Evidence supporting the use of statins to protect against cardiotoxic chemotherapy has been strengthened with new data from a propensity-matched analysis.
Σάββατο, 9 Ιανουαρίου 2021
Treating critically ill COVID-19 patients with Roche's Actemra or Sanofi's Kevzara arthritis drugs significantly improves survival rates and reduces the amount of time patients need intensive care, study results showed on Thursday.
Τετάρτη, 6 Ιανουαρίου 2021
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
On January 4, U.S. Food and Drug Administration (FDA) Commissioner , and Director of the FDA’s Center for Biologics Evaluation and Research , issued the following statement on FDA-authorized dosing schedules for each COVID-19 vaccine.
, and colleagues reported the prospective pooled analysis of six phase III trials in the IDEA collaboration in The Lancet Oncology. The analysis showed that noninferiority in overall survival for 3 vs 6 months of adjuvant chemotherapy was not established in patients with stage III colon cancer, and the absolute difference in 5-year overall survival between approaches was 0.4%.
Surgery, in addition to treatments like chemotherapy and radiation therapy, may improve survival for certain patients with metastatic breast cancer. A research team studied nearly 13,000 patients with stage IV disease and found that those who had surgery in addition to other treatments had a survival advantage over those who had other treatments alone. These findings were published by Stahl et al in Annals of Surgical Oncology.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
Δευτέρα, 4 Ιανουαρίου 2021
after neoadjuvant chemotherapy can accurately predict disease recurrence and survival across all breast cancer subtypes, according to the findings from a meta-analysis presented at the 2019 San Antonio Breast Cancer Symposium by , Professor and Director of Research Operations in Pathology at The University of Texas MD Anderson Cancer Center, Houston.
This is really about organizing the workflow in pathology to standardize how we evaluate response after neoadjuvant treatment.
Looking ahead, if we can standardize the reporting of residual cancer burden, that will only improve its usefulness in determining long-term prognosis.
Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. The CDC has issued updated guidance for people with underlying medical conditions who are considering getting the coronavirus vaccine. "Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19," the CDC said in the guidance posted on Saturday. "mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine." Both the Pfizer and Moderna vaccines use mRNA, or messenger RNA. The CDC guidance had specific information for people with HIV, weakened immune systems, and autoimmune conditions such as Guillain-Barre syndrome and Bell's palsy who are thinking of getting the vaccine. People with HIV and weakened immune systems "may receive a COVID-19 vaccine. However, they should be aware of the limited safety data," the CDC said. There's no information available yet about the safety of the vaccines for people with weakened immune systems, the CDC said. People with HIV were included in clinical trials, but "safety data specific to this group are not yet available at this time," the CDC said. Cases of Bell's palsy, a temporary facial paralysis, were reported in people receiving the Pfizer and Moderna vaccines in clinical trials, the FDA said Dec. 17. But the new CDC guidance says the FDA "does not consider these to be above the rate expected in the general population. They have not concluded these cases were caused by vaccination. Therefore, persons who have previously had Bell's palsy may receive an mRNA COVID-19 vaccine." Researchers have determined the vaccines are safe for people with GBS, a rare autoimmune disorder in which the body's immune system attacks nerves just as they leave the spinal cord, the CDC said. "To date, no cases of Guillain-Barre syndrome (GBS) have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials," the CDC guidance says. "With few exceptions, the independent Advisory Committee on Immunization Practices (ACIP) general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines." For months, the CDC and other health authorities have said that people with certain medical conditions are at an increased risk of developing severe cases of COVID-19. Sources: CDC: "COVID-19 Vaccination Considerations for Persons with Underlying Medical Conditions"
Now that COVID-19 vaccines are being distributed, the American Association for Cancer Research (AACR) has called for people with cancer to be considered as a high priority group. "The available evidence supports the conclusion that patients with cancer, in particular with hematological malignancies, should be considered among the high-risk groups for priority COVID-19 vaccination," says the AACR's COVID-19 and Cancer Task Force. A review of literature suggests that COVID-19 fatality rates for patients with cancer were double that of individuals without cancer, the team notes. The higher mortality rates still trended upward, even after adjusting for confounders including age, sex, and comorbidities, indicating that there is a greater risk for severe disease and COVID-19 related mortality. The new AACR position paper was published online December 19 in Cancer Discovery. "We conclude that patients with an active cancer should be considered for priority access to COVID-19 vaccination, along other particularly vulnerable populations with risk factors for adverse outcomes with COVID-19," the team writes. However, the authors note that "it is unclear whether this recommendation should be applicable to patients with a past diagnosis of cancer, as cancer survivors can be considered having the same risk as other persons with matched age and other risk factors. "Given that there are nearly 17 million people living with a history of cancer in the United States alone, it is critical to understand whether these individuals are at a higher risk to contract SARS-COV-2 and to experience severe outcomes from COVID-19," they add. Allocation of Initial Doses There has already been much discussion on the allocation of the initial doses of COVID-19 vaccines that have become available in the US. