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The Scope of the Problem

Cancer in Adolescents & Young Adults The Great Divide. Why Clinical Trials are Critical. The Scope of the Problem. British Columbia Cancer Agency Vancouver Nov. 29, 2003. NCI Young Adult Initiative to Overcome a Great Divide. MIND THE GAP.

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The Scope of the Problem

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  1. Cancer in Adolescents & Young AdultsThe Great Divide Why Clinical Trials are Critical The Scope of the Problem British Columbia Cancer AgencyVancouverNov. 29, 2003

  2. NCI Young Adult Initiative to Overcome a Great Divide MIND THE GAP Children’s Oncology GroupSWOGCALGBECOGGOGACoSOGRTOG

  3. Adolescents / Young Adults (AYA) & Cancer FACT One in every 210 persons in the U.S. develops cancer between ages of 15 and 30

  4. FACT The incidence of cancer among adolescents and young adults was on the rise The causes of these cancers and of the increased incidence are not known

  5. FACT In teenagers, cancer is the second most common cause of death due to disease Cancer kills more adolescentsthan AIDS, heart disease, cerebrovascular disease, pneumonia, influenza, cystic fibrosis, diabetes, and asthma combined.

  6. Suicide 3,994 Heart Disease 1,031 Pneu. / Influenza 189 Cerebrovasc. Dis. 199 Top 5 Causes of Death due to Disease* U.S., 2000 15-24 Years 1 Neoplasms 2 1,809 3 4 5 *Accidents and Homicide excluded Miniño AN, et al. National Vital Statistics Report 2002;50(15):1-120

  7. FACT >70% of adolescents & young adults with cancer are being cured … but

  8. 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 Age at Diagnosis (Years) older adolescents & young adults with cancer have had less benefit from medical advances than younger or older patients Survival Increase 1975-1998

  9. Cancer in Older Adolescents & Young Adults Dilemma ofMultiple Gaps Photo by K. Tartikoff

  10. 6% 11% Cancer Patients, New Diagnoses % of all Cancer Patients 2% 0.75% Birth 15 30 40 44

  11. Survival

  12. Older adolescents & young adults with cancer have had less improvement in treatment outcome than younger or older patients

  13. 2003Projected 5-Year Survival of Patients with Cancer by Era, SEER, 1975-1998 80 Year of Diagnosis 70 Survival (%) 60 50 40 0 10 20 30 40 50 60 70 Age at Diagnosis (Years)

  14. 2.38% 2.4% 1.8% 1.72% 1.60% All Age Average = 1.5% / yr 1.2% 0.6% -0.27% 0% -0.3% Relative Change in 5-Year Survival1975 to 1997, SEER Data courtesy of Lynn Ries, SEER, NCI Average Annual % Change 0-4 5-9 10- 15- 20- 30- 35- 40- 45- 50- 55- 60- 65- 70- 25- 14 19 24 29 34 39 44 49 54 59 64 69 75 Age at Diagnosis (Years)

  15. Is the Survival Gap Closing?

  16. Age 15-29 Years Survival 5-Year Survival Rates, SEER, 1975-1993 80 5-Year Survival (%) 70 Age 0-14 Years 60 1975 1980 1985 1990 1995

  17. 0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39 Mortality National Cancer Mortality Reduction1990-1998 3% 2.8% 2.6% Average Annual % Change 1.8% 2% 1.5% 1.5% 1.1% 1% 0.9% 0.4% 0% Age (Years)

  18. CLINICAL TRIAL PARTICIPATIONGap

  19. disproportionately under-represented on clinical trials Older adolescents & young adults are

  20. Enrollment on National Treatment Trials, 1990-98 Cooperative Group Accruals 9,949 Data courtesy of Montello M, Budd T, CTEP, NCI 10,000 8,000 6,720 Rx Trial Entries 5,937 6,000 4,006 4,000 3,240 3,168 2,000 1,352 944 0 0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39 Age (Years)

  21. Hypothesis The Deficit in Progress is due to the Clinical Trial Participation Gap

  22. AYAs with cancer have benefited less because they are disproportionately under-represented on clinical trials

  23. National Treatment Trial Accruals, 1990-1998 25% p = .001 20% 11689 12000 15% % Reduction in Mortality 10% 5% 7875 8000 Clinical Trial Accruals 6733 0% 1,000 10,000 Accruals (log) 4786 3837 3532 4000 1491 1071 0 ASCO 2002 Mortality rate reduction is correlated with clinical trial participation National Cancer Mortality Reduction, 1990-1998 3% Average Annual % Reduction in Cancer Mortality 2% 1% 0% 0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39 Age (Years)

