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  • July 21, 2016 6:47 AM | Ashley Monson (Administrator)

    En Español

    TUESDAY, July 19, 2016 (HealthDay News) -- Maternal infection with the mosquito-borne Zika virus can pose serious dangers to the fetus.

    Now, scientists say they've gained new insight into how the virus infects the fetus, and a potential means of preventing infection.

    Zika can cause serious birth defects if a woman becomes infected while pregnant. Thousands of babies have been born in Brazil with abnormally small heads and brains, a condition called microcephaly.

    "Very few viruses reach the fetus during pregnancy and cause birth defects," noted study lead researcher Lenore Pereira, a professor of cell and tissue biology at the University of California, San Francisco.

    Gaining a better understanding of how Zika does this "may be the most essential question for thinking about ways to protect the fetus when the mother gets infected," she said in a university news release.

    Based on work in the laboratory, Pereira's team discovered that Zika infects numerous types of cells in the placenta and amniotic sac, the fluid-filled sac that surrounds and protects the fetus in the womb. The virus also takes two distinct routes to reach a developing fetus.

    There is a placental route, established in the first trimester of pregnancy, or a route across the amniotic sac that only becomes available in the second trimester, the research team reported.

    In their tests, the researchers also found that an older antibiotic called duramycin effectively blocked the virus from replicating in the type of cells that they believe help transmit Zika along both routes.

    In prior lab work, duramycin has been found to help fight off dengue and West Nile viruses, which are flaviviruses -- the same group of viruses that comprises Zika.

    "Duramycin efficiently blocks infection of numerous placental cell types and intact first-trimester human placental tissue by contemporary strains of Zika virus recently isolated from the current outbreak in Latin America," study co-author Eva Harris said in the news release. She is professor of infectious diseases and vaccinology at the University of California, Berkeley's School of Public Health.

    Early science like this often fails to pan out in humans, so more research is necessary. However, Harris believes that "duramycin or similar drugs could effectively reduce or prevent transmission of Zika virus from mother to fetus across both potential routes and prevent associated birth defects."

    The findings were published July 18 in the journal Cell Host & Microbe.

    More information

    The U.S. Centers for Disease Control and Prevention provides more information onmosquito-borne diseases.

    This Q&A will tell you what you need to know about Zika.

    To see the CDC list of sites where Zika virus is active and may pose a threat to pregnant women, click here.

    SOURCE: University of California, San Francisco, news release, July 18, 2016

    -- Robert Preidt

    Last Updated: Jul 19, 2016

    Copyright © 2016 HealthDay. All rights reserved.


  • July 20, 2016 11:57 AM | Ashley Monson (Administrator)

    July 19, 2016 by Bruce Goldman in Medicine & Health / Neuroscience

    A new study shows that taking estrogen has a negligible effect on the mental skills of postmenopausal women. Credit: Shutterstock/Africa Studio

    A study led by a scientist at the Stanford University School of Medicine shows that hormone therapy has a negligible effect on verbal memory and other mental skills regardless of how soon after menopause a woman begins therapy.

    The study is the first large, long-term clinical trial to compare the effects of estradiol, a type of estrogen, on the mental capabilities of women who commence treatment soon after menopause versus those who begin after a long delay.

    "Our results suggest that healthy women at all stages after menopause should not take estrogen to improve memory," said the study's senior and lead author, Victor Henderson, MD, professor of health research and policy and of neurology and neurological sciences. "At the same time, they don't need to be overly concerned about negative effects of estrogen on memory."

    The study, published online July 18 in Neurology, addresses one specific aspect of a longstanding controversy concerning the benefits and harms of hormone therapy for postmenopausal women, whose bodies no longer produce estrogens and progesteroneas they did during childbearing years.

    Doubts about benefits

    Hormone therapy was extremely popular in the United States in the latter part of the last century, but its use—while still widespread, with users numbering in the millions—has dropped off considerably since 2002, when findings from the Women's Health Initiative, a large-scale longitudinal study, raised deep doubts about many of what had been believed to be the treatment's broad benefits.

