In an interview with PharmaShots, Andrew Spiegel, Executive Director of the Global Colon Cancer Association shares the details of the campaign and put colors on the impact of complete biomarker testing for advanced CRC patients.

Shots:

• The Clear Your View campaign is an awareness initiative sponsored by Guardant Health to raise awareness of the importance of complete biomarker testing before starting 1L treatment for all advanced cancer patients, with a focus on colorectal cancer and NSCLC patients.
• The campaign encourages physicians to stop, test and wait for the complete genomic profile of a patient's cancer before starting first-line therapy
• It is currently recommended that patients with advanced colorectal cancer be tested for six genomic alterations or biomarkers including KRAS, NRAS, BRAF, ERBB2 (HER2), and NTRK as well as microsatellite instability (MSI).

Tuba:  What is colorectal cancer? Where does it start?

Andrew: Most colorectal cancers (CRC) start as a growth, known as a polyp, on the inner lining of the colon or the rectum. These cancers can also be called colon cancer or rectal cancer, depending on where they start but are often grouped together because they have many features in common.1 According to the American Cancer Society, colorectal cancer is the third most common cancer diagnosed among both men and women in the U.S.

There are different types of polyps, each with a different risk of colorectal cancer. If not detected early, certain types of polyps can become cancerous over time. For example, hyperplastic polyps and inflammatory polyps are more common but generally are not pre-cancerous. Adenomatous polyps (adenomas) have a higher risk of developing into cancer. Sessile serrated polyps (SSP) and traditional serrated adenomas (TSA) have a higher risk of colorectal cancer and are often treated like adenomas.2 Other factors, aside from the type of polyp, can signal if there may be an increased risk in developing colorectal cancer. This includes if a polyp larger than one centimeter is found, if more than three polyps are found, or if dysplasia is seen in the polyp after it has been removed. Screening for colorectal cancer is important to monitor the development of polyps and other risk factors associated with the development of colorectal cancer. For more details on the types of polyps and conditions that can lead to colorectal cancer, see the American Cancer Society: Understanding Your Pathology Report: Colon Polyps.

Tuba:  Why is there a need to raise awareness on the need for complete biomarker testing for patients with advanced colorectal cancer (CRC)?

Andrew: Unfortunately, many patients with metastatic or advanced colorectal cancer may not be receiving the most appropriate therapy due to the absence of complete biomarker testing before starting first-line treatment.

Over the last decade, the National Comprehensive Cancer Network has expanded guidelines to recommend all patients with metastatic colorectal cancer receive testing for six genomic alterations or biomarkers including KRAS, NRAS, BRAF, ERBB2 (HER2), and NTRK as well as microsatellite instability (MSI) to help inform first-line treatment decisions.3,4 Yet, even with these expanded guidelines, only 40% of patients with advanced CRC receive the recommended biomarker testing, putting the majority of these patients at risk for receiving inappropriate treatment.5 In a recent report published in JCO Precision Oncology, 72% of patients who were given an anti-EGFR therapy did not have guideline-aligned testing for RAS and BRAF biomarkers to determine if they were eligible for that treatment. When the right therapy is matched to the patient’s genomic profile, it can significantly improve survival for patients with advanced CRC.6

Tuba:  What are the different advocacy groups that collaborated with Guardant Health for the Clear Your View campaign?

Andrew: In addition to the Global Colon Cancer Association, where I work as an Executive Director, Guardant Health has partnered with the Colorectal Cancer Alliance, Fight CRC, KRAS Kickers, and PALTOWN to raise awareness of the important role complete biomarker testing play in guiding initial treatment decisions for newly diagnosed patients with advanced CRC.

Tuba:  What is the Clear Your View campaign? What is the focus behind the campaign?

Andrew: The Clear Your View campaign is an awareness initiative sponsored by Guardant Health to raise awareness of the importance of complete biomarker testing before starting first-line treatment for all advanced cancer patients, with a focus on colorectal cancer and non-small cell lung cancer (NSCLC) patients.

Now in its second year, the campaign urges oncologists to stop, wait, and treat for every advanced NSCLC or CRC patient. Oncologists should STOP and order all guideline-recommended biomarker tests and WAIT to get complete test results before determining the most appropriate therapy. They should TREAT these patients by choosing the right therapy with confidence.

Tuba:  What are the different biomarkers that need to be tested before initiating the treatment for CRC?

Source; Clear Your View

Andrew: It is currently recommended that patients with advanced colorectal cancer be tested for six genomic alterations or biomarkers including KRAS, NRAS, BRAF, ERBB2 (HER2), and NTRK as well as microsatellite instability (MSI).3,4 It is important to note, however, that medical guidelines continue to update and expand their recommendations, so this list may expand in the foreseeable future.