  24. Confirmatory hypothesis testing?

  25. Change in 5-Year Survival, SEER, 1975-1997 2.08% Males 1.99% 2.0% 1.81% Females 1.65% Hypothesis Generated:women >> men on clinical trials 1.5% 1.38% 1.15% 1.09% 1.0% Average Annual % Change 0.70% 0.65% 0.59% 0.40% HypothesisGenerated :boys > girlson clinical trials .5% 0.22% 0.22% 0% -0.21% -0.35% - .5% 0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39 -1.0% -0.93% Age at Diagnosis (Years)

  26. Hypothesis Confirmed Clinical trial participation among 0-19 year-olds: boys > girls Hypothesis Confirmed Clinical trial participation among 25-39 year-olds: women >> men 5370 4537 3793 2941 2251 1884 1752 970 1376 0-4 5-9 10-14 15-19 Accrual to National Treatment Trials, 1990-1998 6000 4925 5000 Males 4000 Females 2981 3000 2000 959 1000 921 686 510 437 445 0 20-24 25-29 30-34 35-39 Age (Years)

  27. Race &Ethnicity

  28. 400 African-American 250 2000 200 300 1500 Male Female 150 200 1000 100 100 500 50 0 0 0 0 0 0 0 0 0 5 5 5 5 5 5 10 10 10 10 10 10 15 15 15 15 15 15 20 20 20 20 20 20 25 25 25 25 25 25 30 30 30 30 30 30 35 35 35 35 35 35 40 40 40 40 40 40 Ethnicity Not Specified Native Indian or Alaskan Native Asian-American 80 20 120 60 15 90 40 10 60 20 5 30 0 0 0 National Clinical Trial Accruals, 1997-2001 Bleyer A, Budd T, Montello M: POGO News, Fall 2002, pp. 8-11 White, Non-Hispanic Hispanic Accruals1997-2001 Age at Entry (Years)

  29. Specific Cancers

  30. 600 400 200 0 0 5 10 15 20 25 30 35 40 0 0 0 5 5 5 10 10 10 15 15 15 20 20 20 25 25 25 30 30 30 35 35 35 40 40 40 400 320 240 160 80 0 National Clinical Trial Accruals, 1997-2001 Brain Non-Hodgkin Lymphoma - 400 300 200 100 0 Accruals1997-2001 Bone Sarcoma Soft-Tissue Sarcoma 600 400 200 0 Age at Entry (Years)

  31. Why the Accrual Gap?

  32. SOCIOPOLITICALCULTURE Gap

  33. Participate in Clinical Trials Management Sites of Cancer Patients, U.S. in part from Lui L, et al, Cancer 97, 1339, 2003 100% 80% Referral Gap AYA cancer patients are least likely to be referred to comprehensive cancer centers. Community Oncology 60% 40% Tertiary Cancer Centers 20% 0% <15 15-40 >40 Age (Years)

  34. OlderAdolescents Challenges Young Adults Children Parenthood Pregnancy Stamina Endurance Fertility Cancer, Suicide: The Most Common Disease Killers MarriageSpousal Conflicts Domicile, Home Health Insurance Alcohol, Drugs,Nicotine, Addiction Autonomy Independence Social Acceptance Peer Pressure Education Maturity IQ, EQ Athleticism Career Choice Growth Employment HIV, STDs Self-Image,Body Image Significant Other Sexuality

  35. HEALTH INSURANCEGap

  36. 2.2% 2.0% 1.5% Ave. Annual % Cancer Mortality Rate Reduction, 1990-1998 1.1% 1.0% 0.9% 0.4% 0% 0-19 20-24 25-29 30-34 35-39 Percentage of the U.S. Population < 65 Years of Age who are Insured, according to Age General Accounting Office. Analyses of the March|2000 Current Population Survey of Nonelderly (<65) and of Young Adults (18-24-Year-Olds). Wash., D.C. 90 80 % Insured 70 60 50 0-17 18-24 25-34 35-44 45-54 55-64 - Age (Years)

