Posted: 02 May 2019 08:30 AM PDT

The Environmental Protection Agency reaffirmed its position that glyphosate (the chemical at the center of the Roundup lawsuits) does not cause cancer when used as directed. (Reuters)

Lessons learned from profanities, promises, and hospice care. (Art of Oncology)

Nonsmokers may account for more cases of lung cancer than previously recognized, and the number of cases continues to increase. (Journal of the Royal Society of Medicine)

Merck announced that a randomized trial of pembrolizumab (Keytruda) met one survival endpoint but missed another as first-line treatment for advanced gastric/gastroesophageal juncture cancer.

Eli Lilly will stop development of two once-promising cancer drugs, the combination PI3K/mTOR inhibitor (LY3023414) and the CHK1 inhibitor prexasertib. (FiercePharma)

In other Lilly-related news, a federal appeals court sided with the company in finding that a vitamin regimen used with the lung cancer drug pemetrexed (Alimta) has patentability, a decision that could extend the patent life of the drug. (Seeking Alpha)

The epidemiology of human papillomavirus (HPV)-positive oropharyngeal cancer has shifted from middle-age to older (≥65) white men. (Journal of Clinical Oncology)

A new industry-sponsored study in breast cancer has the lofty goal of determining whether comprehensive analysis of clinical and genetic information can help prevent the disease in high-risk women. (iGAP Registry)

Use of less-intensive treatment strategies for HPV-positive oropharyngeal cancer should be restricted to clinical trials, according to a provisional clinical opinion from the American Society of Clinical Oncology.

A new analysis of the Health Professionals Follow-Up Study showed that alcohol drinkers had a lower risk of dying of prostate cancer compared with men who did not drink. (Journal of Clinical Oncology)

Canadian dentists are identifying more oral cancers and premalignant lesions than ever. (University of Toronto, Journal of the American Dental Association)

A urine-based assay matched the Pap test for accuracy in detecting high-risk human papillomavirus that causes cervical cancer. (University of Manchester, BMJ Open)

The growing number of cancer survivors has created a growing demand for specialists to manage cancer- and treatment-associated cardiovascular problems. (American College of Cardiology)

2019-05-02T11:30:00-0400

Vaccine reduces HPV prevalence among teen girls by 86% in 10 years - Healio

Posted: 30 Apr 2019 12:42 PM PDT

ATLANTA — Within 10 years of vaccine introduction, HPV prevalence decreased 86% among females aged 14 to 19 years in the United States, and 71% in women aged 20 to 24 years, according to study findings presented at the CDC's Epidemic Intelligence Service, or EIS, conference.

Speaking during a news conference, Nancy McClung, PhD, an EIS officer in the CDC's National Center for Immunization and Respiratory Diseases, called the findings "very encouraging."

"The HPV vaccine prevents HPV infections that cause cancer and other conditions, and cervical cancer is the most common cancer caused by HPV in females," McClung said. "The CDC has been monitoring HPV infection among females in the United States since the vaccine was first introduced in 2006."

According to the study, McClung and colleagues used the National Health and Nutrition Examination Survey to evaluate quadrivalent vaccine (4vHPV)-type prevalence among 4,674 females in the prevaccine (2003–2006) and vaccine (2013–2016) eras overall and by race and ethnicity.

Nancy McClung

Results showed that among females aged 14 to 19 years, 53.9% received more than one dose of vaccine, including 52.6%, 58.1% and 59.5% of non-Hispanic white, non-Hispanic black and Mexican American females, respectively. Among women aged 20 to 24 years, coverage with more than one dose was 51.5%, including 58.5%, 45% and 33.8% in non-Hispanic white, non-Hispanic black (45%) and Mexican Americans, respectively.

In the younger cohort, the 4vHPV-type prevalence decreased from 11.5% to 1.8% from the prevaccine to vaccine era (adjusted PR = 0.14; 95% CI, 0.08–0.24), with steep declines seen in all three groups. In the older cohort, prevalence decreased from 18.5% to 5.3% (aPR = 0.29; 95% CI, 0.15–0.56).

"Importantly, we found that these decreases were being observed across racial and ethnic groups," McClung said. "These findings show how well the HPV vaccine is working to prevent HPV infection and the potential of HPV vaccination to reduce cervical cancers and other cancers caused by HPV in all women in the future." – by Caitlyn Stulpin

Disclosures : The authors report no relevant financial disclosures.

