FDA has cleared the first at-home self-collection kit for HPV screening, removing significant obstacles to cervical cancer detection.
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The kit includes the only FDA-approved HPV assay to individually identify six high-risk genotypes and is the most comprehensive HPV screening tool available in the U.S. today.
“The population that ends up dying from cervical cancer, which is highly preventable, are these populations that have historically fallen through the cracks of the healthcare system,” said Claire Marie Porter, reporter with The Cancer Letter. “So, this kind of levels the playing field.”
On this week’s episode, Claire and Jacquelyn Cobb, associate editor of The Cancer Letter, talk about why approximately 12,000 cases of cervical cancer still occur every year in the U.S. when it’s considered one of the most preventable of all cancers. Because 99% of cases are caused by high-risk HPV, widespread vaccination and screening could, in theory, almost entirely eliminate the disease.
“I mean, this story is like, come on, let’s cure a cancer,” Jacquelyn said.
We also hear from Otis Brawley, the Bloomberg Distinguished Professor of Oncology and Epidemiology at the Johns Hopkins Kimmel Cancer Center, on the history of the Pap smear, and what has changed over the last century of cervical cancer screening.
“The self HPV testing is a tremendous improvement, especially amongst women who don’t want a Pap smear or don’t want a pelvic examination,” Brawley said. “I don’t need to tell you how invasive it is. And we’ve actually started learning that it’s certain types of HPV that are more likely to regress versus others.”
Stories mentioned in this podcast include:
- Self-collection kits for HPV are among innovations adding momentum to eradication of cervical cancer
- Long-awaited results from first phase III trial of a RAS inhibitor in pancreatic cancer shows that daraxonrasib doubles median OS
- Calabresi’s “Cancer at a Crossroads” report was the first step toward historic doubling of the NIH budget
- Most Favored Nation drug pricing could put China on top
- Bridging communication and genomics: A path toward equitable cancer care
- FDA adds stereotactic breast biopsy needles to the shortage list
- CMS proposed rule would implement electronic prior authorization requirements for covered drugs in federal health plans
- At Friends meeting, data quality, modern evidence generation, and early regulatory alignment top the list of “next steps” for external control arms
This episode was transcribed using transcription services. It has been reviewed by our editorial staff, but the transcript may be imperfect.
The following is a transcript of this week’s In the Headlines, a weekly series on The Cancer Letter Podcast:
Jacquelyn Cobb: This week on The Cancer Letter Podcast.
But just how interlocked HPV and cervical cancer are and how it’s literally-
Claire Marie Porter: 99% of cervical cancers are preventable. Together with cervical cancer screening, the HPV vaccine, and follow-up, multiple sources told me that cervical cancer can be eliminated within our lifetime in theory.
Jacquelyn Cobb: Yeah. I mean, this story is like, come on, let’s cure cancer.
Claire Marie Porter: What other cancers are we talking about like that? It feels really poignant.
Paul Goldberg: You’re listening to the Cancer Letter Podcast. The Cancer Letter is a weekly independent magazine covering oncology since 1973. I’m your host, Paul Goldberg, Editor and Publisher of The Cancer Letter.
Jacquelyn Cobb: And I’m your host, Jacquelyn Cobb, Associate Editor of The Cancer Letter. We’ll be bringing you the latest stories, groundbreaking research and critical conversations shaping oncology.
Paul Goldberg: So let’s get going.
Jacquelyn Cobb: Hello, Claire. How are you?
Claire Marie Porter: Hey, I’m good. How are you? How’s Portland? Is it cold?
Jacquelyn Cobb: It is a little cold. That’s so weird that you ask that because I’ve been really actively pondering this recently because it feels like a proper spring in a way that I can’t remember having in a long time. I must have in Boston, right? But I think maybe one year recently we went to Oregon from February to March. So it’s the first time it feels like for me in a while that I’ve had a proper spring where it’s 40s at night, 60s, and the flowers are blooming, and I’m really liking it. I like sort of this proper middle, but we are not having sort of what … I know my friends in DC and in New Jersey, I think my parents were saying that it’s 90 last week at some point. I don’t know if you have a similar thing.
Claire Marie Porter: Yeah. It’s this false summer. It’s really confusing. And I think what’s happening here is not great. A lot of animals are coming out, the toads, the frogs, the whatever, and the flowers are blooming and then it’ll freeze. And right now, it’s like 50 degrees and quite cold here. I’m freezing. We had to turn our heat back on, so it’s been a bit of a whiplash. I don’t like it.
