II International Workshop on Interim-PET in Lymphoma IIL HD 0801 study Ercole Brusamolino, IRCCS Policlinico San Matteo, University of Pavia, Italy on behalf of the Intergruppo Italiano Linfomi (IIL)

Organizing Committee : M.Meignan (France), A.Gallamini (Italy), C.Haioun (France)

Menton, April 8-9th, 2010 under the auspices of GELA, IIL, EORTC, SFMN

IIL HD 0801 study Early salvage with high-dose chemotherapy and autologous stem cell transplantation in advanced stage Hodgkin lymphoma that are PET-positive after two courses of ABVD and comparison of RT on prior bulk versus no RT in PET-negative patients at the end of chemotherapy

IIL HD 0801 study Study coordinators P.L. Zinzani (Bologna) A. Levis (Alessandria)

Central PET review A. Castagnoli (Prato)

Central statistician G. Ciccone (Torino)

IIL HD 0801 study Writing Committee E. Brusamolino (Pavia) A. M. Carella (Genova) A. Castagnoli (Prato) G. Ciccone (Torino) A. Levis (Alessandria) U. Ricardi (Torino) L. Rigacci (Firenze) A. Santoro (Rozzano) P. L. Zinzani (Bologna)

Background: IIL-GITIL study 1.00

90%

87%

89% 86% P R O B A B I L I T Y

.75

.50

OS Pts BEACOPP

155

14

ABVD

166

15

.25

1

Events

2

3

HR

p

1.03

0.94

4

5 Years

Interim PET as prognostic indicator

Cumulative failure-free survival

1

0,8 IPSandPET IPS 0-2, PET2neg IPS 0-2, PET2pos IPS 3-7, PET2neg IPS 3-7, PET2pos

0,6

0,4

0,2

log rank, p ~ 0

0

0

1

2

3

4

5

Time in years

Gallamini, 2007

IIL HD 0801 inclusion criteria • • • • • • •

Classical Hodgkin lymphoma Stage IIB-IV Age 18-70 No prior therapy Written informed consent ECOG PS 0-3 Baseline FDG-PET

IIL-HD 0801 Outline

Staging including CT/PET scan Stage IIB-IV

2 ABVD

-

PET

4 ABVD

-

PET

Random RT bulky

No RT

+

Salvage HD 0802

+

End points • Primary: – 2-yr PFS – 2yr EFS for adjuvant RT [phase III study]

• Secondary : – Complete remission rate – 2-yr EFS (relapse, progression, toxic events and death) – 2-yr overall survival

FDG-PET is mandatory after two courses of ABVD Central revision for positive PET or PET with minimal residual uptake

IIL-HD 0802 Outline

Salvage of PET-2 positive pts PET-2 positive Peripheral stem cell harvesting

IGEV x 4

-

PET

+

High dose melphalan + ASCT

BEAM + ASCT

no

BEAM + ASCT

HLA identical donor

yes

RIC allo (Flu-Cy)

nov-09 dic-09 gen-10 feb-10 mar-10

lug-09 ago-09 set-09 ott-09

giu-08 lug-08 ago-08 set-08 ott-08 nov-08 dic-08 gen-09 feb-09 marapr-09 maggiu-09

IIL-HD0801 accrual rate

160

140

120

100

80

60 Attivazione Centri

40

20 Arruolamento Pazienti

0

IIL-HD0801 121 pts 2 ABVD

neg: 75%

PET-2: 103 pts

4 ABVD

neg: 92 %

PET-6: 41 pts

pos: + 25%

Salvage pos: 8 %

Bulky mediastinum: 33 pts

PET-2 negative: 20 (60%)

positive: 13 (40%) Off-study to HD 0802

ABVD x 6 and random for RT, if PET-6 negative

Pet-2 centralized revision: 21 + 6 (pending)

Local Positive (13) MRU (8)

Centralized positive

negative

11 (85%)

2

1

7

IIL-HD0802 : 25 pts

22 PET-2 positive 3 PET-6 positive Evaluable for IGEV: 10

CR: 8

PR:1

Dead: 1