Covid-19 Impact on Cancer Therapeutics, Deferred Diagnostics, Treatments, and Risks
SAN FRANCISCO, Aug. 18, 2021 /PRNewswire/ -- Nathan Sassover, Founder/CEO of World Cancer Institute observed outcome of recent Federal agencies research and ASCO sponsored surveys:
"In assessing the Clinical Analysis by National Cancer Institute that COVID-19 Vaccines may be less effective in certain categories of Cancer Patients but that other research confirms an overall Covid recovery outcome from cancer patients contracting COVID-19 as being comparable to those without Cancer."
Sassover further noted: "After internal clinical review by medical staff of the National Cancer Institute the consensus opinion and determination is that COVID-19 vaccines might not stimulate effective immune responses in certain cancer patients particularly those with blood cancers, according to several new studies."
"World Cancer Institute observes that doctors have generally recommended that their patients with cancer receive vaccines to protect against infection with SARS-CoV-2, the virus that causes COVID-19."
What is notable, clinically validated and now a focus of additional research is that some people with cancer may not be as protected by the vaccines as people without the disease, results from three new studies suggest.
The findings provide some of the first data on the efficacy of COVID-19 vaccines in people with cancer, who were largely excluded from the initial trials testing the vaccines.
Cancer is ranked among the leading diseases resulting in mobility and mortality. Cancer treatments or therapies are increasingly aimed at eliminating or slowing growth of cancerous abnormal cells by interfering with specific molecules like DNA or proteins that contribute to cancer cell growth.
The coronavirus disease 2019 (COVID-19) pandemic led to prioritizing emergency care dedicated to infection management. Other conditions, such as cancer management, may have been affected during the sanitary lockdown . Consequences of this "distraction effect" are suspected, but the immediate impact of this pandemic is still unknown . The ONCOCARE-COV study evaluated changes in oncological care pathways during the COVID-19 crisis.
Early reports suggested increased mortality from COVID-19 in patients with cancer but lacked rigorous comparisons to patients without cancer. The project objective was whether a current cancer diagnosis or cancer history is an independent risk factor for death in hospitalized patients with COVID-19.
Patients and Methods
We identified patients with a history of cancer admitted to two large hospitals between March 13, 2020, and May 10, 2020, with laboratory-confirmed COVID-19 and matched them 1:2 to patients without a history of cancer.
Compared with the same trimester in 2019, oncological activity decreased dramatically on all essential oncological care pathway steps during the COVID-19 pandemic. The trends and comparisons of monthly activity volume are depicted ion
Colon and breast cancer screening test fell by 86% to 100%, respectively. All activities linked to sampling, histopathological (−48%), and biomolecular analyses (−69%) were drastically reduced. A decrease in medical announcement consultations (−54%) and oncogeriatric evaluations (−86%) was also observed; fewer medical patient files (−31%; including those of new patients; −39%) were reviewed in MTBM. Regarding treatment, systemic chemotherapy (−9%) and radiotherapy (−16%) experienced a lighter decline, whereas oncological surgical procedures were heavily impacted (−30%) over a 2-month period. All clinical research trials were stopped for 3 months (data not shown), and all hyperthermic intraperitoneal chemotherapies were postponed.
Although the COVID-19 outbreak occurred earlier and with more intensity in Colmar, it had a comparable impact in both areas regarding MTBM and DAP.
COVID-19 has had a dramatic impact on all aspects of the cancer care pathway, particularly in terms of screening, diagnosis, and surgical treatment.
To the best of our knowledge, this is the first study assessing the overall management of cancers from screening to treatment. Screening and a drop in the number of screening-related samples were observed in Belgium . Reduction in cancer diagnoses has been noted in other European countries, particularly for colon and skin cancers [4, 5]. Primary care was also impacted, with urgent cancer referrals falling by 60%,
In the U.K. . We experienced a similar decrease in new oncological referrals. In Spain, outpatient visits decreased, and remote visits using phones or internet became a standard . As in a U.S. tertiary care cancer center (MD Anderson Cancer Center), oncological surgical care was drastically reduced because of limited availability of health personnel, logistical resources, and available beds . Facing this resource scarcity, an international collaborative group recommended a fair and consistent prioritization to maximize health benefits, considering the patient, its disease, and its prognosis .
