NCI Fights COVID-19 Problem | Targeted Oncology

Studies on the use of anticancer drugs to treat patients with the 2019 Coronavirus Disease (COVID-19), emphasizing the flexibility of clinical trials, and important serological studies to better understand the virus Only a small part of the initiative taken by the National Cancer Institute (NCI) is according to agency director Norman E. “Ned”, Dr. Sharpless, to support the fight against the pandemic.¹

As of early December 2020, nearly 70 million cases of COVID-19 and more than 1.4 million deaths have been reported worldwide, according to the World Health Organization.² In the United States, the CDC has recorded more than 10 million cases since January 21, 2020, including more than 250,000 deaths.³

Researchers are working to understand the impact of COVID-19 diagnosis on cancer patients. NCI-designated cancer centers are among more than 120 institutions that are part of the COVID-19 and Cancer Consortium (CCC19), and data on adult patients diagnosed with COVID-19 and with a history of cancer. Collect and analyze. Persons currently suffering from invasive solid tumors or hematological malignancies.

Data revealed factors associated with increased mortality from all causes at 30 days in patients with cancer and COVID-19: increased age, gender in men, smoking status, combination therapy with hydroxychloroquine and azithromycin And both require a comparison of combination therapies and two or more comorbidities. The results showed factors unrelated to mortality, such as race and ethnicity, obesity, types of malignancies, types and up-to-date chemotherapy, and recent surgery (Table).^Four

NCI has important expertise and many external capabilities for cutting-edge research in emergencies, “Sharpless said in a virtual conference presentation. “So it’s no wonder that when the pandemic actually happened, NCI was asked to intervene and provide a scientific response.”

The model predicts the effects of care disruption

The modeling effort took place earlier this year and the results were published in the June edition of Science. Leverage NCI’s Cancer Intervention and Surveillance and Surveillance Network (CISNET) to better cancer management interventions in terms of prevention, screening, and treatment, as well as their impact on population trends in both incidence and mortality understood.^Five

“We asked CISNET researchers to consider what we were thinking at the time was a very serious disruption to cancer treatment. [in terms of] Delays in screening, diagnosis, and treatment, “said Sharpless. “We asked [them to make] What we came up with was an important assumption about interruption of care [so we can gain some insight into] What will be the cancer mortality rate over the next 10 years? “

As the CISNET model advances, researchers have focused specifically on breast and colorectal cancer, according to Sharpless. Analyzing the cumulative excess mortality modeled by these diseases from 2020 to 2030, researchers predicted more than 10,000 deaths, or a 1% increase in mortality, over the next decade, Sharpless said. Stated. It is believed that the same confusion is occurring in other malignancies.

“The assumptions we made about the care turmoil are rather conservative estimates, and we feel that the actual turmoil seen in hospitals across the country is greater than we had predicted in June. “Sharpless said. “This is something we all have to keep in mind. We need to share some joint responsibilities. [to determine] How to maintain a cancer treatment business during a pandemic and not trade one public health crisis for another. “

During the pandemic, data show a reduction in cancer screening, diagnosis, and care reduction or postponement6. Sharpless emphasized that these disruptions are likely to have long-term implications for cancer mortality. To counter this, he added, the oncology community needed to come together to find safe and innovative ways to prioritize the care of cancer patients.

“We don’t want patients to be at risk for COVID-19 and its caregivers, but we need to get back into business,” Sharpless said.

NCI takes action

NCI’s response to pandemics includes diversion of anti-cancer drugs to treat COVID19, launch of NCI COVID-19 in Cancer Patient Studies (NCCAPS), guidance and specials in clinical trials in the field of oncology. Providing procedures and conducting serological studies on SARS-CoV. It provides the flexibility and opportunity to study 2 (the virus that causes COVID 19), and participants.

Diversion of anti-cancer drug

Certain drugs that are active in solid tumors and hematological malignancies are also active in the symptoms of COVID-19.

FDA-backed therapeutic efficacy 7 of leronlimab for the treatment of malignant tumors of the breast demonstrated in patients with COVID-19 in a recent Phase 2 CD10 trial (NCT04343651) for mild to moderate symptoms of COVID it was done. 19.⁸

“We are very familiar with the potential of Leron Limab. [in patients with COVID-19] This is due to the completion of Phase II trials for mild to moderate symptoms, “said Dr. Nader Pourhassan, president and chief executive officer of CytoDyn, which is responsible for manufacturing agents, in a statement.

In November, a protocol for a phase II clinical trial aimed at evaluating leronlimab as a treatment for patients with COVID 19 suffering from long-distance symptoms was submitted to the FDA. If successful, this treatment is the first for patients experiencing prolonged symptoms of the virus, accounting for up to 10% of all patients with COVID-19.

Adaptation of clinical trial efforts

During the pandemic, many laboratories were closed, the timeline for clinical trials was delayed, and adjustments were needed to continue investigating life-saving drugs for patients in greatest need.

Recognizing the challenges pandemics pose for clinical trials, NCI worked with the FDA to provide flexibility in the efforts supported. For example, it is now possible to transfer patient care to various participating research sites. Local health care providers can provide research activities to facilitate continued care. Currently, oral medications may be shipped directly to study participants from NCI and study sites to reduce unnecessary risk. Remote informed consent by telephone is now accepted along with the patient’s written signature.

