Chemotalk Newsletter

Chemotalk Newsletter, Vol. 63: July 1, 2013

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Good July to all ...

As promised, this month will feature a wrap-up of the important stories that emerged from the American Society of Clinical Oncology (ASCO) convention last month. It isn't as important that we remember the names of all of these drugs, as that we understand how they stand to improve treatment. We begin with:

BEVACIZUMAB IS FIRST AGENT TO SIGNIFICANTLY IMPROVE SURVIVAL IN RECURRENT CERVICAL CANCER.

Bevacizumab significantly improved overall survival when added to CHEMOTHERAPY for patients with RECURRENT/PERSISTENT or METASTATIC CERVICAL CANCER, according to a planned interim analysis of the Gynecologic Oncology Group (GOG) 240 study (Abstract 3). This is the first time that a targeted agent has demonstrated such an improvement in gynecologic cancer.

"Unfortunately, women with metastatic and recurrent cervical cancer have very few therapeutic options. The standard regimen of cisplatin plus paclitaxel is associated with median overall survival of under 12 months," said Krishnansu Sujata Tewari, MD, of the University of California, Irvine, Medical Center.

In the GOG 240 study, patients were assigned to either of two chemotherapy regimens involving cisplatin plus paclitaxel or topotecan and paclitaxel, and then randomly assigned to receive 15 mg/kg of bevacizumab or not. Treatment cycles were repeated every 21 days until disease progression, unacceptable toxicity, or complete response. More than 70% of patients in both groups had received prior platinum-based therapy; the groups were well matched with regard to age, histology, race, disease stage, and performance status.

This initial interim analysis showed that the topotecan-paclitaxel regimen was neither superior nor inferior to the cisplatin-paclitaxel regimen, while the second interim analysis did show superiority when bevacizumab was added to either chemotherapy regimen. In fact, Dr. Tewari said that the survival analysis conducted earlier in 2013 led ASCO to make a rare exception and allow the abstract into the public domain well in advance of its presentation.

A total of 225 patients received chemotherapy alone and 227 received chemotherapy along with bevacizumab. With a median follow-up of 20.8 months, the median overall survival was 17 months with bevacizumab and 13.3 months without it. "The 3.7-month improvement is felt to be clinically meaningful," Dr. Tewari said.

Bevacizumab also improved progression-free survival over chemotherapy alone. The median progression-free survival in the bevacizumab group was 8.2 months, compared with 5.9 months in the chemotherapy alone group. The response rate was also better with bevacizumab, at 48% vs. 36%; there were 28 complete responses in the patients who received bevacizumab and 14 in the chemotherapy-alone group.

The advantage seen with bevacizumab persisted in some subsets of patients, including those between the ages of 48 and 56, those with recurrent/persistent disease (although not among the 76 patients with metastatic disease), and those with squamous histology. "Perhaps most importantly, when the disease was in the previously irradiated pelvis, bevacizumab was still effective," Dr. Tewari said.

The median overall survival for those patients who received cisplatin plus paclitaxel was 14.3 months, significantly less than the 17.5 months for those who received cisplatin, paclitaxel, and bevacizumab. Similarly, the median overall survival for those who received topotecan plus paclitaxel was 12.7 months, compared with 16.2 months when bevacizumab was added to that regimen.

There were four adverse-event deaths in each group. Patients who received bevacizumab experienced more occurrences of thromboembolism, gastrointestinal fistula, genitourinary fistula, hypertension, and neutropenia. "Although both thromboembolic events and fistula were increased in the bevacizumab arms, these rates were relatively low, below 10%," Dr. Tewari said.

Dr. Tewari concluded that these results justify further study of this and related agents and also noted that the huge international burden associated with cervical cancer should play an important role in future research. "The discovery of survival gains such as that concurred by anti-VEGF therapy needs to be followed by cost-effectiveness studies to best determine how to balance the societal burden and, at the same time, provide these therapies to those who are in the greatest need," he said.

