2021 ASCO Annual Meeting: Immunotherapy for Melanoma and Non-Small Cell Lung Cancer, PSA Screening for Prostate Cancer in Young Black Men, HPV Vaccination and Cancer Rates, and Effects of Medicaid Income Eligibility Limits on Cancer Survival Rates

2021 ASCO Annual Meeting; #ASCO21
May 19, 2021
ASCO Staff

Due to the ongoing COVID-19 pandemic, the 2021 ASCO Annual Meeting will be held virtually from June 4 to 8. Thousands of oncology professionals and allied members of the cancer care community from around the world will gather online to learn about the latest research in the treatment and care of people with cancer.

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Today, these research studies were highlighted: 

Immunotherapy combination slows the progression of advanced melanoma  

Who does this study affect: People with newly diagnosed, untreated advanced melanoma.  

What did this study find: Results from the phase 2/3 RELATIVITY-047 clinical trial show that a combination of immunotherapy medications, relatlimab and nivolumab (Opdivo), can help slow the growth of advanced melanoma. The researchers found that the immunotherapy combination doubled the amount of time that the melanoma was stopped compared with giving nivolumab alone.    

Immunotherapy has become an important treatment approach for stage III and stage IV melanoma. Nivolumab is an FDA-approved PD-1 immune checkpoint inhibitor that helps the body’s immune system target and destroy melanoma cells. Relatlimab is a type of immunotherapy that targets the lymphocyte-activation gene 3 (LAG-3). The LAG-3 gene controls a pathway that reduces the function of immune cells called T cells. Relatlimab releases the limits put on T cells by LAG-3. In this study, the researchers wanted to find out if targeting both PD-1 and LAG-3 pathways at the same time could more effectively slow or stop the growth of melanoma.  

This study included 714 people from around the world with advanced melanoma who had not been treated yet. There were 355 people in the group that received both relatlimab and nivolumab in a single infusion. The remaining 359 people were placed in the group to receive only nivolumab. Study participants were followed for a median of just over 13 months. The median is the midpoint, meaning half of the people were followed for fewer than 13 months and the other half were followed for more than 13 months. In the group that received relatlimab and nivolumab, the cancer was stopped for a median of 10.1 months, compared with a median of 4.6 months in the group that received only nivolumab. At 12 months, the cancer was still stopped in about 48% of the people receiving the treatment combination, compared with 36% of the people receiving the single drug.  

The treatment combination did cause more side effects in study participants, including serious side effects. Among the people receiving the combination treatment, just under 1 of every 5 participants (18.9%) had a serious side effect, and there were 3 deaths related to treatment in this group. Among those receiving only nivolumab, about 1 of every 10 participants (9.7%) had a serious side effect, and there were 2 treatment-related deaths. Side effects of any severity caused about 15% of people to stop receiving the combination treatment and about 7% of people to stop receiving nivolumab only.  

What does this mean for patients: The combination of relatlimab and nivolumab shows promise as an effective first treatment for slowing the growth of advanced melanoma.  

“Our results demonstrate that combination therapy with nivolumab and relatlimab is a potential novel treatment option for patients with previously untreated, unresectable, or metastatic melanoma.”  

—lead author Evan J. Lipson, MD
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland 

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Atezolizumab delays recurrence in people with earlier-stage non-small cell lung cancer  

Who does this study affect: People with stage II to stage IIIA non-small cell lung cancer (NSCLC).   

What did this study find: The IMpower010 phase 3 clinical trial found that the immunotherapy drug atezolizumab (Tecentriq) can delay cancer recurrence in people with stage II to stage IIIA NSCLC when given after surgery and chemotherapy. The treatment worked best on tumors that express the PD-L1 protein, but it also worked on some tumors that did not have any PD-L1 expression. About half of all people diagnosed with early-stage NSCLC have a tumor that expresses PD-L1. 

