Adults whose insurance covers lung cancer screenings were more likely to receive invasive screening procedures than patients in clinical trials, according to a study published in the 

. However, the out-of-pocket costs associated with downstream procedures may discourage adults with abnormal results to pursue their follow-up tests.

Among a group of 6,268 national employer-insured adults who received at least 1 low-dose CT scan (LDCT), 462 individuals (7.4%) followed up with a secondary or downstream procedure within the 12 months following screening.Women (adjusted odds ratio [aOR], 0.82; 95% CI, 0.68-0.99) and adults over the age of 65 (aOR, 1.62; 95% CI, 1.28-2.04) were more likely to follow-up with a downstream procedure.

The most common downstream procedure was a needle biopsy (69.0%), followed by cytology (23.6%), bronchoscopy (18.6%), and surgery (23.8%). A total of 93 patients (20.1%) received a lung cancer diagnosis following screening.

Overall, lung screening for this population costs $5,060,511.04 (an average of $740.06 perpatient). In comparison, the total out-of-pocket cost with this population was $427,069.74 ($62.46 per person.)

“[Out-of-pocket] costs associated with follow-up testing represents an underdiscussed risk, and the SDM should include patient financial consequences,” explained Tina D. Tailor, MD, Duke University Medical Center, Department of Radiology, and colleagues, in the study. “Given the existing disparities in lung cancer incidence and outcomes which cause disproportionate burden to vulnerable populations, failure to comprehensively address costs associated with [lung cancer screening] may disincentivize or discourage screening and/or necessary follow-up testing for certain populations. This may inadvertently widen existing lung cancer disparities.”

In 2010, the Patient Protection and Affordable Care Act (PPACA) was enacted. This requires non-grandfathered private and commercial insurers to cover USPSTF Grade A and B recommendations without cost-sharing. In addition, Medicare and most state Medicaid programs cover annual lung cancer screening with LDCT. Consequently, there has been a steady uptake in screening utilization since 2013.

In this study, researchers retrospectively analyzed data collected from patients between the ages of 55 and 79 who received screening between 2015 and 2017, noting the types and frequencies of downstream invasive procedures. Researchers then determined total costs per-episode (defined as a lung cancer screening exam and downstream procedure) and out-of-pocket costs using linear and logistic regression. Findings did not reveal an association between downstream procedures and race/ethnicity, poverty level, geographic division, or health plan type.

The out-of-pocket cost increased with each downstream procedure. The cost for these procedures managed between $0 and $342.05 with a median cost of $50.79. Of the 466 patients who received at least 1 follow-up procedure, 61% experienced an out-of-pocket cost.

Patients who received a lung cancer diagnosis at their consequent procedure paid an average of $332.24 and out-of-pocket costs for patients in this population ranged between $0 and $1,341.52. Those who did not pursue a downstream procedure after their screening did not experience out-of-pocket costs.

Notably, patients living in the Pacific region were more likely to have 0 out-of-pocket costs in comparison to patients in the East northern Central Region (OR, 1.67; 95% CI, 1.26-2.22). Patients living in the West-South Central Region were the least likely to have 0 out-of-pocket costs (OR0.76; 95% CI, 0.61-0.95).

Health plan types also impacted patient costs. Zero costs were associated with POS and PPO (OR, 0.67; 95% CI, 0.57-0.80) plans as opposed to HMO plans (OR, 0.49; 95% CI, 0.29- 0.83).

“Even a small [out-of-pocket] cost can induce burden among the financially fragile, such as those living at or below the federal poverty level, necessitating trade-offs between paying their cost share and other household or health expenses,” the study authors concluded. “Innovative insurance design needs to align insurance premiums or an [out-of-pocket] bundle covering the entire [lung cancer screening] episode to decrease the financial burden across the population of [lung cancer screening]-eligible individuals.”

Study authors acknowledged was limited by patients being required to have at least 12 months of continuous insurance coverage in 1 plan to be included. Consequently, patients switching insurances or who became uninsured during the study period were not included and therefore the procedural rates and costs may be underrepresented. Furthermore, the majority of included patients had POS health plans and the findings therefore may not be generalizable to other health plan types. Finally, costs did not consider procedure related complications. Further research should seek to address these factors to better assess the screening-related costs and expenditures.

Tailor TD, Bell S, Fendrick AM, Carlos RC. Total and out-of-pocket costs of procedures after lung cancer screening in a national commercially insured population: estimating an episode of care. 

J. American College of Radiology (accepted preproof). 

Available from: https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb-assets/Health%20Advance/journals/jacr/PreProofJACR_Manuscript_JACRAD-D-21-00091-1632519372147.pdf

Articles

A total of 7.4% of patients received a secondary or downstream procedure within the 12 months following their lung cancer screening.


Cost May Prevent Patients from Pursuing Procedures After Free Lung Cancer Screenings

The initial findings from the IMPACT study (NCT00261456) revealed that men who carry the 

 pathogenic variants are at an increased risk for prostate cancer compared with age-matched non-carrier individuals.

 The risk identified in these pathogenic variants, which are associated with Lynch Syndrome, highlight the potential value of regular prostate-specific antigen (PSA) screening starting at age 40.

“Prostate cancer screening isn’t recommended for the general population, but we believe it could benefit some groups of men at high inherited risk. Our new findings show that PSA testing in men with Lynch syndrome is much more likely to pick up life-threatening prostate cancer than in the general population,” Rosalind (Ros) Eeles, FMedSci, PhD, FRCP, FRCR, IMPACT study lead, professor of oncogenetics at The Institute of Cancer Research and a consultant in clinical oncology and oncogenetics at The Royal Marsden NHS Foundation Trust, said in a news release.