Jacquelyn Cobb: Yeah. Yeah. That’s what’s weird is we had some warmth, but that’s what I mean, I think actually we are having some flowers bloom, but I get the sense that we’re not going to … Maybe we’ll have one frozen night or a couple frozen nights, but looking at the weather report, I’m like, “Okay, it seems fine-ish, maybe.” But I want to talk to you later, not on the podcast because it is the wrong topic, but I really want to talk to you about if you ever track amphibian migration because I just learned about that and I feel like that’s something that would be up your alley.
Claire Marie Porter: Oh, yeah.
Jacquelyn Cobb: We can talk about that.
Claire Marie Porter: You know me.
Jacquelyn Cobb: Just to give a little bit of editorial gossip or editorial—what did Paul call it last week—newsroom gossip? Last week was really interesting because me, Paul and Claire … Sara was at a conference and me, Paul, and Claire all had sort of just fallen to our laps almost really..stories that were very in our wheelhouse, each of us. So that was really just on, again, that sort of background gossipy editorial planning side of things.
It was a really cool week in that way because we were all just following our passion. So Claire had sort of this HPV story, this public health story, this more feature-y story where she talked to a patient. And again, not going to give too many spoilers, but I had a story about just a super nerdy pancreatic cancer sort of milestone. It was the first time that a phase III trial of a RAS inhibitor in pancreatic cancer specifically had read out. And that alone probably would’ve been a story.
At least it definitely would’ve been covered by us, but what made it even better was that it had really, really great results. It’s reportedly the first time a drug has shown a greater than one year survival in metastatic pancreatic cancer. It doubled the median OS of the results of the trial results were that the drug doubled median OS from like 6 months-ish to 13.2, I think. Or don’t quote me on that, look in the story. But yeah, that was just a really exciting story and got it to look into molecular stuff, how it worked.
RAS was infamously called the undruggable target for a long time. So I got to just sort of nerd out about that for a while. And then Paul wrote an incredibly very policy-heavy story, sort of zooming out abstract, what is the future of oncology as a whole, really big picture stuff. And sort of working with the cancer center leaders and all of his networking, that’s his favorite thing to do. So I feel like we all just got what we wanted. If there was like more than 24 hours in the day, would’ve been an ideal week.
Claire Marie Porter: Right. Seriously.
Jacquelyn Cobb: Also, we had a guest editorial by John Stanford of Incubate talking about the most favored nation drug pricing. And then we had a sponsored article and cancer policy was pretty dense as well. Stereotactic breast biopsy needles are on the shortage list, FDA shortage list, as well as some other kind of nuanced things. Friends of Cancer Research had a meeting on external control arms, et cetera. So definitely peruse at your leisure. So yeah, that’s my job is the headlines, but I’ll pop it over to Claire to sort of run through what our plan is. We have a little bit of a weird podcast plan, so I will let Claire discuss.
Claire Marie Porter: Sure. Well, I’ll just briefly introduce my story so there’s some context for what happens next. The newsy bit, is that FDA has approved the first at-home self-collection kit for HPV. And this is something that advocates and cancer prevention folks have been pushing for for about two decades.
It grew out of this NCI-led public-private partnership where basically FDA needed to see that unsupervised collection and clinician-based collection were clinically equivalent. So that was the final data that was needed.
So this kit now kind of paves the way for more of this and it’s a big deal in terms of health equity, especially, for numerous reasons, there are lots of people who avoid getting a Pap smear, whether it’s because of access to the space, medical trauma, sexual trauma, the list goes on. And the population that ends up dying from cervical cancer, which is highly preventable, are these populations that have historically fallen through the cracks of the healthcare system.
So this kind of levels the playing field.
The one patient that I spoke with, or not patient, but a user of a self-collection kit on one of the mobile “Game Changer” buses in Boca Raton, Florida, run by Sylvester, described the experience as just empowering. And she felt like it was so easy. She couldn’t believe how easy it was. It felt safe. It felt quick. Just kind of a very different set of vocabulary words than you would ever use to describe a speculum-based exam at your OB-GYN. So exciting.
As many of my sources said, anyone who’s had a speculum-based exam would never be like, “That was fun. Let’s do it again.” It’s not fun. So, it’s kind of opening up this new category of care in the cancer prevention space and at large. So, all that said, a piece of this story that was so interesting to me, but just ultimately didn’t make it into the final piece was Dr. Otis Brawley talking about the evolution of Pap smears, the history of cervical cancer screening, which is more in depth than I expected. And so I wanted to include some of that storytelling from his perspective because he does it so well. So we’re going to pop it over to Otis to tell us more about the history of pap smears.
