Conference Coverage: QCCA, NCCN, AACR

QCCA Panel Highlights Expansion of Innovation at Independent Community Oncology Practices

Members from independent oncology practices gathered to discuss value management, theranostics, clinical trial access, and innovations in pharmacy at the Quality Cancer Care Alliance (QCCA) Summer 2022 National Leadership Summit, held August 10 to 12 at The Bell Harbor International Conference Center in Seattle, WA.

With its theme of “Harnessing Innovation in Independent Community Oncology,” the summit included panels on topics such as chimeric antigen receptor (CAR) T-cell therapy, and the shift from the Oncology Care Model to the Enhancing Oncology Model.

To kick off the meeting, Sibel Blau, MD, president and CEO of QCCA, led a panel on integrating innovation into independent community oncology. Joining Blau, who is medical director of hematology-oncology at Northwest Medical Specialties in Puyallup, Washington, to share how their practices are innovating in the field were:

• Alti Rahman, MHA, MBA, practice administrator at Oncology Consultants of Houston, Texas;
• Beth Page, LCSW, director of compliance at Cancer Specialists of North Florida;
• Frank Senecal, MD, director of oncology at the Franciscan Healthcare System, Northwest Medical Specialties; and
• Justin Floyd, DO, president of Cancer Care Specialists of Illinois.
  Value Management

According to Rahman, value and impact are 2 main factors of innovation.
“If you don’t value it, you won’t change it,” Rahman said, noting that change must start at the top with alignment of values between an organization’s management and executive board, because value management is needed at all levels and in all aspects of an organization.

Further, work structure, whether there is an established team focusing on the issue, and what resources are being invested to create this innovation all determine how much value is put into the innovation.

“It’s not something that you’re looking at generating a [return on investment] out of,” Rahman emphasized. “It is something that you invest in in order to create stronger foundations and roots in what we’re doing in community practice.”

He summarized his second point as “if you can’t measure it, you can’t change it.”

Based on this, it is important for the organization to set a clear goal within its limits, as well as understand the magnitude of the issue at hand and how the innovation’s impact is being measured.

Rahman explained that the provider’s job starts in the middle of the patient’s journey after receiving a diagnosis. However, the provider must not only focus on how to make things work efficiently at an operational level, but also think about the patient’s journey so far and how their life will be affected after treatment.

Rahman pinpointed prior authorization as an area in need of overhaul; he said it adds unnecessary time to the process of getting treatment to patients. To address this, Oncology Consultants investigated how time was being spent during each prior authorization process and consequently invested in automation, reducing the average turnaround from 20 minutes to 11.8 minutes.

Additionally, after analyzing the process and filtering out which parts did not add value, including redundancies and repetitions, the overall time of the authorization process went from 2 to 3 days, on average, down to 1 day, measuring from the time the physician ordered the therapy to the prior authorization’s final approval by the payer.

“As we look at our organization, we have to continuously assess what we’re doing and then review the capacity for change and improvement throughout as a culture of innovation,” Rahman closed.

Theranostics
Page explained theranostics, which are precision therapies that combine therapeutics, diagnostics, and nanoscience. This type of treatment uses 1 radioactive drug to identify and diagnose a malignancy, and another to deliver therapy for the malignancy and any metastatic tumors.

By comparison, traditional radiation targets only 1 disease site, which makes radiation less effective for patients with metastatic tumors. Radiation can also damage healthy tissue surrounding the malignancy.

Theranostics available at Cancer Specialists of North Florida include lutetium Lu 177 vipivotide tetraxetan (Pluvicto), lutetium Lu 177 dotatate (Lutathera), and radium Ra 223 dichloride (Xofigo). Data that Page presented at the QCCA Summit showed that Lutathera and Xofigo result in more than $8053 and $2279 in average profits per injection, respectively, based on information collected by the practice.

Page emphasized the importance of operationalizing this therapy correctly, stressing that practices that fail to set up the correct system risk losing all profit.

To avoid this loss, while also minimizing waste and improving the patient experience, Page explained that Cancer Specialists of North Florida has a team that meets the same day every week. This team includes 1 member who handles scheduling, 1 part-time nurse who stays in the room with the patient for 6 hours to avoid pulling a nurse from the clinic’s chemotherapy floor, and 1 imaging tech who is with the patient for around 30 minutes to administer the doses.

This team moves among sites on different days of the week, but it always consists of the same members on the same schedule.