Gottfried E. Konecny, MD, of the David Geffen School of Medicine at the University of California, Los Angeles, said that there is "an extraordinarily good rationale" for targeting VEGF in this disease setting. "I think GOG 240 can be seen as a practice-changing study," Dr. Konecny said. He noted that the results may not be applicable to metastatic patients, given that only 17% of those in this trial had metastatic disease. "I think for cervical cancer it is incredibly important to move bevacizumab into earlier disease stagesŠ. Maybe this is a situation where the benefit of [the drug] will translate into a reduction in mortality."

In a Post-Plenary Discussion Session, Dr. Terwari said that he hopes that the manufacturer of bevacizumab will open a dialogue with the U.S. Food and Drug Administration to work toward the drug's approval for these patients with cervical cancer. Dr. Konecny agreed, saying "I personally think it should be" approved.

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SORAFENIB SHOWS BENEFIT IN REFRACTORY DIFFERENTIATED THYROID CANCER

Sorafenib significantly improved progression-free survival for patients with radioactive iodine (RAI)-refractory DIFFERENTIATED THYROID CANCER. The DECISION trial was the first phase III study to demonstrate efficacy of any agent for the treatment of progressive RAI-refractory differentiated thyroid cancer, said Marcia S. Brose, MD, PhD, of the Abramson Cancer Center of the University of Pennsylvania.

"Sorafenib is a potential new treatment option for patients with locally advanced or metastatic RAI-refractory DTC," Dr. Brose said, presenting the DECISION study results. The drug extended progression-free survival, the primary endpoint of the trial, by 5 months compared with placebo (10.8 vs. 5.8 months, respectively). Most adverse events in the trial were manageable and were consistent with the known safety profile of sorafenib.

RAI-refractory differentiated thyroid cancer is a relatively rare condition, occurring in approximately 5% to 15% of patients with thyroid cancer. The disease has a poor prognosis, and there is no standard therapy, Dr. Brose said. Sorafenib, showed activity as a monotherapy in a phase II trial of patients with advanced refractory thyroid cancer.

The DECISION trial enrolled 417 patients with locally advanced or metastatic RAI-refractory DTC. Patients had progression within the past 14 months. Those who had undergone previous treatment with targeted therapy or chemotherapy were excluded. Patients were randomly assigned 1:1 to 400 mg sorafenib orally twice daily or to placebo. Progression was assessed every 8 weeks, and if disease progressed patients on placebo were allowed to cross over to treatment.

The treatment and study arms were well balanced. The great majority of patients in both groups had distant metastases. Benefit of treatment was seen in all prespecified subgroups and across all regions (North America, Europe, and Asia) and age groups.

Median overall survival (OS) has not been reached, Dr. Brose said, noting that this secondary endpoint of the study will be affected by the large proportion of patients in the placebo arm (71%) who have crossed over to treatment. Additional analyses of OS are planned. No complete response was seen in the study. Partial response (PR) was seen in 12.2% of patients in the sorafenib arm and 0.5% in the placebo arm. Median duration of PR was 10.2 months.

Sorafenib reduced target lesion size in 73% of patients, compared with 27% in the placebo arm. Of note, tumor shrinkage with sorafenib in symptomatic patients was often sufficient to alleviate symptoms, Dr. Brose said.

The most frequent side effects were hand and foot skin reactions, diarrhea, alopecia, rash, fatigue, and hypertension; many of the skin conditions could be managed with over-the-counter products.

The most frequent serious side effects were secondary malignancies, occurring in 4.3% of patients receiving the drug and 1.9% of those receiving placebo. Two deaths attributed to the study drug occurred, one in each arm of the study.

Discussant Ezra E.W. Cohen, MD, of The University of Chicago, congratulated the DECISION investigators for completing a trial "that many thought could never be done because this was thought of as a rare disease. Indeed," he continued, "this is not a rare disease; these patients exist, and there are patients dying [as a result of] DTC, and we now have a therapy to offer them."