    The evidence since then has been mixed on many counts, with a number of small studies, typically relatively short in duration, continuing to suggest potential benefits from hormone therapy. One question is whether the retention of mental abilities—such as memory, reasoning, planning and selective attention—is improved by starting hormone therapy soon after menopause rather than many years later.

    The new study is part of a recently completed trial, the Early versus Late Intervention Trial with Estradiol, which enrolled large numbers of postmenopausal women to examine hormone therapy's potential for countering atherosclerosis. One thing ELITE sought to determine was whether outcomes for women taking estradiol, the dominant natural sex steroid in premenopausal women, and progesterone, another steroid involved in the menstrual cycle, would be different than that of women who took Prempro, which was used as part of the Women's Health Initiative in the early 2000s. Prempro is a mixture of modified estrogens derived from mares' urine combined with medroxy-progesterone acetate, a substance whose effects approximate but do not duplicate those of progesterone.

    The trial also sought to determine when women should begin hormone therapy to ensure maximal benefits. Depending on the hoped-for clinical outcome, some evidence, mostly from animal studies, suggests that for a woman to benefit from hormone replacement, it may be essential to start soon after menopause, before the rapid postmenopausal decline in estrogen and progesterone availability irreversibly damages hormone-starved cells and tissues.

    Estradiol or placebo

    For the ELITE trial, which took place at the University of Southern California where Henderson's collaborators are based, healthy postmenopausal women were divided into two groups: an "early group," composed of women whose last menstrual period had occurred no more than six years prior to the start of the study, and a "late group," composed of women whose last period had occurred at least 10 years before the start of the study. Women in the two groups were then randomly assigned to daily oral regimens of either estradiol or a placebo. Estradiol-receiving women who hadn't undergone hysterectomies were also given progesterone, which can help protect against estrogens' uterine-cancer-promoting effect. Women receiving placebo instead of estradiol got a progesterone placebo instead of progesterone.

    Henderson and his collaborators received funding to study hormone therapy's effects, over a five-year duration, on these women's cognitive abilities. This adjunct trial, called ELITE-cog, analyzed tests of mental abilities of 567 women between the ages of 41 and 84, representing both the "early" and "late" groups of women. The women's verbal memory; their executive functions, such as judgment, planning, reasoning and focusing attention; and their overall neuropsychological condition were assessed at the beginning of the trial and at 2.5 years and five years later.

    The difference between the two groups of women on any of these measures was negligible, Henderson and his colleagues found. In fact, there was no appreciable difference in test performance between women receiving estradiol and those given a placebo, regardless of how soon after menopause the women began treatment, the study indicated.

    Even when the scientists, in a separate analysis, excluded data from all women in the "early group" who'd begun hormone therapy any later than three years after menopause, they observed neither positive nor negative effects on these women's mental ability compared to that of women initiating treatment more than 10 years after menopause.

    Henderson, who is also the director of the Stanford Alzheimer's Disease Research Center, cautions that because women with cognitive deficits or outright dementia were excluded in this analysis, the study's results apply only to women with good mental skills at the time they begin treatment. Also, the findings cannot be extrapolated to cardiovascular or other health outcomes of hormone therapy, which must be assessed individually, he said. Indeed, Henderson noted that there's now some evidence that hormone therapy, initiated early, may have beneficial cardiovascular effects, while it is clear that late hormone therapy can contribute to heart disease.

    Hormone therapy during the first five years after the onset of menopause is still approved for relief of moderate-to-severe hot flashes and night sweats, and also has beneficial effects on bone density. "If you're considering hormone therapy for those reasons, this study indicates that there's no particular reason to fear harmful effects on cognition over a five-year period of use," said Henderson. "But there's no reason to expect that this treatment, by itself, will result in meaningful improvement of mental abilities, either."

    The work is an example of Stanford Medicine's focus on precision health, the goal of which is to anticipate and prevent disease in the healthy and precisely diagnose and treat disease in the ill.

    More information: Victor W. Henderson et al. Cognitive effects of estradiol after menopause, Neurology (2016). DOI: 10.1212/WNL.0000000000002980 

    Provided by Stanford University Medical Center

    "Hormone therapy for postmenopausal brain performance has no effect, whether started early or late" July 19, 2016 http://medicalxpress.com/news/2016-07-hormone-therapy-postmenopausal-brain-effect.html


  • July 20, 2016 11:32 AM | Ashley Monson (Administrator)

    The Centers for Disease Control and Prevention reported Thursday that Neisseria gonorrhoeae ― that is, the bacteria that causes gonorrhea ― could be developing resistance to our last-line antibiotics that treat it.

