Interim PET in patients with Hodgkin Lymphoma Observational Study in Poland
Jan Maciej Zaucha,Bogdan Małkowski, Menton 9th April 2010
GOALS
To validate prospectively the results of previously published studies of high negative and positive predictive value of interim PET in patients with Hodgkin lymphoma
To answer whether interim PET scanning after 1st ABVD cycle is as good (better ?) as after 2nd cycle
To test the hypothesis that interim PET criteria after ABVD chemotherapy for HL could be standardized (thanks to cooperation with the team of friends from Cuneo, Italy) and applied in any Polish center willing to utilize PET scanning for clinical decisions in the future - by creation a Polish PET Network)
Inclusion criteria Patients with Hodgkin lymphoma: early stage unfavorable (I-IIA with risk factors) and advanced stage (IIB-IV) >18 years old Karnofsky Performance Status >50%
Schema of the sudy Clinical staging: CT and PET/CT
Baseline PET(0)
1 ABVD No change in treatment is allowed
Early response assesment
Interim PET(1)
2 ABVD Only, if PET1 positive or MRU
Treatment escalation is allowed if PET persistent positive
Early response assesment
Interim PET(2)
ABVD x N
Final response assesment
RT if planned or decided
PET(3)
ABVD administration ABVD chemotherapy at least for the first 2 cycles will be given REGARDLESS of the results of WBC and ANC Growth factors will be administrated at the discretion of primary physician RDI should be >90%
FDG-PET analysis
Visual analysis with 5-point scale (London criteria) are used for PET interpretation Refrence scale: Mediastinum (MBPS, mediastinal blood pooled structures) and Liver Collection of „raw” data (including SUVmax, pattern of uptake- focal or diffuse) not only final results: positive, MRU or negative Debatable images will be discussed by Polish-Italian Reviewers
PARTICIPATING CENTERS: 13 GDYNIA CO GDYNIA CO OLSZTYN CO
BYDGOSZCZ CO BYDGOSZCZ CO WARSZAWA Warszawa COI COI IHiT HEM IHiT HEM WIM HEM WIM HEM
POZNAŃ HEM POZNAŃ HEM
ŁÓDZ CO ŁÓDZ CO SIEDLCE CO SIEDLCE CO
WROCŁAW HEM WROCŁAW HEM
OPOLE HEM OPOLE HEM GLIWICE CO GLIWICE CO
ACTIVE CENTERS: 8
LUBLIN CO LUBLIN CO
Early results Center
Pts (#)
PET1 PET1 PET1 NEG(%) MRU (%) POS(%)
WROCL HEM POZNAŃ HEM W-WA CO
8
3
4
1
5
3
1
1
2
2
0
0
GDYNIA CO ALL pts
37
15
12
10
52
23 (44) 17 (33) 12 (23)
Polish PET-centre Central panel for PET reviewing
Reviewer 1
Reviewer 2
PET-1 + PET2 + PET-0
Reviewer 3
Reviewer 4
Reviewer 5
Reviewer 6
Reviewer 7
Pos./ neg.
Pos./ neg.
Pos./ neg.
PET reporting Pos./ neg.
Pos./ neg.
Pos./ neg.
Pos./ neg.
Central Data Center @ INFN
Concordance analysis
Periodical PET supervision Coordinating Clinical Center
Courtesy to dr Alberto Biggi Cuneo Italy
Schema of the sudy in the Regional Oncology Center in Gdynia Clinical staging: CT and PET/CT
Baseline PET(0)
1 ABVD No change in treatment is allowed
Early response assesment
Interim PET(1)
2 ABVD
Treatment escalation is allowed if PET persistent positive
Early response assesment
Interim PET(2)
ABVD x N Final response assesment
RT if planned or decided
PET(3)
Patients Characteristics (46pts) Age Median (range) years Sex Female/Male (%/%) STAGE
30 (21-70) 22/24
(48/52)
I-IIA No
(%)
11
(24)
STAGE IIB-IV No
(%)
35
(76)
IPS= 0-2 IPS>2
No No
26 9
RESULTS Regional Oncology Center in Gdynia (46pts) Interim NEG PET (%)* PET1
MRU POS (%)* (%)*
15 12 10 (41) (32) (27) PET2 24 9 4 (65) (24) (11) *- % of pts with PET done
MISSING ALL
9
46
5
42
Median follow-up: 11,9 (0,7-22,9) months
RESULTS Regional Oncology Center in Gdynia (46pts) Interim NEG PET (%)* PET1
MRU POS (%)* (%)*
10 (27) PET2 4 33 (89) (11) *- % of pts with PET done #- 4pts awaiting PET2
27 (73)
MISSING ALL
9
46
5
42#
PET1POS PATIENTS (10pts) 3 pts only PET1: 1 pt-no PET2, progression during treatment 2 pts PET2 awaiting PET2 (very early)
7pts
PET2 done 2 pts PET2 positive 5 pts PET2 MRU/NEG
RESULTS Regional Oncology Center in Gdynia (28pts) PET1
PET2 No
NEG NEG MRU POS POS POS
NEG MRU NEG NEG MRU POS POS
NEG/MRU
10 1 10 3 2 2 0
% 21
75
5
18
2 0
7 0
Median follow-up: 12,8 (0,8-22,9) months
PET1POS/PET2 NEG-MRU PATIENTS (5) 1 pt.(POS/MRU) active disease at final PET 1pt. (POS/NEG) completed RT, final PET negative, very short follow-up 3pts- continue ABVD chemotherapy
Summary PET1 positivity seems to happen more often (27%) compared to PET2 positivity (11%) PET1 negativity is a very strong predictor of PET2 negativity Too short follow-up for patients with PET1POS/PET2NEG/MRU
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