While sorafenib appears to be an active agent that extends PFS in the population of patients with this disease, Dr. Cohen said, it does not appear to induce complete response or cure the disease. It is unlikely that a benefit in OS will emerge in the trial, primarily because most of the patients in the placebo arm were crossed over to treatment with the drug. "The critical issue is who to treat and when to treat them," he said. "Not all patients with DTC need therapy. When we see these patients, we need to individualize their care."

Dr. Cohen noted that some oncologists are already using sorafenib and other VEGFR-inhibiting drugs off-label for treatment of RAI-refractory DTC, and resistance to this class of drug has been noted in some patients. Therapeutic options for these patients must be addressed in future clinical trials, he said.

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ALTHOUGH BETTER DEFINED, ROLE OF PSA IN PROSTATE CANCER SCREENING REMAINS CONTROVERSIAL

In recent years, there has been an adjustment in the scientific thinking about the utility of screening men for prostate cancer using prostate-specific antigen (PSA). That shift has been slow to occur in daily practice as a result, in part, of a feeling among the health care community that there is still not a clear answer to the question: Which, if any, men should be screened for prostate cancer?

"This is a real decision that has to be made by physicians and patients every day," Ethan M. Basch, MD, MSc, of The University of North Carolina at Chapel Hill, said. "It is not necessarily clear by looking at various recommendations or trying to read the studies what the right answer is."

PSA came into use in the 1980s, first as a method of monitoring recurrent disease, and later as a way to screen for prostate cancer. After the introduction, prostate cancer diagnosis sharply increased and subsequently, mortality began to decline. "However, the extent of PSA's impact on the mortality decline has remained highly debated to this day," Dr. Basch said. This debate leaves the fate of PSA screening up in the air, if one assumes that the goal of screening is to reduce overall and disease-specific death and disability.

Recently, ASCO, the American Urological Association, the American College of Physicians, and the U.S. Preventive Services Task Force have released revised prostate cancer screening guidelines that recommend reducing or completely eliminating the use of PSA screening for prostate cancer.

Peter T. Scardino, MD, of Memorial Sloan-Kettering Cancer Center, noted how far the area of prostate cancer detection has come compared with the era before PSA screening when more men presented with advanced and difficult-to-cure cancer. However, he acknowledged that some of the recent criticism of the biomarker has been appropriate. For example, in recent years there has been too much screening of elderly men with short life expectancies, the criteria for biopsy have been too liberal, and too many low-risk, low-stage cancers are being treated aggressively, causing more harm than good, he said.

He recommended that men undergo risk-adjusted screening by age and PSA level to reduce false-positive results starting at age 45; that false positives be further reduced by adding additional markers such as the 4K panel that includes total PSA, free PSA, intact PSA, and human kallikrein 2. He also noted that active surveillance is more widely recommended for low-risk cancers and that more treatment is done by high-volume physicians and centers, reducing the harm of necessary therapies.

"Young men with a PSA value of below 1 don't need to be tested for another 5 years or until age 50 or 60, and if men age 60 have a PSA below 1 than there is no need for further screening in their lifetime," Dr. Scardino. "The answer is to screen in a smarter way."

In contrast, Timothy J. Wilt, MD, MPH, of the University of Minnesota and Minneapolis VA Health Care System, thinks that the smarter way to screen for prostate cancer is to not screen with PSA at all. "New science clearly shows that men can make a wise health care choice by choosing against the PSA test, and physicians can provide high-quality, high-value, cost-conscience care by recommending against it," said Dr. Wilt, explaining that the benefit of testing does not exceed the harm of testing and subsequent downstream evaluation and treatment.

Gone are the days of simple screening messages: "Get tested. Get treated. It could save your life." The message that physicians must communicate to patients is more complicated now; however, according to Dr. Wilt, patients expect their physicians to provide counsel with what they believe is the appropriate science to guide decisions.

