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Change in Anatomic Distribution of Relapses with Accelerated Chemotherapy in Ewing Sarcoma RB Womer, AR Weiss, DC West, MD Krailo, PS Dickman, B Pawel,

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Presentation on theme: "Change in Anatomic Distribution of Relapses with Accelerated Chemotherapy in Ewing Sarcoma RB Womer, AR Weiss, DC West, MD Krailo, PS Dickman, B Pawel,"— Presentation transcript:

1 Change in Anatomic Distribution of Relapses with Accelerated Chemotherapy in Ewing Sarcoma RB Womer, AR Weiss, DC West, MD Krailo, PS Dickman, B Pawel, for the Children’s Oncology Group AEWS0031 Committee

2 INT-0091: Design RANDOMIZERANDOMIZE VDC + I/E LOCALCONTROLLOCALCONTROL VDCA + I/E

3 INT-0091: Addition of IE Improved EFS Grier et al., NEJM 348:698, 2003

4 INT-0091: IE Decreased Local Relapses Grier et al., NEJM 348:699, 2003

5 AEWS0031 Design RANDOMIZERANDOMIZE VCR Dox CPM IFOS ETOP VCR Dox CPM IFOS ETOP VCR Dox CPM IFOS ETOP VCR Dox CPM IFOS ETOP Regimen A q3w x 2 Local Control q2w x 3 q3w x 5 q2w x 4 Regimen B

6 AEWS0031 Accrual  Open May 2001-August 2005  Localized ESFT, age <50 years  Total 587 patients enrolled  19 ineligible − 12 wrong diagnosis − 4 metastases at diagnosis − 3 treatment before enrollment or randomization  Thus 568 eligible patients

7 AEWS0031 Accrual by Strata* StratumStratum nameAccrual 1< 17y, non-pelvic419 2< 17y, pelvic93 3> 18y, non-pelvic57 4> 18y, pelvic18 *ineligible patients included

8 AEWS0031 Randomization Age Group | Standard Intensive | Total -----------+----------------------+---------- -17 | 253 248 | 501 18+ | 31 36 | 67 -----------+----------------------+---------- Total | 284 284 | 568 | Standard Intensive | Total -----------+----------------------+---------- Non-Pelvic | 237 243 | 480 Pelvic | 47 41 | 88 -----------+----------------------+---------- Total | 284 284 | 568

9 AEWS0031 Patient Characteristics CharacteristicsStandard (N=284) Intensive (N=284) Age at Study Entry Median (Range)12 (0-33)13 (0-45) Male154 (54%) Female130 (46%) White252 (89%)250 (88%) Black8 (3%)6 (2%) Other14 (5%)16 (6%) Race Not Reported10 (4%)12 (4%) ESR (mm/hr)31.4 (32.2)32.9 (28.3) LDH (IU/l)448.2 (414.0)451.5 (437.2) Pleural Effusions at Diagnosis19 (8%)21 (9%) Gross tumor resection prior to start of chemotherapy47 (17%)48 (17%)

10 AEWS0031 Patient Characteristics 2 Primary SiteStandard (N=284) Intensive (N=284) Skull, maxilla, mandible15 (5.5%)12 (4.3%) C, T, L Vertebrae11 (3.9%)28 (9.9%) Ribs, Sternum29 (10.3%)25 (8.9%) Sacrum16 (5.6%)8 (2.8%) Pelvis31 (11%)33 (11.6%) Scapula, clavicle14 (4.9%)14 (5.0%) Upper limbs20 (6.9%)19 (6.7%) Lower limbs81 (28.7%)68 (22.5%) Soft Tissue67 (23.6%)76 (26.8%) Total flat bones116 (41.2%)120 (42.5%) Total long bones101 (35.6%)87 (30.6%) Fracture at primary site9 (3.5%)14 (5.5%)

11 AEWS0031: Primary Tumor Treatment Standard (A)Intensive (B)All Surgery only494748 Radiation only182421 Surgery + radiation332729 No primary treatment121.5 Percentages of patients who had:

12 AEWS0031: EFS for all eligible patients 0.00 0.25 0.50 0.75 1.00 Estimated Proportion Event-Free 0246 Years Standard Intensive Regimen p=0.023

13 AEWS0031: OS for all eligible patients 0.00 0.25 0.50 0.75 1.00 Estimated Proportion Surviving 0246 Years Standard Intensive Regimen p=0.026

14 AEWS0031: Events  126 relapses  74 Standard, 52 Intensive  15 SMN (8 Reg. A, 7 Reg. B)  11 secondary AML/MDS − 5 Standard, 6 Intensive  3 secondary OS  1 Diffuse large B cell lymphoma  1 toxic death (Intensive)  1 narcotic overdose (recreational)

15 AEWS0031: Patterns of Relapse 123 Relapses* 72 Standard 51 Intensive 18 Local only 39 Distant only 15 Combined16 Local only 27 Distant only 8 Combined 54 Distant 35 Distant 20 Lung16 Bone11 Other7 Multiple11 Lung15 Bone6 Other3 Multiple

16 AEWS0031: Patterns of Relapse 123 Relapses* 72 Standard 51 Intensive 18 Local only 39 Distant only 15 Combined16 Local only 27 Distant only 8 Combined 54 Distant 35 Distant 20 Lung16 Bone11 Other7 Multiple11 Lung15 Bone6 Other3 Multiple

17 AEWS0031: “Other” Sites of Relapse StandardIntensive CNS (Brain, spinal cord) 70 Miscellaneous4 (pleura, nodes, soft tissue, liver) 6 (pleura, mediastinum, marrow)

18 A few statistics  P (local recurrence) Reg. A v. Reg B: 0.86  P (distant recurrence) Reg A. v. Reg B: 0.06  P (distant or combined) Reg A v. Reg B: 0.017  P (CNS recurrence) Reg A v. Reg B: 0.02

19 AEWS0031: Conclusions  Accelerated chemotherapy reduces lung and “other” (especially CNS) relapses  It has no effect on local or skeletal relapses

20 AEWS0031: Implications of Relapse Patterns  Either accelerated (q2w) chemotherapy is particularly effective against micrometastases in the lungs and CNS,  Or there is a biologically distinct group of Ewing sarcomas with a particular propensity for lung and CNS relapse, that is especially sensitive to accelerated chemotherapy  Or both,  Or neither

21

22 VDC/IE Regimens for ESFT RegimenYearsEFS95% Intervals INT-0091 B (CCG-7881/POG-8850) 1988-9269%66-72% INT-0154 A, B (CCG-7942/POG-9354) 1995-9871%67-75% AEWS0031 A (q3w)2001-200570%63-75%

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