    The CDC’s current gold standard treatment for gonorrhea is a combination of two drugs, azithromycin and ceftriaxone, to ensure that if one drug doesn’t kill the bacteria, the other will finish the job. Now, a rise in antibiotic resistance among these two bacteria since 2014 has experts worried.

    “History has taught us that this bacteria has the ability to develop resistance to antibiotics, and sometimes it can do it quite quickly,” Dr. Robert Kirkcaldy, a medical epidemiologist in the CDC’s STD prevention division told The Huffington Post.

    “Our ability to cure people of gonorrhea is going to fade unless we take steps now address growing antibiotic resistance.”

    That said, the United States has not encountered any cases of gonorrhea that are untreatable so far, and despite rising antibiotic resistance, overall resistance rates for the combination treatments are relatively low: just 2.5 percent for azithromycin and 0.8 percent for ceftriaxone.

    As it stands, gonorrhea is the second-most common sexually transmitted infection in the United States, with more than 350,000 reported cases of the infection in 2014. And while gonorrhea has traditionally has been easy to cure, if left untreated, it can cause severe reproductive health problems for women, including pelvic inflammatory disease, infertility and ectopic pregnancy.  

    A perfect storm: cunning bacteria, too few drugs

    Our blind faith in innovation and technology is partially to blame for antibiotic-resistant bacteria’s rise. An over-reliance on these medicines, including for infections that are not bacterial, has hastened bacterial mutations and helped contribute to antibiotic resistance.

    To keep up with infectious bacteria’s evolution, we need to discover new antibiotics if we want to battle gonorrhea version 2.0.

    Unfortunately, we’re not keeping up our end of the bargain. Antibiotic discovery peaked in the 1950s, and according to Pew Charitable Trusts, we haven’tdiscovered a registered class of antibiotics since 1984.

    “If there were an unlimited number of drugs, it may not be an issue,” Kirkcaldy said. “But the number of new drugs is dropping at the same time that bacteria continues to evolve and develop new resistance.”

    Discovering new antibiotics is difficult and costly, and there isn’t much incentive for drug companies to invest in it, according to David Payne, head of the Antibacterial Discovery Performance Unit at GlaxoSmithKline. 

    “The problem with this therapy area is that the return on investment on an antibiotic― if you apply the traditional pharmaceutical model ― is very low,” Payne told the podcast Signal in July. As it stands, GlaxoSmithKline is one of the only big drug makers left in antibiotic production. 

    ”When you couple all of the challenges of discovering and developing antibiotics with the fact that the return on investment in the current pharmaceutical model is very low, this becomes a very unattractive area for companies to invest in,” Payne said.

    The rise of superbugs

    Earlier in July, experts confirmed the second case of a superbug resistant to the last-line of antibiotics in a patient who had undergone surgery in a New York hospital in 2015. Following the report, experts expressed fear that antibiotic-resistant infections could become a routine reality in the near future.

    The CDC considers infections acquired in healthcare settings to be among the most urgent and serious antibiotic-resistant bacteria threats, because they can lead to sepsis or death. 

    What many Americans might not realize is how different the strains of antibiotic-resistant bacteria are from one another. “The bugs that affect people who were in the intensive care unit are going to be different than other infections that affect people in the community or other STDs,” Kirkcaldy said.

    Two million people in the United States become infected with antibiotic-resistant bacteria every year, and 23,000 die as a direct result of those infections, the CDC reports.

    How to turn the tide on antibiotic resistance

    “We need to try to prevent these infections from occurring in the first place,” Kirkcaldy stressed.

    To protect yourself from gonorrhea and other sexually transmitted infections, practice abstinence or use condoms correctly every time you have sex. High-risk individuals, including women younger than 25, people who have multiple sexual partners or those with a new sexual partner, should be screened for gonorrhea every year. 

