male, on the mature squamous epithelium of the male external skin, we can see lesions that are white, red, or pigmented before vinegar and magnifying lenses.
 
Xian Wen Jin, MD:
Dr. Monk, I have a question for you.  You were talking about Pap and HPV co-testing.  If I have a 45-year-old woman who had the double testing, co-testing, a year ago, and cytology is negative but HPV was positive.  Now, a year later, she has repeat co-testing.  Again, the HPV is positive, and she is very concerned about the risk of cervical cancer.  What would you tell her, and what would you do for her in this clinical situation?
 
Bradley J. Monk, MD:
I am going to take you back to the first scenario.  When the patient has a normal Pap and is HPV positive, there are 3 scenarios:  
 
1) she is acutely infected, and she is going to get over it.  That is what usually happens, and that is why you repeat it in 1 year because that is what you think is going to happen;  
 
2) she is chronically infected, so when you test her in 1 year, if she still has it, she is chronically infected;  
 
3) as you said, the HPV test is not perfect.  It is a safety net.  It may overcome the liability or the disadvantages of the Pap test.   
 
So, she has been tested now twice, a year apart.  Not only I would tell her - to your question - that her risk now is very high for getting cervical cancer, I would say, “That is why I am going to examine your cervix under magnification.  That process is called colposcopy, and that is why I am going to do a biopsy.”  I would hopefully make her feel better that when I did that, and if the biopsy was negative, then I would say, “Okay, you are fine, but we are going to watch you closer.” If the biopsy came back positive, I would say, “See I told you so.  That is why we did your HPV test because your Pap test missed it.”
 
Xian Wen Jin, MD:
Thank you.  Nancy, I have another question.  If I have a woman that comes in and tells me she is very concerned about her young daughter, who is currently age 18.  She is very sure or certain that she has been sexually active for the last couple of years, and she is asking you if she should bring her daughter for her first Pap smear - and perhaps talk about birth control issues.  What would you tell this lady?
 
Nancy Berman, MSN:
Well, I would certainly encourage her to bring her daughter in, or have her daughter come in independently at 18.  But I would reassure her that she will not be put through any invasive procedures or exams.  Many young women fear their first pelvic exam, and we really have no evidence that an 18-year old needs that evaluation.  In the absence of any significant signs of possible disease or serious abnormality, we do not need to do a pelvic, but we do need to offer information. We may test for STDs, GC, and chlamydia, by a urine test.  We certainly do not want to do a Pap test, because if that young woman has become sexually active, she most likely has been infected by HPV.  And just remember that an abnormal Pap, called LSIL (low grade squamous intraepithelial lesion), is reflective of HPV infection.  And the LSIL Pap is going to, in most cases go away, as it represents transient infection and transient abnormal change of the cells.  So, the new guidelines are really meant to protect this young woman and prevent her from having over-response and over-treatment of transient HPV infection.  I truly would say to that mom, “I would love to see your daughter, but please reassure her that I will talk with her and determine what tests she needs that are age-appropriate and appropriate to her situation.”
 
Bradley J. Monk, MD:
See what happens though is she comes in, they do a Pap.  It is a high-grade lesion, and they do a biopsy.  It is high-grade dysplasia, CIN 3, then they come and say, “See, Dr. Monk, those guidelines were wrong.”  And I say, “See, I hope you did not treat her because even that lesion can go away.”  There is a risk there.  Now that 18 year old, to take a chunk out of her cervix, which is called a large loop excision, a LLETZ or LEEP, increases her risk of cervical incompetence, infertility, and premature birth unnecessarily.  That is why these guidelines are in place:  so you do not prevent cancer by doing an excision or an ablation on that 18 year old; and if she does not get over it, she will still have it when she is 21 when you start screening her.  You will find it then, you can treat it then, and it is okay.  But we do not want to overtreat that 18 year old.
 
Nancy Berman, MSN:
And I also want to mention that we do have existing guidelines for adolescent women….
 
Bradley J. Monk, MD:
In case you did the wrong test …
 
Nancy Berman, MSN:  
……at around 21.  What I find as a practitioner is often I do see new patients who are under 21 who come to me with an abnormal Pap.  I do not ignore it, but we do have existing guidelines, and I think that might be a little confusing.
 
Bradley J. Monk, MD:
Right.
 
Nancy Berman, MSN:
There are guidelines for adolescents, and it is for just this type of situation.  It helps me understand that I am not going to ignore that result.  But I do have something that guides me, which allows me to follow her up without over response.
 
Xian Wen Jin, MD:
Well, Nancy and Dr. Monk, you clearly explained it well.  I think as clinicians we must remember, as we all try to help our young women patients, that we must not introduce potential harm, and that more does not always mean better.
 