NSCLC is the most common kind of lung cancer. Treatment plans for metastatic or stage IV NSCLC often include immunotherapy, a type of cancer treatment that uses the body’s immune system to fight cancer. Atezolizumab is a checkpoint inhibitor that blocks the PD-L1 protein, which cancer cells use to hide from the immune system. The U.S. Food and Drug Administration (FDA) has already approved atezolizumab to treat metastatic NSCLC with high PD-L1 expression. This study is designed to explore whether this immunotherapy is effective in people with NSCLC in earlier stages. While surgery is known to effectively remove many of these cancers, the risk of recurrence for these patients is considered to be high. This is why chemotherapy is often given after surgery. 

Results from this study were based on 1,005 patients who had stage IB to IIIA NSCLC that was completely removed with surgery and then treated with chemotherapy. After chemotherapy, the participants were randomly divided into 2 groups. One group received the addition of atezolizumab, and the other group received best supportive care. Supportive care, or palliative care, means treating symptoms and side effects as needed. To measure how well the atezolizumab worked, researchers looked at the time of disease-free survival. Disease-free survival is the amount of time without any signs or symptoms of cancer after treatment ends. In addition to comparing results based on whether atezolizumab was added to the overall treatment plan, researchers also looked at the differences between patients with a tumor with PD-L1 expression and those with a tumor that did not have PD-L1 expression.  

For people with stage II to IIIA NSCLC, regardless of PD-L1 expression level, researchers found that atezolizumab led to longer disease-free survival compared with best supportive care alone. Adding atezolizumab after surgery and chemotherapy reduced the risk of disease recurrence or death by 21% for this group. The median disease-free survival for these patients was 42.3 months. For patients who received best supportive care, it was 35.3 months. Results were best for people who had received atezolizumab and whose tumor had PD-L1 expression. The median disease-free survival for this group had not been reached when this data was presented. This means that more than half of the patients in this group still had no signs or symptoms of cancer. Researchers saw a 34% reduced risk of recurrence or death when the patients’ tumor expressed PD-L1.

For people with stage IB NSCLC receiving atezolizumab, researchers did not see a statistically significant improvement when compared to those receiving best supportive care at this point in the study’s results. The researchers believe that it may be too early to draw conclusions yet from this research for this group of patients, since stage IB disease is known to recur less frequently than stage II to IIIA disease. 

Side effects were common in both groups. Over 92% of patients receiving atezolizumab and over 70% of patients receiving best supportive care experienced side effects. Serious side effects affected about 22% of the people receiving atezolizumab and about 11% of the participants in the group receiving best supportive care. Among those receiving atezolizumab, the side effects were serious enough that about 18% had to stop receiving treatment. There was also 1 treatment-related death in this group.  

What does this mean for patients: Atezolizumab given after surgery and chemotherapy may help people with stage II to IIIA NSCLC live longer. 

“Though surgery can cure some patients with early-stage lung cancer, disease recurrence is still very common. Until this trial, the only treatment that was known to help reduce that risk for most patients was chemotherapy (or osimertinib for the small group of patients with tumors with an EGFR mutation). These data show that personalized medicine with atezolizumab can reduce the chance of NSCLC returning after surgery for patients who have a tumor that expresses the biomarker PD-L1.”  

—lead study author Heather Wakelee, MD
Stanford University Medical Center 
Palo Alto, CA 

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More frequent PSA screening in younger Black men reduces risk of metastatic prostate cancer at diagnosis and risk of death 

Who does this study affect: Black men younger than 55 who are at high risk for prostate cancer

What did this study find: A large national population-based study of Black men ages 40 to 55 found that more frequent prostate-specific antigen (PSA) screening may reduce the risk of having metastatic disease at the time of their prostate cancer diagnosis and reduce the risk of death. PSA is a protein produced by normal cells, as well as cancerous cells, of the prostate gland.  PSA screening is a blood test used to find prostate cancer before it causes symptoms or signs. 

Currently, guidelines from the U.S. Preventive Services Task Force recommend PSA screening to begin at age 55 for all men. However, some medical societies recommend that PSA screening may begin as early as age 40 for Black men. Younger Black men have a significantly higher risk for prostate cancer and a higher risk of dying from prostate cancer compared with white men. Yet despite this racial difference, Black men are often underrepresented in clinical trials studying prostate cancer screening, including those that have been commonly used by organizations to inform screening guidelines for prostate cancer. As a result, appropriate information to guide the development of screening recommendations for Black men younger than 55 is limited.  

