New Cancer Technology: Is Easy Detection a Reality?
Is Easy DetectionA Reality?
Elaine Schattner, MD, MA, Physician & Patient Advocate, NewYork, NY
Chairman & CEO
Sam Hanash, MD, PhD
Professor of Cancer Prevention and Molecular Pathology
The University ofTexas MD Anderson Cancer Center
Founder and Editor,Timmerman Report
Up For Debate:Why Screen For Cancer?
1. Debate? Pros & Cons of Early Detection
A Bit of History, Stats & Facts
2. Liquid Biopsy: ctDNA, CTCs…
Grail? Cancer Detection vs. Monitoring Q & A
3. Cologuard for Colon and Rectal Cancer Screening Q & A
4.What Limits Adoption of Novel Detection Methods?
Is DTC marketing appropriate? Q & A
Early Cancer Detection: Pros & Cons
If screening is accurate, it could result
in less treatment and better
Save Lives, Extend Lives
less toxic drugs, smaller surgery
Lower costs of care?
Screening can lead to false alarms,
evaluation and treatment of people who
have slow-growing, “benign” tumors.
surgery, medication, radiation
toxicity, even death
needless worry & grief
Costs without reason
Cervical Cancer:A Detection Success Story
high-grade cervical cell dysplasia
History: Before 1960, cervical cancer was a common cause of illness and mortality in U.S. women.
Now: In years since screening with Pap smears began, cervical cancer is infrequent; deaths are rare.
(The Milbank Quarterly, Vol. 90, 2012)
Future: Can we prevent cervical cancer by
immunizing against HPV?.
(Dr. E. Uthman, Wikimedia)
Cancer Care is Expensive
Mariotto et al. NCI 2011;103(2): 117–28.
Cancer Is a Leading Cause of DeathWorldwide
US: 1.7 M cases, 595,690 deaths
Global: 14 M cases, 8 M deaths
Toll expected to surpass 20M in 2020
Many cancer are stage III or IV at diagnosis.
Within the U.S. and globally, this varies
– and is changing.
Cell-free DNA (cf-DNA)
Circulating tumor DNA (ctDNA)
Circulating tumor cells (CTCs)
What is a Liquid Biopsy?
A CTC lights up the androgen receptor
in a metastatic prostate cancer cell
(image from Epic Sciences, San Diego)
DNA sequence from a normal and tumour cell
Blood is chock-full of stuff
Is Screening Blood for Cancer Feasible, orWise?
For Detection or Cancer Monitoring?
Breaking Bad, early episode (AMC)
Around the time ofWalter White’s lung cancer diagnosis:
MightWalter have benefited from early detection?
Breaking Bad, Season 5 (AMC)
Late inWalter White’s journey:
Might he have benefited from monitoring
Esophageal Prostate Pancreas Breast Colorectal Lung
Annual cancer deaths
treatment costs in 2020
Colon Cancer:America’s Second Deadliest
Sources: CDC, MMWR 2013; ACSCancer Stats & Figures (2016)
Poop and Looking Inside:
Ways to Check for Signs of Colon and Rectal Cancer
NCI image (TereseWinslow, illustrator) Colon cancer screening (image: U.S. government, Navy)
How Does Cologuard Compare with FOBT
and Other Colorectal Cancer Screening Methods?
Early Colorectal Cancer Detection is Critical
9 out of 10
survive 5 years
Diagnosed in Stages I or II Diagnosed in Stage IV
1 out of 10
survive 5 years
60% of patients diagnosed
Stagnant screening rates:
(Inadomi JM, et al. Adherence to Colorectal Cancer Screening, a Randomized
Clinical Trial of Competing Strategies. Arch Intern Med. 2012;172(7):575-582).
(only 38% for
2005 2008 2010 2013 2018 2020
How Does CologuardWork?
Stool DNA test: looks for hidden blood
and 11 biomarkers (10 DNA & 1 protein)
Completed at home, returned via UPS,
no medication, no prep, no sedation
FDA-approved & covered by Medicare
Included in American Cancer Society
guidelines & U.S. Preventive Services
Task Force draft guidelines
Cologuard vs. other non-invasive options:
What’s the Experience with Cologuard?
*Patient compliance rate: number of valid test results reported divided by the number of collection kits shipped to patients
60 or more days prior to December 31, 2015 – information from Exact Sciences, for ages 50 -74
Source: Colorectal Cancer Screening with Multi-target stool DNA-basedTesting Previous Screening History of the Initial Patient
Cohort, poster presented at American College of Gastroenterology'sAnnual Scientific Meeting (ACG 2015), Oct. 16-21, 2015
Q & A
What Limits Use of New Cancer ScreeningTools?