    And if you do become infected, treatment ― for both you and your recent partners ― is paramount. It’s also a step that doctors sometimes overlook. 

    “Not only will that protect their partners, but it will also prevent the spread of the infection in the community and will protect the initial patient, because then he or she has less of a likely chance of getting it again,” Kirkcaldy said.

    Beyond preventing and treating sexually transmitted diseases, the World Health Organization has a few suggestions for things doctors, patients and industry can do to fight back against antibiotic resistance

    Antibiotic use in animals is a particularly pressing problem. The same low-dose antibiotics that protect livestock from infection and allow it to grow faster, can pass resistant bacteria to humans through food.

    In the medical realm, health care workers need to stop prescribing antibiotics unless they are absolutely necessary. In turn, patients shouldn’t ask for them unless they have a confirmed bacterial infection. As it stands, almost one third of antibiotics are currently prescribed unnecessarily.

    From a public health perspective, the U.S. government is already taking action to address the imminent threat of antibiotic resistance. The government’s National Action Plan allocated $160 million for the CDC to ramp up testing, surveillance and drug development, specifically strengthening local health departments to monitor and prevent outbreaks. In addition, the National Institutes of Health received a $100 million budget increase to fight antimicrobial resistance.

    Still, experts aren’t completely reassured by the government windfall.

    “It’s a big deal, I totally agree, but I’m still a little shocked that it hasn’t happened sooner,” Lance Price, a molecular epidemiologist and director of George Washington University’s Antibiotic Resistance Action Center told the Washington Post in December.

    “I would hate for people to think that this is actually sufficient.”

    Source: Huffington Post

  • July 20, 2016 11:31 AM | Ashley Monson (Administrator)

    Women undergoing in vitro fertilization have long worried that the procedure could raise their risk for breast cancer.

    After all, the treatment requires temporarily increasing levels of certain sex hormones to five or 10 times the normal. Two of those hormones, estrogenand progesterone, can affect the course of certain kinds of breast cancer.

    A series of studies over the past decade suggested that these former patients may have little to worry about. Experts remained cautious, however, because women who had undergone I.V.F. in the 1980s had not yet reachedmenopause by the time of the research.

    But the largest, most comprehensive study to date, published Tuesday, provides further reassurance: It finds no increased risk among women who have undergone I.V.F.

    “The main takeaway is there’s no evidence of an increased subsequent risk of breast cancer, at least in the first couple decades,” said Dr. Saundra S. Buys, an oncologist at the Huntsman Cancer Institute at the University of Utah, who was not involved in the new study.

    The issue has nagged at specialists in reproductive medicine for some time. In 2008, a retrospective analysis of medical records, which the authors called “preliminary,” found a potential increase in breast cancer amongI.V.F. patients older than 40.

    Another small study of participants at a treatment center in Israel reported an increased risk of breast cancer among women who start I.V.F. after 30.

    Maddeningly, later findings went the other way, seeming to suggest the danger — if there was one — may be greater for younger women.

    A study with roughly 21,000 participants, published in 2012, found that women in Western Australia who began I.V.F. at 24 or younger had an increased risk of breast cancer. No such link was found among women in their 30s or 40s.

    In 2013, though, researchers published a meta-analysis of eight smaller studies tentatively suggesting that I.V.F. did not seem to raise breast cancer risk over all.

    But it did not rule out the possibility that breast cancer might turn up in a bigger group of women tracked more closely for an even longer period. Experts also worried that infertility itself, not only its treatment, might somehow be linked to breast cancer.

    Tuesday’s report, published in JAMA, goes a long way toward answering the lingering questions.

    The huge study not only found no increased risk among women receiving I.V.F., but also found no greater risk among women who had various types of less intensive treatments to improve fertility.

    More than 25,000 Dutch women, with an average age of 32.8 when they started treatment from 1980 to 1995, were followed for a median period of 21 years.

    The researchers took into account an exhaustive list of factors linked to higher risk of cancer, including each woman’s age at the time she gave birth to her first child, her overall number of births and the number of I.V.F. attempts.

    Because I.V.F. patients tend to have babies later in life than women who do not need assistance, “you have to take that into account,” said Alexandra van den Belt-Dusebout, the study’s first author and an epidemiologist at the Netherlands Cancer Institute in Amsterdam.

