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Pediatric Oncology Research: The Impact of Collaborative Clinical Trials

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Pediatric Oncology Research: The Impact of Collaborative Clinical Trials Mary Lou Schmidt, MD Head, Division of Pediatric Hematology/Oncology Department of Pediatrics – PowerPoint PPT presentation

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Title: Pediatric Oncology Research: The Impact of Collaborative Clinical Trials


1
Pediatric Oncology ResearchThe Impact of
Collaborative Clinical Trials
  • Mary Lou Schmidt, MD
  • Head, Division of Pediatric Hematology/OncologyDe
    partment of PediatricsUniversity of Illinois at
    Chicago
  • College of Medicine

2
Important Concepts
  • Pediatric Oncology Partnerships have led to
    dramatic gains against childhood cancer
  • 2/3 of survivors of childhood cancer have a major
    disability by 25 years of age
  • 15-45 year olds have had NO improvement in their
    survival from cancer in the last 30 years.

3
Childhood Cancers Impact
  • The leading cause of death by disease for
    children lt 15 years of age
  • (greater than HIV, heart disease, cystic
    fibrosis, infection combined)
  • 12,000 US cases/year, 160,000 cases worldwide
  • 20 death rate in Western World (1 in 5 die)
  • 65 of survivors have a major disability
  • 25 of survivors have 3-4 disabilities/one of
    which is life-threatening

4
Pediatric Oncology World Goal
  • Improve the survival rates for childhood cancer
  • Reduce the immediate and long-term side effects
    including
  • second cancers, cognitive deficits,
    musculoskeletal abnormalities, major organ
    dysfunction (lungs, heart, kidneys, liver, etc.),
    infertility

5
Specific types of childhood cancer
  • Hematologic acute leukemias-33
  • lymphomas-12
  • Solid tumors brain tumors-20
  • muscle or bone tumors-12
  • Solid Tumors that affect children lt 8 16
    retinoblastoma, Wilms tumor, neuroblastoma

6
The patients and families
7
5-Year Cancer Survival RatesU.S., 1960-1993
lt15 Year-Olds
A Bleyer
70
5-Year Survival
50
30
Modified from Landis SH et al, CA - Cancer J
Clin 486-29. 1998
1960-3
1970-3
1974-6
1980-2
1983-5
1986-93
1977-9
8
Potential Areas for Cancer Research
  • Epidemiology causes of cancer
  • Pre-clinical studies
  • Biology studies from clinical specimens
  • Clinical Trials Phase I, II, III
  • Quality of Life Studies
  • Late Effects Studies
  • Disparities Studies
  • End of Life Studies

9
Improvement in Annual Cancer Mortality Rate among
U.S. Children lt15 Years of Age 1950-2000
A Bleyer
8
Mortality per 100,000, Age- Adjusted
6
( )
4
2
1950
1960
1970
1980
1990
10
A Bleyer
IRSG
NWTSG
SWOG Pediatric Division
POG
CALGB Pediatric Division
CCG
1960
1970
1980
1990
2000
11
The Childrens Oncology Group
  • 250 institutions US, Australia, Canada,
    Switzerland, the Netherlands and New Zealand
    including
  • St. Jude, Sloan-Kettering, Mayo Clinic, Harvard,
    Stanford, MD Anderson 240 other leading
    academic medical centers
  • 7 Chicagoland COG programs
  • UIC Rush ( Stroger)
  • CMH, U of C, Loyola, Lutheran General, Christ

12
Childrens Oncology Group Clinical Trials
Research Program
  • Goal improve survival and decrease toxic side
    effects by
  • comparing new experimental therapy to current
    standard of care
  • 150 clinical trials currently available for
    different diseases and patients
  • Each trial includes 30-2000 patients
  • Trials frequently randomize patients between 2-4
    different plans
  • Each trial must be locally approved and managed,
  • With high quality data entered on time and
    on-line,
  • And institutional audits passed every 3 years
  • Results are published collaboratively

13
Childrens Oncology GroupClinical Trials
Research Program Succeeds because of
  • Full participation by all US Pediatric
    Oncologists in a
  • Collaborative Spirit, using scarce shared
    resources which has led to amazing forward
    progress
  • Fueling further research education

14
When is a kid a kid?
  • Why have children begun to survive at much higher
    rates than adults?
  • Why have patients ages 15-45 had NO
  • improvement in their survival in 30 years?
  • How can we improve the survival rate for
    adolescents and young adults?

15
(No Transcript)
16
AYA Patients
17
Acute Lymphoblastic Leukemia Disease Free Survival
Stock W Sather H, Dodge RK, Bloomfield CD, Larson
A, Nachman J. Blood 96 467a, 2000.
DFS
16-20 Years (N 103)
CALGB
20-29 Years (N 123)
18
(No Transcript)
19
Relative Participation of U.S. Children and
Adults with Cancer on Clinical Trials
Participating in Clinical Trials
A Bleyer
100
80
60
40
20
0
Adults
Children
20
Accrual to Cooperative Group Clinical Trials
10/97 to 9/98
A Bleyer
1855
2000
Number of Patients on Clinical Trials
1500
1263
997
1000
761
819
413
500
162
126
0
0-4
5-9
10-14
15-19
20-24
25-29
30-34
35-39
Age (Years)
21
Estimated Proportion of Adolescent Young Adults
with Cancer on Clinical Trials
A Bleyer
Number of Patients
0-4
5-9
10-14
15-19
20-30
Age (Years)
22
AYA Patients
23
Impact of support
  • Push all facets of research forward by improving
    enrollment on all possible Children's Oncology
    Group clinical trials at each local institution
  • Specifically focus on adolescents and young
    adults
  • Educate the public and community-based
    practitioners to refer adolescents and young
    adults to the COG centers

24
Funding for COG Clinical Trials
  • National Institutes of Health? ? COG
  • CureSearch website, tissue banks and research
    labs, the 150 COG clinical trials
  • publish clinical trials results
  • auditing 250 COG institutions
  • Estimated actual cost to the local COG
    institution
  • 7000/patient enrolled
  • Each COG hospital/institution receives
  • ____________________________ 2400/patient
    enrolled
  • Local Institutional Funding Gap Coverage who
    pays?
  • The treating institution or philanthropists

25
Requirements for maximum participation in COG
Clinical Trials
  • Salary support for
  • Principal Investigator/MDs
  • Clinical Research Nurses
  • Regulatory Researchers
  • Community educator to improve referrals
  • Travel Funds to COG meetings
  • Supplies-computers, specimen submissions

26
Immediate Impact on Childhood and
Adolescent/Young Adult Cancer
  • Open the broadest pallet of COG clinical trials
    possible and fully participate in all aspects of
    COG
  • Enroll, enroll, enroll all possible patients
  • Collaborate, collaborate, collaborate

27
Thank You!
28
Questions?
  • MARY LOU SCHMIDT, MD
  • Head, Division of Pediatric Hematology/OncologyDe
    partment of PediatricsUniversity of Illinois at
    Chicago
  • College of Medicine
  • telephone  (312) 996-1791
  • e-mail mls3_at_uic.edu
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