This global decrease in all essential oncology care pathway steps contrasts with the relative stability of chemotherapy and radiotherapy use. Patients anteriorly diagnosed with cancers continued to be treated. Limitations of the present study include lack of information on patient characteristics and prognosis. The consequences of delay in diagnosis and treatment have only been estimated in model-based analysis . Complementary qualitative studies are warranted to estimate the real impact on cancer outcomes. The ongoing CAPANCOVID-19 study aims to evaluate the impact of the COVID-19 pandemic on management and outcomes of patients with exocrine pancreatic cancer (https://clinicaltrials.gov/ct2/show/NCT04406571).
The current ONCOCARE-COV study is still in progress, and with a longer follow-up, we will be able to analyze the post lockdown volume of oncological activity and the impact of a possible second COVID-19 epidemic wave in relation to types of cancer.
Men made up 56.2% of the population, with a median age of 69 years (range, 30–96). The median time since cancer diagnosis was 35.6 months (range, 0.39–435); 80% had a solid tumor, and 20% had a hematologic malignancy.
Among patients with cancer, 27.8% died or entered hospice versus 25.6% among patients without cancer. In multivariable analyses, the odds of death/hospice were similar (odds ratio [OR], 1.09; 95% confidence interval [CI], 0.65–1.82).
Notably and of significance is. that the odds of intubation, shock and intensive care unit admission (OR, 0.51; 95% CI, 0.32–0.81) were lower for patients with a history of cancer versus controls.
Patients with active cancer or who had received cancer-directed therapy in the past 6 months had similar odds of death/hospice compared with cancer survivors (univariable OR, 1.31; 95% CI, 0.66–2.60; multivariable OR, 1.47; 95% CI, 0.69–3.16).
Patients with a history of cancer hospitalized for COVID-19 had similar mortality to matched hospitalized patients with COVID-19 without cancer, and a lower risk of complications. In this population, patients with active cancer or recent cancer treatment had a similar risk for adverse outcomes compared with survivors of cancer.
Implications for Practice
This study investigated whether a current cancer diagnosis or cancer history is an independent risk factor for death or hospice admission in hospitalized patients with COVID-19. Active cancer, systemic cancer therapy, and a cancer history are not independent risk factors for death from COVID-19 among hospitalized patients, and hospitalized patients without cancer are more likely to have severe COVID-19.
These findings provide reassurance to survivors of cancer and patients with cancer as to their relative risk of severe COVID-19, may encourage oncologists to provide standard anticancer therapy in patients at risk of COVID-19, and further serve to guide triage in future waves of infection.
ASCO: American Society of Clinical Oncology: Impact of COVID-19
The COVID-19 pandemic affected health care systems globally and resulted in the interruption of usual care in many health care facilities, exposing vulnerable patients with cancer to significant risks. Our study aimed to evaluate the impact of this pandemic on cancer care worldwide.
We conducted a cross-sectional study using a validated web-based questionnaire of 51 item questionnaire obtained information on the capacity and services offered at these centers, magnitude disruption of care, reasons for disruption, challenges faced, interventions implemented, and the estimation of patient harm during pandemic.
A total of 356 centers from 54 countries across six continents participated between April 21 and May 8, 2020. These centers serve 716,979 new patients with cancer a year. Most of them (88.2%) reported facing challenges in delivering care during the pandemic. Although 55.34% reduced services as part of a preemptive strategy, other common reasons included an overwhelmed system (19.94%), lack of personal protective equipment (19.10%), staff shortage (17.98%), and restricted access to medications (9.83%). Missing at least one cycle of therapy by > 10% of patients was reported in 46.31% of the centers. Participants reported patient exposure to harm from interruption of cancer-specific care (36.52%) and noncancer-related care (39.04%), with some centers estimating that up to 80% of their patients were exposed to harm.
The detrimental impact of the COVID-19 pandemic on cancer care is widespread, with varying magnitude among centers worldwide. Additional research to assess this impact at the patient level is required.
What was the impact of COVID-19 pandemic on cancer care at a global level? How did the magnitude of impact vary in different settings?
Our study revealed that the overwhelming majority (88%) of the 356 participating centers on six continents faced challenges in providing usual cancer care for many reasons, including precautionary measures, an overwhelmed health care system, lack of personal protective equipment, and staff shortage. More than a third of these centers reported patient exposure to harm from interruption of cancer-specific care or other medical care. As expected, the impact was more pronounced in low-income countries. The implementation of virtual communication and remote care were prevalent responses in most centers.
