Showing posts with label risk. Show all posts
Showing posts with label risk. Show all posts

Sunday, July 4, 2021

COVID and cancer

 

COVID-19 vaccination in cancer patients: 

What are the vaccines being developed and nearing approval?

The World Health Organization (WHO) currently counts more than two hundred research projects for the development of a vaccine conferring protective immunity against the SARS-CoV-2 virus, among which more than fifty are in clinical development. New technologies, previous experience with vaccine projects against related viruses and the presence of a pandemic health hazard accelerated the usual development cycle from years to months. Presentation of SARS-CoV-2 antigens to the host, in the context of vaccine development, relied on technologies based on messenger RNA (mRNA), inactivated/attenuated or genetically modified viruses, synthetic long viral peptides and plasmid DNA vaccines. Four vaccines have been authorised until April 2021 for use in the European Union (Comirnaty Pfizer/BioNTech, COVID-19 Vaccine Moderna, Vaxzevria AstraZeneca, COVID-19 Vaccine Janssen) while three more are under rolling review by the European Medicines Agency (EMA; CVnCoV, NVX-CoV2373, Sputnik V). More vaccines are under clinical development and are being assessed for efficacy and safety.

Overall mRNA-based vaccines have shown >90% protection from COVID-19 disease with good tolerance, whereas non-replicating adenoviral vector-based vaccines have shown protection rates of 62%-90% conferred by different dosing regimens. Storage requirements and number of doses differ between vaccines and operational practicalities related to transport, administration, recording and follow-up of vaccinated people, and pharmacovigilance are pivotal for the successful roll-out of vaccination programmes and their optimal impact on public health. Despite some preclinical data of reduced neutralising potential of generated antibodies against new, mutated forms of the virus, available clinical evidence suggests that approved vaccines confer protective immunity against new mutational variants of SARS-CoV-2. Moreover, a rational strategy for minimising the risk of emergence of additional virus variants is based on effective mass vaccination programmes for establishment of vaccine-induced immunity in order to prevent new infections and, thus, mutations. Additional questions exist that necessitate generation of data, including long-term safety, duration of immunity, protective immunity against mild as opposed to severe cases of infection as well as immunity in the elderly, vaccine impact on contagious potential of vaccinated people and repeat vaccination intervals.  A combination of severe thrombosis and thrombocytopaenia, of possible immune pathogenesis similar to that seen in heparin-induced thrombocytopaenia, has been observed very rarely following vaccination, mostly with adenoviral vector-based vaccines (Vaxzevria, COVID-19 Vaccine Janssen), occurring during the first few weeks after inoculation. Healthcare professionals and patients should be alert to the signs and symptoms of thromboembolism and/or thrombocytopaenia, and if present, seek specialist medical treatment promptly. In view of the rarity of the side-effect and the risk from COVID-19, the risk/benefit profile of the vaccines is considered favourable by the EMA. The use of all approved COVID-19 vaccines should be in accordance with official national recommendations.

Specifically, for patients with cancer or a history of cancer, strategies of continued generation of data within trials as well in real world settings will provide more insights on vaccine activity, optimal dose and frequency, safety, potential for interaction with malignant disease, antineoplastic therapies or other comorbidities. Consequently, prospective observational studies focusing on patients with active cancer receiving chemotherapy, targeted therapy or immunotherapy, as well as in patients in the chronic phase of disease or in the survivorship phase are warranted and may lead to interventional clinical trials, if needed.

A large array of other vaccine candidates against SARS-CoV-2 are currently under investigation applying various techniques such as mRNA-, protein subunit-, viral vector- or inactivated virus vaccines.

These recommendations should be used as guidance for prioritising the various aspects of cancer care in order to mitigate the negative effects of the COVID-19 pandemic on the management of cancer patients. The situation is evolving, and pragmatic actions may be required to deal with the challenges of treating patients, while ensuring their rights, safety and wellbeing.

Statements:

  • Effective and safe vaccines against COVID-19, authorised after thorough, independent and robust scientific review by regulatory authorities, should be administered in the context of operationally sound vaccination programmes [V]. A pharmacovigilance plan is mandatory in the context of the vaccination programme.
  • Effective mass vaccination programmes coupled to robust pharmacovigilance are key for preventing infections and emergence of viral mutations, while safeguarding favourable vaccine risk/benefit profiles [V].
  • Ongoing scientific assessment by medical and regulatory authorities underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns take into account the pandemic situation and vaccine availability at national level.
  • Continued research in the context of clinical trials and registries as well as in-trial and post-trial follow-up is advised in order to generate more data on vaccine efficacy and safety in the general population as well as in special populations, including patients with active cancer or history of cancer [V].
  • Patients with cancer as a group have been shown to be at higher risk of severe COVID-19 [1]. Among patients with cancer, it seems that haematological and lung malignancies and the presence of metastatic disease are associated with a persistently increased risk. Patients with solid tumours appear to suffer an increased risk, particularly in the first year after diagnosis which drops to baseline if diagnosis is >5 years ago [2]. For any malignancy, active disease confers a significantly increased risk of severe COVID-19 [IV] [3, 4]. However, the higher incidence and severity of COVID-19 in patients with cancer, as opposed to those without cancer, are observations based on non-comparative retrospective studies. Data on the true incidence and direct comparisons remain elusive. Most studies do not have the full denominator to calculate the true incidence [IV].