Lynch syndrome is characterized by pathogenic variants in 

which are mismatch repair genes. The familial cancer syndrome is associated with a predisposition to several cancers, including colorectal and endometrial. Data suggest that these genetic alterations confer an increased risk of early-onset, aggressive prostate cancer as well.

As such, the goals of the IMPACT study were to assess the utility of PSA screening in men with and without germline pathogenic variants in the genes in question, understand the incidence of prostate cancer among these men, and characterize tumors after the first round of screening.

The primary end point of the study was to determine the incidence, stage, and pathology of screening-detected prostate cancer in carriers of these pathogenic variants compared with non-carriers.

Overall, the international prospective study enrolled 828 men with mismatch repair gene pathogenic variants without a previous diagnosis of prostate cancer. Of these, 4 did not undergo PSA screening. Of the men who did undergo PSA screening, 203 were 

 non-carrier controls. An additional 134 

 non-carriers were randomly selected to increase the sample size for the non-carrier control groups.

Additionally, of the 828 men with confirmed pathogenic variants, 186 (19%) had a family history of prostate cancer.

Patients had to be between 40 and 69 years of age. They were required to have undergone genetic testing and tested positive or negative for known familial pathogenic variants. Men who had a 50% risk of inheriting a pathogenic variant but had not undergone genetic testing yet were eligible for enrollment.

Overall, patients were a median age of 53 years (range, 46-59). Most were of European ancestry (94%) and 41% were university graduates. Most patients did not have previous urinary symptoms (78%) or a previous PSA test (62%).

Men whose PSA level was higher than 3.0 ng/mL were offered a transrectal, ultrasound-guided prostate biopsy and histopathological analysis. Additionally, all participants are receiving at least 5 years of annual screening.

Within the first round of screening, 6% (n = 56) of men had a PSA concentration above 3.0 ng/mL and 4% (n = 35) underwent a prostate biopsy.

The results showed a prostate cancer incidence of 1.9% (n = 18; 95% CI, 1.1%-2.9%). The incidence of prostate cancer was 4.3% in 

 carriers (n = 13; 95% CI, 2.3%-7.2%), 0.5% in 

non-carriers (n = 1; 0.0%-2.6%), and 3% in 

 carriers (n = 4; 95% CI 0.8%-7.4%). No cases of prostate cancer were identified in 

Using a PSA threshold of more than 3.0 ng/mL, prostate cancer was detected more frequently among 

 carriers vs non-carriers (4.3% vs 0.5%; 

Ultimately, the positive predictive value of a prostate biopsy with a PSA threshold of 3.0 ng/mL was 51.4% (95% CI, 34%-68.6%). The positive predictive value of a PSA threshold of 3.0 ng/mL was 32.1% (95% CI, 20.3%-46%).

“Targeted screening has the potential to pick out aggressive prostate cancers at an early stage in men at high inherited risk, increasing their chances of survival. Because cancers in these men are more likely to be aggressive and potentially life-threatening, they would need to have radical treatment,” Eeles concluded. “I anticipate that these results, and evidence from our ongoing follow-up work, will influence future national and international screening guidelines for this group of men, with the aim of picking out prostate cancer earlier and potentially saving lives.”

Bancroft EK, Page EC, Brook MN, et al. A prospective prostate cancer screening programme for men with pathogenic variants in mismatch repair genes (IMPACT): initial results from an international prospective study. 

. Published online October 19, 2021. Accessed October 29, 2021. doi:10.1016/S1470-2045(21)00522-2

Targeted prostate cancer screening could benefit men with inherited cancer syndrome. News release. The Institute of Cancer Research. October 19, 2021. Accessed October 29, 2021. 

This article was originally published on OncLive as “PSA Screening for Aggressive Prostate Cancer Supported in Men With Lynch Syndrome–Associated Pathogenic Variants”

The increased risk of prostate cancer associated with MSH2 and MSH6 pathogenic variants point to a need for annual PSA screening in men over the age of 40. 

Relationship Between MSH2, MSH6 and Prostate Cancer Incidence Highlights Value of PSA Screenings

Women between the ages of 25 and 42 years may be able to decrease their risk of developing early-onset colorectal cancer (CRC) by increasing their intake of vitamin D, according to results from a prospective cohort study published in 

Results showed that compared with women who consumed less than 300 IU of vitamin D daily, the HR was 0.51 (95% CI, 0.30-0.86) for those who consumed 300 IU to 450 IU daily, and 0.49 (95% CI, 0.26-0.93) for those who consumed 450 IU or more per day (

for trend = .01). No evidence of a nonlinear association was reported (

for nonlinearity = .50). Moreover, the HR per 400 IU/day increase was 0.46 (95% CI, 0.26-0.83).

“Vitamin D has known activity against CRC in laboratory studies. Because vitamin D deficiency has been steadily increasing over the past few years, we wondered whether this could be contributing to the rising rates of CRC in young individuals,” Kimmie Ng, MD, MPH, study author and director of the Young-Onset Colorectal Cancer Center at Dana-Farber Cancer Institute, stated in a press release.2 “We found that total vitamin D intake of 300 IU per day or more — roughly equivalent to three 8-oz. glasses of milk — was associated with an approximately 50% lower risk of developing young-onset CRC.”