    More than five million babies have been born worldwide through I.V.F. and other assisted reproduction.

    Perhaps the study’s most surprising finding was that breast cancer risk was significantly lower among those women who underwent seven or more cycles of I.V.F., compared with those who received one or two cycles.

    “That’s reassuring, because you would think if you did I.V.F. 10 times, your risk would be higher,” said Dr. Owen K. Davis, the president of the American Society for Reproductive Medicine.

    The study also showed that women who responded poorly to ovarian stimulation in the first I.V.F. attempt also had decreased breast cancer risk.

    Louise M. Stewart, a researcher at the Center for Population Health Research at Curtin University in Perth, Australia, speculated that the finding might explain why women who had I.V.F. at 24 or younger have an increased risk of breast cancer.

    “Young women generally respond well to I.V.F. treatment,” said Dr. Stewart, who was the first author on the Australia study. She suggested the “increased risk we observed in young women may be related to their response to I.V.F. treatment.”

    Mia Gaudet, the strategic director of breast and gynecologic cancer research at the American Cancer Society, applauded the study for adding a “significant amount of evidence that there is no link between I.V.F. and breast cancer.”

    But she warned, “It’s still not conclusive.” For one thing, today’s protocols for I.V.F. differ slightly in the kinds of drugs given and for how long, the researchers noted.

    The researchers have recruited an additional 10,000 Dutch women who had the latest I.V.F. regimen and 5,000 who received other fertility treatments. They will be tracking their health, as well.

    Also, only 14 percent of participants had reached age 60, so this study cannot say much about postmenopausal breast cancer risk.

    “We just may not be seeing breast cancer in these women yet,” Dr. Gaudet said.

    Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.

    A version of this article appears in print on July 20, 2016, on page A15 of the New York edition with the headline: In Vitro Fertilization Is Found to Not Increase Chances of Breast Cancer. Order ReprintsToday's Paper|Subscribe


  • July 20, 2016 11:29 AM | Ashley Monson (Administrator)

    For the first time, researchers have designed what they say is an effective chlamydia vaccine that can be administered nasally. Preliminary findings from animal studies conducted at McMaster University in Canada suggest the test may show promise.

    According to the Centers for Disease Control and Prevention, chlamydia is the most commonly reported sexually transmitted disease (STD) in the United States. It can be cured with prompt antibiotic treatment, but untreated, chlamydia can lead to infertility, genital tract infections and pelvic inflammatory disease. Worldwide, the STD affects 113 million people.

    Researchers’ study, published Tuesday in the journal Vaccine, identified a novel chlamydial antigen called BD584, which may make a good candidate for a vaccine against the most common chlamydia species, Chlamydia trachomatis, which typically is asymptomatic.

    "Vaccine development efforts in the past three decades have been unproductive and there is no vaccine approved for use in humans," study co-author David Bulir, who just finished his Ph.D. in medical sciences at McMaster, said in a news release. "Vaccination would be the best way to way to prevent a chlamydia infection, and this study has identified important new antigens which could be used as part of a vaccine to prevent or eliminate the damaging reproductive consequences of untreated infections."

    The study showed that BD584 reduced chlamydial shedding by 95 percent and hydrosalpinx, which occurs when serious fluids block fallopian tubes, by 87.5 percent.

    Co-author and McMaster Ph.D. student Steven Liang said the vaccine also has the potential to protect against C. trachomatis strains that cause trachoma, an eye infection caused by chlamydia and the leading cause of preventable blindness worldwide.

    Administered nasally, the vaccine could be a simple and inexpensive way to protect against the STD.

    Next, study authors said they would study the antigen’s effectiveness against different strains of chlamydia with different formulations.

    Source: Fox News


  • July 19, 2016 9:40 AM | Ashley Monson (Administrator)

    New research shows that the Zika virus has two routes by which it can infect a developing fetus, depending on when during a pregnancy the infection occurs. It also shows an existing drug might be able to limit the damage wreaked by the virus.

    The new study, by scientists at the University of California at San Francisco and the University of California at Berkeley, suggests that an antibiotic called duramycin seems to be able to block Zika’s ability to latch onto the cells it wants to affect.