Blau added that standard operating procedures are being developed to help practices build these teams.

According to Page, the global theranostics market is estimated to grow 9.6% annually through 2028, reaching a value of more than $123 billion.¹ Primary factors driving this growth are the increase in prevalence of cancer and other chronic illnesses as well as growing investments in biological research. At the same time, this trajectory could be impeded by challenges surrounding the regulatory landscape and a lack of reimbursement policies.
Clinical trials for theranostics therapies are ongoing, with phase 3 trials happening at Telix Pharmaceuticals for TLX591, which is estimated to reach commercialization in the next 12 months.² Additionally, a phase 4 trial at Zionexa is being initiated for Cerianna^.3

CAR T-Cell Therapy, South Sound CARE
Most CAR T-cell therapy programs are available through hospital settings, especially in metropolitan areas. In the northwest United States, according to Senecal, this means many patients eligible for the therapy who are referred to a limited number of centers have to wait longer to access it.
“As a result, there is often a 2- or 3-month waiting list for getting patients into therapy,” Senecal explained. “In addition, the rules and regulations from [Fred Hutchinson Cancer Research Center mean that] patients need to stay in Seattle after they receive their therapy, so patients are making a commitment to stay for a pretty prolonged period of time.”

Senecal is also the founder of the South Sound CARE Foundation (SSCF), which aims to increase access to clinical trials and cancer research closer to patients in the South Sound region, and to provide residents with cancer treatment options such as CAR T-cell therapy that are otherwise unavailable in their area.

Ongoing trials through SSCF are focused on blood cancers, breast cancer, genitourinary cancer, and quality of life, among other topics.

SSCF also has a number of Compassionate Use trials for physicians and providers, designed for patients who are no longer responding to standard-of-care therapy.

“These are individual ‘trials’ in which the FDA and pharmaceutical companies work together to provide access to drugs [that have been] shown effective for specific tumor traits, but [that are] not available through other sources,” according to information provided by the foundation.⁴ “The South Sound CARE team coordinates the process for our patients, facilitating the applications and locating potential Compassionate Use programs within pharma [that are] willing to partner to provide drug free of cost to patients.”

Mobile Pharmacy
According to Floyd, providing specialty drugs to patients has several challenges, including high costs, variable half-lives of drugs, and access to specialty infusion staff. Additionally, many patients have limited access to cancer care, especially if they are older, live in a rural area or otherwise hard-to-access location, or are members of a vulnerable or generally underserved population.

On top of this, patients are sometimes unable to keep their appointments due to travel difficulties, poor health, and various other reasons.
Floyd also noted that, while Cancer Care Specialists of Illinois (CCSI) has been operating successfully for 30 years, he realizes the care design model is geographically challenging.

To overcome some obstacles, CCSI created a “first of its kind” mobile pharmaceutical compounding vehicle that is not a licensed pharmacy but helps to deliver cancer care to patients by providing on-site chemotherapy medication compounding.

Issues with drug waste have also become a large environmental and financial problem. Chemotherapy drugs can be very expensive, and if they are transported to a center and then no longer needed, they must be disposed, contributing to both a waste in resources and high health care costs.

With the use of the mobile compounding vehicle, the chemotherapy medication is not mixed until the patients are seen at the hospital and an exact prescription is made, saving valuable medical resources while reducing cancer care’s environmental footprint.

It also has led to financial savings, with Floyd noting savings of $664,248 in 2020, $804,833 in 2021, and $278,722 so far in 2022.

Finally, Floyd suggested that compounding drugs on site can improve patient access to clinical trials because they are no longer required to travel to a central hub for investigational drugs. 

References
1. At 9.6% CAGR, theranostics market size to cross 123,694 million USD by 2022-2028. News release. Market Study Report; July 6, 2022. Accessed August 23, 2022. https://on.mktw.net/3pD67wn
2. TLX591 prostate cancer. Telix Pharmaceuticals. Accessed August 23, 2022. https://bit.ly/3wrqOiR
3. Clinical utility of FES F18 PET/CT in metastatic breast cancer patients. ClinicalTrials.gov. Updated July 8, 2022. Accessed August 23, 2022. https://clinicaltrials.gov/ct2/show/NCT05068726
4. Open trials. South Sound Care Foundation. Accessed August 23, 2022. https://www.southsoundcarefoundation.org/open-trials

Moonshot 2.0 Will Focus on Caregivers, Learn From Patients

The Biden administration’s reboot of the Cancer Moonshot initiative, Moonshot 2.0, has clear goals: to reduce cancer deaths by 50% over 25 years and to “improve the experience of people and their families living with and surviving cancer.”¹

Doing so will require going beyond the traditional measures of success and truly learning from patients and caregivers living with cancer, Danielle Carnival, PhD, the Cancer Moonshot coordinator in the White House Office of Science and Technology Policy, told those gathered September 16, 2022, for the National Comprehensive Cancer Network Policy Summit, held in Washington, DC.