Although the incidence of CRC has decreased in the United States and many other countries, the rate of adults younger than 50 years of age developing CRC has been on the rise. Due to delays in screening and other clinicopathologic features, cases of early-onset CRC tend to be is usually diagnosed at a more advanced stage. Moreover, although a large portion of early-onset cases do not have a family history of CRC, other known risk factors like obesity have been found to increase the risk of early-onset CRC.

Findings from previous studies have suggested that vitamin D intake may be a protective factor against CRC. However, it remains unknown whether vitamin D intake is linked with risk of early-onset CRC. With consumption of vitamin D–rich food, such as milk, fish, and eggs declining, investigators sought to examine whether vitamin D intake correlated with the risk of early-onset CRC.

To conduct this research, investigators analyzed data from the Nurses’ Health Study (NHS) II, a prospective cohort study of 116,429 female nurses between the ages of 25 years and 42 years. The trial began in 1989 and those enrolled on the NHS II study completed self-administered questionnaires every 2 years on demographics, lifestyle factors, and health-related information. These questionnaires were complemented by assessment of dietary intake through the use of food frequency questionnaires done every 4 years.

Those with inflammatory bowel disease, a previous diagnosis of CRC, implausible data for baseline energy intake or missing data for baseline vitamin D intake were not included in the analysis. Total vitamin D intake was calculated by adding dietary vitamin D intake and supplemental vitamin D intake from supplements or multivitamins.

Body mass index was calculated based on reported height and weight, with weight updated every 2 years. Investigators examined total energy, red meat, processed meat, fiber, calcium, folate, and alcohol. Smoking status was updated biennially for calculation of pack-years smoked. Physical activity was self-reported with questionnaires done every 2 to 4 years. Television viewing time was also used as a measure for sedentary behavior.

The primary end point for the study was the incidence of early-onset CRC, defined as CRC diagnosed before the age of 50 years.

“We also identified unreported lethal CRC cases through family members, the postal system, and the National Death Index. For all deaths due to CRC, we requested consent from the next of kin for acquisition of medical records,” the study authors wrote. “Physicians who were blinded to exposure status reviewed medical records to verify CRC diagnosis and recorded histopathologic findings and anatomic location.”

Of the 94,205 women studied, 111 cases of early-onset CRC during 1,250,560 person-years of follow-up were identified from 1991 to 2015, and the median vitamin D intake among them was 372 IU/day. Moreover, participants under the age of 50 years were less likely to have a high BMI, smoke cigarettes, consume alcohol, spend significant amounts of time watching television, or consume red meat. Additionally, these participants were more likely to consume more dietary fiber, folate, and calcium; use more aspirin and multivitamins; and be physically active and have healthy dietary habits.

Additional data showed that sources of vitamin D intake were inversely associated with reduced risk of early-onset CRC. A stronger association was observed for dietary vitamin D (HR per 400 IU/day increase, 0.34; 95% CI, 0.15-0.79) than supplemental vitamin D (HR per 400 IU/day increase, 0.77; 95% CI, 0.37-1.62). Moreover, vitamin D from dairy products was a significant contributor for this association (HR per 400 IU/day increase, 0.32; 95% CI, 0.12-0.84).

Investigators documented a total of 1,439 newly diagnosed conventional adenomas and 1,878 serrated polyps among participants younger than 50 years of age who had undergone a lower endoscopy from 1991 to 2011. Higher vitamin D intake was also associated with lower risk in this population. Compared with those who consumed less than 300 IU/day, the HR of any conventional adenoma was 0.71 (95% CI, 0.56-0.89) for those who consumed 600 IU/day or less, and the HR for any serrated polyp was 0.85 (95% CI, 0.70-1.03).

“Our results further support that avoiding low vitamin D status is important in younger adults for health and possibly CRC prevention,” study authors wrote. “If confirmed, our findings could potentially lead to recommendations for higher vitamin D intake as an inexpensive low-risk complement to CRC screening as CRC prevention strategy for adults younger than age 50.”

Kim H, Lipsyc-Sharf M, Zong X, et al. Total vitamin D intake and risks of early-onset colorectal cancer and precursors. 

. Published online July 7, 2021. doi:10.1053/j.gastro.2021.07.002

Shining new light on vitamin D and cancer. News release. Harvard University. August 17, 2021. Accessed August 20, 2021. 

This article was originally published on OncLive as “Increased Vitamin D Intake Associated With Lower Risk of Early-Onset CRC”

The data showed that a daily intake of around 300 IU of vitamin D — roughly the same as three 8-oz. glasses of milk — was linked to a nearly 50% decreased risk of early-onset colorectal cancer among women between the ages of 25 and 42 years.



Vitamin D Intake May Be Protective Against Early-Onset Colorectal Cancer

 showed a significant uptick in recent cancer screening procedures like mammography, PSA, Papanicolaou test, and low dose CT scan. This increase directly contrasts the low screening rates observed during the first pandemic peak.

Compared to pre-pandemic times, defined as December 2019 to March 2020, an increase in tests performed during period 7, defined as September 2020 to December 2020, was noted across all types of screening analyzed, with the exception of colonoscopy.

Specifically, these increases ranged from 2.0% for the Papanicolaou test to 24.0% for the prostate-specific antigen test. In this same time range, an increase in positive diagnoses was also observed across all categories, except for colonoscopy; that increase ranged from 1.0% to 38.0%.