Bradley J. Monk, MD:
Now that these guidelines are out there, and they are very clear; everyone can read them, even lawyers.  I guess lawyers can read, I don’t know - it’s a joke - but are you afraid of liability issues?  I mean, as an OB/GYN gynecologic oncologist, I’m afraid if I don’t do colon cancer screening, and I don’t do mammography, breast cancer screening, and they get a colon cancer or a breast cancer, that people are going to say, “Look, you didn’t follow the guidelines!”  Is that a concern for primary care providers?
 
Xian Wen Jin, MD:
I think as physicians and health care providers, the most important thing for us is to provide the best care, highest quality care, to our patients.  Certainly, in this age we are aware of the legal ramifications, but I think the best thing to do for us is to really follow the evidence of science and follow the guidelines that are issued to us by these different organizations.  That actually, I think, puts you in a very good spot.  And even if there are questions down the road, then we are truly following the latest guidelines, and are practicing evidence-based medicine.
 
Bradley J. Monk, MD:
In your talk you were very articulate in saying that there are more than one HPV tests that are available.  As primary care providers, does it matter to you?  I think you said that there are four.  Does it matter to you which one is used?  You know, I don’t want to make this promotional.  But if it matters I think we need to teach the audience what the points are to consider, and if it doesn’t matter just check off the box and let the lab figure it out.
 
Xian Wen Jin, MD:
Again, that is a very interesting question.  I think it is very clinically relevant.  I think the American Cancer Society guidelines stated very clearly that what we need to do with HPV testing is use the test that has been clinically validated rather than something made in the ‘home kitchen.’  And one of the things that we must also keep in mind is there is a difference between clinical sensitivity and analytical sensitivity.  As you mentioned, Dr. Monk, currently there are four (4) HPV tests.  They are approved by the FDA.  Three (3) are based on the DNA detection, one (1) is based on RNA detection, and one (1) of the DNA tests is based on PCR technology.  So, we must keep in mind - what is the clinical sensitivity?  Have they been validated by a large database?  Currently, I think the hybrid capture test, based on HPV and DNA testing, is the best, clinically relevant test for most clinicians to use across the country.  The other tests are a little bit lacking in clinical data.  And there are some questions about PCR-based technology altogether, because we all understand if you repeat a reaction for 30 cycles, you amplify the DNA a million times.  Certainly it is the most sensitive.  However, two copies of HPV DNA, does that translate to clinical significance?  With hybrid capture, we were talking about having about 5,000 copies of HPV DNA present to have a positive test.  So, there is a distinction between analytical sensitivity and clinical, meaningful sensitivity.
 
Bradley J. Monk, MD:
So, there are four FDA-approved tests; three of them are DNA, one is RNA.   
 
Xian Wen Jin, MD:
Correct.  
 
Bradley J. Monk, MD:
I have heard that argument before, but what people say is, “Well, you liked the first one because you say there is more data.  But the first one should have more data because it was first.”  So, that unfairly biases the newer three, and maybe the newer three are better because the technology got better.  How do you respond to that?
 
Xian Wen Jin, MD:
Well I think….
 
Bradley J. Monk, MD:
Because first always has more data.
 
Xian Wen Jin, MD:
True.  And I think for the two HPV DNA based technology…
 
Bradley J. Monk, MD:
Two other ones.
 
Xian Wen Jin, MD:
Two other ones, I think it would be best to wait and see more data.
 
Bradley J. Monk, MD:
Right.
 
Xian Wen Jin, MD:
And they might be as effective.  For the RNA-based technology - again, it is very new - there is only one clinical trial that I am aware of.  I think it is not a matter of my personal preference or my medical center’s preference which one to choose.  I think again, we get back to evidence-based data generated, and what is the best for our patients.
 
Bradley J. Monk, MD:
Nancy, what do you think?
 
Nancy Berman, MSN:
Well, I think for most clinicians who will be taking on HPV testing, it may not be a personal choice.  I think for most clinicians, samples are sent to laboratories based on the setting, based on the practice.  I would just encourage clinicians to know which test are they seeing, and that they are not using a not-FDA-approved, home-brewed type test.
 
Bradley J. Monk, MD:
But although…
 
Xian Wen Jin, MD:
Although these four currently are approved.
 
Nancy Berman, MSN:
Then there are…. yes.
 
Bradley J. Monk, MD:
So, when you say home-brewed, you mean non-FDA approved?
 
Xian Wen Jin, MD:
Right.
 
Nancy Berman, MSN:
Correct.
 
Bradley J. Monk, MD:
Thank you.
 