    Severity and mortality rates from the COVID-19 and Cancer Consortium (CCC19) registry and other cohorts have ranged from 5% to 61% (meta-analysis showed 26%) which is much higher than in the overall population (~2%-3%), but this is with caveats of unadjusted rates, while the cancer population is an older population with more comorbidities, poorer performance status, and many unmeasured confounding and selection biases [IV].

    SARS-Cov-2 infection may also result in significant and devastating delays in screening, diagnosis, treatment and monitoring/surveillance strategies in patients with cancer which can ultimately cause an increased risk of cancer-related morbidity and mortality, as well as major economic burden and high patient volumes needing care in the healthcare systems. Moreover, the impact on clinical trials accrual appears to be very significant and detrimental, although it is hard to measure.

  • Although evidence regarding vaccination in patients with cancer is limited, there is enough evidence to support anti-infective vaccination in general (excluding live-attenuated vaccines and replication-competent vector vaccines) even in patients with cancer undergoing immunosuppressive therapy [5-7]. Reduced protective effects may occur in patients treated with B cell-depleting agents (anti-CD19, anti-CD20, anti-CD10 monoclonal antibodies and CD19 CAR-T cells) in view of suboptimal immune response [8-12]. The level of efficacy may be expected to be generally reduced in certain populations of cancer patients with intense immunosuppression, such as recipients of haematopoietic stem cell transplantation [V] [5-7]. However, based on data extrapolation from other vaccines and the mechanism of action of the COVID-19 vaccines (not live), it is conceivable that the efficacy and safety of vaccination against COVID-19 may be estimated to be similar to that of patients without cancer, although data from clinical trials are lacking [V]. Beyond stem cell transplantation, the efficacy of COVID-19 vaccines can also vary in patients with distinct contexts of malignant disease (tumour type, disease extent, intrinsic or therapy-induced immunosuppression); however, the benefits of vaccination seem to significantly and substantially outweigh the risks [V].

    The timing of vaccination depends on individual therapy scenarios and may ideally occur before systemic therapy starts; however, if the patient has already started systemic therapy, it is reasonable to vaccinate during therapy [V].

  • Vaccinating healthcare staff against influenza has been shown to reduce nosocomial transmission of the infection in cancer care [13]. Furthermore, certain immunocompromised cancer patients might not achieve a sufficient immune response to vaccination. This provides a rationale for vaccinating healthcare staff who work in a high-risk setting against COVID-19 as well [Evidence III for influenza]

    Statements:

    • Patients with cancer have an increased risk of severe COVID-19 (i.e. haematological malignancy requiring chemotherapy or active, advanced solid tumour or history of solid tumour <5 years ago) and should be vaccinated against SARS-CoV-2 regardless of any other indications (i.e. age) and positioned at high prioritisation [V]. Patients who have received B cell depletion in the past 6 months may derive reduced protection. The time-point for vaccination after allogeneic stem cell transplantation should follow general recommendations – usually, in the absence of graft-versus-host disease (GvHD), the vaccine can be applied 6 months post stem cell transplantation [V]. Patients in clinical trials, e.g. immunotherapy, should not be deprived of COVID-19 vaccination; therefore, efforts should be made for clinical trial protocols to allow concurrent COvID-19 vaccines.
    • Healthcare workers caring for patients with cancer with increased risk should be prioritised in receiving vaccination to minimise nosocomial transmission.
    • The efficacy and duration of immunity in patients with cancer are still unknown and unexplored. Given the often-immune compromised status and the frailty of these patients, we suggest monitoring in the context of registries and dedicated clinical trials.
    • Close surveillance and monitoring of patients with cancer is required after COVID-19 vaccination to assess potential adverse events and measure clinical outcomes, e.g. infection, severity and mortality from COVID-19, complications from cancer, etc.
    • Physical distancing measures, masks, face shields, sanitizers and other hygiene measures are still required during the pandemic, including for patients with cancer, and should certainly accompany the vaccination strategies.
Source: https://www.esmo.org/

Saturday, June 15, 2013

Diet and Exercise to Lower Cholesterol

Diet to Lower Cholesterol
Cardiovascular disease has long been the number one health killer, and its related diseases caused by very high mortality rate. And constitutes a major cardiovascular disease risk factor is high cholesterol, however, the vast majority of cholesterol through diet and lifestyle can be a considerable degree of control. Studies have shown that as long as the lower value of 1% cholesterol, the risk of heart disease can be reduced by 2%.