During period 7, the number of colonoscopy tests dropped by 15.0%, and the number of associated diagnoses also dropped by 30.0% when compared with pre-pandemic times. A reduction in the number of screening tests was reported during periods 5 and 6, defined as March 2020 to June 2020 and June 2020 and September 2020, respectively; this decrease ranged from 65.0% to 82.0%, respectively, and 4.0% to 44.0%, respectively.

Moreover, significant shifts were observed with regard to racial distribution of patients undergoing mammography in period 6, defined as June 2020 to September 2020, and period 7, defined as September 2020 to December 2020, vs 3 months pre-pandemic. Higher proportions of non-Hispanic White patients were noted in these 3 time periods, at 83.2% and 82.0% vs 79.0%, respectively (

 < .001). Lower proportions of non-Hispanic Blacks were noted, at 5.2% and 5.3% vs 6.3%, respectively (

 < .001), as well was Hispanic/Latino patients, at 2.4% and 2.6% vs 3.3% (

The racial disparities were illustrated by reduced numbers of non-Hispanic Black and Hispanic patients undergoing mammography during period 7 (n = 1774 and n = 867, respectively) vs the 3 months before the pandemic (n = 1859 and n = 977, respectively; this contrasted with the increase in mammography tests in the whole group of patients analyzed. This finding was further validated by comparably significant shifts observed during periods 6 and 7 vs other pre-pandemic time periods.

“Although the overall increase in screening examinations is reassuring, the decrease in colonoscopy has yet to compensate,” the study authors wrote. “This highlights the importance of home-based alternatives for colon cancer screening in such particular situations. Racial disparities appear to differ between screening procedures, and they are more marked in patients undergoing mammography. Efforts to address these gaps are strongly required to ensure timely and equitable care across the patient population.”

The COVID-19 pandemic underscored pre-existing health disparities between socioeconomic and ethnic groups. However, it remains unclear whether changes in screening tests could disproportionately impact marginalized communities.

As such in this study, investigators set out to evaluate temporal changes in cancer screening tests and diagnoses in the Massachusetts General Brigham System. They also examined socioeconomic, racial, and ethnic features of patients who underwent screening during the pandemic.

Investigators examined cancer screening tests and diagnoses during 7 periods of 3 months: period 1 (March 2, 2019 to June 2, 2019), period 2 (June 3, 2019 to September 2, 2019), period 3 (September 3, 2019 to November 30, 2019), period 4 (December 1, 2019 to March 2, 2020), period 5 (March 2, 2020 to June 2, 2020), period 6 (June 3, 2020 to September 3, 2020), and period 7 (September 4, 2020 to December 5, 2020). The first pandemic peak was period 5 and the second peak was period 7.

Investigators looked at the following screening tests: mammography, PSA, colonoscopy, Papanicolaou test, and low-dose CT scan. To calculate the percent of change in screening tests and diagnoses during pandemic periods vs period 4 was calculated as (Nperiod – Ncontrol)/Ncontrol.

To calculate the corresponding 95% Cis, investigators utilized the Clopper-Pearson method.

To assess the impact of socioeconomic disadvantages on cancer screening, investigators used the Area Deprivation Index (ADI). A higher score translated to a greater disadvantage. To identify a patients’ national ADI, investigators used the Neighborhood Atlas. Pairwise comparisons of gender, age, race, and ADI percentiles between the time periods were calculated.

A total of 382,858 patients underwent cancer screening tests, and the mean age of these patients was 59.9 years (standard deviation, 12.3 years). Just more than half, or 58.6%, were female and the majority (80.1%) were non-Hispanic White.

After a significant decrease in screening from March 2020 to June 2020 (n = 15,453 vs n = 60,344 in period 1 and n = 57,502 in period 2), the highest number of tests were noted during period 7 (n = 72,156), thus surpassing the number reported in the pre-pandemic period (n = 64.269). A comparable trend was showcased with regard to subsequent diagnoses. During the early pandemic, 1,985 positive tests were reported vs 3,476 positive tests in period 7 and 3,423 tests from December 2019 to March 2020.

When examining the different periods prior to the pandemic, periods 1 through 4, more socioeconomic disadvantage observed in those who were screened in period 5, defined as March 2020 to June 2020, in relation to period 4, defined as December 2019 to March 2020.

Additionally, a more favorable socioeconomic status was observed in patients screened in periods 6 and 7, defined as June 2020 to December 2020. Significant changes were noted compared with each of the 4 pre-pandemic periods. The shift in status was reported most importantly in patients who were undergoing mammography and colonoscopy.

Age variation was modest between the different time periods that were evaluated across the screening categories; the standardized mean difference ranged from 0.002 and 0.37 for all pairwise comparisons. Moreover, no difference in gender distribution was noted with regard to colonoscopy and low-dose CT scan in the pandemic time periods vs the preceding periods.

“We identified racial disparities within mammography testing from June to December 2020, with a significant decrease in the proportion of Black and Hispanic patients,” the study authors wrote. “In light of previously established low screening rates in ethnic minorities, these findings are concerning and suggest the pandemic may accentuate racial disparities related to cancer screening.”

Labaki C, Bakouny Z, Schmidt A, et al. Recovery of cancer screening tests and possible associated disparities after the first peak of the COVID-19 pandemic. 

. 2021;39(8):1042-1044. doi:10.1016/j.ccell.2021.06.019

This article was originally published on OncLive as “Cancer Screening Tests Rebound Following First Peak of COVID-19 Pandemic”

Increases were detected in all cancer screening procedures except for colonoscopies. 