Role of Education:
Need for better education of doctors in modern science
- How do practicing physicians learn about new tech?
- Greater education of the public, in science?
Screening Guidelines: Costs & Iffy Insurance Coverage: Regulatory Issues:
Finding Cancer in Other Body Fluids?
What’s the Future of Early Cancer Detection?
Q & A, General Discussion
What we we’ll be speaking about. We encourage discussion.
What’s the debate? Does this apply to all cancers?
This slide tells a story: Henrietta Lacks, as many in the audience may know from Rebecca Skloot’s best-selling book, died in 1951 in Baltimore from cervical cancer. NCI: Before 1950, cervical cancer was a major cause of death among women of childbearing age in the United States. -> Pap smears pick up pre-cancerous changes in cervical cells, as seen here, and early cancers, and have – since 1955 – lowered deaths from cervical cancer in the U.S. by around 74%. The graph shows the trend since 1975. Note: this remains a lethal tumor. NCI recent data: 5-year survival 67.8%. Rate varies (a lot) by region/state; racial disparities exist but have been lessened since 1980 due to screening.
Additional info – if asked: Current U.S. data – CDC, SEER: Fewer than 13,000 new cases of invasive cervical cancer, about 4,120 women will die from it this year. Tends to affect & kill women 30s – 50s (early “peak”) c/w breast, lung and other cancers affecting women. Now ranked 21st most common in U.S (? In women <<10th)
From JNCI review; NCI March 2016: National expenditures for cancer care in the United States totaled nearly $125 billion in 2010 and could reach $156 billion in 2020.
Cancer is lethal –14 million deaths per year (GLOBOCAN, 2008) – rising -> 20 M; 595K in U.S. – latest NCI report. Global figs from IARC/WHO 2012 report
Science Girl clipart
Discussion of what a liquid biopsy is, and some ways of doing it. 1. Blood is loaded with stuff, information – not just for cancer – infection, antibodies, e.g. 2) There are new ways to detect and analyze cancers – individual tumor cells, genetic material they contain and release…Merits, and limits, to each method. The ones that are furthest along are evaluation of DNA in blood, typically cell-free DNA in plasma, and circulating tumor cells. 3) As we’ll consider, liquid biopsies might be used for detecting cancer, or for monitoring tumor changes patients already known to have cancer, such as resistance-conferring mutations in lung cancer patients
Time for Q&A – highlight difference between looking in blood for almost any mutation, which yields potentially many findings of uncertain significance (VUS’s), vs. a focused approach looking for specific, cancer-associated changes in a particular body part
Clarify screening vs. monitoring in patients known to have cancer (more relevant to liquid biopsies than to Cologuard)
Colon cancer mortality and incidence: American Cancer Society, A Cancer Journal for Clinicians 2016; Annual spending: : CDC MMWR 2013; 64(17);464-468 (Sabatino)
Some cancer stats: Deaths – and cases – of colon and rectal cancer have been dropping steadily. Doctors, especially gastroenterologists, attribute the decline to prevention (a term one might question): that by removing pre-malignant polyps in colonoscopy, they’re preventing colon and rectal cancer from forming, from becoming frank tumors. Still, the survival rate at 5 years isn’t great, under 2/3 – reason to find these early.
There’s a reason why I didn’t go into gastroenterology, ES. Talk about colonoscopy (costs, risks); flex-sig (limited)
Old ways of colon cancer screening for blood in stool, vs. Cologuard. We will discuss this in light of recent recommendations in Canada against colonoscopy.
From Exact Sciences: sources: 42% of patients not screened before: Colorectal Cancer Screening with Multi-target stool DNA-based Testing Previous Screening History of the Initial Patient Cohort, poster presented at American College of Gastroenterology's Annual Scientific Meeting (ACG 2015), Oct. 16-21, 2015; ages 50-74 71% patient compliance rate: *Patient compliance rate: number of valid test results reported divided by the number of collection kits shipped to patients 60 or more days prior to December 31, 2015. 88% patients rate Cologuard experience positive: Exact Sciences Laboratories patient satisfaction survey data is cumulative; n = 2,799
Not all cancers can be detected, or monitored in blood. Some strategies – not yet mature – might exploit location in body relative to organ affected