Using the Veterans Health Administration database, this study looked at data from 4,726 Black men between the ages of 40 and 55 who had been diagnosed with prostate cancer from 2004 to 2017. The average age of the men was about 52. In the study, researchers looked at how often the men had received PSA screening in the years before each person’s prostate cancer diagnosis. The researchers defined this screening intensity as the percentage of years the men had received PSA screening during the period before their diagnosis, which ranged from 1 to 5 years. The researchers classified the patients’ data into 2 groups based on their screening intensity. The “Low” group had a lower intensity PSA screening rate, meaning they had been screened less often. The “High” group had a higher intensity PSA screening rate, meaning they had been screened more often. 

The researchers found that the men in the “High” group saw a nearly 40% lower risk of being diagnosed with metastatic disease at the time of diagnosis compared with those in the “Low” group. In addition, around 14% of the men in the “High” group had cancer with a Gleason score of 8 or higher at the time of diagnosis, compared with around 18% of the men in the “Low” group. The Gleason scoring system is used to determine whether a prostate cancer is more or less likely to grow quickly and spread. A Gleason score of 8 or higher is considered a high-grade cancer, meaning it has a higher chance of growing quickly and spreading. The study also showed that men in the “High” group had a lower chance of dying from prostate cancer by about 25%. 

What does this mean for patients: More frequent PSA screening in Black men younger than 55 may help find prostate cancer earlier, leading to fewer cases of newly diagnosed metastatic prostate cancer and a lower chance of dying from the disease. 

“The findings reinforce the importance of early PSA screenings in African American men, as our research suggests that earlier PSA screening may improve their prostate cancer outcomes. The findings also bring us closer to addressing racial disparities that exist in prostate cancer.” 

—lead study author Edmund M. Qiao, BS
University of California San Diego
San Diego, California 

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HPV screening and vaccination has lowered rates of cervical cancer; rates of other HPV-related cancers have increased

Who does this study affect: People who have been diagnosed with human papillomavirus (HPV) or an HPV-related cancer and those in the general population at risk for HPV.  

What did this study find: A study that looked at the rates of HPV-related cancers across the U.S. population showed that while rates for cervical cancer have declined over the past 17 years, rates of other HPV-related cancer have been on the rise. The researchers found that trends in the rates of HPV-related cancers vary depending on several factors, including the type of cancer, age, and sex.  
 
The rate of cervical cancer has decreased by about 1% each year over the last 17 years. The researchers suggest that this is due, in part, to existing vaccination and screening guidelines for cervical cancer. In contrast, the rates of other HPV-related cancers have increased by 1.27% each year for women and 2.36% each year for men. These cancers—anal, rectal, oropharyngeal, and vulvar cancers—do not have screening or HPV vaccination guidelines.  

HPV is a common virus that spreads from person to person during skin-to-skin contact. Specific types, or strains, called “genital HPV” spread most commonly through sexual activity.  Some types can become a lasting infection that leads to precancerous lesions or cancer. HPV is associated with 4.5% of all cancers worldwide. The U.S. Food and Drug Administration (FDA) first approved a vaccine against HPV in 2006 for women and girls between the ages of 9 and 26 and, over time, has expanded its HPV vaccination approval to include all people between the ages of 9 and 45. 

By looking at data from the United States Cancer Statistics program between 2001 and 2017, researchers found that changes in HPV-related cancer rates depended on cancer type, age, and sex.  

  • Younger women from ages 20 to 24 had a greater improvement in cervical cancer rates than older women. Incidence in this younger age group decreased by 4.64% per year. Since screening guidelines for this age group have not changed, the researchers suggest that the HPV vaccine has had an impact on lowering cervical cancer rates.  

  • Among women 55 and older, the researchers predict that anal and rectal cancers will be diagnosed as frequently as cervical cancer by 2025. 

