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  • #76
    Doctors call cancer patients cured after gene therapy a decade ago

    In a study published Wednesday, doctors from the University of Pennsylvania said cancer in two patients is not detectable more than a decade after a treatment known as CAR T cell therapy.

    An early trial of the CAR T treatment was conducted in 2010 on three patients with chronic lymphocytic leukemia. The therapy removes the white blood cells that fight viruses from a patient's body in order to genetically engineer them to fight cancer before infusing them back into the patient’s circulation, The New York Times reported.

    “We thought they would be gone in a month or two,” Carl June, the trial's principal investigator, told the Times of the cells used in the treatment.

    But on Wednesday, June, along with J. Joseph Melenhorst and David Porter, published a report in Nature saying that the cancer in two of the patients in the trial was gone, and the CAR T cells were still in their bloodstreams.

    “CAR T cells remained detectable more than ten years after infusion, with sustained remission in both patients,” the report said.

    “I’m doing great right now. I’m still very active. I was running half marathons until 2018,” 75-year-old Doug Olson, one of the patients in the trial, told The Associated Press. “This is a cure. And they don’t use the word lightly.”

    The CAR T treatment has also been known to cause serious side effects including high fevers, comas, extremely low blood pressure and death. The treatment type has not yet been successful on solid tumor forms of cancer such as those found in breast and prostate cancer patients, the Times added.

    “Now we can finally say the word ‘cure’ with CAR T cells,” June added to the Times.

    https://thehill.com/policy/healthcar...y-a-decade-ago


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    • #77
      The search for next-generation cancer treatments

      A flood of cancer drugs has entered the market over the last decade, and some have been game changers for treating the disease.
      • However, most are yielding only incremental advances: They're important to patients, but may be ballooning the already enormous cost of cancer care.

      Why it matters: Some experts argue that the financial incentives to develop drugs mimicking those already on the market are detrimental to patients because they divert resources from truly transformative discoveries.

      What's happening: Immunotherapies — which harness a person's own immune system to fight cancer cells — have attracted the most attention.
      • CAR-T therapies, which modify a person's immune cells to attack cancer cells, have been successful in treating some blood cancers and melanoma. Researchers are now trying to adapt them for treating breast, lung and other "solid tumor" cancers.
      • Checkpoint inhibitordrugs — like Keytruda and Yervoy — block specific proteins on the immune system's T cells so they can attack cancer cells. Several have been approved by the FDA to treat breast, cervical, colon and other cancers.
      • Keytruda, for example, has significantly improved the survival rates of patients with non-small cell lung cancer, though it still hovers at just 23% over five years in patients who haven't previously received other treatments and is even lower in those who have.

      Reality check: The treatments are expensive. They only work in some people — and it isn't clear why.
      By the numbers: The number of cancer drugs approved by the FDA rose from eight in 2009 to 57 in 2020, according to a study published in JAMA Network Open in December.
      • But of the 332 approvals over those 12 years, only 16% were based on new drug approaches.
      • The rest were additional approvals of an existing drug or first approvals of a "me-too" drug that enters an existing class of treatment.

      The big picture: The U.S. spends hundreds of billions of dollars on cancer care each year, a portion of which is paid out of pocket by patients themselves.
      • But experts question how much the last decade of advances have actually moved the needle.
      • The 92 new cancer drugs approved for the first time between 2000 and 2016 extended overall survival by a median of only 2.4 months — or 73 days, according to a 2020 study in JAMA Network Open.
      • “Patients need choices and the marketplace needs competition, but unfortunately so much of drug development is redundant without a meaningful improvement in outcomes or lower costs for patients," said former FDA deputy commissioner and NIH oncologist Anand Shah.

      The other side: Pharmaceutical Research and Manufacturers of America, the drug industry trade group, said the studies “are biased and seem intended to diminish the massive progress that has been made in the last three decades to bring cancer deaths down and the incalculable value of the hope and extended life these treatments bring to people with cancer and their families."

      Between the lines: Some of these approvals allowed new types of drugs to be used for different tumors, which is clearly meaningful to patients. And me-too drugs can also have value, like if they have milder side effects in a particular patient or are more convenient to administer.
      • But overall, even as the total number of drug approvals spiked each year, the portion of those drugs that were truly novel declined, according to the JAMA study.
      • Since blockbuster drugs are known to work on a particular target, companies "keep tweaking that pathway and coming up with variations on a theme, and that does come at the exclusion of other potentially novel targets," says Russell Pachynski, a professor of oncology at Washington University in St. Louis who specializes in prostate cancer.

      Plus, me-too drugs don't drive down drug prices.
      • "When you’re getting to a 5th and 6th cancer drug in a class, you’re not addressing that unmet medical need, but you’re also not getting price competition. Multiple drugs in a class of cancer medications don’t lead to reduced prices," said Aaron Kesselheim, a professor of medicine at Harvard Medical School.

      The other side: Although these new precision therapies are expensive and have had narrow success, the hope is they'll eventually offer a better approach than the current system of going through a list of treatment options to find one that works.
      • "If it is effective, [CAR-T] is a one dose therapy — once and done," says Yvonne Chen, a scientist at UCLA who designs CAR-T cells.Factoring in the total cost of medical care, "it is far more economically efficient compared to having three, four, five lines of therapies that eventually fail or fail from that start."

