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median age = 46.6 years ; range = 18.7-70.2 years ). The study , published in The New England Journal of Medicine , found that arsenic trioxide plus ATRA resulted in a two-year event-free survival rate of 97 percent , compared with 86 percent for ATRA plus chemotherapy ( overall difference = 11 %; 95 % CI 2-22 ; p < 0.001 for non-inferiority ; p = 0.02 for superiority ). After a median follow-up of 34.4 months ( range = 0.5 to 55.8 months ), the two-year OS rate was 99 percent with ATRA plus arsenic trioxide ( 95 % CI 96-100 ) and 91 percent with ATRA plus chemotherapy ( 95 % CI 85-97 ; p = 0.02 ). The two-year disease-free survival rate was 97 percent ( 95 % CI 94-100 ) and 90 percent ( 95 % CI 84-97 ), respectively ( p = 0.11 ). The cumulative incidence of relapse at two years was 1 percent with arsenic trioxide and 6 percent with chemotherapy ( p = 0.24 ).
In the induction phase , patients received daily ATRA 45 mg / m 2 and arsenic trioxide 0.15 mg / kg administered intravenously daily until bone marrow remission . In the comparator arm , patients received ATRA with idarubicin for induction , followed by ATRA and chemotherapy in the consolidation and maintenance setting . All patients treated with arsenic trioxide experienced a hematologic complete remission ( CR ), compared with 95 percent of those in the comparator arm ( p = 0.012 ). The median time to CR was 32 days ( range = 22-68 days ) and 35 days ( range = 26-63 days ), respectively ( p = 0.61 ). Among those who achieved CR in this phase , 146 went on to receive consolidation therapy , and all evaluable patients achieved molecular remission ( n = 75 in the arsenic trioxide arm and n = 70 in the chemotherapy group ).
Grade 3 / 4 thrombocytopenia and neutropenia lasting more than 15 days occurred more often in the chemotherapy group , while grade 3 / 4 hepatic toxicity was more common with arsenic trioxide ( 63 % vs . 6 %; p value not provided ).
Arsenic trioxide was approved in 2000 for patients with refractory or relapsed APL following retinoid and anthracycline chemotherapy . The drug carries a boxed warning for differentiation syndrome and cardiac conduction abnormalities .
Sources : Teva press release , January 15 , 2018 ; Lo-Coco F , Avvisati G , Vignetti M , et al . Retinoic acid and arsenic trioxide for acute promyelocytic leukemia . N Engl J Med . 2013 ; 369:111-21 .
Study Claims Medicaid Changes Could Lead to Hospital Closures Researchers are cautioning that undoing Medicaid expansions ( which occurred under the ACA ) may lead to hospital closures . Decreased Medicaid revenue would be to blame , according to the report published in Health Affairs .
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The investigators examined data from the Centers for Medicare & Medicaid Services on hospital closures and financial performance between 2008 and 2016 . Closure rates were stable between 2010 and 2012 among states that moved to expand Medicaid coverage , compared with states that opted not to expand .
In 2013 , after the Supreme Court ruled that states had the option to expand Medicaid to cover all adults earning up to 138 percent of the federal poverty level , closure rates began to diverge . The hospital closure rate among non-expansion states was 0.45 per 100 hospitals in 2012 and jumped to 0.90 per 100 hospitals . Also , between 2008 and 2016 , non-expansion states had a total increase of 0.43 closures per 100 hospitals , while expansion states ’ closure rates decreased by 0.33 per 100 hospitals . In states with expanded coverage , hospitals were 84 percent less likely to close , according to the report .
Certain hospitals are at an increased disadvantage : Hospitals in urban areas ( with an uninsured patient rate of at least 30 % prior to ACA implementation ) were 92 percent less likely to close after Medicaid expansion , and rural hospitals serving the same proportion of uninsured patients were 91 percent less likely to close after expansion . The National Rural Health Association reports that since 2010 , more than 80 rural hospitals have closed and more than 670 are at financial risk of closing .
Sources : Lindrooth RC , Perraillon MC , Hardy RY , et al . Understanding the relationship between Medicaid expansions and hospital closures . Health Aff . 2018 ; 37:111-20 ; Modern Healthcare , January 8 , 2018 .
