Self-administered Pap test a new option in cancer screening

[00:00:00] Host Amber Smith: Upstate Medical University in Syracuse, New York invites you to be "The Informed Patient" with the podcast that features experts from Central New York's only academic medical center. I'm your host, Amber Smith. Alternatives to the traditional Pap smear at womens' gynecologic exams are on the way, and I'm talking with an associate professor of obstetrics and gynecology at Upstate to find out more. Dr. Rinki Agarwal is also the medical director for the Upstate Cancer Center's gynecologic oncology program. Welcome back to "The Informed Patient," Dr. Agarwal.

[00:00:36] Rinki Agarwal, MD: Thank you for having me.

[00:00:38] Host Amber Smith: Could you please describe how the traditional pap smear is done?

[00:00:42] Rinki Agarwal, MD: Sure. So, as Amber has said, I'm a gynecologic oncologist, so I see patients who have been diagnosed with either a cervical cancer or high grade dysplasia. And, that's typically that somebody has already identified a problem, and that's when they're coming to my office.

The pap smears are done, typically, in a primary care setting, so that would be your Ob-gyn or a primary care physician, APP (advanced practice provider), one of those providers, done in an office setting where you have an exam room, you're undressed from the waist down. An examination is performed, including a speculum examination, and cells are collected directly from the cervix by the health care provider, and then sent to

[00:01:34] Host Amber Smith: Now, how reliable are pap smears in detecting cancer cells?

[00:01:38] Rinki Agarwal, MD: So, pap smears have been around now for over 40 years, 50 years almost and have been amongst the great success stories when used in screening for cancer. Cervical cancer has decreased dramatically in the U.S. population when cervical cancer screening is completed. And the idea is that the test was to diagnose cervical cancer, but it has evolved into now being able to diagnose precancers so that patients are treated for the precancer, that's managed, and it's led to an overall decrease in the occurrence of cancers, and that's where a lot of the difference has been.

[00:02:29] Host Amber Smith: Now you used the word dysplasia. Is that pre-cancer?

[00:02:34] Rinki Agarwal, MD: That's pre-cancer, correct. There's different kinds of dysplasia. There is mild and severe dysplasia, and it's the severe dysplasia that gives you this potential of converting into cancer. And typically, there is a substantial amount of time from a person developing dysplasia to occurrence of cancer or transformation into cancer.

So if there was good screening technique used at the time, in that whole several year timeframe where somebody has dysplasia or pre-cancer because they went through a screening process, that would be a mechanism how you would prevent the occurrence of cancer.

[00:03:18] Host Amber Smith: I see. Now during the Pap test is the physician or the provider able to visualize dysplasia or something that looks abnormal, or is it only discovered once the specimen goes to the laboratory?

[00:03:32] Rinki Agarwal, MD: So both are true, if if it is a substantial amount of dysplasia causing visible changes on the cervix, then that will be picked up by the examining individual, the physician or APP. But, otherwise the Pap smear is designed to capture a lot of the cellular structure as well as HPV (human papilloma virus) DNA. And the current screening protocols allow for testing with one or both of those techniques. And then it's picked up by the lab.

[00:04:04] Host Amber Smith: So why has this self collection option been developed?

[00:04:09] Rinki Agarwal, MD: That's a great question. if I can kind of describe, I've said that the cervical screening using a Pap smear is very effective. And I also emphasize the words "when used." So the problem right now is that when it's applied, it's great, but the majority of cervical cancers in the United States or in the world are occurring right now in populations or patients who have not gone through the screening process. And that can be because of a number of different barriers, but in addressing some of those barriers, you're trying to use other tools.

If self-administered Pap smears closes that gap and makes screening possible for patients who otherwise would have difficulty getting to it -- hesitation, access issues -- trying to solve a problem for what's an effective test when utilized.

[00:05:12] Host Amber Smith: So how would this self collection method work? Is it a kit that would come to the home, or would you get them from the doctor's office?

[00:05:21] Rinki Agarwal, MD: This has been used in other countries already, and it's approved in one of two ways right now, with the second being tested. What is approved, as of May of this year, by the FDA, is a Pap smear collection kit that is available at the doctor's office. So the patient goes in, self-administers the test in the physician's bathroom, and the collection is done right in the office, and the results come back to the physician.

So it's overcoming a certain barrier of going through the examination and the hesitation that people have going through the whole experience of having a Pap smear test.So I think it applies to a certain population that would not go through the screening because the exam is uncomfortable. I don't think it replaces the full examination and the benefits of the examination. Like I said, the cervix is visualized, a full examination is done. And there is information that the provider is able to utilize for the patient in that situation. But if there is a barrier to going through the examination because of the awkwardness of it, this particular format would help address that.

There is a second method that's in development, and the rollout and how it's going to be executed in the U.S. health system remains to be seen, where the kit could be sent to the patient. So the kit is sent to the patient, and they administer the test themselves, put it in a mailing kit, and it goes to the lab with the results coming to the provider. The idea there, the execution, there's a number of studies that have looked at how this could be executed. It is likely to be covered by insurance because it's an FDA-approved process. But how is it coming to individual patients or regions and practices is something that will evolve over the next few months to years as it becomes more widely available. Even as we're recording this today, the first set of test kits that would be available to physicians to use in their offices has just become available.

[00:07:43] Host Amber Smith: This is Upstate's "The informed Patient" podcast. I'm your host, Amber Smith. I'm talking with Dr. Rinki Agarwal. She's an associate professor of obstetrics and gynecology at Upstate and also the medical director for the Upstate Cancer Center's gynecologic oncology program.