Nancy Berman, MSN:
Dr. Monk, I have a question.  We have talked about very young women, but we need to look at the older woman.  One of the scenarios that we may come upon is a woman who has had significant high-grade disease.  Perhaps she was in her mid fifties (when she had high-grade disease), and now she reaches the age of 65.  I would like to ask you, what will you do about screening that woman?
 
Bradley J. Monk, MD:
So, one of the points of the guideline is when to stop.  We talked about when to start.  The stop, the cessation is at age 65, but only for patients who have not had disease before.  In this particular scenario, she has had disease within the last 20 years, and screening needs to continue.  But I think the point is well taken that if she was treated, and she is Pap/HPV negative today, it still holds for 5 year screening intervals.  Do you see what I am saying?  The fact that she had disease before, does not make that 5-year security blanket a 3-year security blanket.  It is still 5 years.  And I guess my question back to you is, since I do hysterectomies as a surgical oncologist, when I send these patients back to you that have had hysterectomies, do you keep doing Pap tests on them?
 
Nancy Berman, MSN:
The woman who has had precancerous lesions or cancer of the cervix - and that was the reason for hysterectomy - should be screened …vaginal cancer risk is so rare.  The guidelines support the fact we should not screen women vaginally that have had hysterectomy for benign reasons.
 
Bradley J. Monk, MD:
So, fibroids, or bleeding, or whatever.
 
Nancy Berman, MSN:
Correct.
 
Bradley J. Monk, MD:
Do you do a pelvic exam on that patient?
 
Xian Wen Jin, MD:
Well, I think that comes into the question.  When a complete hysterectomy was done for benign reasons we understand the cervix anatomically is absent.
 
Bradley J. Monk, MD:
Right.
 
Xian Wen Jin, MD:
Therefore, there would be no future value of doing a so-called cervical cancer screening.  What we are doing is the vaginal vault, and as Nancy pointed out correctly, the incidence is very low.  The only instance I would agree with you, is that women who had a hysterectomy for precancerous lesions - that is a different clinical scenario.  We do need to continue screening.  But if somebody had a fibroid or functional bleeding leading to a complete hysterectomy, we really should stop doing any cervical cancer screening in that clinical situation.
 
Bradley J. Monk, MD:
But I am not going to let you weasel out.  Does she need a pelvic exam?
 
Xian Wen Jin, MD:
Well, if it is a complete hysterectomy, that means both ovaries are gone, so there is really no value to do anything pelvic to examine the organs that are already absent.
 
Bradley J. Monk, MD:
That is what I think.  I wanted to hear you guys say that.  As primary care doctors, you might feel different.
 
Nancy Berman, MSN:
Right now, well I think the American College of Obstetricians and Gynecologists’ most recent bulletin suggests that it is a decision to be made between a woman and her provider.
 
Bradley J. Monk, MD:
Fair enough.
 
Nancy Berman, MSN:
But I also want to mention that we have a discrepancy in lay terminology versus medical terminology.  The laywoman says, “I had a complete hysterectomy,” which in her mind says, “I no longer have ovaries.”  What I have found, and what we need to be aware of, is that the supracervical hysterectomy, (hysterectomy above the cervix) has been a more popular procedure perhaps in the recent decade.  There are often women that I see who do not, number one, know what a cervix is, let alone know if they still have a cervix.  And I do not want to forget to mention that that woman who still has a cervix and who had a supracervical hysterectomy requires screening according to guidelines.
 
Bradley J. Monk, MD:
Perfect.
 
Xian Wen Jin, MD:
If I may add, when we talk about hysterectomy we need to be precise, accurate, knowing what it is, and what is included in the surgical specimen.
 
Bradley J. Monk, MD:
And you were very good that way, you were very good.  
 
Xian Wen Jin, MD:
Nancy, you brought up, and I agree 100%, that the guidelines we are talking about are guidelines.  I think a clinician’s judgment on an individual basis is still paramount in clinical practice.  Basically the main message is:  we start screening later, we extend the interval longer, and we stop screening a little earlier than 70 years old.  So, Nancy, I have a question.  To be honest, I think some of the providers in the audience, and that may include some of our colleagues, would be concerned because you are telling women to come in less frequently, and we order fewer tests that we used to order frequently.  Does that translate to the loss of a patient, or perhaps even tie into financial revenue?  How do you address those concerns of our providers?
 
