Rituximab (MabThera)

Question 1

Population of GELA LNH 98.5

Answer 1

Elderly with previously untreated DLBCL

Question 2

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

Answer 2

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

Question 3

Control arm of GELA LNH 98.5

Answer 3

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)

Question 4

Primary endpoint of GELA LNH 98.5

Answer 4

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.

Question 5

Secondary endpoint of GELA LNH 98.5

Answer 5

OS, PFS, DFS, response rates, toxicity

Question 6

Inclusion criteria of GELA LNH 98.5

Answer 6

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

Question 7

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

Answer 7

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.

Question 8

N of GELA LNH 98.5

Answer 8

399

Question 9

Median Follow-Up Period of GELA LNH 98.5

Answer 9

10 years

Question 10

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

Answer 10

75% (compared to CHOP: 63%)

Question 11

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

Answer 11

8% (compared to CHOP: 6%)

Question 12

Number of events recorded under R-CHOP in GELA LNH

Answer 12

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

Question 13

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

Answer 13

80/204 (39.6%)

Question 14

Median PFS of R-CHOP in 10 years

Answer 14

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

Question 15

Median OS of R-CHOP in 10 years

Answer 15

8.4 years (compared to CHOP: 3.5 years)

Question 16

10 year OS rate in R-CHOP

Answer 16

43.5% (compared to CHOP: 27.6%)

Question 17

Key message 1:

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

Answer 17

16 (%)

Question 18

Key message 2:

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

Answer 18

22 (%)

Question 19

Key message 3:

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

Answer 19

40 (%); CURE.

Question 20

Key message 4:

Benefits of ___ cycles of R-CHOP are sustained over 10-year period.

Answer 20

8

Question 21

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

Answer 21

similar

Question 22

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

Answer 22

prefer (81% of population)

Question 23

DFS of R-CHOP arm in GELA LNH 98.5

Answer 23

Not yet reached (p<0.001)

Question 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.

Answer 24

not higher

Question 25

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

Answer 25

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