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