Relevance Be better prepared for any future crises.
World Cancer Institute Overview:
COVID-19 Clinical Efficacy across Cancer Solid Tumor and Hematologic Malignancies
COVID-19 Vaccines May Be Less Effective in Some People with Cancer
COVID-19 vaccines might not stimulate effective immune responses in people with cancer, particularly those with blood cancers, according to several new studies.
Doctors have generally recommended that their patients with cancer receive vaccines to protect against infection with SARS-CoV-2, the virus that causes COVID-19. But some people with cancer may not be as protected by the vaccine as people without the disease, results from three new studies suggest.
The findings provide some of the first data on the efficacy of COVID-19 vaccines in people with cancer, who were largely excluded from the initial trials testing the vaccines. Three groups working independently in the United States, the United Kingdom, and France conducted the studies.
Two of the studies found that COVID-19 vaccines might not stimulate effective immune responses in some people with blood cancers. These findings highlight the need for more research on this group in particular, the investigators said.
"Patients with blood-related cancers often have dysfunctional immune systems, and as a result they're just not able to respond as well to the COVID-19 vaccine as other people," said Elad Sharon, M.D., M.P.H., a senior investigator at NCI, who was not involved in the new studies but is leading a clinical trial testing COVID-19 vaccines in people being treated for cancer.
The new findings, Dr. Sharon added, are consistent with previous studies showing that people whose immune systems may have been weakened by cancer or its treatments may not develop effective immune responses to the flu vaccine.
Profiling Vaccine Immune Responses in Patients with Blood Cancers
In the US study, nearly half of the patients with blood cancers—31 out of 67 patients (46%)—did not produce detectable antibodies to the SARS-CoV-2 spike protein following two doses of the Pfizer-BioNTech COVID-19 vaccine. The researchers concluded that the 31 patients were "nonresponders" to the vaccine.
"The findings confirm what we have suspected all along, which is that immunocompromised people aren't going to have the same immune responses to COVID-19 vaccines as people in the initial clinical trials testing these vaccines," said study leader Ghady Haidar, M.D., of the University of Pittsburgh School of Medicine.
Patients in the study had B-cell chronic lymphocytic leukemia, lymphomas, multiple myeloma, and other blood cancers. Those with B-cell chronic lymphocytic leukemia were the least likely to respond to the vaccine, the researchers found.
Their results appeared on April 7 in medRxiv, a preprint publication. Preprints are complete and public drafts of scientific studies that have not yet been peer reviewed.
The study was small and needs to be confirmed by larger studies, Dr. Haidar cautioned. Another limitation was that the researchers did not determine whether antibodies from vaccine responders were able to neutralize SARS-CoV-2.
Nonetheless, all three new studies provide important information for patients, said Dr. Haidar.
"People with weakened immune systems need to be aware of these results, so they can live their lives safely and reduce the risk of developing COVID-19," he said. "We don't want these people to assume that they're protected when they may very well not be."
His team is also studying COVID-19 vaccine responses in people with HIV/AIDS, autoimmune conditions, and transplant recipients. These studies, Dr. Haidar noted, should eventually help inform responses to a critical question: What can doctors do for people who do not mount an immune response to the vaccine?
"It's frustrating to be a physician and not have an answer to this question," he continued. "But people should not despair. For the time being, they should continue to use masks and social distance until the science catches up and we have something more concrete to offer."
European Studies Provide Additional Data on Vaccine Responses
The leader of the UK study, Sheeba Irshad, M.D., Ph.D., of King's College London, echoed these recommendations. "Until more studies looking specifically at COVID-19 vaccines in patients with cancer are available, it is important for patients with cancer to continue to observe all public health measures in place, even after vaccination," Dr. Irshad said.
Getting vaccinated is also important for those in close contact with people with cancer, she stressed, both to protect the patient and to promote herd immunity more broadly.
In their study, Dr. Irshad and her colleagues analyzed immune responses to the Pfizer-BioNTech COVID-19 vaccine—including antibody production, virus-neutralizing ability, and T-cell responses—in people with and without cancer. After one dose of vaccine, those with cancer generally had weaker immune responses than people without the disease, the researchers reported in Lancet Oncology on April 27.
