Time is of the Essence
For patients diagnosed with late-stage cancer, the longer treatment is delayed, the poorer the clinical prognosis,1-4 yet capturing a comprehensive picture of the disease is essential for determining the most appropriate first-line treatment. This is underscored by the fact that some 50% percent of advanced cancer patients will not survive long enough to undergo second-line therapy.5 When oncologists have the benefit of comprehensive genomic profiling (CGP), they are able to make optimal treatment decisions.6 Unfortunately, not all advanced cancer patients who could benefit from targeted therapies are being tested. For example, 80% of patients with advanced non-small cell lung cancer7 and 60% of patients with late-stage colon cancer do not receive guideline-recommended CGP.8
The Race Against Time
Genomic testing with tissue requires significant clinical resources, patient risk, healthcare costs, and time. Oncologists often order single-gene testing, intuiting that testing for fewer genes will require less time. However, this approach takes weeks because the tests are run sequentially. Furthermore, even when a broad tissue panel is ordered, 33% to 79% of the time tissue depleted, rendering “quantity not sufficient” (QNS), either due to actual specimen size, tumor cellularity, or both.9-11 The entire tissue testing process is lengthy, delaying treatment as disease progresses.
In addition to the health and survival implications, studies show that the process of waiting, in and by itself, can greatly increase anxiety and depression and diminish health-related quality of life for oncology patients.12,13
To address the urgency of the clinical circumstances, oncologists are often compelled to begin uninformed treatment while awaiting results. Consequently, patients are put on immunotherapy, chemotherapy, or both, despite many clinical studies indicating that biomarker-positive patients who receive the appropriate targeted therapy have greater progression-free survival rates and higher overall response rates.14-20
Treat at the Speed of Cancer
A blood test is less invasive, safer, and less painful. Research indicates that patients have a better experience with liquid biopsy over surgical biopsy.21 Beyond improving the patient’s quality of life, liquid biopsies are also easier for oncology practices by eliminating a myriad of logistical challenges associated with tissue.
Guardant360 CDx,22,23 the first comprehensive liquid biopsy approved by the FDA, provides guideline-recommended genomic results in 7 days, to facilitate rapid clinical decision making. The assay uses proprietary next-generation sequencing technology to simultaneously detect mutations in a broad panel of clinically-relevant solid tumor genes. Real-time notifications are sent when results are ready, so that providers can quickly see the report with matched therapy or clinical trial insights.
Leading with liquid biopsy circumvents the unpredictable and lengthy process of tissue testing, providing a minimally-invasive, swift, accurate, and repeatable alternative that has been FDA-validated. Indeed, as precision medicine continues to advance the practice of oncology, Guardant360 CDx liquid biopsy is quickly becoming the new standard of care.
- Mohammed N, Kestin LL,Grills IS, et al. Rapid disease progression with delay in treatment of non–small cell lung cancer. Int J Radiat Oncol Biol Phys. 2011;79(2):466-472.
- Hanna T, King WD, Thibodeau S, Jalink M, Paulin GA, et al. Mortality due to cancer treatment delay: systematic review and meta-analysis BMJ 2020; 371 :m4087
- Shen SMH, Hung YC, Kung, PT, Yang WH, Wang YH, Tsa WC. Factors involved in the delay of treatment initiation for cervical cancer patients, Medicine. 2016 August. Volume 95 – Issue 33 – p e4568
- Mohammed N, Kestin LL, Grills IS, Battu M, Fitch DL, Wong CY, Margolis JH, Chmielewski GW, Welsh RJ. Rapid disease progression with delay in treatment of non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Feb 1; 79(2):466-72. doi: 10.1016/j.ijrobp.2009.11.029. Epub 2010 May 13.
- Schwartzberg L, Korytowsky B, Penrod JR, et al. Real-world clinical impact of immune checkpoint inhibitors in patients with advanced/metastatic non–small cell lung cancer after platinum chemotherapy. Clinical Lung Cancer. 2019; 20(4): 287-296.
- Nesline MK, DePietro P, Dy GK, et al. Oncologist uptake of comprehensive genomic profile guided targeted therapy. Oncotarget. 2019 Jul 23; 10(45):4616-4629.
- 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. Published Online First. 2019 April 15.
- Gutierrez et al. 2019 JCO Precision Onc.
- Denisov E, Gerashchenko T, Zavyalova M, Manskikh V, Choinzonov E, Nadezda C, Perelmuter V. Inter- and intratumor heterogeneity in hepatocellular carcinoma. 2016. 10.1007/978-3-319-34214-6_14.
- Wu J, Hu S, Zhang L, Xin J, Sun C, Wang L, Ding K, Wang B. Tumor circulome in the liquid biopsies for cancer diagnosis and prognosis. Theranostics. 2020 Mar 15; 10(10): 4544–4556.
- Shaw AT, Riely GJ, Bang Y-J, et al. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann Oncol. 2019; 30(7):1121-1126.
- Rosenbaum EH, Rosenbaum IR. Hurry up and wait. Coping Magazine. n.d.
- Moseholm E, Rydahl-Hansen S, Overgaard D, et al. Health-related quality of life, anxiety and depression in the diagnostic phase of suspected cancer, and the influence of diagnosis. Health Qual Life Outcomes. 2016 May 20; 14:80.
- Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis. Ann Oncol. 2019; 30(5): v851-v934.
- Garon EB, Hellmann MD, Costa EC, et al. Five-year long-term overall survival for patients with advanced NSCLC treated with pembrolizumab: Results from KEYNOTE-001. J Clin Oncol. 2019; 37(28):2518-2527.
- Camidge DR, Dziadziuszko R, Peters S, et al. Updated efficacy and safety data and impact of the EML4-ALK susion variant on the efficacy of alectinib in untreated ALK-positive advanced non–small cell lung cancer in the global phase III ALEX Study. J Thorac Oncol. 2019; 14(7):1233-1243.
- Novartis. Efficacy of Tafinlar-Mekinist in metastatic non-small cell lung cancer with BRAF V600E. n.d. https://www.hcp.novartis.com/products/tafinlar-mekinist/metastatic-nsclc/efficacy/ Accessed online Jan. 10, 2020.
- Gadgeel SM, Garassino MC, Esteban E, et al. KEYNOTE-189: Updated OS and progression after the next line of therapy (PFS2) with pembrolizumab (pembro) plus chemo with pemetrexed and platinum vs placebo plus chemo for metastatic nonsquamous NSCLC. J Clin Oncol. 2019; 37(suppl; abstr 9013)
- Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006; 14;355(24):2542-2550.
- Venkatesan S, Charles Swanton C. Tumor Evolutionary Principles: How Intratumor Heterogeneity Influences Cancer Treatment and Outcome. American Society of Clinical Oncology Educational Book 2016; 36, e141-e149.
- Lee MJ, Hueniken K, Kuehne N, et al. Cancer Patient-Reported Preferences and Knowledge for Liquid Biopsies and Blood Biomarkers at a Comprehensive Cancer Center. Cancer Manag Res. 2020 Feb 13; 12:1163-1173.
- U.S. Food & Drug Administration. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. Fda.gov. Aug. 7, 2020. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test.
- Guardant. Backgrounder: Guardant360® CDx now FDA approved. n.d.