Over the past 20 years, Carnival noted, the age-adjusted death rate from cancer has dropped approximately 25%, aided by groundbreaking advances in treatments, prevention tools such as the human papillomavirus vaccine, improved use of screening that allows lesions to be removed at precancerous stages, and large decreases in long-term cigarette use, “especially in young people.”

Carnival said the first Moonshot initiative in 2016 created 70 new partnerships and drove passage of the 21st Century Cures Act, invested $1.8 billion in research, and streamlined the FDA’s decision-making timeline for new therapies. “Despite progress of lives extended and lives saved, cancer is still the No. 2 cause of death in America,” she said. “We lose more than 600,000 Americans a year to cancer, and 1.8 million families each year are devastated by a cancer diagnosis.”

But many issues remain—cancer is often diagnosed late, and too little is done to prevent cancer. “We have stark inequities in access to diagnosis, access to treatments and trials, and inequities in outcomes,” Carnival said. “We know too little about how to target treatments to the right patients. She also noted that there is a lack of good strategies for developing treatments, including childhood cancers.

Worst of all, she said, “We leave most patients and caregivers to navigate the disease and its aftermath, including survivorship, on their own and we don’t learn from the experiences of most patients.”

Those experiences include dealing with treatments that are too toxic and too unaffordable, insurance processes that are impossible to navigate, and survivorship plans that may be incomplete or nonexistent.

Addressing this list—tackling the medical, financial, and emotional burdens of cancer by providing support throughout diagnosis, treatment, and survivorship—represents a “shared agenda” for Moonshot 2.0, Carnival said.

To take on this agenda, the Biden administration has created an interagency Cancer Cabinet, which includes representatives from HHS, the CDC, the Department of Veterans Affairs, and the Environmental Protection Agency, among other entities. In mid-September, President Joe Biden named former biotech executive Renee Wegrzyn, PhD, to head Advanced Research Projects Agency-Health, or ARPA-H, which will take on the bolder, riskier projects that the National Institutes of Health typically won’t pursue.² Alongside these steps, Carnival said, Biden has signed an executive order on biotechnology manufacturing to ensure products are made in the United States.

One such effort includes a large clinical trial, she said, that “if successful, will identify effective blood tests for detection of 1 or more cancers, so that we can reach more people with early detection and get them into a pipeline to get follow-up and diagnostics.” Such steps will help close the screening gap that results in some populations not receiving a cancer diagnosis until the disease reaches later stages.

Broader parts of the Biden administration agenda, such as reducing out-of-pocket costs for Medicare beneficiaries, “will impact tens of thousands of cancer patients who could see their prescription drug costs go down by thousands annually,” Carnival said. Prevention efforts include new funds to clean Superfund sites and $200 million in CDC grants for cancer prevention programs that will “reach every state, US territory, and tribal organization,” Carnival said.

Private sector efforts and partnerships are working to also improve equity in screening. Carnival listed projects across the country that included mobile and home screening projects and development of new tools in concert with pharmaceutical companies and groups such as the American Cancer Society and the National Minority Quality Forum. Carnival said prior authorization and reimbursement challenges are definitely part of the agenda.

Carnival said the administration wants to hear from those directly affected by cancer. The website whitehouse.gov/cancermoonshot includes links for patients and families to include written or video testimony.

“The goals and priorities for the Cancer Moonshot must be informed by those with direct experience with cancer. So please share your stories of inspiration and knowledge,” she said. The Moonshot relaunch featured stories from 3 individuals with direct experience with cancer, “and those 3 individuals happen to be the president, the first lady, and the vice president of the United States. This is personal to them.” 