Researchers assess a person's response to COVID-19 vaccination in part by measuring the levels of specific antibodies in blood.
Credit: Adapted from the Centers for Disease Control and Prevention
"The findings imply that vaccination with a single dose of the [Pfizer-BioNTech] vaccine leaves most patients with cancer wholly or partially immunologically unprotected," said Dr. Irshad. The study included 151 people with cancer (95 patients with solid cancers and 56 patients with blood cancers) and 54 people without cancer (known as a control group).
The "extremely poor immune responsiveness" in patients with blood cancers is of particular concern, Dr. Irshad noted, because immunocompromised patients may harbor persistent SARS-CoV-2 infections, potentially leading to the emergence of new variants of the virus.
Within two weeks of a second vaccine dose, immune responses improved substantially among most patients with solid cancers (e.g., breast, colorectal), the researchers found. The study was not large enough to reach conclusions about the effect of a second dose in patients with blood cancers.
The third study, conducted by French researchers, also found differences in immune responses between people with and without cancer. After the first dose of the Pfizer-BioNTech vaccine, nearly half of the 110 patients with cancer showed no antibodies to the SARS-CoV-2 spike protein, they reported April 28 in Annals of Oncology.
The seroconversion rate was only 55% in patients with cancer, though it reached 100% in the 25 people in the control group. Seroconversion refers to the time from vaccination to when antibodies of the virus become present in the blood.
NCI-Supported Trial Will Study Moderna Vaccine
Since these studies appeared, Dr. Sharon and his colleagues have launched an NCI-supported clinical trial at the NIH Clinical Center in Bethesda, MD. The study will assess the ability of the Moderna COVID-19 vaccine to stimulate an immune response in 120 adults who are undergoing treatment for various types of cancer.
Half of the patients will be receiving immunotherapy drugs known as PD-1/PD-L1 inhibitors for solid tumors as part of their care. The others will be undergoing treatment for blood cancers such as leukemia, lymphoma, and multiple myeloma, or will have undergone a stem cell transplant for their cancers.
The research community does not know what effect, if any, treatment with an immunotherapy drug could have on the use of COVID-19 vaccines. Immune checkpoint inhibitors—such as PD-1/PD-L1 inhibitors—enhance the ability of the immune system to detect and attack cancer cells.
"Will the patient get more antibodies as a result of having a PD-1 or PD-L1 on board?" Dr. Sharon asked. "This is the kind of question we're trying to answer. And depending on what we learn, the results might help us guide further efforts in developing treatments for cancer going forward."
The researchers will assess immune responses by looking at antibody levels and the activation of T cells associated with SARS-CoV-2 infection in blood and saliva samples. Patients will be tested at planned intervals following the second dose of vaccine—after 1 week, 1 month, 6 months, and a year.
"We actually have the opportunity to explore something—a virus—that no human had ever really had immunity to," Dr. Sharon said. "This could help us to better understand defects in the immune system and whether there are ways that we can shore up those defenses."
About World Cancer Institute
The World Cancer Institute is a global forum and catalyst for worldwide dialogue and the advancement of clinically validated evidence based treatment modalities directed toward the most challenging disease of our time.
The Institute's primary objective is to enlarge the clinical framework and therapeutic possibilities resulting from the convergence of integrative cancer care conjoined with treatment protocols which have also demonstrated promising indications in providing measurable, enhanced QoL—Quality of Life during treatment programs.
A New Perspective in Global Cancer Treatment:
Systems Biology Confronting the Complexity of Cancer
Predictive OncoEpigenomics as indicative and causative cellular aberrations in Cancer cell development, replication and proliferation.
The way we think about Cancer must evolve.
World Cancer Institute's global initiatives are directed toward advancing cancer clinical protocols conjoining pathway-specific immunotherapies and multi compound combinations with important new DNA targeting drugs based on molecular cancer genetics, Epigenomic diagnostics and Epigenetic intervention via DNA programmable genetic pharmacology and other emerging integrative cancer immunotherapeutics.
World Cancer Institute's mandate for proactive care conjoins clinical objectives targeting a broader spectrum of intervention and cancer preventive modalities combined with more informed use of biologic therapeutics for progressively enhancing the body's internal restorative capacities to heal.
Karen Howard News@WorldCancerInstitute.com
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