Otis Brawley: The history of cervical cancer screening is actually quite instructive of a lot of things in cancer. It’s important to remember that Dr. Papanikolaou, who was at New York Hospital in New York, he was a Cornell physician. Dr. Papanikolaou developed the Pap smear in the 1930s and ’40s, and he became a huge advocate of the Pap smear. He got the American Cancer Society, who was already into early detection regarding breast and colon cancer, to become an early advocate for the Pap smear.
And by the way, in the 1930s, cervical cancer was a bigger killer of women in breast cancer. I don’t know if that was true in the ’40s or not, we can check, but in the ’30s, it definitely was. The American Cancer Society in the late ’40s and early ’50s began a series of what were called demonstration projects, where they encouraged use of the Pap smear.
Now, what ultimately happened was they demonstrated that nobody knew how to read cytology. Indeed, cytology was not a specialty of pathology at that time. There were a whole bunch of Pap smears that were misread by pathologists who didn’t know how to read pathology, and that led to some people getting unnecessary treatment at the time.
Unnecessary treatment can involve hysterectomy, it can involve colonization of the cervix where a large part of the end of the cervix is cut out. When that happens, a woman can end up with cervical incompetence if she gets pregnant, meaning the baby will fall out. Sometimes we have to do what’s called a cervical cerclage, which is like a purse string stitching of suture around the cervix to literally tie the baby in.
Eventually, we got our X-ray and it took throughout the 1950s and ’60s for cytology to become a recognized subspecialty of pathology and people got better at reading cytology. We ended up with cytotechnicians because you can imagine it’s really boring to sit there and have to read 80 Pap smears a day under a microscope and very few doctors were willing to do that. And so we ended up training cytotechnicians to do it.
Then there was this incredible push towards screening for cervical cancer in the 1960s and ’70s. The American Cancer Society literally had commercials about it. It was actually the first time that they were allowed to say the word cancer on television.
Claire Marie Porter: So, then in the 1980s, Harald zur Hausen figured out that cervical cancer was caused by the human papillomavirus. And in 2008, was awarded the Nobel Prize in Physiology or Medicine for his discovery. Then throughout 1930 and onward, there’s this literature about how cervical cancer must be a sexually transmitted disease. Some of that data was as simple as nuns never got it unless they were bad girls before they went to the convent and prostitutes very commonly did get it. And then second, wives that came after women who died of cervical cancer very often got cervical cancer. So there was always speculation, could it be gonorrhea, could it be chlamydia, it could be the herpes virus? And finally zur Hausen settled it. And about that time, people started speculating that there was some dysplasia that did not progress to cervical cancer.
Otis Brawley: And there are these pictures that people have drawn where you can go from normal cervical epithelium towards dysplastic epithelium, toward more dysplastic epithelium. We actually called it CIN1, CIN2, CIN3. As the number goes up, it gets more dysplastic or it looks more unlike normal tissue. There’s a good phrase for dysplasia, a good definition of dysplasia. Then you go from CIN3 to carcinoma in situ, which looks like cancer, but it’s not invasive yet. And then you go on to invasive cancer.
In the ’80s and ’90s, we started realizing that some of these things would go to CIN2 and then regress back to normal, or even sometimes go to CIN3 and regress back to normal. And most of the ones that went to CIN1 regressed back to normal.
And so in the 1990s, the National Cancer Institute did a series of clinical studies, huge, large trials, and those trials actually demonstrated that a large number of women who had cervical dysplasia, CIN1 and 2 especially, could be watched and did not need to be aggressively treated. Up until that point, some women got hysterectomies because of CIN1 or 2. More commonly, they got laser ablation of their cervix or they got cauterization of their cervix, or they got freezing of their cervix, or they got a conization, and a lot of that treatment was unnecessary. And there was this sort of come to Jesus moment in the late 1990s when the gynecologic community actually realized that for several decades, they had been over-treating cervical cancer.
Claire Marie Porter: So it’s kind of like what happened with mammography too.
Otis Brawley: Yeah. Yeah. Actually in the 1970s, late ’70s, early ’80s, there was an American Cancer Society demonstration project on breast cancer. They call these things demonstration projects, interestingly. And they found out that a large number of pathologists couldn’t read needle biopsies. And as a result, there were some women who ended up getting mastectomies that didn’t need mastectomies.
Claire Marie Porter: Devastating.