References
1. Fact sheet: President Biden reignites Cancer Moonshot to end cancer as we know it. News release. The White House. February 2, 2022. Accessed September 21, 2022. bit.ly/3w14Ofg
2. Klein E. What Joe Biden knows that no one expected him to. The New York Times. September 18, 2022. Accessed September 21, 2022. https://www.nytimes.com/2022/09/18/opinion/biden-invention-arpa-h.html

Neighborhood Adversity Is Associated With Increased Risk of ER– Breast Cancer, TNBC for Black Women in the United States

In the United States, Black women have a 40% higher mortality rate from breast cancer than White women, explained Julie R. Palmer, ScD, MPH, the Karin Grunebaum Cancer Research Professor at Boston University School of Medicine. Palmer was presenting at the 15th American Association for Cancer Research Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved.^1,2

This is the worst disparity present in breast cancer data, with the discrepancy in rates not improving during a period of over 20 years, she explained.

“We know that a big part of the reason [for this disparity] is access to care, and by that, I mean true access, which takes into account everything from economics, being able to get there, to how physicians and other providers treat a person and communicate,” she said. “But it’s not only that, there are other differences too.”

Palmer explained that the data show differences in the occurrence of tumor subtypes between White and Black women as well.

“We’re all aware that triple-negative breast cancer [TNBC]—which is the most aggressive, occurs at younger ages, and is more difficult to treat—occurs at least twice as often on average among Black women [than] in any other group in the United States,” Palmer said. “22% of the tumors in Black women are triple negative versus 10% to 12% in the other [population] groups. So having more of these aggressive tumors will necessarily lead to more mortality, which then brings me to the question: Why is there more [TNBC in Black women]?”

This is a question many in the field have been working to answer for some time, Palmer said. She noted that the answer is likely multifactorial, with some causes that are biological and perhaps even genetically derived.
Several investigators are assessing the issue with varying lenses. For example, Lisa A. Newman, MD, MPH, FACS, FASCO, FSSO, chief of the Section of Breast Surgery at NewYork-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, and leader of the multidisciplinary breast oncology programs at NewYork-Presbyterian David H. Koch Center, is an investigator working to assess patterns of breast cancer subtypes in different regions of Africa. Additionally, looking at data within the United States, Melissa B. Davis, PhD, has been investigating evolutionarily conserved genetic variants that play a role in the immune system. Based on the data Newman and Davis have presented, Palmer concurred that biology does seem to be a part of the picture in terms of risk factors.

She noted there are also behavioral differences that differ across culturally defined groups in the United States that may be contributing to the disparity in breast cancer rates among Black women versus other population groups. In particular, a diet high in fruits and vegetables has been shown to reduce the risk of estrogen receptor–negative (ER–) breast cancer and TNBC. As diets and access to healthy food can differ across populations, diet may be another contributing factor in the different rates, Palmer said.

Additionally, breastfeeding has been found to be an important protector against TNBC, Palmer noted. For a multitude of reasons related to the history of Black women in the United States, Black women are often less likely to breastfeed.

“So my team and others have been doing work on these factors. But then I also feel we need to go beyond just these individual factors, which leads us to some social factors, neighborhood-level factors, and in particular stress,” Palmer said. “Stress is another factor that, in some ways, disproportionately affects Black individuals in this country because of the anti-Black racism that exists, which has [been] shown to have one of the most powerful effects on people. That was the reason for this work that we began doing.”

Experiencing stress can be a good thing in certain situations in which it may positively affect behavior. However, chronic stress has significant negative impacts on the body.

“Things get overburdened in both the sympathetic nervous system and the hypothalamic pituitary adrenal system. Then different biomarkers that are involved in inflammation, depression, and the immune system come into play more,” Palmer said. “That leads to a cascade of events with possible epigenetic modifications playing a role, [as well as] telomere shortening, and all of that can lead to cancer development, including possibly breast cancer.”

Additionally, the characteristics of a neighborhood can be a contributing factor to chronic stress. These include low neighborhood socioeconomic status (NSES), concentrations of disadvantaged individuals, neighborhood violence, lack of green spaces, and lack of social cohesion, as well as loud noises and associated difficulties with sleeping.

“A neighborhood that lacks safety can be a more stressful place to live in. Also, [findings from] randomized trials of different communities that changed the environment of similar housing so that one sees a lot of greenery and the other doesn’t have shown that [greenery] has a real impact on mental health and well-being. So a lack of green space can have an effect,” Palmer said. “Then simply the noise that is more likely to be a problem in disadvantaged neighborhoods can lead to sleep problems, which also leads to more stress.”