When counseling his patients, Dr. Wilt explains that PSA is unlikely to prevent death from prostate cancer, that an elevated PSA typically leads to further, possibly unnecessary, testing, and that if cancer is found, the decision to undergo or delay treatment is often difficult. If patients still desire to undergo PSA testing, the threshold for abnormal PSA levels should be increased and the testing interval should be widened to decrease overdiagnosis, overtreatment, and diagnostic treatment harms.

Studies examining changes in quality of life, conducted by Harry J. de Koning, MD, PhD, of Erasmus Medical Center, the Netherlands, and colleagues, indicate that common side effects of treatment, such as incontinence and erectile dysfunction, have a significant effect on the overall benefit of PSA screening. Looking at data from the European Prostate Cancer Screening Trial, if screening men age 55 to 69 at 1-year intervals resulted in 72.7 life years gained per 1,000 men, an adjustment for quality of life in years would subtract 16.7 life years.

"To some extent PSA testing is promising, but it is crucial to quantify unfavorable side effects," Dr. de Koning said. "It is true that the benefits are probably diminished by about 20% when you take into account quality of life."

The use of PSA as a diagnostic biomarker clearly has its challenges, but currently, it remains the best serum-based marker for diagnosis of prostate cancer, according to Phillip G. Febbo, MD, of the University of California, San Francisco. After the FDA approved PSA as a screening test in 1994, it took about 15 years before prospective, randomized controlled studies had mature data with endpoints that could provide insight to the actual value of PSA. "The bottom line is given the natural history of localized prostate cancer, any biomarker to improve on PSA faces a significant challenge with respect to prospective trials," Dr. Febbo said.

Among the best candidates being researched are derivatives of PSA, such as total PSA or free PSA, and a host of additional biomarkers examined in preliminary or single-institution studies. However, many of the markers that have shown initial promise often fail to come to market because of inadequate analytic and clinical validation.

"If the discussion today is about overdiagnosis of indolent disease, I don't think we need a better diagnostic test as far as finding the disease, we need a better diagnostic test that can find clinically important disease," Dr. Febbo said.

There are two tests being used to help reduce the need for repeat biopsy after initial elevated PSA: urine PCA3, a noncoding mRNA, and tissue GSTP1 promoter methylation (Confirm MDx). PCA3 is now commercially available. Research has shown its sensitivity to be 67% with a negative predictive value of 90%. It has also been found to be superior to PSA in predicting prostate cancer in men with elevated PSA and a previous negative biopsy; however, its FDA indication is only for that narrow group of patients.

Researchers have also known for years that GSTP1 promoter methylation is one of the earliest molecular events in prostate cancer. In addition, because it is found in more than 90% of prostate cancers, it has been evaluated as a potential diagnostic. A tissue-based assay is available, working off the field effect of prostate cancer. If a patient with an elevated PSA has a negative biopsy, the tissue can be submitted for Confirm MDx; if methylation is not observed, patients return to PSA screening.

Whatever step comes next in screening for prostate cancer (or any other cancer), Dr. Basch emphasized the need for an improved regulatory framework that requires a demonstration of clinical benefits or an assessment of harms for screening tests. Although increased scrutiny could delay tests getting to market, or possibly increase the cost of development, clear evidence is necessary to avoid another "PSA situation" in which, more than 30 years after its discovery, the benefits of PSA are still unclear, whereas its substantial harms and unnecessary costs have been clearly established.

"It will be up to payers, as well as guideline developers, providers, and patient groups to insist on a compelling level of meaningful evidence prior to widespread adoption of new screening tests," Dr. Basch said.

* * * BIG TEN UNIVERSITIES FORM CANCER RESEARCH CONSORTIUM

In athletics, the Big Ten universities compete against each other but now many will join together against a common foe ‹ CANCER.