Cancer Screening Rates Bounce Back Post COVID-19 Pandemic Peak

The National Comprehensive Cancer Center Network (NCCN) has released a statement imploring health care employers to mandate COVID-19 vaccinations among their employees. 1,2

Because patients with cancer are known to be more susceptible to experiencing complications from COVID-19, and certain populations may not mount an effective immune response to vaccination, the NCCN COVID-19 Vaccination Advisory Committee stated that it was “incumbent on healthcare workers” to be vaccinated against the virus.

“Cancer care providers have a responsibility to their patients and colleagues to do everything they can to reduce the spread of COVID-19; that includes getting vaccinated,” Robert W. Carlson, MD, chief executive officer of the NCCN, stated in a press release. “We know [patients with cancer] already face a higher risk from COVID-19 and must be protected during their many interactions with healthcare workers. According to the science, vaccines are our best option to safely protect ourselves and the people around us from this potentially deadly disease.”

Although the vaccination of healthcare workers will not serve to prevent all exposure to SARS-CoV-2, it confirms that the community is doing everything possible to protect more patients from infection. Moreover, many institutions have been reported to have experienced transmission clusters among healthcare workers during the pandemic, despite mitigation efforts.

For example, 3 clusters of COVID-19 infections among healthcare workers that were not associated with patient exposure were identified at The University of Texas MD Anderson Cancer Center.3 Investigators defined a “cluster” as 2 or more cases of SARS-CoV-2 in healthcare workers who worked in the same unit at the same time.

The initial cluster involved works from an ancillary services unit, with contacts traced back to a gathering in a break room in which 1 employee was symptomatic but not yet diagnosed with the virus. Subsequently, 7 employees were infected with COVID-19. The second cluster was comprised of 4 employees and was determined to be community related. The third cluster involved 2 employees with possible transmission while working in the same office at the same time.

The institution implemented a step-up approach to control infection spread among employees. This included universal masking, stronger cleaning practices, increased awareness, and the implementation of surveillance testing.

According to the committee, these kinds of events can have a significantly negative impact on healthcare systems.

FDA approved the Pfizer-BioNTech COVID-19 vaccine

 (previously referred to as BNT152b2; Comirnaty) for use in the prevention of COVID-19 disease in individuals aged 16 years or older.4 The vaccine has been available for emergency use in this population since December 11, 2020,5 and the authorization had been expanded to include individuals between the ages of 12 years and 15 years, as of May 10, 2021.6

FDA granted emergency use authorization (EUA) to the Moderna COVID-19 vaccine

 to prevent COVID-19 infection in individuals aged 18 years or older.7 The Johnson & Johnson single-dose vaccine also received EUA from the regulatory agency in February 27, 2021, for the same indication.8

In January 2021, the NCCN issued guidance that stated that all patients with active cancer, or with active, recent, or planned cancer treatment, should be considered highest priority to receive 1 of the COVID-19 vaccines granted for emergency use.9

In the event of limited vaccine supply, the NCCN specified that patients with active cancer who were on treatment including those on hematopoietic and cellular therapy; those planning to initiate treatment; and those who received treatment less than 6 months ago, be among the first to receive vaccination. Patients who were receiving hormonal therapy were the only exception to this recommendation.

Data from a recent study have demonstrated that COVID-19 vaccination induced high rates of seroconversion in patients with cancer, although those with hematologic malignancies have showcased lower immunogenicity and those who received prior immunosuppressive therapies appear to be less responsive.10

These data indicate that most patients with a cancer diagnosis have a high chance of responding to vaccination, even those who were receiving active treatment with chemotherapy, targeted therapy, or immunotherapy. As such, investigators concluded that the findings underscore the continued need to vaccinate patients with cancer urgently and broadly.

“We’re deeply committed to doing everything to protect our patients from COVID-19,” Brahm Segal, MD, Roswell Park Comprehensive Cancer Center, co-leader of the NCCN COVID-19 Vaccination Advisory Committee, stated in a press release. “Our patients come to our centers for high-quality and cutting-edge cancer care. We must insist they are protected as much as possible from COVID-19 during medical visits, and this requires that our workforce be immunized.”

Cancer guidelines organization supports mandatory COVID-19 vaccination for health workers. News release. National Comprehensive Cancer Network. August 19, 2021. Accessed August 23, 2021. 

National Comprehensive Cancer Network vaccine statement. August 19, 2021. Accessed August 23, 2021. 

Ariza-Heredia EJ, Frenzel E, Cantu S, et al. Surveillance and identification of clusters of healthcare workers with coronavirus disease 2019 (COVID-19): multidimensional interventions at a comprehensive cancer center. 

. 2021;42(7):797-802. doi:10.1017/ice.2020.1315

FDA approves first COVID-19 vaccine. News release. August 23, 2021. Accessed August 23, 2021. 

FDA takes key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine. News release. FDA. December 11, 2020. Accessed August 23, 2021. 

Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic. News release. FDA. May 10, 2021. Accessed August 23, 2021. 

FDA takes additional action in fight against COVID-19 by issuing emergency use authorization for second COVID-19 vaccine. News release. FDA. December 18, 2020. Accessed August 23, 2021. 

Johnson & Johnson COVID-19 vaccine authorized by US FDA for emergency use – first single-shot vaccine in fight against global pandemic. News release. Johnson & Johnson. February 27, 2021. Accessed August 23, 2021. 