  37. DISCIPLINE and SCIENCEGap

  38. Adolescents & Young Adults Hodgkin’s Osteosarcoma Ewing’s Sarcoma Giant Cell Tumor of Bone Rhabdomysarcoma – t (2,13) Soft-Tissue Sarcoma – non-RMS Desmoplastic Round Cell Tumor Oligodendroglioma CNS Germ Cell Tumors Melanoma – non-Solar Type Ph+ Lymphoblastic Leukemia T-Cell Leukemia – Hox+ Type Acute Progranulocytic Leukemia Acute Myeloid Leukemia – inv16 Type Testicular Carcinoma Ovarian Ca – Borderline & Malig.Germ Cell Colon Ca – Microsatellite Instability Type Hepatic Ca – Fibrolamellar Variant & Trans.-cell Nasopharyngeal Ca – Undiff. Type (WHO III) Bronchoalveolar Ca Adults Carcinomas Aerodigestive Genitourinary Breast Skin etc. Children ALL NHL PNET Wilms’ Tumor Neuroblastoma Retinoblastoma Craniopharyngioma Rhabdomyosarcoma Birth 10 20 40 Years

  39. CCG-1800 Series 16-21 Year-Olds(N = 175) 68+2% Acute Lymphoblastic Leukemia • Stock W, Sather H, Dodge RK, Bloomfield CD, Larson A, Nachman J. Blood 96: 467a, 2000. Same Results in France! 75% vs. 40% 5-Year Survival Boissel N, Auclerc MF, Lheritier V, et al. Should adolescents (15-20y) with ALL be treated as old children or young adults ? Comparison of the French FRALLE-93 and LALA-94 trials J Clin Oncol,2003:2(5):774-780 DFS 16-20 Years (N = 103) CALGB 20-29 Years (N = 123)

  40. Acute Myelogenous Leukemia Adults (MDACC) vs 16-21 Year-Olds (CCG) MDACC to use DCTER (CCG-2891) for all patients 1-60 years of age Leukemia Insights 7:1-2, 2002 EFS CCG-2891 Timed-Intensive CCG-2891 Standard MDACC Jeha S, Estey E, Woods W

  41. Ewing’s Sarcoma • Segura A et al, Valencia, Spain • Med Pediat Oncol in press • 16 young adults age15-42 (median 23) • Pediatric regimen: EVAIA, Spanish Society of Pediatric Oncology • Improved outcome over historical controls Also, Ferrari A (Italy), Rhabdomyosarcoma Mitchell AE (Australia), Osteosarcoma

  42. Survival of 60 10-24 year-olds with bone tumours Mitchell AE, ...Sexton M, Ashley D: Cancer in Adolescents and Young Adults: Treatment and Outcome in Victoria, Australia. Med J. Austr, in press 1.0 Paediatric Teaching Hospital % on Clinical Trials 50% (N = 26) 0.75 p=0.052 40% Survival 30% 0.5 Adult Teaching Hospital 20% 0.25 10% (N = 18) 0 0% 10-15 16-24 0 20 40 60 Age (Years) Months

  43. Orphaned Tumors in Pediatric Oncology Non-Rhabdomyo- sarcoma SarcomasSynovial CellFibro-, Lipo-MPNSTOthers Melanoma • Carcinomas • BreastOvaryTestesColonLiver

  44. FACILITIES & SERVICESGap

  45. No Man’s Land Facilities & Services Gap Childrens Hospitals and Facilities Adult Patient Hospitals 0 15-19 30-34 70+ Age (Years)

  46. Is the Accrual Gap Closing?

  47. 28,553 27,156 23,131 20,949 20,571 16,887 3,989 3,431 3,402 3,615 3,154 2,842 2000 2001 2002 National Cooperative Group Treatment Trial Accruals since 1997 30,000 25,000 21,685 20,884 Age 19,368 20,000 > 40 Years 15,000 14,650 13,560 12,057 10,000 3,549 3,430 3,319 15-39 Years 5,000 3,762 3,894 3,716 0-14 Years 0 1997 1998 1999 Courtesy M Montello, T Budd, CTEP

  48. National Cooperative Group Treatment Trial Accruals since 1997 Patients <45 Years of Age 8,000 Age 2,351 2,490 3,124 6,000 2,451 30-44 Years 2,812 2,597 1059 1079 868 4,000 865 15-29 Years 619 805 3,762 3,894 3,716 3,615 2,000 3,154 0-14 Years 2,842 0 1997 1998 1999 2000 2001 2002

  49. Is the AYA Population Increasing?

  50. Predicted Change in U.S. Population vs. Age from 2000 to 2010 Projected by U.S. Census Bureau 23.1% 20% 11.5% 10% 7.2% % Change, 2000 to 2010 4.8% 2.4% 0% -3.0% -5.4% -10% -7.4% -9.1% -16.2% 15- 19 20- 24 25- 29 30- 34 35- 39 40- 44 <5 5-9 10-14 45+ Age (Years)

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