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Flashcards in Rituximab (MabThera) Deck (25)
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1

Population of GELA LNH 98.5

Elderly with previously untreated DLBCL

2

Treatment arm of GELA LNH 98.5 (specify dose and dosing interval of Rituximab)

Rituximab-CHOP: Rituximab (375 mg/m2 on day 1 of each of the 8 cycles), CHOP x 8 cycles

3

Control arm of GELA LNH 98.5

CHOP: Cyclophosphomide (750 mg/m2), Doxorubicin (50), Vincristine (1.4 -2 on day 1), Prednisone (40 mg/m2/day on days 1 to 5 in each treatment cycle)

4

Primary endpoint of GELA LNH 98.5

EFS; Events defined as:disease progression or relapse, initiation of a new
(unplanned) anticancer treatment (eg, radiation therapy), or death from any
cause without progression.

5

Secondary endpoint of GELA LNH 98.5

OS, PFS, DFS, response rates, toxicity

6

Inclusion criteria of GELA LNH 98.5

60-80 yo, previously untreated CD20-positive DLBCL, stage II-IV disease, ECOG 0-2

7

Exclusion criteria of GELA LNH 98.5 (name at least 2)

previous history of indolent lymphoma, central nervous system
or meningeal involvement, a history of active cancer during the previous
5 years, any serious active concomitant disease, or if, in the opinion of
the investigator, the patient’s general condition was not suitable for the
administration of 8 courses of CHOP therapy. Patients with a cardiac
contra-indication to doxorubicin (abnormal contractibility on echocardiography),
or a neurologic contra-indication to vincristine were also excluded
from the study. In addition, patients with positive serology for HIV or a
history of unresolved hepatitis B virus infection (defined by the presence of
HBs antigen, or HBc antibody without HBs antibody) were excluded.

8

N of GELA LNH 98.5

399

9

Median Follow-Up Period of GELA LNH 98.5

10 years

10

Complete response (CR) rate of R-CHOP in GELA LNH 98.5

75% (compared to CHOP: 63%)

11

Partial response (PR) rate of R-CHOP in GELA LNH 98.5

8% (compared to CHOP: 6%)

12

Number of events recorded under R-CHOP in GELA LNH

131/202 (64.9%) (compared to CHOP: 124/204 (62.9%)

13

Number of patients with progression under R-CHOP in GELA LNH trial

80/204 (39.6%)

14

Median PFS of R-CHOP in 10 years

4.8 years (36.5%, 95% CI 29.7-43.3) (compared to CHOP: 1.2 years)

15

Median OS of R-CHOP in 10 years

8.4 years (compared to CHOP: 3.5 years)

16

10 year OS rate in R-CHOP

43.5% (compared to CHOP: 27.6%)

17

Key message 1:
There is an overall increase of ____% in OS and PFS in R-CHOP vs. CHOP alone

16 (%)

18

Key message 2:
There is an increase of ____% in OS and PFS in R-CHOP among those who achieved CR

22 (%)

19

Key message 3:
At 10 years of treatment, more than ____% of elderly patients were alive. Thus the goal of treatment is _____.

40 (%); CURE.

20

Key message 4:
Benefits of ___ cycles of R-CHOP are sustained over 10-year period.

8

21

MabEase showed that Rituximab (MabThera) SC has ______ efficacy to Rituximab (MabThera) IV in 1L DLBCL

similar

22

According to PrefMab, Patients strongly _____ Rituximab (MabThera) SC over the IV format (PrefMab)

prefer (81% of population)

23

DFS of R-CHOP arm in GELA LNH 98.5

Not yet reached (p<0.001)

24

According to the GELA LNH 98.5 trial, The risk of death due to other diseases or secondary cancers was _____ in the R-CHOP group.

not higher

25

2 major treatment benefits of R-CHOP regimen in the GELA LNH 98.5 trial.

1.) A decrease in the number of patients with disease progression during
treatment (REFRACTORY PATIENTS).
2.) A decrease in the number of RELAPSING patients.