Leaders from the universities' cancer centers kicked off the Big Ten Cancer Research Consortium in Chicago. They are uniting to transform cancer research through collaborative oncology trials that leverage the scientific and clinical expertise of the Big Ten universities.

"Tremendous strengths exist in the cancer centers of the Big Ten," said Dr. Patrick J. Loehrer Sr., director of the Indiana University Melvin and Bren Simon Cancer Center. "This is a rare opportunity for the universities to work together as part of a regional team science initiative to advance cancer research. The advantage of this, particularly during a time of austerity for research, is that we can build upon the strengths of the institutions and fortify some of the shortcomings. This allows us to be lean, efficient, but most importantly, collaborative."

Dr. Steven T. Rosen, director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, added: "By uniting to transform cancer research through collaborative oncology trials, we will be able to leverage the scientific and clinical expertise of the Big Ten Universities. The consortium will benefit patients because researchers will work together to turn ideas into potential new treatments. I view this as the beginning of a broad spectrum of potential research, training and care initiatives that will benefit our patients and society."

The clinical trials that will be developed will be linked to molecular diagnostics, enabling researchers to understand what drives the cancers to grow and what might be done to stop them from growing.

Also, the consortium forms a powerful collaboration because of the impact each university already has made in cancer research and the solid research infrastructure already in place at each university. The consortium also leverages geographical locations and existing relationships among the cancer centers.

"For research to be truly impactful, we must work together. Collaborating with other institutions gives us another opportunity for a broader and deeper brain trust while allowing implementation of novel ideas in a more representative patient population. The synergy, the collaboration, the implementation all are aimed at one ultimate goal -- making a real difference for patients," said Dr. Maha Hussain, associate director of clinical research at the University of Michigan Comprehensive Cancer Center.

The Big Ten Cancer Research Consortium creates a unique team-research culture in which cancer leaders will collaborate with and mentor the research leaders of tomorrow with the goal of improving the lives of all cancer patients. The consortium will provide junior faculty and fellows the opportunity to write, conduct and complete trials, which would not normally be done at a single institution or on a national level for young investigators.

The following universities and cancer centers comprise the Big Ten Cancer Research Consortium:

‹- Indiana University (Indiana University Melvin and Bren Simon Cancer Center)

-- Northwestern University (Robert H. Lurie Comprehensive Cancer Center)

‹- Penn State University (Penn State Hershey Cancer Institute)

‹- Purdue University (Purdue University Center for Cancer Research)

‹ Rutgers University (The Cancer Institute of New Jersey becomes part of Rutgers on July 1)

‹- University of Illinois (University of Illinois Cancer Center)

‹- University of Iowa (Holden Comprehensive Cancer Center)

‹- University of Michigan (University of Michigan Comprehensive Cancer Center)

‹- University of Minnesota (Masonic Cancer Center)

‹- University of Nebraska (Fred & Pamela Buffett Cancer Center)

‹- University of Wisconsin (Carbone Comprehensive Cancer Center)

The Indianapolis-based Hoosier Oncology Group will serve as the administrative headquarters for the Big Ten Cancer Research Consortium. Since 1984, Hoosier Oncology Group has initiated more than 150 trials with more than 4,000 patients.

* * * BEVACIZUMAB AND IRINOTECAN OFFER SIGNIFICANT CLINICAL BENEFITS FOR PATIENTS WITH MGMT-NONMETHYLATED GLIOBLASTOMAS

Bevacizumab and Irinotecan (BEV/IRI) added to radiation significantly improved progression-free survival (PFS) in patients with newly diagnosed MGMT-nonmethylated glioblastomas compared with standard therapy with temozolomide (TMZ) and radiation, based on data from the GLARIUS trial. Presenting the data, Ulrich Herrlinger, MD, of the University of Bonn, Germany, showed that BEV/IRI reduced the risk of progression by 70% and was superior to standard therapy.

