Should interim restaging FDG-PET change the planned

Prospective, biopsy controlled determination of. “positive PET”. •. Therapy interval 2 weeks. •. PET 10-14 days post cycle 4. •. Treatment is adapted by biopsy,.
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Should interim restaging FDG-PET change the planned management of DLBCL

Craig Moskowitz, MD Clinical Director, Division of Hematologic Oncology Member, Memorial Sloan-Kettering Cancer Center

MSKCC 01-142: DLBCL: Risk Adapted for Therapy CS IIX, III or IV disease, age-adjusted IPI 1, 2, or 3 Risk Factors, Transplant Eligible •

R-C1000HOuncappedP-14 x 4

+

PET

-

• •

Repeat Bx

Bx -



Bx + •

ICE X 2

ICE X 3

RICE x 1

followed by

followed by HDT/ASCT

Observation



Prospective, biopsy controlled determination of “positive PET” Therapy interval 2 weeks PET 10-14 days post cycle 4 Treatment is adapted by biopsy, not PET No radiation therapy permitted except for testicular disease IT methotrexate for aaHR, paranasal sinus, testis, BM

MSKCC 01-142: Patient Characteristics Characteristic

Characteristic 98

CD10

26/91

57 41

BCL6

60/89

MUM1

36/87

Median age Range >60

47 20-65 16

P53

38/82

KPS normal

85

CS

IV

64

Cell of Origin* GC Non-GC PMLBL Indeterminate

40% 30 30 4

aaIPI

LR LIR

Excluded 21 49 79% 28

Median Ki-67 (MIB1) ≥ 80%

63% 37

N Gender

Male Female

HIR HR

DLBCL: Risk adapted therapy MSKCC 01-142 POD-1

R-CHOP-14 x 4 (98 enrolled)

Interim PET 97 pts PPV 26%

Positive

38 pts Bx. Pos.

Negative

NPV 88%

59 pts Bx. Neg

5 pts

33 Pts

3 EF

28 EF

52 EF

Total of 10 patients dead of disease

MSKCC 01-142: Outcomes Overall Survival

1.0

1.0

.9

.9

.8

.8

Overall Survival

Progression Free

Progression Free Survival

.7 N=98, 83 censored

.6 .5 .4 .3

.7 N=98, 88 89 censored

.6 .5 .4 .3 .2

.2 .1

.1

0.0

0.0 0

6

12

18

24

30

36

42

Months

48

54

60

66

72

0

6

12

18

24

30

36

42

Months

48

54

60

66

72

MSKCC 01-142: Outcome By Previously Identified Prognostic Factors PFS: Cell of Origin 1.0

.9

.9

.8

.8

Progression Free

Progression Free

PFS: Age Adjusted IPI 1.0

.7 .6

LIR: N=21, 17 CENSORED HIR: N=49, 44 CENSORED

.5

HR: N=28, 22 CENSORED

.4 .3 .2

.7 .6

GC:

PMBL: N=28, 23 CENSORED .4 .3 .2

P=0.29 .1

.1

0.0

0.0

0

6

12

18

24

30

36

42

48

54

60

66

N=37, 30 CENSORED

NGC: N=28, 25 CENSORED

.5

72

Logrank p= 0.68 0

6

12

18

24

30

Months

42

48

54

60

66

72

66

72

Months

PFS: Proliferation by Ki-67

PFS: By Interim PET/Biopsy 1.0

1.0 .9

PET Pos/Bx Neg: n=33, 28 censored

.8

.8

Progression Free

PET Neg: 59, 52 censored

.9

Progression Free

36

.7 .6 Bx Pos: n=5, 3 censored

.5 .4 .3 .2