“We know this is successful [effort]..

The outbreak of NCI treatment trials has returned to near normal … we surveyed researchers, and they really like some of these flexibility, “Sharpless said. “This is probably a pandemic silver lining. We learned how to do trials in modern times with zoom chat and telemedicine. We will not forget those lessons. Many of these flexibilitys will be clinical in the future. It is suitable for testing and will affect the way NCI does business even after a pandemic occurs. [over].. “

Data collection

NCCAPS (NCT04387656) is a longitudinal natural history study of COVID-19 in cancer patients. Researchers are tracking patients and collecting relevant data to better understand how the virus and its symptoms develop and evolve.⁸ The goal of this study is to inform future treatment decisions for cancer patients who are also diagnosed with COVID 19. A comprehensive dataset collects information about cancer, treatment, symptoms, course, recovery, and comorbidities with long-term follow-up.

In this study, researchers collect blood samples to estimate antibody response and genetic susceptibility. These samples are also used in the development of biomarkers. It is estimated that 2000 patients will be enrolled in this study.

The trial started in the spring of last year in about six weeks and is currently available on about 1,000 sites in the United States. For patients with a history of cancer and COVID-19 infection, the outbreak has begun to be fairly robust, “says Sharpless. “It is very valuable to understand the biomarkers that predict the adverse outcomes of cancer patients, and to understand the long-term history of the disease or the so-called long-distance COVID-19 condition we are currently seeing. I believe. Some patients. “

Participation in serology research

In October 2020, NCI launched the COVID-19 Serological Science Network (SeroNet) with the aim of supporting the national research community to enhance antibody testing capabilities and better understand the immune response to viruses. I launched it.⁹

“NCI has a long history in serology research and is wonderful. [laboratory] We are conducting serological research on the response of the human papillomavirus vaccine. It was one of the standard laboratories of the World Health Organization and other international organizations, “says Sharpless. “When the pandemic began, we converted the lab to the SARS-CoV-2 Coronavirus Lab …[We wanted to] Create a network to increase the capacity of coronavirus and serology tests in the United States. “

Agency expects SeroNet to involve more than 25 academic, governmental, and private sector biomedical research institutes in assessing immune response to viruses as a means of expediting testing and developing new treatments and vaccines. doing. To support this initiative, the US Congress has approved $ 306 million for NCI to develop, validate, improve, and apply serological testing and related technologies, according to NCI.

Maintaining the flexibility of research grants

NCI has also endeavored to provide some flexibility to grantees who have experienced interruptions in research activities.

“this is [a] hard [time] For trainees who need to move on to the next stage of training, or [who need to] Get a job, “Sharpless said. “This was also difficult for the scientist. [laboratories] It has been closed or clinical research efforts have been suspended. NCI with the wider National Institutes of Health [NIH]Is trying to send a message to grantees to allow as much flexibility as possible during a pandemic so that the study can return to normal as quickly as possible. “

The flexibility provided by NIH includes extending application deadlines, allowing institutions to use NCI grants to maintain salaries and benefits, extending project timelines and reporting requirements, and early stages. This includes extending the qualification period for investigators and trainees and taking over institutional training. We will subsidize with prior approval.

_reference:

_{1. Sharpless N.COVID-19: View from NCI. Presentation location: 38th CFS® Virtual Conference. November 4-6, 2020.}

_{2. Weekly epidemiological updates – December 1, 2020. who. Updated December 7, 2020. Accessed December 7, 2020.}

_{3. CDC COVID data tracker. Centers for Disease Control and Prevention. Updated November 5, 2020. Accessed on November 5, 2020.}

_{4. Kuderer NM, Choueiri TK, Shah DP, etc. Clinical effects of COVID-19 on cancer patients (CCC19): Cohort study. The lancet. 2020; 395 (10241): 1907-1918. doi: 10.1016 / S0140-6736 (20) 31187-9}

_{5. Sharpless NE. COVID-19 and cancer. Science. 2020; 368 (6497): 1290. doi: 10.1126 / science.abd3377}

_{6. Ducharme J, Barone E. COVID-19 Four graphs of how the pandemic changed cancer treatment. time. August 28, 2020. Accessed on November 5, 2020}

_{7. Phase 1b / 2 CytoDyn’s first mTNBC patient is in remission, oncologists have ordered the end of treatment with carboplatin (chemotherapeutic drug) and are continuing leron limab only as monotherapy. The patient’s testimony about her condition almost 6 months after Leron Limab treatment is very strong. news release. CytoDyn, Inc. March 12, 2020. Accessed on December 7, 2020}

_{8. Cytodyn submits a protocol to the US FDA for Phase 2 clinical trials in COVID-19 patients with long-distance symptoms. news release. CytoDyn Inc. November 17, 2020. Accessed on December 7, 2020}

_{9. NCICO VID-19 in Cancer Patient Studies (NCCAPS). National Cancer Institute. May 21, 2020. Accessed on November 5, 2020}

_{10. NIH launches COVID-19 Serology Science Network to announce recipients of grants and contracts. news release. National Institute of Health. October 8, 2020. Accessed on November 5, 2020}

_{11. Carolan A. Ned Sharpless: “There is nothing to stop us” —NCI is celebrating the 50th anniversary of the National Cancer Institute. Gun letter. October 16, 2020. Accessed on November 5, 2020}