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Pediatric Oncology Research: The Impact of Collaborative Clinical Trials

Pediatric Oncology Research: The Impact of Collaborative Clinical Trials. Mary Lou Schmidt, MD Head, Division of Pediatric Hematology/Oncology Department of Pediatrics University of Illinois at Chicago College of Medicine. Important Concepts.

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Pediatric Oncology Research: The Impact of Collaborative Clinical Trials

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  1. Pediatric Oncology Research:The Impact of Collaborative Clinical Trials Mary Lou Schmidt, MD Head, Division of Pediatric Hematology/OncologyDepartment 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 Cancer’s Impact The leading cause of death by disease for children < 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 WorldGoal • 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 < 8: 16% retinoblastoma, Wilm’s tumor, neuroblastoma

  6. The patients and families……

  7. Adults 5-Year Cancer Survival RatesU.S., 1960-1993 <15 Year-Olds A Bleyer 70 % 5-Year Survival 50 30 Modified from Landis SH et al, CA - Cancer J Clin 48:6-29. 1998 1960-3 1970-3 1974-6 1977-9 1980-2 1983-5 1986-93

  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. IRSG NWTSG SWOG Pediatric Division POG CALGB Pediatric Division CCG Improvement in Annual Cancer Mortality Rate among U.S. Children <15 Years of Age: 1950-2000 A Bleyer 8 Mortality per 100,000, Age- Adjusted 6 ( ) 4 2 1950 1960 1970 1980 1990

  10. ' Children s Oncology Group C. O. G A Bleyer IRSG NWTSG SWOG Pediatric Division POG CALGB Pediatric Division CCG 1960 1970 1980 1990 2000

  11. The Children’s 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. Children’s 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. Children’s 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. AYA Patients

  16. CCG-1800 Series 16-21 Year-Olds (N = 175) 68+2% 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)

  17. Therapy at Centers Participating in Clinical Trials Adults Children 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% Children Adults

  18. Number of Patients with Cancer Only 22 (of 761) entered onto adult Cooperative Group trials 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)

  19. At Cooperative Group Institution;not on Cooperative Group Trial On Cooperative Group Trial The Adolescent-Young Adult Gap in Cancer Clinical Trials 40% 60% 33% 29% 11% 60% 50% 6% 10% 2% 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)

  20. AYA Patients

  21. 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

  22. 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

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

  24. 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

  25. ThankYou!

  26. Questions? MARY LOU SCHMIDT, MD Head, Division of Pediatric Hematology/OncologyDepartment of PediatricsUniversity of Illinois at Chicago College of Medicine telephone:  (312) 996-1791 e-mail: mls3@uic.edu

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