To evaluate the impact of neighborhood factors that may contribute to chronic stress, Palmer explained it was necessary to geocode addresses (converting addresses into geographic coordinates). Investigators placed a number on every address associated with a patient included for assessment. That number, which corresponds to either a house or housing unit, can then be linked to other databases that provide information about the characteristics of the people who live in a certain area within which that number exists.

“The best sources of data for these types of neighborhood variables I’m interested in are the ones that relate to social and economic conditions [that] come from the US Census Bureau—the long form ones which most of us have probably never filled out,” Palmer said.

With these data, Palmer and her colleagues worked to develop scores representing either neighborhood disadvantage or NSES based on different variables. For example, Palmer explained that when looking at the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program data, the investigators identified where individuals included in the SEER data set were living, and that’s the score the investigators would use for their assessment.

“So the analysis we did was in the Black Women’s Health Study. This study has been going on now for over 27 years, with the same 59,000 women who enrolled back in 1995. Not everyone is still filling out the questionnaires, but a very large proportion is,” Palmer said. “There’s a lot of data in there on individual-level factors. We also have geocoded addresses for every 2 years throughout the time [period] and then linked to those 2 databases.”

When the study began, participants’ median age was 38 years, and their residence spread throughout the country, Palmer explained. The investigators then learned of new breast cancer cases through self-reporting in these biannual questionnaires, but also through linkage with 24 state cancer registries in states in which most participants lived. Palmer noted that for patients who are lost to follow-up, they would also link to a national death index to find out about rates of mortality.

When breaking up the compiled data for analysis, the investigators first looked at the variable of neighborhood concentrated disadvantage. They then used a continuous score for each person and divided it into quartiles.
“We were comparing women who lived in the highest-quartile disadvantaged [area], so those are the ones in the most disadvantaged neighborhood, versus those in the lowest quartile,” Palmer said.

Palmer explained that the data showed a statistically significant increase in incidence of ER– breast cancer in the most disadvantaged neighborhoods. Specifically, high levels of neighborhood adversity were associated with a 25% increased risk of both ER– breast cancer and TNBC.

“Given that US Black women, regardless of their own education or income, are more likely to reside in disadvantaged neighborhoods, this factor may contribute to racial disparities in incidence of ER– breast cancer and TNBC,” Palmer said.

References
1. Palmer JR. Neighborhood disadvantage and individual-level life stressors in relation to breast cancer incidence in US Black women. Presented at: 15th 2. AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; September 16-19, 2022; Philadelphia, PA.

NIH Explores New Field of Liberation Data Science in All of Us Research Program

Through the All of Us Research Program at the National Institutes of Health (NIH), scientists are able to get data into the hands of community members outside the health care field, explained Karriem Watson, DHSc, MS, MPH, chief engagement officer of the All of Us Research Program at NIH, during a presentation at the 15th American Association for Cancer Research Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved.¹ The All of Us Research Program encourages public access and knowledge of the public’s own data to better assess the implications on the public’s own communities.

Watson explained that in Chicago, health disparities and life expectancy gaps have been broad topics of discussion among health care professionals and community members for many years. However, many elected officials in the city who made decisions that could impact these health issues remained unaware of the disparities in cancer incidence and outcomes and the impact on their communities. Further, these officials were the ones making decision regarding the allocation of government support and assistance for health care needs.

To better educate these elected officials on the incidence of cancer and its impact in the city, Watson and his colleagues worked to bring these data to the attention of elected officials. Further, the researchers helped explain and analyze the data and the implications for their communities in laymen’s terms.

“When you [give these] data...to communities and not only encourage them to utilize [the data], but also make your faculty and staff accessible to those communities to help them navigate and understand that data—that’s really what we like to think of as liberation data science,” Watson said.

As the All of Us Research Program continues to work to provide a broader data set for the purposes of public access, Watson explained that the goal is to enroll a million or more individuals across the United States over the next 10 years.

“We’re right at about 523,000 people enrolled today, and of those, about 372,000 participants have donated data that allow us to do a truly deep dive,” Watson said. “Then 80% of those in the 372,000 are in underrepresented groups in biomedical research, and 45% of those are self-identified racial and ethnic minorities.”

To access these data, Watson explained that 3 levels are available. The first level is the public tier that is available to anyone with digital access, which Watson acknowledged as a potential limitation for universal applicability.
“So we use that term ‘anyone,’ but that’s contextualized,” Watson said. “It’s available to anyone with internet access. And it’s available to those that are able to look and understand the electronic health record (EHR) and see aggregated data about what conditions we have.”

