care therapy backgrounder september 2015. key cancer trends
TRANSCRIPT
![Page 1: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/1.jpg)
CARE Therapy Backgrounder
September 2015
![Page 2: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/2.jpg)
KEY CANCER TRENDS
![Page 3: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/3.jpg)
The US has about 12% of the world’s cancer cases
1.7M new cases in the US in 2014
14M cases Worldwide in 2014
Prevalence is highest where lifespan is longest
5 types of cancer make up nearly half of all cases
![Page 4: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/4.jpg)
1994 2004 2014
Population (M) 263.1 292.8 318.9
New Cases (M) 1.21 1.37 1.67
Incidence (per 100K) 0.484 0.476 0.460
Mortality (per 100K) 211.7 186.8 173.8
Source: US Census Bureau (population), SEER-9 Cancer Statistics Factsheets (all cancer sites, M+F)
Despite improvements in incidence and mortality, US cancer diagnoses are growing faster than the population
CAGR 94-14
1.62%
0.97%
-0.21%
-0.98%
(slowing growth, aging, becoming more diverse)
(improving due to lower smoking rates, better screening, and diet)(due to improved therapies)
(accelerating – see next slide)
Trend
![Page 5: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/5.jpg)
An aging population with higher cancer prevalence rates is driving the outsized growth in cancer diagnoses
![Page 6: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/6.jpg)
Growth in US Cancer diagnoses is projected to accelerate from 1.6% to 2% CAGR, reaching 2.3M by 2030
Source: Journal of Clinical Oncology April 2009
Driving Factors:• Aging Population• More minorities
“Demographic changes in the United States will result in a marked increase in the number of cancer diagnoses over the next 20 years. Continued efforts are needed to improve cancer care (especially) for older adults and minorities.”
2% CAGR
1.6% CAGR
2,300
![Page 7: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/7.jpg)
The prevalence cost of cancer care in the US was estimated at $138B in 2014
• $10,298 per cancer survivor per year• Total cost of care is projected to grow
at 3.3% CAGR, assuming current trends in incidence, mortality, and costs
The cost of cancer care is expected to increase even faster; Insurers are pressured to mitigate cost
Medicare, Medicaid, and Private Insurance pay for most of the cost of care
![Page 8: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/8.jpg)
CANCER TREATMENT
![Page 9: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/9.jpg)
The Cancer Treatment Spectrum
1. Surgery – used to remove or de-bulk cancers
2. Chemotherapy – broad spectrum therapy, best for cancer that has spread
3. Radiation Therapy – targeted therapy, best for cancer that is localized
4. Immune Therapy – getting the body to recognize and fight cancer with immune response
5. Targeted Therapy – includes Gene therapy
6. Transplantation – Bone marrow, stem cells, etc.
![Page 10: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/10.jpg)
Radiation Therapy Facts• About 2/3 of all cancer patients receive radiation therapy
– Approx 1.1M US patients in 2014• Breast, Prostate, and Lung cancer made up slightly more than half of all US patients
– Around 88% of radiotherapy patients were treated with a linear accelerator in 2004
– The average cost of radiation therapy is estimated at $17,400• The average patient undergoes 29 treatments (2003 data)
• $600 average Medicare reimbursement cost per session (2015 data)
• In 2008, there were about 4,500 licensed radiation oncologists in the US– The average oncologist sees between 200 and 300 patients annually (avg = 244)
• There are an estimated 2,100 radiation therapy locations in the US– These locations employ an estimated 35K people full-time
• About 2/3 of these are regularly trained on new equipment and therapies
Sources: Physician characteristics and distribution in the US (2010)2004 IMV medical information division2003 Society for Radiation oncology Administrators Benchmarking Surveywww.RT Answers.org
![Page 11: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/11.jpg)
Step 1: Imaging• Precise shape and location of
tumor are determined
Step 2: Treatment Plan• Total Dosage (typically 45-60 Grey)
• Number of sessions (averages 29)
• Dose per session (typically 1.8 to 2.0 Grey)
Step 3: Radiotherapy• Tumor is exposed to radiation
(typically x-rays) from multiple angles
• Targeting typically includes some healthy tissue to ensure the cancer is exposed entirely
Radiation Therapy Treatment Process
![Page 12: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/12.jpg)
How Radiation Therapy Works
Radiation is targeted at the tumor cells
The objective is to causeun-repairable DNA breaks
and reproductive cell death
DNA breaks are caused by one of two ways:
Indirect route: water ionization
Direct route: linear energy transfer
![Page 13: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/13.jpg)
Complications with Radiotherapy
Skin and organs can
absorb radiation
Stray ionization
into healthy tissue
Absorption by surrounding
healthy tissue
These complications can create unwanted side-effects
![Page 14: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/14.jpg)
The Side Effects of Radiotherapy can be serious
Acute Side Effects• Damage to epithelial surfaces
• Nausea/vomiting
• Mouth/throat/stomach sores
• Intestinal discomfort
• Swelling/Inflammation
Chronic Side Effects• Fibrosis
• Hair loss
• Dryness (salivary/tears)
• Cognitive decline
• Infertility
• Radiation proctosis
• (rarely) cancer, heart disease
Mitigation Techniques• More accurate ionizing beams
• 3D conformal (IGRT, 3DCRT, IMRT)• Stereotactic (SRS/SBRS)• Volumetric modulated arc (VMAT)
• Proton/particle therapy • Delivers more energy to the
tumor / less to healthy cells• On average, is 2.4X more costly*
than standard IMRT
• Drugs • To treat the side effects
• …and now: CARE therapy• Priming the body to withstand
higher doses of radiation
* (2004). Advantage of protons compared to conventional X-ray or IMRT in the treatment of a pediatric patient with medulloblastoma. Int. J. Radiat. Oncol. Biol. Phys. 58, 727–734.