So for the self tests, are women going to be able to collect samples from their cervix? And if not, will they get a collection that will be able to be as reliable as the traditional Pap smear?

[00:08:16] Rinki Agarwal, MD: To answer that question, the best way to proceed is to talk about what the test is testing for. Right now, Pap smears can be tested for cell abnormalities. So that's called cytology. It can be tested for HPV (human papillomavirus) DNA. And, some pap smears are used with both testing for the cytology, the cells, as well as the DNA testing can be done.

The self-administered test is only going to test for HPV DNA, and therefore getting right at the cervix and being able to collect those specific cells is not important for this test. And because it cannot be reliably done, it was excluded from the development of the testing. Having said that, just the HPV testing alone is a perfectly viable method of doing cervical cancer or dysplasia screening because the HPV DNA presence is a harbinger or a factor that's going to provide information regarding risk of developing dysplasia or cancer. So it's a very effective test, and it's used even in settings where a healthcare provider is actually doing the examination.

[00:09:34] Host Amber Smith: Do you think that women will be able to stick with the traditional method, or are they going to be asked to do the self exam?

[00:09:43] Rinki Agarwal, MD: I think it remains to be seen because there are certain things that are attractive about being able to do a self-administered examination or a cervical cancer screening test, because if it takes the exam out of the time that the patient has with the physician, if it makes their time used for counseling and to address their issues that they want to bring to the physician, if it reduces the amount of commitment they have to make in order to come and see the physician for the visit -- because telemedicine is also available now as a format -- there are ways that this could basically have a bigger uptake. But for the moment, I think that the best place or the best use case for the self-administered test is for situations where people would otherwise not be able to access getting the Pap smear testing in the traditional manner at all.

[00:10:42] Host Amber Smith: Well, how often is cervical cancer screening recommended?

[00:10:46] Rinki Agarwal, MD: Right now the exams are once a year for just general gynecologic exams, and then the Pap smear testing is for cytology or just the cells, looking at the cells in under the microscope, is once every three years. But if you did the HPV testing or HPV with looking at the cells or cytology testing, that would be once every five years.

[00:11:11] Host Amber Smith: And what age do women begin this screening, and when does it end?

[00:11:18] Rinki Agarwal, MD: So you would start screening at 21 and typically the end date is based on what the history for the individual has been, but it is either 65, or 20 years of basically having very normal Pap smears.

[00:11:36] Host Amber Smith: Since this test is designed to discover cervical cancer in its early stages, can you walk us through what typically might happen if a woman's Pap test finds some unusual cells? What happens after that?

[00:11:48] Rinki Agarwal, MD: So the Pap test that's done in a traditional manner has both HPV and cytology done on it typically. So that would give the provider information on both of those pieces of data. And based on what those results show, there could be additional exams in the office, things called A colposcopy additional biopsies or additional procedures dictated by having those two pieces of information.

Because the self-administered Pap smear is only going to have the HPV DNA tested, and cytology is not part of the test, there will be an intermediate step where the patient who has a positive test for HPV DNA presence of certain types. So the testing for HPV looks at numerous strains of HPV DNA, and they can find high risk HPV DNA. If that's present, then that patient is at increased risk of having cervical dysplasia, would be contacted, called back into the office and undergo an examination in the traditional manner with collection of cytology, with the visual assessment, additional biopsies, possibly the colposcopy. And what range that would take is based on the results that we're dealing with.

[00:13:15] Host Amber Smith: It's very individualized it sounds like.

[00:13:19] Rinki Agarwal, MD: Yes.

[00:13:19] Host Amber Smith: If cancer is discovered, though, what are the options for treatment these days for cervical cancer?

[00:13:27] Rinki Agarwal, MD: So the treatment options range from surgery, chemotherapy and radiation, and combinations of those things. But, the range and success of those is dependent on successful identification, hopefully at an early stage, and then very effective use and compliance with the treatment that is recommended at that time.

But the early stage, which is -- cervical cancer has the availability of screening techniques that we've already talked about, but it also has the availability of vaccinations for prevention of cancer.

So in the United States, our view, I'm an oncologist, and my view is that we have tremendous tools so that my practice of taking care of patients who have cervical cancer should be a shrinking demographic that should be very few far between or hopefully never see them again would be an ideal thing for us to see.

But if somebody still falls through the cracks and does develop cervical cancer, the ideal situation would be that they were screen detected, they were detected early. And screening does make it more possible for patients to have an earlier detection at an earlier stage for the cervical cancer. And those then are treated with curative intent. That means that you manage the cancer and the patient is cured and can move on in their life.

[00:15:03] Host Amber Smith: So it sounds like the keys are the HPV vaccine and regular cervical cancer screening.

[00:15:10] Rinki Agarwal, MD: Well summarized.

[00:15:13] Host Amber Smith: Well, thank you so much for your time.

[00:15:15] Rinki Agarwal, MD: It's a topic that obviously is really dear to me.

[00:15:19] Host Amber Smith: My guest has been gynecologist Rinki Agarwal, who serves as medical director for the Upstate Cancer Center's gynecologic oncology program. "The Informed Patient" is a podcast covering health, science and medicine, brought to you by Upstate Medical University in Syracuse, New York, and produced by Jim Howe. Find our archive of previous episodes at upstate.edu/informed. If you enjoyed this episode, please tell a friend to listen too. And you can rate and review "The Informed Patient" podcast on Spotify, Apple podcasts, YouTube, or wherever you tune in. This is your host, Amber Smith, thanking you for listening.