Changes in lifestyle towards a healthy way

If you have high cholesterol (200 mg / dL or more) trouble, you can try by the U.S. Heart, Lung and Blood Institute (National Heart, Lung, and Blood Institute) of the proposed “therapeutic lifestyle change” (Therapeutic Lifestyle Changes , TLC) diet.

It is a positive lifestyle reduces the body’s cholesterol levels to reduce the incidence of heart diseases. Its main objectives are as follows:

1. Reducing sodium intake to 2,400 milligrams per day
2. To determine the daily intake of saturated fat of total daily calorie intake of less than 7%
3. Restrict access of calories from fat, total daily calorie intake does not exceed 25% to 35%
4. Limit dietary cholesterol (dietary cholesterol) of less than 200 mg per day, it comes from animal sources of food.
5. Restrict carbohydrate intake accounted for 50% of total daily calories to 60%, make sure it is rich in complex carbohydrates, mostly from (complex carbohydrates) food such as whole grains, vegetables and fruit.

Dietary Guidelines for therapeutic lifestyle

Therapeutic lifestyle diet emphasizes a balanced intake of various types with low saturated fatty acids, low in cholesterol and trans fatty acids, beneficial for cardiovascular health and more.

Dietary recommendations include:

1. Bread / cereal: whole grain bread, cereal pieces, such as oatmeal or brown rice.
2. Vegetables: Eat more dark green vegetables, beans, soy milk, tofu and other soy products.
3. Meat: Remove fat, retain lean part of the peeled poultry consumption, and limit intake of animal organs.
4. Choose a good oil: more choice of unsaturated vegetable oils such as soybean oil, canola oil, corn oil or olive oil.
5. Dairy products: skim or low-fat milk, yogurt, yogurt or low-fat cheese and so on.

In addition, it should eliminate the salt and seasonings to replace the use of herbs and spice.

Exercise can lower cholesterol

TLC appropriate program of physical activity is another key. In addition to regular exercise can help you manage your weight, adjusting blood fat, reduce arterial accumulation of cholesterol, enhance the beneficial HDL (high density lipoprotein), and improve overall cardiovascular function. Study found that jogging habits, their body fat clearance rate faster than people who do not exercise 70%.

You do not have to be marathon runners or mountain climbers, but persistent and progressive sport, and allows you to achieve the maximum cholesterol-lowering effect. Started by a number of simple activities, such as walking, climbing stairs, gardening or dancing. And then advanced to a higher intensity activities, try brisk walking, swimming, tennis or riding a bicycle and so on. Goal is to reach almost every day for at least 30 minutes of aerobic exercise. Once you change your diet and start exercising, you will see a decline in cholesterol and weight values, that is, to pay the maximum return.

Friday, May 31, 2013

Heart Attack Causes

Heart Attack Causes
There are few different things that heart attack causes have in common. The primary one, however, is that all these causes put unnecessary strain and stress on the body and the heart. In order to limit your potential for a heart attack it is important to know what the causes are. If you know what causes a heart attack you can develop a plan to eliminate these causes from your life. It may be difficult to eliminate all of the heart attack causes from your life because there are factors at work that you have no control over, such as genetics. However, there are some causes that you can strive to minimize or even eliminate.

One of the most common heart attack causes is stress. If you are a constant worrier who doesn’t get much sleep then you are at a greater risk of having a heart attack. When you are stressed out your body goes into overdrive. This puts unnecessary strain on the heart muscle. Over time, this constant strain on the heart will gradually weaken it. In turn, you may have a heart attack. Good ways to deal with stress include doing something that you enjoy that also has a benefit for the heart. This could include things such as taking a long walk or jumping in the pool to go for a swim. The idea is to take your mind off of what is stressing so that your heart can get a workout in a good way.

Obesity is also one of the major heart attack causes. Becoming obese is directly related to your diet in most cases. If you are putting bad foods into your body you will likely see your weight climb. When this happens you are putting extra pressure on your heart. Your heart must work faster and harder in an effort to carry all of the excess weight around. A poor diet will also contribute to plaque buildup in your arteries. If you have substantial buildup in your arteries then eventually it will stop the blood flow to your heart. Once this happens you will have a heart attack.

Heart attack causes are often things that can be avoided if you decide to take care of yourself both mentally and physically. Making an effort to live more of a stress free lifestyle while also eating healthier can reduce your risk of a heart attack in no time flat.

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