Watson also noted that at the public tier, people can look at the research project directory. He explained this is particularly important for those in the community who donate their data because they are able to then see how that information is being used for research purposes. Additionally, the public can see specifically what types of questions researchers are asking in reference to the use of their data.

“This is something that we’re really excited about,” Watson said.

Additional tiers available for access to the All of Us Research Program data set include the register tier data and the control tier data, which can supply information specific to the needs of each tier level.

“So for example, at the register tier data, we have information from our surveys,” Watson said.

“We recently launched a social terms of health survey and a survey on COVID-19, where we asked questions about discrimination, questions about food insecurity, questions about social isolation as a result of the pandemic. And imagine that data coupled with EHR data from over 270,000 participants and physical measures, and even data like wearables.”

Due to the access limitation of wearables as a measurement method, Watson explained that the All of Us Research Program donated wearables to populations who don’t typically get to participate in studies of this kind to broaden the medical data collected.

In the next access tier at the control tier level, Watson noted that the program gathered not only what is available at the register tier, but expanded it further to include spending demographics, unshipped event dates, and genomic data derived from whole-genome sequencing.

Additionally, Watson explained the program will soon also be able to provide 3-digit zip code data as well at the control tier access level, with more than 24,300 health conditions and over 15,300 unique lab values.

“Today, we have about 42,000 of our participants who have identified in their EHR that they have been diagnosed with cancer. That’s 18% of our participants living with cancer or having a diagnosis of cancer,” Watson said.

“You think about some of the top cancers, like skin cancer, breast cancer, prostate cancer, colorectal, and lung. From these projects, we have over 2000 projects in our research tier registry. These are just a snapshot of 162 that are looking at the intersectionality of cancer, asking questions like the impact of nutrition and physical fitness on prostate cancer, social determinants on colorectal cancer, breast cancer genomic variants, and then personal family history of cancer.” 

Reference
Watson KS. The All of Us Research Hub: a dataset for all of us. Presented at: 15th American Association for Cancer Research Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; September 16-19, 2022; Philadelphia, PA.

AACR Progress Report Highlights New Drugs Along With Disparities, Challenges of Obesity, Aging Population

The past year has brought plenty of good news: 8 new anticancer therapies, 10 new uses for existing drugs, and 2 new diagnostic imaging agents, according to American Association for Cancer Research (AACR). More people than ever in the United States are living after being treated for cancer—18 million.¹

The rate of cancer mortality continues to fall, tumbling 2.3% between 2016 and 2019. Overall, the age-adjusted US cancer death rate fell 32% from 1991 to 2019.²

Yet, as noted in AACR’s annual Cancer Progress Report, cancer remains a top killer, claiming more than 600,000 lives each year in the United States. Disparities in who gets cancer—and who gets access to the best care—remain “a pervasive public health problem,” according to the report released September 21, 2022, which covered data from August 1, 2021, to July 31, 2022.³

This year’s report came with a new warning: The Supreme Court decision and subsequent actions by states to restrict reproductive rights will have “serious detrimental effects” on health care that could affect patients with cancer. A statement released with the report warns that cancer treatments could be withheld if they might affect a pregnancy, causing disease to progress, “making it more difficult to treat and more likely to threaten the life of the woman.”

Failure to prevent cancer or ensure that equitable treatment exacts a toll, both in human and economic terms, the report states. Direct medical costs for cancer care in the United States “were estimated to be $183 billion in 2015, the last year for which these data are currently available; this cost is projected to increase to $246 billion by 2030.”

Despite all the advances in treating cancer, AACR said the need to prevent disease is urgent because the cancer burden will rise with an aging population. Tremendous progress has been made in reducing smoking and increasing breast cancer screening, but there are troubling signs: uptake of vaping by teens and suboptimal rates of lung cancer screening.1
Based on current trends, the report states, the number of new cancer cases each year will reach 2.3 million by 2040, with 80% occurring among those 55 years and older. The report highlights the vulnerability of those living HIV if they develop cancer as they age; more than half (57%) will occur among those at least aged 65 years, and this segment of the population will grow from 54.1 million in 2019 to 81 million in 2040, according to the report.