Nancy Berman, MSN:
Right.  It is so in the best interest of the patient to avoid over screening, and I understand the resistance by clinicians who may feel they will lose women who see the Pap as the definition of the annual exam.  There have been some studies done looking at screening, the decrease of screening frequency, and whether women return.  There has been some data showing that women will continue to return.  I live in an area where, economically, so many women have lost insurance, and coming in for a well-woman exam becomes less of a priority.  But we may see a change in the coming years, as more women are insured.  So, I again stress that we must teach the value of all that we do:  that the Pap is such a small piece of that, and I continue to try and teach my patients.  I do see patients who come back.  I do not always know how many have not come back, obviously, but it is education, and it is reteaching.  The new guidelines are really different because we have over-taught the Pap. Even  something as small as medical assistants who bring patients back (to the exam room) and ask, instead of an open-ended question, “What brings you here today?”  I still hear, “Are you here for your Pap?”  So, we have a long way to go to teach, not just the patient, and not just the clinician, but also everybody in the practice setting to teach women.
 
Xian Wen Jin, MD:
I agree.  I think one of the key points of the new updated 2012 Guidelines is that less actually is better; we should screen in a much smarter way.  As you mentioned earlier in each of your talks, if you look at the impact of cervical cancer diseases in the population, the major impact is really in the under-screened population, not in the well-screened population.  Another common question that we run into sometimes, and maybe Dr. Monk and Nancy you can answer, is that we have a woman test HPV-positive.  If I say to that woman, “Sue, you are HPV-positive,” immediately there are many questions like, “Oh my goodness, who gave it to me?  When and how?  Is he doing something that he should not be doing?”  As clinicians, we should be prepared to have a meaningful dialogue, a positive dialogue with our HPV-positive women.  How would you counsel your patient in this situation?
 
Nancy Berman, MSN:
To begin with, and I mentioned a little bit in my presentation, this is truly a time to piggyback messages.  I have found that women who come to see me - many who have had 25 or 30 years of Pap tests and, for the most part, never knew what the Pap was - think that it detects many, many things and do not really understand.  We need to talk to all women about HPV.  And to say to every woman I see who has friends, nieces, daughters, that we all need to know that HPV is the cause of cervical cancer, and that most people have it.
 
Xian Wen Jin, MD:
Absolutely.  I think one of the distinctions that Dr. Monk mentioned earlier is that HPV is transmitted sexually.  However, it behaves differently from the traditional STD entity because the HPV infection is a very latent virus infection.  It means that if a woman in her mid-forties or fifties comes in and tests positive for HPV, that certainly does not reflect the current sexual practice of her partner; perhaps she contracted HPV during her high school or even college years, and the virus has been there since that time.
 
Bradley J. Monk, MD:
…Undetectable.
 
Xian Wen Jin, MD:
Undetectable.
 
Bradley J. Monk, MD:
…Until now.
 
Xian Wen Jin, MD:
Yes.
 
Bradley J. Monk, MD:
…When it is associated with disease.
 
Xian Wen Jin, MD:
Right.
 
Nancy Berman, MSN:
That kind of leads me into another question.  We have talked about the very young and the much older woman, but there are so many women in those middle years that may be co-tested and are negative on both tests.  Well, we know that the rate of divorce in the United States is at a level above 50%, and we have a lot of midlife women who are now going out and becoming sexually active with new partners.  Let’s talk about and review how we address the woman who has been negative/negative (Pap (-) / HPV (-), but has now become sexually active, and possibly infected by HPV.  Do we change the screening frequency?
 
Xian Wen Jin, MD:
I think what we frequently encounter in our daily practice is that if this woman had negative co-testing results last year, or even today as a matter of fact, and she goes out and meets Mr. Wrong who gives her HPV 16 or even 18, what would happen to this woman’s risk of cervical cancer down the line?  Well, there are two things:  one is, as Dr. Monk mentioned earlier, most HPV infections do go away.  That even if they become a persistent infection, which is a necessary step to developing cervical disease cancer down the line - Nancy, you mentioned in your talk - that there is a very long lead time for cervical cancer to develop.  The analogy to a primary care provider is that, similar to colon cancer, it really takes time from the incident infection of HPV 16 or 18 for invasive cervical cancer to be present.  The time is about 10 years approximately. So, let’s say she meets the Mr. Wrong, and is infected with lots of HPV 16 tomorrow.  We still have time to bring her back to screen and catch that high risk HPV infection.  That is to say, that her infection does not go away, and if it does not go away, or is persistent, we have time to catch it.  We want to make sure and explain to our patient that screening practice should not change based on sexual practice, and that is based on the fact that this is a very slow, latent infection virus.  Most of them do go away, and if they do not go away leading up to the end result of cervical cancer, we have ample time to catch it before it becomes a major problem.   
 
Well thank you, Dr. Monk and Nancy, for such a meaningful discussion related to this topic.  I certainly learned a lot today.