Otis Brawley: And so anyway, we’ve gotten better since the 1990s. There’s a bunch of women who have cervical dysplasia who get “watch and wait,” and so it has improved. The self HPV testing is a tremendous improvement, especially amongst women who don’t want a Pap smear or don’t want a pelvic examination. I don’t need to tell you how invasive it is. And we’ve actually started learning that it’s certain types of HPV that are more likely to regress versus others. And then, of course, the vaccines came along and became available 20 years ago and we’ve gotten better with them. The initial vaccine was just for Type 16 and 18. Then there was the quadrivalent vaccine, which was good for 16, 18, and two other types of HPV. And now, there’s a 9-valent vaccine now there.
Jacquelyn Cobb: So, that was Otis Brawley. So interesting. And I know that just to sort of connect what he said with something that we’ve been talking about, Claire, and we’ve been trying to stay up to date on, is this change in how many shots, the HPV vaccine, and the change in scheduling potentially and data on that. I am clearly not up to date on it.
Claire Marie Porter: Right. So this didn’t make into the story, but the HPV vaccine, Gardasil, it’s been around for a while and there is now talk of this one shot vaccine. It’s not been approved yet, but this Gardasil one shot, a single dose regimen for HPV. And some studies and international bodies who support single dose effectiveness globally, it’s really important because access to the vaccine remains limited. So, fewer than 30% of adolescent girls worldwide have been vaccinated for HPV, and a single dose regimen would be easier for people to get. And, yeah, World Health Organization has recommended that since 2022. Until now, no study had directly assessed whether a single dose regimen would provide protection comparable to that of two doses. So stay tuned.
But I think one thing, just a bit of a zoom out too, and this is more of maybe U.S. focal conversation, but misconceptions about HPV and myths about HPV have really prevailed. And I’ve learned more about this since joining The Cancer Letter just last year. There was a survey that showed that most Americans don’t really understand that HPV leads to cancer and that the HPV vaccine prevents many of those cancers.
Electra Paskett speaks about this a lot. She’s in my story and she talks a lot about how we need to kind of rebrand the HPV vaccine and kind of reemphasize that this vaccine is a cancer prevention vaccine. It literally prevents these cancers. Back in the ’90s, maybe earlier than that. But I mean, I remember it was just kind of talked about as this green light for promiscuity, right? It’s not what it is, that’s just not a fact. But we are also meeting this moment with another moment where people at the top, our HHS secretary, is a bit of a vaccine skeptic, not a bit, but a vaccine skeptic. And so it’s coming to a head with this conversation, I think. And then we have cancer vaccine spaces opening up in other ways and therapeutic ways. So, I imagine this to be an ongoing conversation.
Jacquelyn Cobb: Something really stuck with me about that story that I just maybe is a cool thing to wrap up on and what you’re related to what you’re talking about. And I want to try to find the actual exact words because I feel like they’re important, but cervical cancer can be eliminated within our lifetime. That was really interesting to me because I am going to the gynecologist and one of our coworkers were like, “No more scoot, scoot.” And only maybe half of our listeners are going to understand what that means, but it’s like that is such a … Again, as a user of these technologies, it’s a little bit of a different conversation than just in the abstract. But even that, I still was so unaware of how … I thought it was like, “Oh, you must be able to get cervical cancer another way.” And I’m sure that there are, again, nuances I’m not familiar with, but just how interlocked HPV and cervical cancer are and how it’s literally-
Claire Marie Porter: 99% of cervical cancers are preventable. Yeah. But together with cervical cancer screening, the HPV vaccine and follow-up, multiple sources told me that cervical cancer can be eliminated within our lifetime in theory.
Jacquelyn Cobb: So crazy.
Claire Marie Porter: Yeah.
Jacquelyn Cobb: I mean, this story is like, come on, let’s cure cancer.
Claire Marie Porter: Oh, I was just saying, I mean, what other cancers are we talking about like that? It feels really poignant and something that needs to be said more than once and in many ways.
Jacquelyn Cobb: Yes. Yes, absolutely. And especially considering we’re talking about this need of education and awareness being sort of this, or at least one of the missing links here. So we’ll be shouting it. But yeah, thank you so much, Claire. I guess we’ll wrap up and thank you, Otis, wherever you are-
Claire Marie Porter: Thanks Otis!
Jacquelyn Cobb: … for talking to us and I’m sure he’ll be back on the podcast soon too. So see you all the listeners next week.
Claire Marie Porter: Thanks.
Jacquelyn Cobb: Thank you for joining us on The Cancer Letter Podcast, where we explore the stories shaping the future of oncology. For more in depth reporting and analysis, visit us at cancerletter.com. With over 200 site license subscriptions, you may already have access through your workplace. If you found this episode valuable, don’t forget to subscribe, rate, and share. Together, we’ll keep the conversation going.
Paul Goldberg: Until next time, stay informed, stay engaged, and thank you for listening.