NCCN shares new guidance principles for vaccinating people with cancer against COVID-19. News release. National Comprehensive Cancer Network. January 22, 2021. Accessed August 23, 2021. 

Thakkar A, Gonzalez-Lugo JD, Goradia N, et al. Seroconversion rates following COVID-19 vaccination among patients with cancer. 

. 2021;39(8):1081-1090.e2. doi:10.1016/j.ccell.2021.06.002

An official statement has been signed and issued by the National Comprehensive Cancer Center Network insisting that health care systems mandate COVID-19 immunizations for their workers

NCCN Issues Statement, Insists on Mandatory COVID-19 Immunization for Health Care Workers

The COVID-19 pandemic has disproportionately affected patients with cancer, explained Chastity M. Washington, MPH, CHES, director at the Center for Cancer Health Equity, The University of Ohio Comprehensive Cancer Center, James Cancer Hospital.

Washington presented on Cancer Health Equity in the COVID-19 Era at 

. In an interview with Oncology Nursing News®, Washington provided a brief introduction to how the pandemic specifically affected different populations of patients with cancer.

Her presentation at the meeting highlighted “the impacts of the pandemic, on those disparities, on the social determinacies of health on the health care system itself, the differences we’ve seen in cancer patients with covid, the impact of some of the preventative things related to cancers, such as screenings, there were delays in getting preventative screenings, there were delay in diagnostics, there was also a brief period of time when some of the clinical trials were shut down. So, how all those things impact cancer patients in general, but then also how they have sort of an extra impact those vulnerable minority, economically disadvantaged populations that we serve.”

Videos

“There were delays in getting preventative screenings, there were delay in diagnostics, there was also a brief period of time when some of the clinical trials were shut down.”

The COVID-19 Pandemic Disproportionately Affects Patients with Cancer

Oncology nurses taking care of patients treated with immunotherapy can ensure they continue to receive this therapy and lower hospitalizations by remaining diligent in suspecting and detecting immune-related adverse events (irAEs), said Grace Cherry, RN, MS, NP, UCLA melanoma program, during a presentation at the 5th Annual School of Nursing Oncology meeting.

“If you're an oncology nurse, you will have patients with immunotherapy–which is why we want to make sure that we are really familiar with these side effects,” Cherry emphasized.

IrAEs are currently unpredictable. They can appear at any time, in any organ or tissue. There are currently no markers to indicate which patients will have a reaction, although it is suspected that those who are autoimmune are at greater risk.

Common irAEs include fatigue, dermatitis, colitis, endocrinopathies, hepatitis, and pneumonitis. However, there are also rare irAEs that can occur, such as neurological, hematological, cardiac, musculoskeletal, and renal symptoms. Cherry urges oncology nurses to always “be suspicious.”

“I would like to invite for you to be that person who will be suspicious. Be that person who will [ask]: Is this an immune related adverse event?” encouraged Cherry. “And report it… because if it is [an irAE] we can treat them with prednisone, and the expectation is that it will get better.”

The primary principle of irAE management is early diagnosis. For this to be possible, patients must be taught to communicate any change they experience.

Communication, communication, communication,” stressed Cherry. “We have to let them know how to communicate to us if they're having symptoms. Do they know who to call? Do they have a phone number? Do they know to call on the weekend if they’re having a cough or profuse diarrhea?

The second step is to rule out other causes. IrAEs are unpredictable and difficult to diagnose, so Cherry advises involving other specialists with different instruments and training whenever possible. For example, if a patient experiences blurry vision, it is important to call an ophthalmologist, because they can look inside the eyeballs and provide a truly thorough evaluation.Using an interdisciplinary team is often the best way to receive early and accurate diagnoses.

Cherry also emphasized the importance of understanding common terminology criteria for adverse event (CTCAE) because it provides clinicians with a common language. Generally, immunotherapy can be continued with frequent monitoring as long as the AE is grade 1.

Grade 2 indicates that immunotherapy should be held, and symptoms managed. If symptoms are improved to grade 1, the therapy can continue. Glucocorticosteroids are recommended at 0.5–mg/kg per day if symptoms persist beyond 5 to 7 days.

If symptoms are not improved with use of steroids and worsen to a grade 3, not only should immunotherapy be held, but the glucocorticosteroids dosage should be increased to 1 to 2 mg/kg per day and hospitalization should be considered.

If the irAE reaches grade 4, therapy should be discontinued, and the patient should receive urgent intervention.

There are currently 7 FDA approved immunotherapies. Anti-PD-1 therapies such as nivolumab (Opdivo), pembrolizumab (Keytruda), and cemiplimab (Libtayo), are generally much better tolerated than anti-PD-L1 drugs like atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi), or the anti-ctla-4 therapy, ipilimumab (Yervoy).

The standard treatment for irAE is systemic steroids therapy; 0.5 to 2 mg/kg/d of prednisone or equivalent should be administered in either IV or oral form, depending on the severity, and should be tapered gradually over the next 4 to 6 weeks. Various literature suggests that the use of steroids does not impact the efficacy of the immunotherapy, said Cherry.

If steroid therapy does not induce a positive response within 2 to 3 days, the next step is usually an immunosuppressant. Guidelines recommend infliximab for colitis, mycophenolate for hepatitis, and an antifungal prophylaxis for pneumocystis.

Prednisone can affect glucose levels, so blood sugar should be monitored when administering that steroid. In addition, PP1 and H2 blockers are recommended to prevent gastritis, while vitamin-d and calcium are encouraged to prevent osteoporosis.

