GELF 94: study objective

1
GELF 94 study objective

• To compare in patients from 18 to 60
• with follicular lymphoma of high tumor burden a
  conventional chemotherapy regimen
• associated with Interferon alfa for 18 months
• to
• 4 courses of CHOP followed by a high dose of
  chemotherapy and T.B.I.with
• an autologous stem cell transplantation

2
GELF94 Inclusion criteria

• Patient with newly diagnosed follicular lymphoma
  aged 18 to 60
• Patient with stage II, III and IV disease with at
  least one of these adverse parameters
• presence of B symptoms
• poor PS gt 1
• above normal value of LDH
• above normal value of ß2 microglobulin
• Large tumor burden defined by tumoral massgt7cm,
  serous effusion, compression or symptomatic
  splenomegaly

3
GELF94 Study design
Interferon alpha 5MU S.C. 3 times a week 18
months
1 2 3 4 5 6
8 10 12 14
16 18 CHVPIF arm
months
PBSC reinjection
TBI

Cyclophosphamide Etoposide
CHVP regimen
1 2 3 4 5 6
CHOP regimen

CHOPASCTarm
4
GELF94 results

• 402 patients were included from July 1994 and
  March 2001 by 35 centers
• One patient was excluded because of a benign
  disease
• 401 patients were analysed
• Stopping date for analysis 1/12/2002
• Median follow-up 56 months

5
GELF94 Response to induction
35 (17) 27 (14) 129
(62) 123 (64) 12 (6)
31 (16) 23 (11)
6 (3) 2 (1)
4 (2) 3 (1)
0 (0) 5 (2)
1 (1)
79
78
Death
Not evaluable
6
EFS selon Traitement (SD 01/12/2002)
7
OS selon Traitement (SD 01/12/2002)
8
GELF94 no difference in terms of EFS?

• Different timing for induction evaluation
• 35 events at 11 weeks in transplantation arm
• vs
• 37 events at 24 weeks in conventional arm

9
GELF94 Study design
Interferon alpha 5MU S.C. 3 times a week 18
months
1 2 3 4 5 6
8 10 12 14
16 18
months
Response evaluation at 24 weeks
PBSC reinjection
TBI

1 2 3 4 5 6

Response evaluation at 11 weeks
10
GELF94 EFS of selected patients in CR or PR at 6
months

• Comparison of all patients in CR or PR at 6
  months from diagnosis
• after 6 courses of CHVPInterferon
• after the end of ACST

11
EFS selon Traitement (Base RC/RP / SD
01/12/2002)
12
GELF94Chartflow of the patients

• In CHVPIF arm, 129 patients (62) accomplished
  all the therapy including 74 CR (35) and 55 PR
  (26) at 18 months
• In CHOPASCT arm, on 150 pts eligible for
  transplantation, 137 were really transplanted
  (91)
• Median duration of hospitalization was 22 days
• One toxic death at D55 (from an intersticial
  pneumonia)

13
OS selon Traitement (FLIPI IntermediateHigh / SD
01/12/2002)
14
EFS selon Traitement (FLIPI IntermediateHigh /
SD 01/12/2002)