Single Dose of HPV Vaccine May Be Enough to Guard Against Cervical Cancer

Researchers found women who only got 1 of 3 recommended Cervarix doses still showed immune response 4 years later

By Dennis Thompson

HealthDay Reporter

MONDAY, Nov. 4 (HealthDay News) -- Just one dose of a human papillomavirus (HPV) vaccine may be enough to provide long-term protection against cervical cancer in women, a new study suggests.

The HPV vaccine is currently recommended as a three-dose series, but doctors have found it difficult to finish out the series for many girls.

However, the researchers discovered active human papillomavirus antibodies in Costa Rican women four years after they had received only one dose of Cervarix, a vaccine that protects against two HPV strains.

The study also found that women who received two doses six months apart appeared to have just as much antibody protection against HPV as those who received three doses.

Funded by the U.S. National Cancer Institute (NCI), the study was published in the November issue of Cancer Prevention Research.

HPV vaccination rates in the United States are low. In 2012, only about 54 percent of girls even received one dose, and just 33 percent went on to receive all three shots, according to a recent report from the U.S. Centers for Disease Control and Prevention.

But the impact of only having to get one or two doses of the vaccine would be felt most in developing countries, where cervical cancer death rates are higher but the high cost of the vaccine makes it difficult to protect all women.

"Vaccination with two or even one vaccine dose could simplify the logistics and reduce the cost of vaccination in the developing world, where more than 85 percent of cervical cancer occurs and it is the most common cause of cancer death in women," said study author Mahboobeh Safaeian, an investigator in the NCI's division of cancer epidemiology and genetics.

More than 275,000 women die from cervical cancer each year worldwide, making it the sixth-leading cause of cancer death, according to the World Health Organization. In the United States, active screening programs have reduced the cervical cancer death rate to about 3,900 women a year, according to the CDC.

HPV vaccine doses run about $130 apiece, according to the American Cancer Society, and cost is a big consideration, one expert noted.

"If you reduce the cost by a third, you can give it to three times as many people," said Dr. Shashikant Lele, clinical chief of gynecologic oncology at Roswell Park Cancer Institute, in Buffalo, N.Y. "If one dose is adequate to protect, we can vaccinate three times the number of women with the same amount of money."

Researchers made these findings during a clinical trial to test the effectiveness of Cervarix in women from Costa Rica.

They measured immune response to the vaccine in blood samples drawn from 78, 192 and 120 women who received one, two and three doses of the vaccine, respectively.

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Blood Test for Pancreatic Cancer Shows Promise in Early Trial

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New Hope for Breast, Prostate Cancer Testing

'Markers' in blood, tissue might help determine best treatment for each patient, studies suggest

By Dennis Thompson

HealthDay Reporter

MONDAY, Oct. 28 (HealthDay News) -- Doctors believe they have found telltale signs that can indicate whether breast or prostate malignancies will remain dormant or develop into aggressive cancers.

These indicators -- called "biomarkers" -- are found in the blood or tissues of people with breast or prostate cancer. Researchers hope to one day use them to develop tests that will determine the cancer treatment each patient will need.

"It's a dream, I would say, at the moment. And it's a hope," Dr. Clifford Hudis, president of the American Society of Clinical Oncology (ASCO), said of the potential for using biomarkers to help determine a person's risk of aggressive cancer. "But it's not yet clinically validated, and it's not useful yet for patients."

Two research teams are scheduled to present their findings on possible biomarkers for breast and prostate cancer this week at the International Conference on Frontiers in Cancer Prevention Research, hosted by the American Association for Cancer Research, at the National Harbor in Oxon Hill, Md.

Doctors with the University of Pennsylvania reported that the presence of a protein called Vav2 in breast tissue might indicate whether a precancerous condition called ductal carcinoma in situ, or DCIS, will develop into invasive breast cancer.

Meanwhile, Johns Hopkins researchers said chromosomes in a man's blood might provide evidence that a prostate cancer will develop in an aggressive manner.

There is widespread concern that in both DCIS and prostate cancer, doctors tend to overtreat patients.

Two-thirds of DCIS cases never progress to full-fledged invasive cancer, ASCO's Hudis said, "which means when we treat DCIS, we are treating many people who would never have developed invasive cancer."

And few men with prostate cancer actually die as a result of the cancer, which has prompted much debate over whether doctors should treat it, said William Phelps, program director for the American Cancer Society. The available treatments often lead to unpleasant side effects such as incontinence and impotence.

