New Cancer Technology: Is Easy Detection a Reality?

Elaine Schattner M.D., M.A.
Elaine Schattner M.D., M.A.Journalist, Physician, Healthcare Advocate
FINDING CANCER
Is Easy DetectionA Reality?
Moderator:
Elaine Schattner, MD, MA, Physician & Patient Advocate, NewYork, NY
Kevin Conroy
Chairman & CEO
Exact Sciences
Madison,WI
Sam Hanash, MD, PhD
Professor of Cancer Prevention and Molecular Pathology
The University ofTexas MD Anderson Cancer Center
Houston,TX
LukeTimmerman
Biotech Journalist
Founder and Editor,Timmerman Report
Seattle, WA
Session Plan:
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?
Science #Education…#Regulation…#Costs…
Is DTC marketing appropriate? Q & A
#cancertech 2
Early Cancer Detection: Pros & Cons
Point:
If screening is accurate, it could result
in less treatment and better
outcomes.
Save Lives, Extend Lives
MinimizeTreatment
less toxic drugs, smaller surgery
Cure?
Lower costs of care?
Counterpoint:
Screening can lead to false alarms,
evaluation and treatment of people who
have slow-growing, “benign” tumors.
Overtreatment
surgery, medication, radiation
toxicity, even death
needless worry & grief
Costs without reason
#cancertech 3
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)
#cancertech 4
Cancer Care is Expensive
Mariotto et al. NCI 2011;103(2): 117–28.
#cancertech 5
#cancertech 6
Cancer Is a Leading Cause of DeathWorldwide
Annual toll:
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.
NewTech!
#cancertech 7
Cell-free DNA (cf-DNA)
Circulating tumor DNA (ctDNA)
Circulating tumor cells (CTCs)
Exosomes
Micro-RNA
Other
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
(WellcomeTrust image)
Blood is chock-full of stuff
#cancertech 8
Is Screening Blood for Cancer Feasible, orWise?
#cancertech 9
Fishing Expedition?
Deadliest Catch, (Discovery image)
Q & A
#cancertech 10
Liquid Biopsies:
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
during treatment?
#cancertech 11
#cancertech 12
134,490
new diagnoses
15,690
26,120
41,780 40,890
49,190
158,080
Esophageal Prostate Pancreas Breast Colorectal Lung
Annual cancer deaths
$20 billion
projected annual
treatment costs in 2020
Colon Cancer:America’s Second Deadliest
Sources: CDC, MMWR 2013; ACSCancer Stats & Figures (2016)
#cancertech 13
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)
#cancertech 14
How Does Cologuard Compare with FOBT
and Other Colorectal Cancer Screening Methods?
#cancertech 15
Early Colorectal Cancer Detection is Critical
And Underused:
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
stages III-IV
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).
50%
52%
59% 58%
(only 38% for
colonoscopy)*
80% 80%
2005 2008 2010 2013 2018 2020
#cancertech 16
How Does CologuardWork?
#cancertech 17
 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?
#cancertech 18
71%
Patient
compliance*
88%
Patients rated
experience
positive
42%
Patients never
screened before
*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
including genetics
- How do practicing physicians learn about new tech?
- Greater education of the public, in science?
Screening Guidelines: Costs & Iffy Insurance Coverage: Regulatory Issues:
#cancertech 19
Finding Cancer in Other Body Fluids?
#cancertech 20
Is Advertising OK?
#cancertech 21
Q & A
What’s the Future of Early Cancer Detection?
Q & A, General Discussion
#cancertech 22
Thank you!
#cancertech
Kevin Conroy
@ExactSciences
Sam Hanash
@MDAndersonNews
LukeTimmerman
@ldtimmerman
Elaine Schattner
@ESchattner
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New Cancer Technology: Is Easy Detection a Reality?