GLARIUS was a phase II study in which 182 patients with MGMT-nonmethylated glioblastoma were randomly assigned in a 2:1 ratio to receive BEV/IRI (116 patients) or TMZ (54 patients). All patients received radiation therapy at the standard dose for 6 weeks. Patients in the BEV/IRI arm received four cycles of BEV over 6 weeks of radiation and then received BEV/IRI every 2 weeks until disease progression. Patients in the TMZ arm received six courses of TMZ. Six-month progression-free survival (PFS) was the primary endpoint of the study. Secondary endpoints included overall survival (OS), steroid use, and toxicity.

Six months following random assignment, PFS was significantly higher for patients receiving BEV/IRI (9.74 months vs. 5.99 months for TMZ. For the secondary endpoint, OS was significantly longer for patients receiving BEV/IRI (16.6 months vs. 14.8 months for TMZ). Lower steroid use was also observed in patients receiving BEV/IRI. Following progression, patients were allowed to cross over to the BEV/IRI arm of the study. Of 46 patients whose disease progressed on TMZ, 29 crossed over to the BEV/IRI arm (63%). Higher rates of severe vascular events occurred with BEV/IRI and higher rates of severe hematotoxicity occurred with TMZ.

Albert Lai, MD, PhD, of the University of California, Los Angeles, discussed the GLARIUS study in the context of other studies that used bevacizumab to treat glioblastoma multiforme (GBM). "GLARIUS explores an alternative for MGMT-unmethylated GBM," he said. PFS and OS data from each arm correlate well with similar data from other studies, and he indicated that "BEV/IRI appears superior to TMZ for patients with MGMT-unmethylated GBM." Dr. Lai described the strengths of the study as the focus on the nonmethylated group, capturing bevacizumab crossover and steroid reduction, and the planned quality of life and mini­mental state examination analysis.

Dr. Lai questioned the use of bevacizumab in patients with GBM. Although there is general acceptance that bevacizumab helps patients with GBM, it has been difficult to show its benefit. In all GBM studies exploring the use of bevacizumab, the overall survival analysis is plagued by the crossover designs. In addition, he said that maintenance of function should be rigorously measured, as it may be the most important and relevant endpoint. He posed the question of whether, with toxicity affecting quality of life, physicians are trading steroid toxicity for bevacizumab toxicity.

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Finally, less technical but equally important news:

ORAL CANCER SNEAKS UP

Michael Douglas's assertion that oral sex caused his ailment brings the disease to the fore.

By Donald G. McNeil Jr. and Anahad O'Connor

The actor Michael Douglas has done for THROAT CANCER what Rock Hudson did for AIDS an Angela Jolie did for prophylactic mastectomy. By asserting last week that his cancer was caused by a virus transmitted during oral sex, Mr. Douglas pushed the disease onto the front pages and made millions of Americans worry about it for the first time.

In this case, it was a subset of Americans who normally worry more about being killed by cholesterol than by an S.T.D. The typical victim is a middle-aged, middle-class, married heterosexual white man who has had about six oral sex partners in his lifetime.

The virus, human papillomavirus Type 16, also causes CERVICAL CANCER. So is there any early oral screening that a man can have -- an equivalent to the Pap smear, which has nearly eliminated cervical cancer as a death threat in this country?

The answer, according to cancer experts and a recent opinion from the United States Preventive Services Task Force, is no. And for surprising reasons.

The Pap test -- invented in 1928 by Dr. George N. Papanicolaou -- involves scraping a few cells from the cervix and checking them under a microscope for precancerous changes. Precancerous cells have a "halo" around the nucleus, while cancerous ones have larger, more colorful nuclei, said Dr. Paul D. Blumenthal, a professor of gynecology at Stanford University Medical School.

`` In theory, it should be similarly easy to scrape and examine throat cells. But in fact, cancer specialists said, doing so would be useless.

Virtually all cancers on the mouth, tongue, gums, hard palate or anywhere in front of the uvula (the "punching bag" dangling from the soft palate) are caused by tobacco and alcohol.