Reference :

McClung NM, et al. Human papillomavirus prevalence among females in the United States, overall and by race/ethnicity, National Health and Nutrition Examination Survey, 2003–2006 and 2013–2016; Presented at: Epidemic Intelligence Service conference; April 29-May 2, 2019; Atlanta.

The HPV vaccine is important for preteens and teenagers. What about older women? - Washington Post

Posted: 13 Apr 2019 12:00 AM PDT

By Daphne Miller

April 13

'Is Gardasil 9 right for me?" my patient asked during a recent office visit.

She is 45, recently divorced from her husband of 20 years and crafting her online dating profile. She's also wondering whether she is a candidate for the vaccine that protects against nine strains of the human papilloma virus (HPV) — a virus that causes most cervical, oral and anal cancer.

Ten years ago, L — I'm referring to her by her first initial to protect her privacy — brought her then preteen daughter to a pediatrician to get her immunized against HPV.

"I asked the pediatrician whether I should also get the shot because it did not exist when I was a kid," L said. "She told me I was too old."

But recently some of L's 40-something friends have had their first-ever abnormal Papanicolaou (PAP) smear and tested positive for "high-risk" HPV. They've needed regular visits to the gynecologist for colposcopy (an examination of the cervix using a microscope) with uncomfortable cervical biopsies, an ordeal L wants to avoid.

Querying Dr. Google, she learned that condoms are not an effective prevention against HPV but noticed that the Food and Drug Administration had expanded the use of Gardasil 9 to include women up to age 45. While insurance won't cover the three-shot series for her age group, she is ready to pay the steep $600-plus vaccine cost — but only if I, her physician, think the investment is worthwhile.

I didn't know what to tell her but I decided to do some digging.

Before having sex

At this point, it's pretty clear that if you get the HPV vaccine series before ever having sex, it works really well. A review of 26 randomized controlled trials shows that giving the vaccine to preteen and teenage girls before they become sexually active will protect them from genital warts and HPV-related precancers that show up on PAP screening.

These studies also show that the vaccine reduces the total number of colposcopies, biopsies and other procedures. And while it's still too early to say for sure, it looks like the HPV vaccine may protect this group of girls from developing cervical, oral and anal cancers, diseases that can appear several decades after initial HPV infection.

(There is a consensus that giving the HPV vaccine to boys will also prevent HPV-related cancers, although males are not the focus of this report.)

I also know the vaccine is safe; in the review of the HPV studies, severe adverse events were rare and were not significantly higher in vaccine recipients than in those who received a placebo injection.

But L had a number of partners in her early 20s followed by many years of monogamy. Does the vaccine make sense for her and the roughly 30 million other women under 46 who missed the opportunity to get the HPV shots as kids? After all, studies show that most women get exposed to at least one strain of HPV within a couple of years after first having sex and that the likelihood of exposure increases with each sexual partner. While most women clear their infections within 12 to 24 months, a small percentage go on to develop cervical precancers or cancers — which is why cervical cancer screening is important.

To answer L's question, I looked up the guidelines for HPV vaccination put out by the Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), a group of medical experts that determines which vaccines we should use in the United States. Despite the FDA's recent approval of the vaccine for women up to age 45, I saw no mention of women over age 26 in the ACIP guidelines.

Then I moved to the American College of Obstetrics and Gynecology website to see what it said about HPV vaccination for older women. ACOG's Practice Advisory encourages me to "welcome conversations" with women up to age 45 and that "any decision to be vaccinated should be individually based using shared decision making and clinical judgment based on those patients' circumstances, preferences, and concerns."

I'm all for collaborating with my patients to come up with a game plan but to do this I need data. How was I to know what "circumstances" might make the vaccine more or less effective? And what "preferences" or "concerns" was the vaccine likely to address?

Plenty of confusion

To get some clarity on ACOG's recommendations, I called Lois Ramondetta, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center. She is on the ACOG HPV immunization expert working group. She said that the ACIP was doing a cost-benefit analysis and would soon decide whether to recommend the HPV vaccine up to age 45. But she agreed that, at the moment, there is plenty of confusion about which older women would benefit.

"Perhaps it would be very useful for someone who hasn't been exposed, and who's intimacy situation has changed," she told me.