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommended that the first wave of vaccinations, described as Phase 1a, should be administered to US healthcare workers (about 21 million people) and residents of long-term care facilities (about 3 million). The next priority group, Phase 1b, should consist of front-line essential workers, a group of about 30 million, and adults aged 75 years or older, a group of about 21 million. When overlap between the groups is taken into account, Phase 1b covers about 49 million people, according to the CDC. Finally, Phase 1c, the third priority group, would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in Phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million people. "Cancer is one of the categories of individuals at high risk," said Antoni Ribas, MD, PhD, AACR president and chair of the AACR COVID-19 and Cancer Task Force. "At the ACIP vote on December 20, the priority access was assigned to Phase 1c, but this results in a potential significant delay in vaccination for the particularly vulnerable population of patients with cancer at this time of highest risk, with the winter worsening of the COVID-19 pandemic." "Any delay in vaccine access will result in loss of life that could be prevented with earlier access to vaccination," Ribas told Medscape Medical News. He noted that the task force agrees that people whose work is essential to run society should receive priority vaccination, but consideration should be given to first vaccinating patients with cancer who are at increased risk of dying if they get COVID-19. "This would include the 2 or 3 million people in the US who currently are receiving treatments for cancer, in particular if they have blood cancers or lung cancer, as they are at a particularly higher risk of dying based on the studies we reviewed," he said. Patients With Cancer a 'High Priority' for COVID-19 Vaccine 1/4/2021 https://www.medscape.com/viewarticle/943308_print https://www.medscape.com/viewarticle/943308_print 2/3 "Moreover, a subset of cancer patients appears to have prolonged viral shedding, placing their healthcare providers and caregivers at higher risk." The best scenario, Ribas emphasized, "would be that with two approved COVID-19 vaccines there is enough stock in the next few weeks to vaccinate all individuals assigned to Phase 1b and 1c." Questions Remain Approached for independent comment, Cardinale Smith, MD, PhD, chief quality officer for cancer services for the Mount Sinai Health System in New York City, agreed with the AACR task force. "I share that they should be high priority," she said, "But we don't know that the efficacy will the same." Smith noted that the impact of cancer therapy on patient immune systems is more related to the type of treatment they're receiving, and B and T cell responses. "But regardless, they should be getting the vaccine, and we just need to follow the guidelines," she said. The AACR task force notes that information thus far is quite limited as to the effects of COVID-19 vaccination in patients with cancer. In the Pfizer-BioNTech BNT162b2 COVID vaccine trial, of 43,540 participants, only 3.7% were reported to have cancer. "It is clear that we need more data and specific studies in patients with cancer, but this should not delay access to priority vaccination," said Ribas. "There is considerable experience with other vaccines, such as the yearly flu vaccine, in cancer patients with very good safety records." Other large COVID-19 vaccine trials will provide further follow-up information on the effectiveness of the vaccines in patients receiving different cancer treatments, they write, but for now, there is "currently not enough data to evaluate the interactions between active oncologic therapy with the ability to induce protective immunity" to COVID-19 with vaccination. Ribas pointed out that studies of natural immune response to COVID-19 have documented that patients with hematologic malignancies have a suboptimal ability to mount an immune response to the virus. This results in these patients having a "remarkably" high risk of fatality compared with other patient populations with COVID-19 infection. "The fact that the antibody and T-cell responses to the COVID-19 vaccines are higher than in many individuals with natural COVID-19 infection provides an even stronger rationale to offer vaccination to persons with lower immune responses to the virus," he said. "Although ongoing studies will provide more information about how to best protect cancer patients with vaccines, at present, there is no evidence that the vaccine should be delayed in cancer patients. "Of course, patients with cancer should consult with their healthcare providers about their potential risks and benefits to decide whether getting vaccinated is right for them," he added. In a recent interview with Medscape Medical News, Nora Disis, MD, a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, University of Washington, Seattle, also discussed vaccinating cancer patients. She pointed out that even though there are data suggesting that cancer patients are at higher risk, "they are a bit murky, in part because cancer patients are a heterogeneous group." "For example, there are data suggesting that lung and blood cancer patients fare worse," said Disis, who is also editor-in-chief of JAMA Oncology. "There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities." She also pointed out the likelihood that individualized risk factors including the type of cancer therapy, site of disease, and comorbidities "will shape individual choices about vaccination among cancer patients." It is also reasonable to expect that patients with cancer will respond to the vaccines, even though historically some believed that they would be unable to mount an immune response. "Data on other viral vaccines have shown otherwise," said Disis. "For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection." Several of the authors of the AACR position paper, including Ribas, report relationships with industry as detailed in the paper.
Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Anthony Fauci, MD, says the coronavirus pandemic may get worse in coming months, including a post-holiday surge in cases. In an interview on CNN, Fauci was asked if he thought "the worst was yet to come." He said, "I do." "We very well might see a post-seasonal ― in the sense of Christmas, New Year's ― surge, and, as I have described it, as a surge upon a surge," said Fauci, the director of the National Institute of Allergy and Infectious Diseases. Fauci said holiday travel could cause a spike in cases. Besides exposing themselves at airports, travelers usually mix households when they arrive at their destinations, he said. Even though health authorities urge people not to travel, "it’s going to happen," Fauci said. "We are really at a very critical point. ... So I share the concern of President-elect (Joe) Biden that as we get into the next few weeks, it might actually get worse," Fauci said. Biden recently said that the "darkest days" in the coronavirus pandemic are ahead and urged Americans to prepare themselves for a difficult struggle. Fauci has agreed to serve as Biden’s top health adviser. December has already been the hardest month for the COVID-19 pandemic in the United States. More than 65,000 people have died of coronavirus-related reasons so far this month, compared to only about 37,000 in November, according to the Covid Tracking Project. Hospitalizations are up, with more than 100,000 people in the hospital per day since Dec. 2. Overall, there have been more than 19 million confirmed cases in the United States and more than 333,000 COVID-related deaths ― the most of any nation in the world. COVID-19 vaccinations should bring the pandemic under control, but it will take many months for the United States to develop herd immunity, Fauci said. Health care workers and residents of long-term care facilities are the top priority groups receiving the vaccine. "I hope that by the time we get to the fall we will reach that critical percentage of people that we can really start thinking about a return to some form of normality," Fauci said. Fauci, who just turned 80, got a COVID-19 vaccination recently. He said he had no side effects besides arm soreness for about