Cherry reminded nurses that irAEs are treatable. She recounted how gratifying it feels as an oncology nurse to successfully catch and manage an irAE and allow a patient to continue treatment.

As an example, she recalled a patient who was successfully treated for their adrenal insufficiency with 20mg hydrocortisone twice a day and was consequently able to continue their monthly monotherapy of nivolumab.

“I have to say personally, it's really gratifying when we catch patients with adrenal insufficiency, because.. they look so sick, and they feel horrible, but when we properly diagnose, and give the supplement of hydrocortisone, symptoms immediately get better. So, it's really, really gratifying. But even more gratifying than that is they continue to take therapy that is lifesaving.”

Some patients receiving immunotherapy are apprehensive to receive the COVID-19 vaccine. However, the NCCN has stated that patients with cancer respond well to messenger RNA SARS-CoV-2 vaccines and should continue to be prioritized for immunizations. Exceptions include patients who have received stem call transplant, cellular therapy, major surgery or have acute leukemia.

Both the NCCN and the Society of Immunotherapy of Cancer have patient geared resources for understanding immunotherapy. Furthermore, both the NCCN and ASCO release regularly updated immunotherapy management guidelines for clinicians.

Cherry also urges that patients use immunotherapy wallet cards and that families and caregivers be incorporated in the symptom management process. Any change from baseline should be reported right away.

“Communication is the key. Communication with patients. Communication with other health care providers. Early reporting is so important, make sure your patients know who to call, how to call, how to report symptoms. Let them know what their baseline is. If it's anything different, report it to us. Our job is to figure out is this immune related or not… So, we continue to give these treatments safely, so that our patients can continue with their life saving treatments.”

Cherry G. Management of Immune Related Adverse Events (irAE). Presented at: 5th Annual School of Nursing Oncology; August 6-7, 2021; Virtual.

“If you're an oncology nurse, you will have patients with immunotherapy–which is why we want to make sure that we are really familiar with these side effects.”

Immunotherapy Related AEs Are Manageable with Nurse Intervention

“Smarter screening” strategies may play a crucial role in helping Latina and Black women survive breast cancer at the same rates as their White counterparts, according to a presenter at the 

 School of Nursing Oncology virtual conference.

During her presentation, Olufunmilayo I. Olopade, MD, FACP, OON, American Cancer Society clinical research professor at the University of Chicago’s Center for Clinical Cancer Genetics & Global Health, stressed the need to better understand how breast cancer affects Latina and Black women to improve their survival outcomes following treatment.

“We want to make sure we can provide the right treatment for the right patient at the right time,” explained Olopade. “Then, we can keep our families healthy…what we're looking for in preventive oncology, we can do in the clinic and we can also do it in the population. [We] identify individuals who have already had cancer as a way for us to reach their family members.”

Olopade told the attendees that screening has been an effective tool at reducing breast cancer deaths. However, in her research, Black women in and around the Chicago, Illinois area get screened at rates higher than the national average, yet still have poorer outcomes than White women — even though patients achieve pathologic complete responses at similar rates.

Over time, she said she has learned from genomic assays that breast cancer is not simply one disease but is made up of several different ones. Furthermore, she noted how she has learned that screening for early detection of breast cancer should no longer be age based.

“What we learned from Chicago is that Black and Brown women, and in fact, all young women who get breast cancer under the age of 14, are the ones that are having the worst disparity. In all other cancers, older women tend to do worse,” she said. “We suddenly say, ‘Everyone starts screening at 40,’ [but] there are some women who would have had breast cancer that would have the potential to kill them before they ever get that first mammogram.

“So that’s why we're going away from talking about age-based screening to begin to say, ‘Let us personalize screening.’ Let us all figure out what exactly we are at risk for. Are we at risk for a ‘cheetah’ type of cancer? Or are we at risk for a ‘snail’ type of cancer that grows very slowly?”

Patterns of Inherited Breast Cancer in Black Women

Olopade has studied patterns of inherited breast cancer women in Nigeria, Cameroon, Uganda, Brazil, and among Black women in the United States. Those data, along with findings from the CARRIERS study which included 32,247 women with breast cancer and 32,544 controls, show that 

 are the most important genes for assessing breast cancer risk in this patient population. Black women who harbor these genes develop cancer are almost 15 years younger at diagnosis on average compared with White women who carry the same pathogenic variants.

“These are women who get breast cancer at a very young age. So that’s why we cannot use a one-size-fits-all [approach], and then say, ‘Oh, but you know, 

 are not important.’ They are important. It all depends on your population. When you test 1000 cases and 1000 controls in Nigeria and you have almost 12% of them showing up with a mutation in

, you’re going to focus on that as an intervention for cancer control.”

Determining a patient’s individual risk is challenging, in part because Black women tend to be underrepresented in clinical trials in the United States and abroad. Genomic testing for precision risk assessment will transform cancer care, Olopade said.

“We can’t just take what is being shown in White women and then expect it to work for Indian women, expect it to work for Asian women, expect it to work for women from Africa,” she added. “So, what is the heterogeneity? What is it that we need to do for Black and Brown women?”

This is where investigators need to go beyond race and ethnicity, she said. Physicians can use data from genome-wide association studies (GWAS) to develop a polygenic risk score (PRS), which is calculated for an individual based on the presence or absence of risk variants identified in large GWAS studies. PRS can provide better insight than traditional risk models, especially in these populations. The model can estimate risk for a Black or Brown woman based on the proportion of African ancestry in her DNA.