"The treatments themselves are not very good," Phelps said of prostate cancer. "If the treatments were fairly nondamaging, you'd just say, 'Well, let's treat everybody.'"

The Pennsylvania researchers examined 211 remnants of tissue samples that had been taken to diagnose breast cancer. Of the samples, 42 were normal breast tissue, 71 were DCIS and 98 were invasive breast cancers.

DCIS involves the presence of abnormal cells inside a milk duct in the breast. In "pure" DCIS, the cells have not become cancerous and started to spread, said senior research investigator Marina Guvakova, an adjunct assistant professor in the department of surgery at the University of Pennsylvania.

However, there also are forms of DCIS that involve either fully invasive cancer or micro-invasive cancer, in which fewer than 10 percent of the abnormal cells have spread beyond the original tumor.

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Mood Disorders May Persist After Cancer Dx (CME/CE)

By Sarah Wickline, Contributing Writer, MedPage Today Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse PlannerNote that this cohort study demonstrated several novel predictors of anxiety and depression among patients after a cancer diagnosis.Be aware that the overall prevalence of anxiety and depression was roughly 30 percent.

In the year following a cancer diagnosis, some patients showed lingering or late-onset anxiety and/or depression, although most appeared to cope relatively well, researchers found.

Among 1,154 patients followed from initial cancer diagnosis, about 20% met criteria for clinically relevant anxiety and roughly 10% were found to have depression 6 and 12 months later, according to Allison W. Boyes, PhD, of the University of Newcastle in Australia, and colleagues.

Significant predictors of development of late-onset or persistent mood disorders in the prospective study included high levels of such disorders 6 months after diagnosis, but also such factors as gender, type of cancer, and certain coping styles, the researchers reported online in the Journal of Clinical Oncology.

"This is one of the first studies to examine the prevalence and predictors of the short-term courses of anxiety and/or depression among a diverse sample of cancer survivors in early survivorship," the researchers wrote.

They noted that most cancer survivors in this group showed psychological resilience, with either no mood disruption or only transient anxiety or depression.

Boyes and colleagues asserted that targeted screening and early intervention should be considered for more vulnerable patients to prevent or reduce the severity of psychological disorders.

Participants were recruited from the ongoing Cancer Survival Study, each having been diagnosed in the past 6 months with one of the top eight incident cancer types in Australia: prostate, colorectal, female breast, lung, melanoma, non-Hodgkin's lymphoma, leukemia, or head and neck cancer.

Along with a detailed questionnaire, each participant filled out the 14-item Hospital Anxiety and Depression Scale (HADS) initially at 6 months after diagnosis and again 12 months after diagnosis. Participants were designated as anxiety or depression cases at a particular assessment if HADS scores at in the relevant domains reached at least 8 on the 21-point scales.

The personal questionnaires assessed patient health behaviors, psychological history and social support systems. Up-to-date medical and treatment records were available for each patient.

Among those asked to participate in the study, 43% agreed. Sample retention between the two assessments was 95%. Participants were 18 to 80 years old and 58% were male.

Odds ratios were adjusted based on information obtained from the patient questionnaires concerning: marital status, education, employment, health insurance coverage, size of household, geographic location, the use of complementary therapies for cancer-related purposes, and the presence of physical comorbidities and/or significant life events that could have been a source of stress.

At the 6-month assessment, 22% (95% CI 20%-25%) qualified as anxiety, and after 12 months, 21% (95% CI 19%-24%) persisted.

At both 6 and 12 months, 13% (95% CI 11%-14%) qualified as depression, and 9% (95% CI 7%-10%) had comorbid anxiety and depression.

Overall, 70% (95% CI, 68%-73%) did not develop anxiety at any time, 82% (95% CI, 79%-84%) did not develop depression, and 87% (95% CI, 85%-89%) did not develop comorbid anxiety-depression.

Boyes and colleagues found that, among patients showing anxiety or depression during the study period, the trajectories varied. About half of patients qualifying as mood disorder cases had the conditions at both assessments. The remainder were about equally divided between those who qualified for case status only at the 12-month evaluation and those who met case criteria at month six but not at month 12.