  • Cervical cancer is the only cancer in this study that had enough data to look at trends in younger adults. The other HPV-related cancers are often diagnosed in older people. More research will need to be done to see how effective the HPV vaccine is at preventing these cancers that are diagnosed later in life.  

  • Over 80% of men with an HPV-related cancer have oropharyngeal cancer. They are much more likely to get this cancer than women. The group at highest risk of HPV-related oropharyngeal cancer are white men aged 60 to 69 years.  The researchers suggested that factors playing a role here include the fact that fewer males and older people have received HPV vaccination while men also use tobacco and alcohol more.  

What does this mean for patients: It is important for everyone to get the HPV vaccine when they are eligible to reduce cancer rates. This includes boys and men, as well as people between the ages of 27 and 45 who did not get the vaccine when they were younger. People who have already had an HPV infection can also get the HPV vaccine since it can prevent additional infections of other types of HPV. Talk with your doctor about cancer screening recommendations and cancer risk reduction steps that fit your care. 

"It is likely that the significant decrease in cervical cancer incidence results from clear guidelines for cervical cancer screening and may also reflect promotion and acceptance of vaccination, particularly in younger women.”

—  lead study author Cheng-I Liao, MD 
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan 

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Long-term cancer survival rates are better in U.S. states with higher Medicaid income eligibility limits 

Who does this study affect: Americans with cancer whose income falls within poverty levels.   

What did this study find: In the United States, the Medicaid program provides health insurance for more than 72 million people who have a low income. Medicaid programs are operated independently by each state, and the income limits used to determine whether someone may receive Medicaid benefits vary from state to state. This study found that adults under age 65 with newly diagnosed cancer and a low income had a lower risk of dying if they lived in a state with a higher income limit for Medicaid eligibility.  

The researchers looked at data from the National Cancer Database covering more than 1.4 million adults who were 18 to 64 years old and newly diagnosed with any of 17 common cancers from 2010 to 2013. They measured how long individuals lived from the time of their diagnosis until December 31, 2017, for a maximum of 8 years of follow-up. Income eligibility limits for state Medicaid programs were divided into 3 categories based on the percentage of the Federal Poverty Level (FPL) that the state used:  

  • Low: Eligibility requires a person’s income to be 50% or less of FPL 

  • Middle: Eligibility requires a person’s income to be between 51% and 137% of FPL 

  • High: Eligibility requires a person’s income to be 138% or more of FPL  

The FPL is issued every year by the U.S. Department of Health and Human Services, and it is scaled by the number of individuals in a household. For example, the 2021 FPL is $12,880 per year for a household of 1 person and $26,500 per year for a household of 4 people. The FPL is higher in Alaska and Hawaii. In 2014, a part of the Patient Protection and Affordable Care Act (ACA) allowed states to expand Medicaid coverage for low-income adults. However, not all states expanded Medicaid eligibility. The individuals in this study were diagnosed with cancer before expansion of Medicaid was allowed and their health was observed during the years when expanding Medicaid eligibility was an option.  

In the data in this study, 22% of individuals lived in states with a Low Medicaid income eligibility limit, 43.5% lived in states with a Middle limit, and 34.5% lived in states with a High limit. After statistical analysis, the researchers saw that people with cancer in states with Low and Middle limits were more likely to die of early- or late-stage cancer than those who lived in states with a High limit. For example, compared to those living in states with a High limit, people with early-stage breast cancer had a 31% higher risk of dying if they lived in a Low limit state and a 17% higher risk of dying if they lived in a Middle limit state.  

What does this mean for patients: People with newly diagnosed cancer who have a low income have a lower risk of dying if they live in states that set Medicaid income limits at higher levels, regardless of the stage of their disease or being under age 65.   

“To date, little has been known about the effects of Medicaid income eligibility limits on cancer outcomes. Our research provides strong evidence that state expansion of Medicaid is associated with better long-term survival among newly diagnosed cancer patients.”  

—lead study author Jingxuan Zhao, MPH
American Cancer Society
Atlanta, Georgia 

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