“We can now identify women who are in the top percentile, [representing] 5% of women who have a risk that is actionable before the age of 50. If we can find those women before the age of 50, or even if we can…can really track them [and] counsel them, and then we can put them on a screening, that is going to be different because they are at risk for [estrogen receptor]-negative breast cancer, [and] I think that will really help the field. We’re talking about deescalating—not just using more and more treatment. We have to deescalate in what we're doing for early detection. We have to use innovations.”

Olopade OI. Retooling precision oncology for true equity of cancer care. Presented at: 5th Annual School of Oncology Nursing; August 6-7, 2021; virtual.

Hu C, Hart SN, Gnanaolivu R, et al. A population-based study of genes previously implicated in breast cancer. 

. 2021;384(5):440-451. doi:10.1056/NEJMoa2005936

This article was originally published on OncLive as, “

Smarter Screening, Risk Assessments Are Key to Eliminating Racial Disparities in Breast Cancer Outcomes

“We want to make sure we can provide the right treatment for the right patient at the right time,” says Olufunmilayo I. Olopade, MD, FACP, OON. 

 Personalized Screenings are Needed to Address Racial Disparities in Breast Cancer Outcomes 

Multicancer early detection (MCED) tests demonstrated a strong capacity for delivering accurate and specific cancer signal origin (CSO) predictions across various tumor types. These results suggest that MCED tests should be included as a complement to existing single-cancer screening tests.

Specifically, data from The Circulating Cell-Free Genome Atlas Study (CCGA; NCT02889978), published in 

 showed that cancer signals were detected across more than 50 tumor types and that the MCED tests demonstrated a specificity for cancer signal detection of 99.5% (95% CI, 99.0%-99.8%). The overall sensitivity for cancer signal detection was 51.5% (n = 1453/2823; 95% CI, 49.6%-53.3%) and the sensitivity of the tests increased with disease stage; sensitivity for stage I disease was 16.8% (95% CI, 14.5%-19.5%), 40.4% (95% CI, 36.8%-44.1%) for stage II, 77.0% (95% CI, 73.4%-80.3%) for stage III, and 90.1% (95% CI, 87.5%-92.2%) for stage IV.

Overall, the accuracy of CSO prediction in true positives was 88.7% (95% CI, 87.0%-90.2%).

Investigators also reported that the MCED test demonstrated a cancer signal detection sensitivity of 40.7% (95% CI, 38.7%-42.9%) in an analysis was conducted in a cohort of patients with 12 prespecified cancers which account for approximately 66% of annual cancer deaths annually in the United States. Specifically, this cohort included patients with either anal, esophageal, lung, pancreatic, bladder, head and neck, stomach, ovarian, liver/bile duct, and colorectal cancers, as well as lymphoma and plasma cell neoplasms.

Further, an analysis of patients with stage I-III disease showed that the sensitivity of cancer signal detection with the MCED tests was 67.6% (95% CI, 64.4%-70.6%).

“Finding cancer early, when treatment is more likely to be successful, is one of the most significant opportunities we have to reduce the burden of cancer,” Eric Klein, MD, the chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic, said in a press release from ESMO.

 “These data suggest that, if used alongside existing screening tests, the multicancer detection test could have a profound impact on how cancer is detected and, ultimately, on public health.”

Widespread detection of cancer prior to stage IV disease could reduce cancer-related deaths by more than 15% within 5 years. Five single-cancer screening tests available for use in the United States for detection of breast, colorectal, cervical, lung, and prostate cancers, which account for 42% of annual cancer incidence rates. The use of cancer screening tests have contributed to the reduction of cancer-specific mortality, however, they are associated with high rates of false positives, over-diagnosis, and over treatment.

MCED tests represent a potential new approach to detecting signals for multiple cancer types by utilizing cell-free DNA (cfDNA) or other circulating analytes in the blood shed by tumors. As such, CCGA study investigators sought to develop and utilize a MCED test to detect cancer signals across multiple cancer types, as well as predict CSO with just a single blood draw.

From August 2016 and February 2019, this prospective, multi-center, case-control, observational study with longitudinal follow-up, enrolled 15,254 patients from 142 sites in North America. The study was then divided into 3 prespecified sub-studies that included a discovery cohort, a cohort that examined training and validation with the selected and updated assay and classifiers, and clinical validation cohort, reported here.

Patients eligible to enroll on the study were those 20 years and older, who received a diagnosis of cancer and/or were scheduled to undergo biopsy or surgical resection for a confirmed or highly suspected malignancy. Those who had previously undergone chemotherapy, radiotherapy, or definitive local therapy were not eligible to enroll.

The primary end point of the sub-study was to evaluate MCED test performance for cancer signal detection, CSO prediction, and the rates of both combined. Key secondary end points included test performance by age group, test performance for cancer signal detection by method of cancer diagnosis, and test performance for cancer signal detection in a prespecified group of 12 cancer classes.

In total, 5309 patients were enrolled on the third sub-study, 4077 of whom were included in the analysis. Of the evaluable patients, 2823 had a confirmed cancer diagnosis, and 1254 did not have a cancer diagnosis. The most common reasons for exclusion from the analysis were incomplete 1-year follow-up for noncancer participants (n = 324), presence of nonmalignant conditions at enrollment (n = 283), and unconfirmed cancer or treatment status at blood draw (n = 171).

Multicancer early detection tests provided specified and accurate cancer signal origin detection across more than 50 tumor types. 

Prevention