    “It was day and night. There was either infection or no infection, depending on how much drug you used,” Lenore Pereira, one of two contributing authors of the study, said in an interview.

    Read full article here.

  • July 19, 2016 9:37 AM | Ashley Monson (Administrator)

    Media Statement

    For immediate release: Monday, July 18, 2016
    Contact: Media Relations,
    (404) 639-3286

    CDC is assisting in the investigation of a case of Zika in a Utah resident who is a family contact of the elderly Utah resident who died in late June. The deceased patient had traveled to an area with Zika and lab tests showed he had uniquely high amounts of virus—more than 100,000 times higher than seen in other samples of infected people—in his blood. Laboratories in Utah and at the Centers for Disease Control and Prevention (CDC) reported evidence of Zika infection in both Utah residents.

    State and local public health disease control specialists, along with CDC, are investigating how the second resident became infected. The investigation includes additional interviews with and laboratory testing of family members and health care workers who may have had contact with the person who died and trapping mosquitoes and assessing the risk of local spread by mosquitoes.

    A CDC Emergency Response Team (CERT) is in Utah at the request of the Utah Department of Health. The team includes experts in infection control, virology, mosquito control, disease investigation, and health communications.

    “The new case in Utah is a surprise, showing that we still have more to learn about Zika," said Erin Staples, MD, PhD, CDC’s Medical Epidemiologist on the ground in Utah. “Fortunately, the patient recovered quickly, and from what we have seen with more than 1,300 travel-associated cases of Zika in the continental United States and Hawaii, non-sexual spread from one person to another does not appear to be common."

    As of July 13, 2016, 1,306 cases of Zika have been reported in the continental United States and Hawaii; none of these have been the result of local spread by mosquitoes. These cases include 14 believed to be the result of sexual transmission and one that was the result of a laboratory exposure.

    Since early 2016, CDC has worked with state, local, and territorial public health officials to protect pregnant women from Zika infection, through these activities:

    • Alerts to pregnant women to avoid travel to an area with active Zika transmission, to women in these areas to take steps to prevent mosquito bites, and to partners of pregnant women to use a condom to prevent sexual transmission during pregnancy.
    • Development and distribution of PCR and IgM testing kits to confirm Zika virus infection.
    • Establishment of CDC Emergency Response Teams to rapidly deploy to assist with Zika-related preparedness and response activities in the United States.
    • Deployment of experts to assist in enhancement of mosquito surveillance and testing.
    • Collaboration with FDA, blood collection centers, and other entities in the public and private sectors on enhancement of surveillance of blood donations.
    • Guidance to prevent sexual transmission, particularly to women who are pregnant.
    • Guidance for clinicians on the care of pregnant women who may have been exposed to Zika.
      Studies in collaboration with Brazil, Colombia, and other countries to better understand the link between Zika infection and birth defects, including microcephaly.

    For more information about Zika: http://www.cdc.gov/zika/.

    ###
    U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES


  • July 19, 2016 9:05 AM | Ashley Monson (Administrator)

    MADISON, Wis. — Of the hundreds of monkeys in the University of Wisconsin’s primate center, a few — including rhesus macaque 827577 — are now famous, at least among scientists tracking the Zika virus.

    Since February, a team led by David H. O’Connor, the chairman of the center’s global infectious diseases department, has been conducting a unique experiment in scientific transparency. The tactic may presage the evolution of new ways to respond to fast-moving epidemics.

    Dr. O’Connor and his colleagues have been infecting pregnant female macaques with the Zika virus, minutely recording their symptoms, and giving them blood tests and ultrasounds. But then, instead of saving their data for academic journals, the researchers have posted it almost immediately on a website anyone can visit.

    The openness of the process thrills scientists, who say it fosters collaboration and speeds research.

    “David’s work is very useful,” said Dr. Koen Van Rompay, a virologist at theCalifornia National Primate Research Center at the University of California, Davis. “We all learn from each other and make sure we don’t duplicate each other’s work.”