Tuba:  What are the drawbacks of incomplete biomarker testing?

Andrew: Unfortunately, current rates of biomarker testing in advanced NSCLC and CRC fail to meet recommended medical guidelines.5,7,8,9 When there is incomplete biomarker testing before starting treatment, this can lead to inappropriate treatment selection and patients may not receive potentially life-changing precision medicines. Instead, patients may be prescribed chemotherapy or immunotherapy, which may not be as effective as a precision medicine targeting a biomarker. Testing for all guideline-recommended biomarkers can help predict which patients are most likely to respond to a certain treatment and which will not respond and is one of the best ways to ensure that the patient receives the best treatment from the start.

Tuba:  Why are genotyping rates so low?

Andrew: Various factors contribute to oncologists not comprehensively genotyping their patients before starting treatment, including physician-reported gaps in the knowledge and skills needed to incorporate genotyping into clinical practice; challenges in keeping track of the latest recommendations; the time frame associated with getting complete genotyping results using tissue biopsies; and the cost of tests when not covered by insurance.5,8,9

Also, historically, oncologists have relied on tissue biopsies which can often take 21 days to return results. With liquid biopsies, two of which were recently FDA approved, oncologists, can receive comprehensive genomic results from a simple blood draw in a week, helping them move beyond the limitations of tissue biopsies to match patients with the best treatments faster. Obtaining clinically relevant genomic information through a simple blood draw also potentially helps patients avoid an additional tissue or surgical biopsy.

Q8.  Last year, the campaign focused on NSCLC, so what will be other indications that could be incorporated in the coming years?

Andrew: The American Cancer Society estimates that in 2021 lung cancer and colorectal cancer will be the first and third cause of cancer deaths in the U.S., respectively. Currently, the campaign is focused on the cancers that have the greatest unmet medical need and have more effective targeted therapies aimed at biomarkers. However, there is a great opportunity to increase awareness of the need for biomarker testing in other cancer indices including advanced breast cancer, gastrointestinal cancers, and bladder cancers.

Q9. Why do you think there is a need for awareness campaigns in oncology? How is it helping patients?

Andrew: Although the Clear Your View campaign is targeted at oncologists, the broader goal is to advocate for patients with advanced cancers so that they can receive the most comprehensive testing and targeted first-line treatments that will hopefully extend their progression-free survival. Campaigns like this one provide a unique opportunity to educate and inform not only healthcare providers but policy makers, payers, patients, and the general public on all of the latest testing and treatment options that are available for patients diagnosed with cancer.

Main Image Source: Yale University

References

1. American Cancer Society. Key Statistics for Colorectal Cancer.. Accessed 15 April 2021.
2. American Cancer Society. Understanding Your Pathology Report: Colon Polyps (Sessile or Traditional Serrated Adenomas).. Accessed 14 April 2021.
3. National Comprehensive Cancer Network. Guidelines for Patients: Colon Cancer 2018..Accessed online April 15, 2021.
4. National Comprehensive Cancer Network. Guidelines for Patients: Rectal Cancer 2018.. Accessed online April 16, 2021.
5. Gutierrez ME, Price KS, Lanman RB, et al. Genomic Profiling for KRAS, NRAS, BRAF, Microsatellite Instability (MSI) and Mismatch Repair Deficiency (dMMR) among Patients with Metastatic Colon Cancer. JCO Precision Oncol. December 2019.
6. Kopetz S, Grothey A, Yaeger R, Cutsem E, et al. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E Mutated Colorectal Cancer. New England Journal of Medicine. 2019; 381:1632-1643.
7. Leighl NB, Page RD, Raymond VM, et al. Clinical Utility of Comprehensive Cell-Free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. 2019;25(15)4691-4700.
8. Carter GC, Landsman-Blumberg PB, Johnson BH, et al. KRAS testing of patients with metastatic colorectal cancer in a community-based oncology setting: a retrospective database analysis. J Exp Clin Cancer Res. 2015;34:29.
9. Charlton ME, Kahl AR, Greenbaum AA, et al. KRAS Testing, Tumor Location, and Survival in Patients with Stage IV Colorectal Cancer: SEER 2010-2013. J Natl Compr Canc Netw. 2017.

About Andrew Spiegel:

Andrew Spiegel has two careers: a self-employed civil litigation attorney for more than 30 years, and more two decades of experience as both a personal and professional advocate for patients and their families. A global non-profit executive, Spiegel travels around the world speaking on health policy matters to ensure patients remain at the forefront.

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