The kind of chronic HPV 16 infection that leads to oral cancer occurs much farther down, near the base of the tongue. Adding to the difficulty, the infection is often "deep down in the crypt of the tonsils", said Dr. Eric Moore, a Mayo Clinic surgeon specializing in such cancers.

The tonsils, an expanse of lymphoid tissue that includes much more than the two back-of-the-throat bumps removed in tonsilectomies, have deep folds and crevices.

"If you spread them out, they're 2 feet by 2 feet," said Dr. Marshall R. Posner, medical director for head and neck cancer at Mount Sinai Medical Center. "You cant swab them. It's just not possible." By contrast, the end of the cervix swabbed during a Pap test is only about two square inches and easily reached with a speculum. It is impossible even to see deep tonsillar tissue without a scope that goes through the nose. Probing this area would set off ag and vomit reflexes so strong that patients might have to be anesthetized.

A saliva test can detect ann oral HPV infection. But that's not useful, since 85% of the population catches at least one of the 100 different human papillomaviruses that circulate. Most infections are beaten by the immune system in a year or two. Even among those who get an oral HPV 16 infection, less than 1% will go on to develop throat cancer.

"If I tell you that you have HPV in your mouth, it's not going to help you if I don't have anything to offer you, and you're going to live with the aniety and fear that you might get cancer," sai Dr Robert I Haddad, chief of head and neck cancer at the Dana Farber Cancer Institute in Boston. "But I I tell a woman that she has an abnormal Pap smear, there's something she can do about it."

Someone with chronic HPV 16 year after year would be at the highest risk for throat cancer -- but even then it is not clear what to do. Probing through all the tonsillar tissue under anesthesia looking for something worrisome to biopsy would be difficult and expensive and could set off bleeding near the entrance to the lungs.

Even when surgeons find large, cancerous lymph nodes, the primary tumor that seeed them sometimes turns out to be a speck only a sixteenth of an inch wide buried near healthy tissue, Dr. Moore said.

Although throat cancer caused by HPV is increasing, it is relatively rare. About 25,000 cases a year are diagnosed in the United States, compared with 226,000 LUNG CANCERS. But it is growing in importance as smoking-related oral cancers decline.

Oral sex has become more common since the sexual revolution of the 1960s, but not astonishingly so. According to Debby Herbenick, a director of Indiana University's Center for Sexual Health Promotion, the mean number of lifetime oral sex partners reported by American men 35 to 54 is six. Men 55 to 64 report five, and men 25 to 34 report four. Men over 65 an under 25 report three.

However, such "fairly modest changes" in sexual habits do not explain why the cancer risk has doubled or tripled over the years, said Gypsyamber D'Souza, a viral cancer specialist at Johns Hopkins Bloomberg School of Public Health. It has risen the most in white men 45 and up. The older age is explained by the act that, like cervical cancer, it can take decades to develop.

Men are twice as likely as women to get it, according to Dr D'Souza, and it is more common among whites than blacks, perhaps because whites are more likely, by 90% to 69%, to have ever performed oral sex.

And straight men are more likely to get the cancer than gay men. One theory is that there may be more HPV in vaginal fluid than on the penis, said Dr. Lori J Wirth, a head and neck cancer specialist at Massachusetts General Hospital.

The lack of a screening test means that a doctor should be seen as soon as symptoms appear: a lump in the neck, a sore throat or ear pain that persists for two weeks, or what Dr. Posner called "the hot potato voice: the way you talk when something is burning the back o your throat."

Though no studies proving it have been done, Gardasil an Cervarix, the vaccines to prevent cervical cancer from HPV Types 16 and 18, should also prevent this oral cancer and should be offered to boys and young men, several doctors said.

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See you in August ....

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And if you have any thoughts of how this newsletter could be improved, please email me directly, at Elaine@elainejesmer.com.

Elaine Jesmer

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