In contrast to the survival data, the national mortality rate includes every death in the U.S. and it allows more recent trend assessment, such as shown here for 1990-1998. Again, there is a steep V-shaped curve. [+] The critical question, or course, is why the deficit in survival and mortality in AYA patients? [with a negligible reduction in cancer mortality among 20-24 year-olds, even during our last decade] [If 2% expected and 1% observed, the 1% or 116,000 15-45 y/o per year = 1160 excess deaths annually (vs. 100 deaths due to APAP per year, Houston Chronicle, 9/20/02]
Outcomes by therapy for younger patients (age younger than 60 years) with Philadelphia chromosome–negative precursor B-lineage acute lymphoblastic leukemia. In the CD20-positive subset, (A) complete remission (CR) duration and (B) survival by inclusion or exclusion of rituximab therapy, and (C) survival by hyper-CVAD (fractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone) regimen (standard, modified hyper-CVAD 1 with rituximab inclusive of anthracycline intensification, or modified hyper-CVAD 2 with rituximab eliminating anthracycline intensification) are depicted. (D) Survival by regimen (without rituximab) for the CD20-negative group is also depicted.
Event-free survival (EFS) and overall survival (OS). At 42 months, EFS was estimated to be 55% (95% CI, 48% to 62%), and OS was estimated to be 60% (95% CI, 53% to 66%). ALL, acute lymphoblastic leukemia; CR1, first complete remission.
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Treating Young Adults with Acute Lymphoblastic Leukemia: Is this progress? M. Rytting, M.D. M.D. Anderson Cancer Center
<ul><li>Why have a trial of therapy for ALL in this population? </li></ul><ul><li>What therapy should be the standard arm? </li></ul><ul><li>After the first trial, what is next? </li></ul>
Cancers in Young Adults, Age 15-19 Years SEER, 1975-1998, U.S. Lymphoma Leukemia Germ Cell Sarcoma Brain 7% Testis 9% Ovary 7% Hodgkin's 16% NHL 8% ALL 6% AML 5% CNS 10% Soft Tissue Sa 7% Osteosarcoma 5% Ewing's 2% Melanoma 7% Thyroid Other 12%
National Cancer Mortality Reduction 1990-1998 Age (Years) 2.8% 2.6% 1.8% 0.9% 1.5% 0.4% 1.1% 1.5% 0% 1% 3% 2% Average Annual % Reduction 0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39
ALL in AYA Patients <ul><li>What age range should be targeted? </li></ul><ul><ul><li>Pediatric evidence supports at least up to age 21 </li></ul></ul><ul><li>Above 21 and under __?__ is the experimental group </li></ul><ul><li>This group is generally going to be underinsured </li></ul><ul><li>They do not go to pediatric clinics or hospitals (though some of them could fool you) </li></ul>
Adult Trials in ALL <ul><li>ALL represents about 1% of adult malignancy </li></ul><ul><li>Stratification by age not usually done or reported </li></ul><ul><li>The cure rate for all adults as a group is consistently around 40% </li></ul>
Recent Pediatric Trial Results for Adolescents with ALL
Applying Pediatric-based Therapy to Young Adults with ALL <ul><li>There are currently a handful of published studies, and the number is growing </li></ul><ul><ul><li>Some ongoing studies are currently in abstract form </li></ul></ul><ul><li>How many randomized? </li></ul><ul><li>Patient characteristics? </li></ul><ul><li>Subsets that do better? </li></ul>