Significant predictors of anxiety at 12 months included the following: Anxiety at 6 months (relative to no anxiety at 6 months): OR 10.7, 95% CI 7.2-15.0Depression at 6 months (relative to no depression at 6 months): OR 1.9, 95% CI 1.2-3.1Female gender (relative to male): OR 1.8, 95% CI 1.3-2.6"Fighting spirit" coping (relative to other coping styles): OR 1.7, 95% 1.1-2.8

For depression, the following factors were significantly associated with case status at 12 months: Depression at 6 months: OR 6.9, 95% CI 4.0-12.2Anxiety at 6 months: OR 2.6, 95% CI 1.6-4.4Low physical activity but not sedentary (relative to "sufficiently active"): OR 2.1, 95% CI 1.2-3.6Cancer not in remission (relative to remission): OR 1.8, 95% CI 1.1-2.9Lung cancer diagnosis (relative to melanoma): OR 5.3, 95% CI 1.9-15.1"Cognitive avoidance" coping: OR 1.7, 95% CI 1.1-2.8

Patients with comorbid anxiety-depression also had physical inactivity as a significantly predictor, along with both current and past smoking, with odds ratios ranging from 1.6 to 3.7.

"Given that feelings of vulnerability are common when active treatment is completed, it may be reassuring to give survivors in late treatment the message that most will adjust well and require only low-intensity supportive care, including information and self-management support," Boyes and colleagues wrote.

Routine psychological screening may not be necessary for all cancer survivors, the researchers suggested.

Instead, they advocated "targeted screening" of survivors with the risk factors for mood disorders identified in the study.

"Intervention trials focusing on psychological functioning, coping style, and health behaviors are warranted," Boyes and colleagues concluded.

The study was funded by the National Health and Medical Research Council, Cancer Council of New South Wales, Hunter Medical Research Institute, Honda Foundation and the University of Newcastle.

Study authors declared they had no relevant financial interests.

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After the Cancer the Worry Remains (CME/CE)

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By John Gever, Deputy Managing Editor, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse PlannerAnxiety, not depression, is the most common mental health issue facing long-term cancer survivors and their spouses.Note that the study suggests that efforts should be made to improve the identification and treatment of anxiety in long-term cancer survivors and their spouses.

Anxiety, not depression, is the most common mental health issue facing long-term cancer survivors and their spouses, a large meta-analysis found.

With data pooled from 26 studies, rates of depression in people surviving at least 2 years after a cancer diagnosis did not differ significantly from those seen in controls (relative risk 1.11, 95% 0.96-1.27, P=0.17), whereas anxiety was significantly more frequent in the survivors (RR 1.27, 95% CI 1.08-1.50, P=0.0039), according to Alex J. Mitchell, MD, of Leicester Partnership Trust in Leicester, England, and colleagues.

Rates of both depression and anxiety were similar among long-term survivors and their spouses included in 17 studies, although the data from those analyses suggested that women worried more than men irrespective of whether they were survivors or spouses.

"Our findings underline the importance of detection and treatment of anxiety disorders, not only depression," Mitchell and colleagues wrote in Lancet Oncology, adding that future research should address these conditions among patients receiving noncurative, palliative care.

In an accompanying commentary, Julia Addington-Hall, MD, of the University of Southampton in England, said the study sheds light on an under-recognized psychological effect of cancer survivorship.

"Much of this [past] research has been focused on depression, with anxiety being neglected by comparison," she wrote.

"The increased risk of anxiety [shown in the current analysis] in long-term cancer survivors justifies taking a fresh look at anxiety in these patients, including methods for identification of those at high risk, and provision of appropriate care and treatment."

Another cancer specialist, Ashley Sumrall, MD, of Carolinas Healthcare's Levine Cancer Institute in Charlotte, N.C., said anxiety needs to be addressed in cancer patients.

"Most of our cancer patients suffer from anxiety and depression that impact their quality of life," she told MedPage Today. "In the past, we tended to lump these two together, when, in fact, anxiety can impact the patient's care more than depression can. Anxiety increases levels of stress in the body and can also correlate with poorer outcomes. We've seen that time and time again."

In the study, Mitchell and colleagues searched the published literature for studies on prevalence of mood disorders among spouses and patients who had survived at least 2 years with a cancer diagnosis. They found a total of 16 that compared prevalences of depression and/or anxiety in cancer survivors versus healthy controls, and another 12 assessing these conditions in survivors and their spouses.

Some of these studies were based on national registry data and were quite large -- one drew on the U.K. General Practice Research Database and included data on more than 26,000 patients and 104,000 matched controls.

Pooled data from the studies on survivors versus controls yielded the following results: Depression prevalence: 11.6% in survivors (95% CI 7.7%-16.2%), 10.2% in controls (95% CI 8.0%-12.6%)Anxiety prevalence: 17.9% in survivors (95% CI 12.8%-23.6%), 13.9% in controls (95% CI 9.8%-18.5%)

For both calculations, excluding one study that Mitchell and colleagues considered to be a "methodological outlier" did not change the findings.

