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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, for the Children’s Oncology Group AEWS0031 Committee. VDCA. VDC. VDCA + I/E. VDC + I/E. INT-0091: Design. L O C A L C O N

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change in anatomic distribution of relapses with accelerated chemotherapy in ewing sarcoma

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

int 0091 design

VDCA

VDC

VDCA

+

I/E

VDC

+

I/E

INT-0091: Design

L

O

C

A

L

C

O

N

T

R

O

L

R

A

N

D

O

M

I

Z

E

int 0091 addition of ie improved efs
INT-0091: Addition of IE Improved EFS

Grier et al., NEJM 348:698, 2003

int 0091 ie decreased local relapses
INT-0091: IE Decreased Local Relapses

Grier et al., NEJM 348:699, 2003

aews0031 design

Regimen A

Local Control

VCR

Dox

CPM

VCR

Dox

CPM

VCR

Dox

CPM

VCR

Dox

CPM

RANDOMIZE

IFOS

ETOP

IFOS

ETOP

IFOS

ETOP

IFOS

ETOP

q3w x 2

q3w x 5

Regimen B

Local Control

q2w x 3

q2w x 4

AEWS0031 Design
aews0031 accrual
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
aews0031 accrual by strata
AEWS0031 Accrual by Strata*

*ineligible patients included

aews0031 randomization
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

aews0031 primary tumor treatment
AEWS0031: Primary Tumor Treatment

Percentages of patients who had:

aews0031 efs for all eligible patients

1.00

0.75

Estimated Proportion Event-Free

Regimen

0.50

Standard

Intensive

0.25

0.00

0

2

4

6

Years

AEWS0031: EFS for all eligible patients

p=0.023

aews0031 os for all eligible patients

1.00

0.75

Regimen

Estimated Proportion Surviving

0.50

Standard

Intensive

0.25

0.00

0

2

4

6

Years

AEWS0031: OS for all eligible patients

p=0.026

aews0031 events
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)
aews0031 patterns of relapse
AEWS0031: Patterns of Relapse

123 Relapses*

72 Standard

51 Intensive

18 Local

only

39 Distant

only

15 Combined

16 Local

only

27 Distant

only

8 Combined

54 Distant

35 Distant

20 Lung

16 Bone

11 Other

7 Multiple

11 Lung

15 Bone

6 Other

3 Multiple

aews0031 patterns of relapse16
AEWS0031: Patterns of Relapse

123 Relapses*

72 Standard

51 Intensive

18 Local

only

39 Distant

only

15 Combined

16 Local

only

27 Distant

only

8 Combined

54 Distant

35 Distant

20 Lung

16 Bone

11 Other

7 Multiple

11 Lung

15 Bone

6 Other

3 Multiple

a few statistics
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
aews0031 conclusions
AEWS0031: Conclusions
  • Accelerated chemotherapy reduces lung and “other” (especially CNS) relapses
  • It has no effect on local or skeletal relapses
aews0031 implications of relapse patterns
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