    Back-to-back epidemics of Ebola and Zika have driven some infectious disease specialists to embrace greater speed and openness. Until now, they felt forced to hoard data and tissue samples: Careers depend on being published in prestigious journals, which often refuse to publish work that has previously been released and may take months to edit papers.

    At the same time, Dr. O’Connor’s openness has exposed some of the more macabre requirements of scientific research.

    Animal rights activists are upset at the brutal reality of infecting female monkeys and dissecting their babies. They argue that the work is unnecessary because scientists have already learned a lot by drawing blood from Zika-infected human mothers and dissecting some human fetuses that have died in the womb or were aborted.

    Read the full article here.


  • July 18, 2016 9:16 AM | Ashley Monson (Administrator)

    by Kristin Jenkins 
    Contributing Writer, MedPage Today

    The first randomized phase III clinical trial to compare irinotecan (Camptosar, Camptothecin-11, CPT-11) and cisplatin (Platinol, Platinol-AQ, CDDP) with standard of care -- paclitaxel (Taxol, Onxal) plus carboplatin (Paraplatin) -- in patients with clear cell carcinoma (CCC) of the ovary found no significant survival benefit between the groups.

    With a median follow-up of 44.3 months, 2-year progression-free survival rates were 73.0% in the irinotecan-plus-cisplatin (CPT-P) group and 77.6% in the paclitaxel-plus-carboplatin (TC) group (HR 1.17; 95% CI 0.87 to 1.58). Two-year overall survival rates were 85.5% with CPT-P and 87.4% with TC (HR 1.13; 95% CI 0.80 to 1.61).

    Both regimens were well tolerated, although the toxicity profiles differed significantly, Aikou Okamoto, MD, of Jikei University School of Medicine in Tokyo and colleagues in the Japanese Gynecologic Oncology Group reported online in theJournal of Clinical Oncology.

    "The previous randomized phase II study[JGOG3014] showed a tendency of progression-free survival superiority of the CPT-P arm in a subset analysis of patients without residual disease or with residual disease of less than 2 cm," the researchers wrote. "However, we could not identify the survival advantage of CPT-P in any subgroup analyses by region, stage, and size of the residual disease in the current phase III randomized trial."

    The study also revealed the limitations of existing anticancer agents to improve prognosis in patients with ovarian CCC. Identification of driver mutations "is a crucial first step toward personalizing treatment of CCC," Okamoto and colleagues emphasized.

    Studies of metastatic clear cell renal cancer have demonstrated the effectiveness of using a combination of targeted treatments such as a PI3K-Akt-mTOR pathway inhibitor as well as anti-angiogenic agents and new immunotherapy drugs, the researchers said. "Therefore, we emphasize that therapeutic regimens should consider such combinations and/or target drugs to improve the prognosis of CCC of the ovary."

    The negative results of this trial highlight two major challenges in cancer research,Emese Zsiros, MD, PhD, of Roswell Park Cancer Institute in Buffalo, NY, said in an interview.

    "In vitro studies on cancer cell lines often do not translate to clinical benefit in patients given the heterogeneity and complexity of cancer in real life," she explained. "Also, if a phase II study does not show significant activity of a new drug or drug combination, it is unlikely to detect a significant clinical benefit in a large phase III study."

    Zsiros, who was not affiliated with the study, also noted that while CCC accounts for only 4-12% of all ovarian cancers in the U.S. and Europe, it is much more common in Japan, accounting for more than 20% of all ovarian cancers.

    Unlike serous ovarian cancer, CCC is often associated with a large one-sided pelvic mass and an increased incidence of hypercalcemia and vascular thromboembolic complications such as deep venous thrombosis and/or pulmonary embolism, she pointed out. The lower proliferation rate and increased resistance to traditional chemotherapeutic agents make CCC "a much more difficult disease to treat."

    Given the relatively poor prognosis and similarity to clear cell renal cancer, patients with CCC of the ovary are best treated as part of a clinical trial exploring alternative or novel agents, Zsiros suggested.

    In the international, multi-institutional study, 667 patients were recruited at 129 centers in Japan, Korea, France, and the U.K., from September 2006 to February 2011. Japanese women made up 93.5% of the study population.

    The median age in both the experimental and standard-of-care groups was 53. A total of 411 patients (66.4%) had stage I disease, and 33.6% had stage II to IV disease. Of the latter group, 23% had stage III/IV disease.