FDA Grants Priority Review to CAR T-Cell Therapy for DLBCL The FDA granted priority review to the chimeric antigen receptor ( CAR ) T-cell therapy tisagenlecleucel for adults with relapsed / refractory diffuse large B-cell lymphoma who are ineligible for or have relapsed after autologous hematopoietic cell transplantation . Tisagenlecleucel is already approved for the treatment of children and young adults with relapsed or refractory B-cell acute lymphocytic leukemia .
The submission is based on data from the phase II JULIET study , in which a single infusion of tisagenlecleucel led to an ORR of 53 percent , with 40 percent of patients achieving a complete response . For 46 participants with at least six months of follow-up from infusion , the ORR was 37 percent , with a complete response rate of 30 percent and a partial response rate of 7 percent .
Sources : Reuters , January 17 , 2018 ; Schuster SJ , Bishop MR , Tam CS , et al . Primary analysis of Juliet : a global , pivotal , phase 2 trial of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma . Abstract # 577 . Presented at the 2017 American Society of Hematology Annual Meeting , December 11 , 2017 ; Atlanta , GA .
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Three Corporate Giants Team Up to Disrupt Health Care Amazon , Berkshire Hathaway , and JPMorgan Chase announced that they will form an independent health-care company for their employees in the U . S .
The companies said the initiative , which is in its early stages , would be “ free from profit-making incentives and constraints ,” but did not specify whether that meant they would create a non-profit organization . Because so few details were released , the tax implications of this new company also are unclear .
“The ballooning costs of health care act as a hungry tapeworm on the American economy . [ We do ] not come to this problem with answers . But we also do not accept it as inevitable .” — WARREN E . BUFFETT
Those familiar with the partnership said it took shape as the three CEOs discussed the challenges of providing health insurance to their employees . They decided their combined access to data about how consumers make choices , along with an understanding of the intricacies of health insurance , could lead to new efficiencies .
“ The ballooning costs of health care act as a hungry tapeworm on the American economy ,” said Warren E . Buffett , who leads Berkshire Hathaway , in a joint statement announcing the partnership . “ Our group does not come to this problem with answers . But we also do not accept it as inevitable .”
The companies said they would initially focus on using technology to simplify care but did not elaborate on how they intended to achieve that or bring down costs . Potential avenues might include creating an online dashboard to connect employees with specialists or striking deals
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with medical testing facilities . Whatever successes they have could become models for other businesses .
Source : The New York Times , January 30 , 2018 .
CDC Director Resigns Over Conflicts of Interest Brenda Fitzgerald , MD , director of the Centers for Disease Control and Prevention ( CDC ), resigned from her appointment over financial conflicts of interest involving investments in health-care businesses . Her investments were “ limiting her ability to complete all of her duties as CDC director ,” according to a statement from the Department of Health and Human Services ( HHS ), which oversees the CDC . “ Due to the nature of these financial interests , Dr . Fitzgerald could not divest from them in a definitive time period .”
Anne Schuchat , MD , is now acting director of the agency and acting administrator of the Agency for Toxic Substances and Disease Registry . Dr . Schuchat has been the CDC ’ s principal deputy director since 2015 and led the organization as acting director from January to July 2017 , before Dr . Fitzgerald ’ s appointment .
Dr . Fitzgerald ’ s resignation follows a recent Politico report that her financial manager bought shares in Japan Tobacco and the drug companies Bayer and Merck after she took the job in July . Her predecessor Tom Frieden , MD , issued a statement after the Politico story was released : “ I have spoken with Dr . Fitzgerald and believe her when she says that she was unaware that a tobacco-company investment had been made . She understands that any affiliation between the tobacco industry and public health is unacceptable . … When she learned of it , she directed that it be sold .”
Dr . Fitzgerald , a former major in the U . S . Air Force , served as Georgia ’ s public health commissioner before being tapped for the CDC job . She was appointed by former HHS Secretary Tom Price , MD , who resigned in late September after his costly travel on chartered plans triggered investigations . ●
Sources : AP News , January 31 , 2018 ; The Washington Post , February 2 , 2018 .
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