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  • July 19, 2018 9:45 AM | Anonymous

    July 19, 2018, Monthly Prescribing Reference  

    The Food and Drug Administration (FDA) has approved Kisqali (ribociclib; Novartis) in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Previously, this CDK4/6 inhibitor was approved for use with an AI to treat HR-positive, HER2-negative breast cancer in postmenopausal women with advanced or metastatic breast cancer.

    In addition, Kisqali has also been approved in combination with fulvestrant to treat postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.

      The approval for Kisqali + an AI in pre/perimenopausal women was based on a double-blind, placebo-controlled study (MONALEESA-7) involving 495 patients who received Kisqali + a nonsteroidal aromatase inhibitor (NSAI) or tamoxifen or placebo + NSAI or tamoxifen; all patients received ovarian suppression with goserelin. The primary endpoint of the study was progression-free survival (PFS). Compared with placebo, treatment with Kisqali was associated with longer PFS (median PFS: 27.5 months vs 13.8 months; hazard ratio [HR] 0.569; 95% CI, 0.436-0.743).

      The combination of Kisqali + fulvestrant was evaluated in a double-blind, placebo-controlled trial (MONALEESA-3) involving 726 postmenopausal women that also measured PFS as the primary endpoint. Compared with the placebo + fulvestrant arm, patients receiving Kisqali + fulvestrant had longer PFS (median PFS: 20.5 months vs 12.8 months; HR 0.593; 95% CI 0.480-0.732; <.0001).

      In a press statement, the FDA noted that the Kisqali approvals were the first to be granted as part of 2 new pilot programs (Real-Time Oncology ReviewAssessment Aid) created to improve the development and review of cancer drugs. “With today's approval, the FDA used these new approaches to allow the review team to start analyzing data before the actual submission of the application and help guide the sponsor's analysis of the top-line data to tease out the most relevant information,” said FDA Commissioner Scott Gottlieb, MD, “This enabled our approval less than 1 month after the June 28 submission date and several months ahead of the goal date.”

      Kisqali is supplied as a 200mg tablet in 14- and 21-count blister packs.

      For more information visit

    • July 10, 2018 10:55 AM | Anonymous

      July 10, 2018, Physician's Briefing/HealthDay News 

      Women enrolled in Medicare who undergo screening mammography seem to have increased awareness and use of other preventive screening measures, according to a study published online June 5 in Radiology.

      Stella K. Kang, M.D., from New York University in New York City, and colleagues used Medicare claims (2010 to 2014) to retrospectively assess whether there is an association between use of screening mammography and use of a variety of other preventive services in female Medicare enrollees.

      Of 555,705 patients, 33.4 percent underwent mammography. The researchers found that women who underwent index screening mammography were more likely than unscreened women to later undergo Papanicolaou test (odds ratio, 1.49), bone mass measurement (odds ratio, 1.70), and influenza vaccine (odds ratio, 1.45), when adjusting for patient demographics, comorbidities, geographic covariates, and baseline preventive care. Among women who had not used these preventive services in the two years before the index mammography, use of these preventive services was similar regardless of false-positive mammography findings or true-negative findings.

      "In beneficiaries of U.S. Medicare, use of screening mammography was associated with higher likelihood of adherence to other preventive guidelines, without a negative association between false-positive results and cervical cancer screening," the authors write.

      Abstract/Full Text (subscription or payment may be required)
    • July 09, 2018 10:08 AM | Anonymous

      Medical News Today

      The merits of vitamin D when it comes to cancer prevention have long been at the heart of medical debates.

      Where some studies have revealed that overall cancer risk is lower in people with higher levels of this vitaminothers have suggested that vitamin D has no impact on a person's vulnerability to the disease.

      Still, the case for ensuring that you get enough vitamin D is fairly strong, as low blood levels of this nutrient have been associated with a raised risk of bladder cancer and, in a study that was published earlier this year, an elevated risk of bowel cancer.

      Previous research has also suggested a link between high vitamin D levels and better survival rates in people going through breast cancer treatment.

      In a pooled analysis of a prospective cohort study and two randomized clinical trials, researchers at the University of California, San Diego School of Medicine in have now investigated whether and to what extent high levels of vitamin D in the blood were associated with a lower risk of developing breast cancer.

      Their analysis — which was conducted in collaboration with specialists from Creighton University in Omaha, NE, the Medical University of South Carolina in Columbia, and the nonprofit organization GrassrootsHealth in Encinitas, CA — suggests that certain levels of vitamin D correlate with a "markedly lower" risk of breast cancer.

      These results are now published in the journal PLOS ONE

      Read more. 

    • July 09, 2018 10:05 AM | Anonymous


      Equip yourself with the latest evidence-based knowledge on several forms of LARC contraception options with this free activity on LARC options. It will help you evaluate safety and efficacy data, understand the common concerns and priorities related to contraception, and have more informed discussions with patients. Plus, earn AAPA Category 1 Self-Assessment CME! 

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    • June 28, 2018 1:34 PM | Anonymous

      HealthDay News 

      Using automated breast density measurements, Norwegian researchers were able to more precisely confirm that women with dense breasts have a higher risk of breast cancer.