![Page 15: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/15.jpg)
What is CARE TherapyTM?• C.A.R.E. stands for Cell Adaptive Response Effect
• CARE therapy is used in conjunction with Radiotherapy– A small pre-dose is used to ‘prime’ the healthy cells near the cancer to
withstand subsequent large doses of radiation• Dose is between 0.02 and 0.1 Gy
– The pre-dose induces a well-known phenomena called Adaptive Response– Adaptive response is the body’s reaction to low levels of stress
• Cells prepares themselves to withstand a larger subsequent stress• In this application, CARE prepares healthy cells to withstand the subsequent higher
doses of radiation therapy
• CARE therapy is patented– US Patent: 20090114846 – Issue Date: June 21, 2011
![Page 16: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/16.jpg)
What is Adaptive Response?
• Adaptive response is the body’s genetic response to environmental stress
• Examples of adaptive response:– Exercise muscle mass– Calorie Restriction longer life– Alcohol “tolerance”– Sunlight tanning of skin– Radiation cellular repair
Things that are beneficial in low amounts, but harmful in high amounts
![Page 17: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/17.jpg)
What we know about Pre-Dose Adaptive Response
Radiation Dose (Gy) 30 Day Survival % Lifespan (days) 0 (control) 100 727 1.0 30 486 0.1 – 24hr – 1.0 70 578 Repair of broken Chromosomes - Human fibroblasts Low Dose Wait High Dose DNA Breaks (Gy) Time (Gy) per cell 0 - 0 0.06 (control) 0.5 - 0 0.09
0 - 4 1.1 High Dose 0.5 0 hr 4 0.7 0.5 5 hr 4 0.45
Based on full body dose experiments on MICE et.al.
1. Pre-dose can lengthen lifespan and survival
2. Pre-dose with a wait time induces cellular repair mechanisms*
Source: Dose-Response Sept. 2010 pp 534-542
Based on experiments with dogs3. Pre-dose can reduce unwanted side effects
Impaired saliva production was avoided in dogs that received pre-dose
Source: REJ Mitchel, (2015) Low-Dose Irradiation Affects Expression of Inflammatory Markers in the Heart of ApoE -/- Mice, PLoS ONE 10(3): e0119661
Red
num
bers
indi
cate
pre
-dos
e am
ount
* We also know which cellular repair genes are switched on
![Page 18: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/18.jpg)
How CARE Pre-Dose Therapy Works
Low Intensity beam irradiates around the cancer site (but not
into it)
Particle Beam
Induces adaptive response in healthy tissue
surrounding the cancer site
![Page 19: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/19.jpg)
Standard Treatment Follow-up ~24 hours later
High intensity beam targeted at cancer site
Previously induced adaptive response minimizes ‘good’
tissue damage and unwanted side effects.
Higher doses are possible at the cancer site
![Page 20: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/20.jpg)
How can CARE therapy be used?
• CARE therapy is a treatment protocol to be used with existing radiotherapy equipment and software controls– It’s just another programmed dose session (29 30 on average)
• CARE therapy can be used in multiple ways:– To minimize unwanted side effects and tissue damage
• CARE may also reduce the side effects of chemotherapy– To deliver more radiation to the cancer site
• Saves cost through fewer treatments (hypofractionation)• Improve outcomes with a higher cancer kill rate
Note: More details are available in a White Paper on CARE therapy.
![Page 21: CARE Therapy Backgrounder September 2015. KEY CANCER TRENDS](https://reader038.vdocument.in/reader038/viewer/2022110403/56649e725503460f94b709da/html5/thumbnails/21.jpg)
THANK YOU