  • 1. FINDING CANCER Is Easy DetectionA Reality? Moderator: Elaine Schattner, MD, MA, Physician & Patient Advocate, NewYork, NY Kevin Conroy Chairman & CEO Exact Sciences Madison,WI Sam Hanash, MD, PhD Professor of Cancer Prevention and Molecular Pathology The University ofTexas MD Anderson Cancer Center Houston,TX LukeTimmerman Biotech Journalist Founder and Editor,Timmerman Report Seattle, WA
  • 2. Session Plan: 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? Science #Education…#Regulation…#Costs… Is DTC marketing appropriate? Q & A #cancertech 2
  • 3. Early Cancer Detection: Pros & Cons Point: If screening is accurate, it could result in less treatment and better outcomes. Save Lives, Extend Lives MinimizeTreatment less toxic drugs, smaller surgery Cure? Lower costs of care? Counterpoint: Screening can lead to false alarms, evaluation and treatment of people who have slow-growing, “benign” tumors. Overtreatment surgery, medication, radiation toxicity, even death needless worry & grief Costs without reason #cancertech 3
  • 4. 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) #cancertech 4
  • 5. Cancer Care is Expensive Mariotto et al. NCI 2011;103(2): 117–28. #cancertech 5
  • 6. #cancertech 6 Cancer Is a Leading Cause of DeathWorldwide Annual toll: 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.
  • 8. Cell-free DNA (cf-DNA) Circulating tumor DNA (ctDNA) Circulating tumor cells (CTCs) Exosomes Micro-RNA Other 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 (WellcomeTrust image) Blood is chock-full of stuff #cancertech 8
  • 9. Is Screening Blood for Cancer Feasible, orWise? #cancertech 9
  • 10. Fishing Expedition? Deadliest Catch, (Discovery image) Q & A #cancertech 10
  • 11. Liquid Biopsies: 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 during treatment? #cancertech 11
  • 12. #cancertech 12 134,490 new diagnoses 15,690 26,120 41,780 40,890 49,190 158,080 Esophageal Prostate Pancreas Breast Colorectal Lung Annual cancer deaths $20 billion projected annual treatment costs in 2020 Colon Cancer:America’s Second Deadliest Sources: CDC, MMWR 2013; ACSCancer Stats & Figures (2016)
  • 14. 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) #cancertech 14
  • 15. How Does Cologuard Compare with FOBT and Other Colorectal Cancer Screening Methods? #cancertech 15
  • 16. Early Colorectal Cancer Detection is Critical And Underused: 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 stages III-IV 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). 50% 52% 59% 58% (only 38% for colonoscopy)* 80% 80% 2005 2008 2010 2013 2018 2020 #cancertech 16
  • 17. How Does CologuardWork? #cancertech 17  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:
  • 18. What’s the Experience with Cologuard? #cancertech 18 71% Patient compliance* 88% Patients rated experience positive 42% Patients never screened before *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
  • 19. What Limits Use of New Cancer ScreeningTools? Role of Education: Need for better education of doctors in modern science including genetics - How do practicing physicians learn about new tech? - Greater education of the public, in science? Screening Guidelines: Costs & Iffy Insurance Coverage: Regulatory Issues: #cancertech 19
  • 20. Finding Cancer in Other Body Fluids? #cancertech 20
  • 22. What’s the Future of Early Cancer Detection? Q & A, General Discussion #cancertech 22
  • 23. Thank you! #cancertech Kevin Conroy @ExactSciences Sam Hanash @MDAndersonNews LukeTimmerman @ldtimmerman Elaine Schattner @ESchattner

Editor's Notes

  1. What we we’ll be speaking about. We encourage discussion.
  2. What’s the debate? Does this apply to all cancers?
  3. 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)
  4. 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.
  5. 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
  6. Science Girl clipart
  7. 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
  8. 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
  9. Clarify screening vs. monitoring in patients known to have cancer (more relevant to liquid biopsies than to Cologuard)
  10. Colon cancer mortality and incidence:  American Cancer Society, A Cancer Journal for Clinicians 2016; Annual spending: : CDC MMWR 2013; 64(17);464-468 (Sabatino)
  11. 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.
  12. There’s a reason why I didn’t go into gastroenterology, ES. Talk about colonoscopy (costs, risks); flex-sig (limited)
  13. 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.
  14. 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
  15. Not all cancers can be detected, or monitored in blood. Some strategies – not yet mature – might exploit location in body relative to organ affected