However, when the researchers included data from the component studies on patients diagnosed with cancer less than 2 years previously, they found that depression was significantly increased in that group relative to those with less recent diagnoses (RR 1.74 relative to diagnoses 2 to 10 years previously, P=0.0009).

The comparisons of depression and anxiety in survivors versus their spouses yielded the following: Depression prevalence: 26.7% in survivors (95% CI 19.8%-34.2%), 26·3% in spouses (95% CI 18.4%-35.0%)Anxiety prevalence: 28.0% in survivors (95% CI 22.3%-33.9%), 40.1% in spouses (95% CI 25.4%-55.9%)

Neither the prevalence of depression nor the prevalence of anxiety differed significantly between cancer patients and their spouses

The difference in anxiety prevalence did not reach statistical significance (RR 0.71, 95% CI 0.44 to 1.14), but that appeared to be because one of the five studies contributing to the analysis was sharply at odds with the other four.

That one study -- involving gynecologic cancer survivors -- showed a tripled rate of anxiety in the patients versus their spouses (RR 3.26, 95% CI 1.64-6.78), whereas the other four all showed reduced rates of anxiety in the patients relative to their spouses.

When the outlier study was excluded, the analysis of the remaining four showed significantly less anxiety among the cancer survivors (RR 0.54, 95% CI 0.42-0.69).

And of those four studies, the one with the largest patient-spouse imbalance in anxiety prevalence, with a relative risk of 0.36, involved prostate cancer survivors -- suggesting that wives may suffer from cancer-related anxiety more than their husbands, regardless of which one of them is the cancer patient.

Limitations to the study cited by Mitchell and colleagues included the usual caveats attached to meta-analyses, as well as a frequent lack of detail in the original studies on patients' mental status or on recruitment methods for healthy controls. Matching of controls to patients was variable in the studies, the researchers also noted. Overall, heterogeneity among studies was high, but there was no evidence of publication bias and excluding methodological outliers had no impact on most results.

The study had no external funding.

Study authors and the editorialist declared they had no relevant financial interests.

John Gever

Senior Editor

John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!

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2 Skin Cancer Drugs Win FDA Approval

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By John Gever, Deputy Managing Editor, MedPage Today

WASHINGTON -- Two new drugs for metastatic or inoperable melanoma, dabrafenib (Tafinlar) and trametinib (Mekinist), were approved by the FDA on Wednesday.

The agency also approved a companion diagnostic test for both agents to detect certain mutations in the BRAF gene that render melanoma cells susceptible to the drugs.

Dabrafenib is an inhibitor of the BRAF gene when it carries the so-called V600E mutation. Trametinib inhibits a target known as MEK and is effective primarily against melanomas carrying either the V600E or V600K mutations.

Approximately half of patients with malignant melanoma are marked by BRAF mutations, the FDA said.

The agency noted that dabrafenib and trametinib were approved separately as stand-alone drugs, not as a combination, although therapy with both drugs together has been tested clinically and appeared to be better than dabrafenib alone.

The diagnostic product, called the THxID BRAF test, was evaluated in the same clinical trials supporting the two drugs' approvals. It was used to select patients for the trials.

Dabrafenib's approval was based primarily on a trial in 250 patients randomized to the drug or a standard chemotherapy agent, dacarbazine. The BRAF inhibitor prolonged progression-free survival by 2.4 months, the FDA said.

Trametinib's pivotal trial involved 322 patients with a chemotherapy regimen as the comparator. Progression-free survival was extended by 3.3 months with trametinib. However, patients previously treated with other BRAF inhibitors, including dabrafenib, did not benefit from trametinib, according to the FDA.

Both drugs had a variety of side effects. For dabrafenib, these included hyperkeratosis, headache, fever, arthralgia, alopecia, hand-foot syndrome, and noncancerous skin lesions. More seriously but less commonly, some patients experienced cutaneous squamous cell carcinomas, hypotensive fever, dehydration, rigors, kidney failure, and hyperglycemia that sometimes required initiation of anti-diabetic drugs.

Adverse effects seen with trametinib included heart failure, pulmonary inflammation, skin infections, and vision loss, as well as less serious effects such as rash, diarrhea, peripheral edema, and acne-like skin eruptions.

Both of the new agents are manufactured by GlaxoSmithKline. The BRAF mutation test is sold by bioMerieux.

John Gever

Senior Editor

John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!

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