      The study included more than 100,000 women and more than 300,000 screening exams.

      "We found that screening examinations of women having dense breasts showed higher rates of recall and biopsy, and higher odds of screen-detected and interval breast cancers than women with non-dense breasts," said the study's senior author, Solveig Hofvind. She is a researcher and head of BreastScreen Norway for the Cancer Registry of Norway.

      Dense breasts pose a challenge when it comes to cancer screening, because dense tissue shows up white on a mammogram. That's also how breast tumors look on a mammogram. Dense breast tissue can actually hide or mask cancers, according to Hofvind.

      The findings were published June 26 in Radiology.

      Dr. Liane Philpotts wrote an accompanying editorial. She is chief of breast imaging at the Yale School of Medicine.

      "Dense breasts are not something that a patient feels. You can only tell if someone has dense breast tissue on a mammogram," Philpotts said.

      Radiologists identify breast density using a standardized scoring technique from the American College of Radiology (ACR). The scoring system runs from A to D. A woman with an A or B doesn't have dense breasts, but someone with a C or D does, she explained.

      About half of American women who are screened for breast cancer have dense breast tissue. As women age, their breasts often become less dense, Philpotts said.

      Instead of using the ACR technique, which relies on a radiologist's subjective judgment, the new study used automated software -- known as automated volumetric analysis -- to classify breast density.

      The Norwegian women in the study were between 50 and 69 years old. The automated software found dense breasts in 28 percent of their screening tests.

      The rates of cancer were 6.7 per 1,000 exams for women with dense breasts and 5.5 for women with non-dense breasts, according to the findings.

      "This study really shows that women with dense breasts did have more cancers. It wasn't a huge amount. It was a small increase, but it was an increase," Philpotts said.

      In addition, women with dense breasts had more interval cancers. These are cancers found between screenings -- for example, when a woman feels a lump in her breast.

      The study found that women with dense breasts were called back for more testing due to suspicious findings and were more likely to have a biopsy to check tissue for cancer than women without dense breasts.

      Women with dense breasts also tended to have larger tumors when cancer was detected -- average of 17 millimeters (mm) vs. 15 mm for women without dense breasts.

      The study also confirmed that it's harder to accurately identify breast cancers in dense breast tissue. Cancers were accurately detected in women with dense breasts 71 percent of the time compared to 82 percent for women without dense breasts.

      "Automated volumetric breast density measurements may be considered a future standard for breast cancer screening, ensuring an objective density classification," Hofvind said.

      Philpotts pointed out that the findings don't necessarily translate to a U.S. population, because the women screened in the study were older, and they were screened every other year instead of annually.

      She said more research is needed to gauge the risks and benefits of the automated software. Hofvind agreed.

      Women with dense breasts generally don't need to be screened more often, according to Philpotts. But they will need some sort of supplemental imaging such as ultrasound or MRI that's better at seeing the difference between dense tissue and cancerous tissue.

    • June 28, 2018 9:22 AM | Anonymous

      Monthly Prescribing Reference 

      Achaogen announced that the U.S. Food and Drug Administration (FDA) has approved Zemdri (plazomicin) for adults (aged at least 18 years) with complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible microorganism(s): Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae. Zemdri, an aminoglycoside antibacterial, is a once-daily intravenous (IV) infusion that was designed to resist aminoglycoside-modifying enzymes.  

      Read more.

    • June 28, 2018 9:20 AM | Anonymous


      Find a PA mentor or mentee with this new, free program in Huddle. Achieve your career goals with the guidance you'll find here, or help advance your fellow PAs with advice. Grow your professional relationships and make new connections that will last. You can enroll as both a mentor and mentee — plus, you can sign up anytime throughout the year. 

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    • June 25, 2018 9:06 AM | Anonymous


      It's that time of year when students don their caps and gowns at commencement, where, if they're lucky, they hear some inspirational words from someone who has "made it." This year, AAPA President Gail Curtis reflects on soccer star Abby Wambach's commencement address to the women of Barnard College. 

      Read more.

    • June 21, 2018 12:43 PM | Anonymous


      Choosing the appropriate pharmacotherapy is essential to managing diabetes and preventing hypoglycemia in your patients with T2DM. A newly released free CME activity, Managing the Risk of Hypoglycemia in Special Patient Populations, outlines risk factors and newer treatment options. Earn AAPA Category 1 CME credit while learning about comorbid conditions that may increase the risk of hypoglycemia in these patients. Plus, don't miss bonus free self-assessment CME with two eCase Challenges! Find it all in AAPA's Learning Central. 

      Read more.

    • June 19, 2018 9:42 AM | Anonymous

      Medical News Today 

      The merits of vitamin D when it comes to cancer prevention have long been at the heart of medical debates. Where some studies have revealed that overall cancer risk is lower in people with higher levels of this vitamin, others have suggested that vitamin D has no impact on a person's vulnerability to the disease. Still, the case for ensuring that you get enough vitamin D is fairly strong.

      Read more.

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