      What to watch: The pipeline of cancer drugs in development is enormous. Although many of them are variations on — and new combinations of — existing treatments, others could deliver the next big advances.
      • Researchers are developing next-gen CAR-T therapies to try to target solid tumor cancers and reduce side effects. They're also working on off-the-shelf versions of the treatments that would potentially be less expensive.
      • Antibodies are being engineered to deliver a payload of drugs to tumor cells. Another class — called bispecific antibodies — binds both tumor and immune cells, bringing them in contact so the immune cells can do their job.
      • Vaccines that use mRNA technology similar to that in some COVID-19 vaccines and neoantigens are also being studied to treat cancer.

      https://www.axios.com/cancer-drugs-n...tml?deepdive=1

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      • #78
        Highly anticipated EPA draft says formaldehyde causes cancer

        Prolonged exposure to formaldehyde — a common industrial chemical — can cause multiple cancers involving the head, neck and blood, according to an Environmental Protection Agency (EPA) draft assessment released Thursday.

        The agency’s latest draft links formaldehyde inhalation to nasopharyngeal cancer, impacting the head and neck; sinonasal cancer, involving the nasal cavity or sinuses; and myeloid leukemia, which impacts bone marrow and blood cells.

        The draft goes further than a previous agency determination, which stated the substance was a “probable human carcinogen.”

        Thursday’s draft release comes after reports that the EPA under the prior Trump administration had suppressed the finding that formaldehyde causes leukemia.

        Politico reported in 2018 that top advisers to then-EPA Administrator Scott Pruitt were delaying the report’s release as part of an effort to undermine the EPA’s research on the risks posed by toxic chemicals. At the time, the agency denied that the findings were being held up.

        Allegations surrounding the agency’s handling of formaldehyde and other chemicals spurred House subpoenas in 2019.

        This is not the first time that the EPA has described formaldehyde in a draft as carcinogenic. That finding was previously revealed in a 2010 rendition of the EPA’s assessment, which underwent review by the National Academies of Sciences, Engineering, and Medicine but was ultimately never finalized.

        If finalized, the finding released Thursday is expected to enable the EPA to pursue more stringent controls on the substance. For now, the public has 60 days to weigh in on the draft, which was issued through the agency’s Integrated Risk Information System (IRIS).

        “I’m really pleased to see this IRIS assessment of formaldehyde — we’ve known formaldehyde is a human carcinogen for years,” Linda Birnbaum, former director of the National Institute of Environmental Health Sciences and the National Toxicology Program, told The Hill.

        “Hopefully, this will finally lead to better regulation,” Birnbaum added.

        Bob Sussman, who served as the EPA’s senior policy counsel and deputy administrator in the Obama and Clinton administrations, respectively, also said that if the finding is finalized it is expected to eventually lead to more controls of formaldehyde.

        “If that stands up during peer review by the National Academy of Sciences, and if EPA then uses the assessment for its risk evaluation under [the Toxics Substances Control Act], EPA will be on a road to impose additional regulation of formaldehyde. It will not happen right away, but that will be where everything points,” he said.

        The EPA is not the only agency to outline carcinogenic impacts of formaldehyde. In 2011, the National Toxicology Program, run by the Department of Health and Human Services, said formaldehyde was a known carcinogen.

        Meanwhile, the World Health Organization’s International Agency for Research on Cancer has considered formaldehyde to be a carcinogen since 2006.

        The EPA said that its finding was based on observations of increased risk of the cancers in groups with workplace exposure to the substance.

        The assessment also explored potential noncancer health effects of formaldehyde inhalation, including the potential impacts on reproductive and developmental health.

        The EPA said studies have shown moderate evidence of increases in both the length of time it takes exposed individuals to become pregnant and certain types of miscarriages. Two pregnancy studies, meanwhile, identified decreased birth weight and head circumference in newborns.

        The assessment likewise found reproductive impacts in male subjects, including one finding that showed lower sperm motility, as well as eventual birth defects in their offspring.

        The assessment also found moderate evidence that the inhalation of this toxin likely causes an increased risk of both allergic conditions and asthma symptoms, and decreased control of asthma symptoms.

        Moderate human evidence showed that long-term inhalation of formaldehyde likely reduces pulmonary function, but evidence was inadequate to determine whether short- or medium-term exposure could have similar impacts, the EPA stated.

        Evaluating the effects of formaldehyde on the respiratory tract more broadly, authors found that inhalation of the toxin causes certain pre-cancerous respiratory disorders. They also noted formaldehyde’s propensity to cause sensory irritation in humans, given appropriate exposure circumstances.

        In response to the EPA’s draft, the American Chemistry Council trade group said it “strongly objects to this decision,” stressing that the release “follows several unheeded calls by industry and lawmakers to address clear process deficiencies” — such as transparency issues, bias and other “irregularities.”

        “We are disappointed that, despite our repeated requests for EPA to address these concerns prior to releasing its draft, the agency has decided to move forward without taking the steps necessary to ensure the assessment is scientifically-sound and worthy of public confidence,” Kimberly Wise White, the American Chemistry Council’s vice president of regulatory & scientific affairs, said in a statement. https://thehill.com/policy/energy-en...-a-carcinogen/


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