    Patients were randomly assigned to receive either:

    • irinotecan at 60 mg/m2 on days 1, 8, and 15 plus cisplatin at 60 mg/m2on day 1 every 4 weeks for six cycles (CPT-P group); or
    • paclitaxel at 175 mg/m2 plus carboplatin at an area under the curve of 6.0 mg/mL/min on day 1 every 3 weeks for six cycles (TC group).

    Of the 619 patients eligible for evaluation, the 332 in the CPT-P group experienced more grade 3/4 anorexia, diarrhea, nausea, vomiting, and febrile neutropenia. The 335 patients in the TC group had grade 3/4 leukopenia, neutropenia, thrombocytopenia, peripheral sensory neuropathy, and joint pain more frequently, the study showed.

    No deaths related to treatment were reported, the researchers said.

    Okamoto disclosed no conflicts of interest, but several of the other study authors disclosed relationships with industry.

    • Reviewed by F. Perry Wilson, MD, MSCEAssistant Professor, Section of Nephrology, Yale School of Medicine and Dorothy Caputo, MA, BSN, RN, Nurse Planner

    LAST UPDATED 07.15.2016

    • Primary Source

    Journal of Clinical Oncology

    Source Reference: Okamoto A, et al "Randomized phase III trial of irinotecan plus cisplatin compared with paclitaxel plus carboplatin as first-line chemotherapy for ovarian clear cell carcinoma: JGOG3017/GCIG trial"JCO 2016; DOI: 10.1200/JCO.2016.66.9010.

  • July 18, 2016 9:13 AM | Ashley Monson (Administrator)

    A new study led by Assistant Medical Professor Philip Smith of The City College of New York's Sophie Davis Biomedical Education/CUNY School of Medicine, and conducted in collaboration with researchers at Yale University and Yeshiva University, found important differences between women and men in their ability to quit smoking when taking medications commonly prescribed to help smokers quit.

    The study, "Sex Differences in Smoking Cessation Pharmacotherapy Comparative Efficacy: A Network Meta-analysis," which reviewed and analyzed evidence from over 14,000 cigarette smokers participating in 28 clinical trials for nicotine patch, varenicline and bupropion, found that across the trials women who were given varenicline were much more likely to quit smoking than women who were given nicotine patch or bupropion. By contrast, among men there were no differences in the likelihood of successfully quitting smoking when given varenicline, bupropion or nicotine patch.

    While the study found that all three medications helped both women and men quit when compared to placebo, the difference was in the relative benefit of the three medications. Clinical trial data consistently show that taking medications can help smokers quit. Some may help more than others, and for women the best choice may be varenicline.

    "Before our study, research had shown that among the choices for medications for smokers who wanted to quit, varenicline was the clear winner when it came to promoting quitting," said Smith. "Our study shows this is clearly the case for women. The story seems less clear among men, who showed less of a difference when taking any of the three medications."

    Roughly one in six adults in the United States smokes cigarettes, which contributes to over 550,000 deaths per year in the U.S. Currently, three types of medications approved by the U.S. Food and Drug Administration can be prescribed to help smokers quit: nicotine replacement therapies, which include the nicotine patch and nicotine gum; varenicline, which is manufactured by Pfizer and sold as Chantix in the United States; and bupropion, which is manufactured by GlaxoSmithKline and sold as Wellbutrin or Zyban.

    The study appears in the journal Nicotine & Tobacco Research.

    Story Source: The above post is reprinted from materials provided by City College of New York. Note: Materials may be edited for content and length.

    Journal Reference:

    Sherry A. McKee, Philip H. Smith, Mira Kaufman, Carolyn M. Mazure, Andrea H. Weinberger. Sex Differences in Varenicline Efficacy for Smoking Cessation: A Meta-Analysis. Nicotine & Tobacco Research, 2016; 18 (5): 1002 DOI: 10.1093/ntr/ntv207

    City College of New York. "Study finds differing treatment options for women smokers." ScienceDaily. ScienceDaily, 13 July 2016. <www.sciencedaily.com/releases/2016/07/160713105742.htm>.


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