Measuring exposure to HPV is tricky. The only option in my lab is to do a cervical swab to test for high-risk HPV genotypes including HPV 16 and 18 — the two strains that cause over 70 percent of HPV-related cancers. This is a great test for diagnosing active infection with HPV but doesn't measure past exposure or latent HPV infections. (To measure these, I would need an antigen test, which is only available in research labs.)

But combing through the data from VIVIANE, one of two big drug industry funded studies to measure the effectiveness of HPV vaccine in older women, I realized that the vaccine was about 80 percent effective at preventing infection with HPV 16 and 18 in women whose cervical swabs were negative for these strains, regardless of past exposure. That sounded pretty good to me. As long as L was HPV genotype 16 and 18 negative, maybe she should get the vaccine.

Not so fast, cautioned Karen Smith-McCune, professor emeritus of obstetrics and gynecology at the University of California at San Francisco. She is an HPV researcher and works in the cervical dysplasia clinic taking care of women infected with HPV.

"When you look at these studies, you have to ask: 'Effective for what?' If your goal is to prevent cancer, we have no proof the vaccine does that in the older age group," she said.

It was true that older women who received the HPV vaccine became infected with HPV 16 and 18 at a lower rate than the women who were unvaccinated. But the advanced precancers, the ones most likely to go on to become cancer, were rare in both the vaccinated and unvaccinated groups, and the difference was not statistically significant.

How is it that the vaccine can prevent infection in older women but does not seem to protect against cervical cancer?

Smith-McCune has a variety of explanations for this, including that new HPV infection in older women may simply be a reactivation of latent infection and less likely to progress to cancer.

"The take-home message is that cervical cancer is really rare in older women who get regular screenings and [the HPV] vaccine adds little in terms of prevention," Smith-McCune said.

Screening older women

Indeed, because we have good screening in the United States, cervical cancer incidence and death rates were low even before the introduction of the HPV vaccine in 2006. In 2017, about 4,000 women died of the disease. (For reference, 41,000 die of breast cancer and 66,000 of lung cancer). Compare that with some low-income countries, such as Malawi or Bolivia, where screening is practically unobtainable and the mortality rate from cervical cancer is three to four times higher.

And what about avoiding costly and uncomfortable colposcopies and biopsies, something that the vaccine did accomplish in younger women — especially those who had never had sex.

Well there were slightly fewer of these procedures in the older women who received the vaccine, but not an amount that was statistically significant.

So what is the best choice for L?

"If she is a 40-something-year-old virgin who decides to start dating, the vaccine will be 100 percent effective," Smith-McCune said. "But beyond that, let's vaccinate adolescents, that is where you have the public health impact."

Smith-McCune added that L should get the recommended cervical cancer screening up to age 65, which means getting a PAP plus HPV test every five years, or a PAP every three years.

At this point, I was pretty sure what I would say to L and other women her age: "The HPV vaccine is unlikely to help but, aside from cost, there is no big downside to getting it."

But then I learned that there is a global shortage of HPV vaccine. According to the World Health Organization, the two manufacturers, Merck and GlaxoSmithKline, are not producing enough. And while there are plans for other pharmaceutical companies in China and India to pick up the slack, right now only 20 percent of countries with the highest rates of cervical cancer are able to immunize girls who are 9 to 14 years old, the age group where the vaccine is known to be most effective.

Given the limited supply and the lack of evidence that the vaccine protects older women from colposcopies or cervical cancer, I agree with Smith-McCune: Let's leave the vaccine for the teens and preteens. And if you are a woman in your mid-40s who is suddenly thrown back on the dating scene, the best strategy is use condoms (because they do protect against other sexually transmitted infections) and get regular cervical cancer screening.

I called L to share what I had learned. She had done some of her own research and came to pretty much the same conclusion.

She was also considering a donation to Gavi, an international organization which gets vaccines to places they are most needed. To me, that sounded like a great way to spend $600.

Daphne Miller is a family physician and author of "Farmacology" and "The Jungle Effect."

Shaving one morning, he felt a small lump under his jaw. It wasn't just a lump.

More than 1 in 5 adults are infected with cancer-causing HPV

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EPA: Glyphosate No Carcinogen; Profanities and Promises; HPV Cancer Shift - MedPage Today

EPA: Glyphosate No Carcinogen; Profanities and Promises; HPV Cancer Shift - MedPage Today

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