Support for Research and Regulatory Activity
Overall, the report connects the long-term, bipartisan congressional investment in cancer research with the remarkable advances in treatments and improved outcomes. AACR leaders call for continued funding for basic research, not only to develop therapeutics, but also to expand use of artificial intelligence in cancer detection and to do more to understand the physical, psychosocial, and financial effects of cancer on survivors. AACR called on Congress to consider tax policies that encourage philanthropic support for cancer groups.

“Basic research discoveries have driven the remarkable advances that we’ve seen in cancer medicine in recent years,” AACR President Lisa M. Coussens, PhD, FAACR, said in the report. “Targeted therapies, immunotherapy, and other new therapeutic approaches being applied clinically all stem from fundamental discoveries in basic science. Investment in cancer science, as well as support for science education at all levels, is absolutely essential to drive the next wave of discoveries and accelerate progress.”

Among the therapeutic advances that the AACR highlighted were the following FDA approvals:

• belzutifan (Welireg) for cancers associated with von Hippel–Lindau disease;
• a new immune checkpoint inhibitor, relatlimab-rmbw, in combination with nivolumab (Opdualag) treat melanoma;
• asciminib (Scemblix), a first-in-class inhibitor of the ABL1 kinase activity of the BCR-ABL1 fusion protein, to treat chronic myelogenous leukemia; and
• zanubrutinib (Brukinsa), which inhibits an enzyme necessary for proliferation of B cells, to treat Waldenström macroglobulinemia and marginal zone lymphoma.

In a Call to Action section of the report, AACR praised the relaunch of Cancer Moonshot and also sought specific appropriations in a number of areas, including reauthorization and funding of the Childhood Cancer Survivorship, Treatment, Access, and Research Act ($30 million); the Childhood Cancer Data Initiative ($50 million); the CDC Division of Cancer Prevention and Control ($462.6 million); and the FDA’s critical regulatory science efforts, with an increase of $318 million ($3.653 billion total).

Disparities
The report notes that overall progress in survival is uneven, and some types of cancer are on the rise, especially those that appear to be related to obesity such as kidney, pancreatic, and uterine cancer. Fatty tissue in women who are overweight is known to release estrogen that can increase the risk of uterine cancer. Between 2000 and 2018, the report states, the greatest increased incidence in pancreatic cancer was seen among women aged 15 to 34 years. Cases of colorectal cancer among young adults are also on the rise.

Cancer disparities are sharp between certain US populations, “including racial and ethnic minorities and several other medically underserved groups [who] have not benefited equally from the advances against cancer,” the report states. Social determinants of health, such as lack of housing, income differences, lack of education, and inadequate or lack of health coverage, all serve as barriers to receiving the best available care. For example, AACR called for reducing barriers for children on Medicaid by ensuring they can see an out-of-state pediatric specialist.

The report also highlighted passage of laws to improve diversity in clinical trials, including the Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act to improve enrollment of minority populations in clinical trials, and the Diverse and Equitable Participation in Clinical Trials Act. The second act requires the FDA to issue trial enrollment rules for drug sponsors, so that patient populations in clinical trials will more closely match the populations with disease.

Challenges Remain
AACR’s report concludes with an overview of the work ahead. “Despite the major progress that is being made against cancer…there are several areas in cancer research and patient care that need to be addressed in order to provide opportunities for further advances,” the report states.

“Racial and ethnic minorities and medically underserved population groups in the United States continue to shoulder a disproportionate burden of cancer. The epidemic of obesity in US adults and youth and that of e-cigarette use in the US youth [continues] to threaten the progress made against cancer. Awareness of and adherence to routine cancer screening continue to be suboptimal. Participation and diversity in clinical trials that are reflective of the US cancer burden continue to be minimal.

“Financial burden of a cancer diagnosis on those directly affected by it, as well as on the US economy, continues to be substantial. And while cancer screening and clinical trials—both of which were severely impacted by COVID-19—are returning to prepandemic levels, the full impact of the pandemic on cancer research and patient care remains to be seen.” 

References
1.Miller KD, et al. Cancer Treatment and Survivorship Statistics, 2022. CA Cancer J Clin 2022;0:1-28. doi:10.3322/caac.21731
2. Siegel RL, et al. Cancer statistics, 2022. CA Cancer J Clin 2022;72:7-33. doi:10.3322/caac.21708
3. AACR Cancer Progress Report 2022. American Association for Cancer Research. September 21, 2022. Accessed September 23, 2022. https://cancerprogressreport.aacr.org/progress/