ASH Clinical News ACN_4.14_Full Issue_web | Page 96

On Location 2018 ASH Annual Meeting
consolidation, and maintenance and for
treating relapsed disease. The challenging
question is, “How do we select from these
options to optimize overall survival and
quality of life?”
We also will be covering the new
technologies and diagnostic strategies,
like gene-expression profiling or minimal
residual disease monitoring. There is no
doubt that these new methods are critical
for interpreting clinical trials data, but I
think they still need to prove their worth
in clinical practice. That’s one of the topics
we’ll be debating: Can we – and should we
– alter our approach based on the results of
these tests, and does that lead to validated
improvements in patient outcome?
For example, a gene-expression
profile might tell us that a patient has
high-risk disease. So, does that mean that
the patient should or should not undergo
hematopoietic cell transplantation in first
remission? When we analyze the genomic
data, we may find that patients with the
most favorable prognosis are the very
ones that benefit most from transplant,
while those with high-risk disease don’t
benefit at all.
We certainly need to gather these data
to understand how to use these technolo-
gies in the future, but, at this point, we don’t
know how to use all this information. That’s
a major challenge for clinicians now.
What do you want people to take away
from this session?
Attendees are going to hear from two lead-
ers in the field about how they approach
the same patient, and our goal is for them
to walk away with practical information
they can use in their clinics. I want to ask
the questions in the moment that people
usually ask at the end of a session. For in-
stance, if one speaker advocates for using a
certain diagnostic technology, my role will
REVLIMID [lenalidomide] capsules, for oral use
Table 5: All Adverse Reactions in ≥5.0% and Grade 3/4 Adverse Reactions in ≥ 1.0% of Patients in the REVLIMID Vs Placebo Arms*
Maintenance Study 1
All Adverse Reactions [a]
Body System
Adverse Reaction
REVLIMID
(N=224)
n (%)
Maintenance Study 2
Grade 3/4 Adverse
Reactions [b]
All Adverse Reactions [a]
Grade 3/4 Adverse
Reactions [b]
Placebo
(N=221)
n (%) REVLIMID
(N=224)
n (%) Placebo
(N=221)
n (%) REVLIMID
(N=293)
n (%) Placebo
(N=280)
n (%) REVLIMID
(N=293)
n (%) Placebo
(N=280)
n (%)
Blood and lymphatic system disorders
Neutropenia c % 177 ( 79.0) 94 ( 42.5) 133 ( 59.4) 73 ( 33.0) 178 ( 60.8) 33 ( 11.8) 158 ( 53.9) 21 ( 7.5)
Thrombocytopenia c % 162 ( 72.3) 101 ( 45.7) 84 ( 37.5) 67 ( 30.3) 69 ( 23.5) 29 ( 10.4) 38 ( 13.0) 8 ( 2.9)
Leukopenia c 51 ( 22.8) 25 ( 11.3) 45 ( 20.1) 22 ( 10.0) 93 ( 31.7) 21 ( 7.5) 71 ( 24.2) 5 ( 1.8)
Anemia 47 ( 21.0) 27 ( 12.2) 23 ( 10.3) 18 ( 8.1) 26 ( 8.9) 15 ( 5.4) 11 ( 3.8) 3 ( 1.1)
Lymphopenia 40 ( 17.9) 29 ( 13.1) 37 ( 16.5) 26 ( 11.8) 13 ( 4.4) 3 ( 1.1) 11 ( 3.8) 2 ( 0.7)
Pancytopenia
c d %
1 ( 0.4) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 12 ( 4.1) 1 ( 0.4) 7 ( 2.4) 1 ( 0.4)
39 ( 17.4) 34 ( 15.4) 39 ( 17.4) 34 ( 15.4) 7 ( 2.4) 1 ( 0.4) 5 ( 1.7) 1 ( 0.4)
Upper respiratory tract
infection e 60 ( 26.8) 35 ( 15.8) 7 ( 3.1) 9 ( 4.1) 32 ( 10.9) 18 ( 6.4) 1 ( 0.3) 0 ( 0.0)
Neutropenic infection 40 ( 17.9) 19 ( 8.6) 27 ( 12.1) 14 ( 6.3) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0)
Febrile neutropenia c
Infections and infestations #
Pneumonias*
c %
Bronchitis c
Nasopharyngitis e
Gastroenteritis
c
31 ( 13.8) 15 ( 6.8) 23 ( 10.3) 7 ( 3.2) 50 ( 17.1) 13 ( 4.6) 27 ( 9.2) 5 ( 1.8)
10 ( 4.5) 9 ( 4.1) 1 ( 0.4) 5 ( 2.3) 139 ( 47.4) 104 ( 37.1) 4 ( 1.4) 1 ( 0.4)
5 ( 2.2) 2 ( 0.9) 0 ( 0.0) 0 ( 0.0) 102 ( 34.8) 84 ( 30.0) 1 ( 0.3) 0 ( 0.0)
0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 66 ( 22.5) 55 ( 19.6) 6 ( 2.0) 0 ( 0.0)
Rhinitis e 2 ( 0.9) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 44 ( 15.0) 19 ( 6.8) 0 ( 0.0) 0 ( 0.0)
Sinusitis e 8 ( 3.6) 3 ( 1.4) 0 ( 0.0) 0 ( 0.0) 41 ( 14.0) 26 ( 9.3) 0 ( 0.0) 1 ( 0.4)
Influenza c 8 ( 3.6) 5 ( 2.3) 2 ( 0.9) 1 ( 0.5) 39 ( 13.3) 19 ( 6.8) 3 ( 1.0) 0 ( 0.0)
Lung infection c 21 ( 9.4) 2 ( 0.9) 19 ( 8.5) 2 ( 0.9) 9 ( 3.1) 4 ( 1.4) 1 ( 0.3) 0 ( 0.0)
Lower respiratory tract
infection e 13 ( 5.8) 5 ( 2.3) 6 ( 2.7) 4 ( 1.8) 4 ( 1.4) 4 ( 1.4) 0 ( 0.0) 2 ( 0.7)
Infection c 12 ( 5.4) 6 ( 2.7) 9 ( 4.0) 5 ( 2.3) 17 ( 5.8) 5 ( 1.8) 0 ( 0.0) 0 ( 0.0)
Urinary tract infection c d e 9 ( 4.0) 5 ( 2.3) 4 ( 1.8) 4 ( 1.8) 22 ( 7.5) 17 ( 6.1) 1 ( 0.3) 0 ( 0.0)
Lower respiratory tract
infection bacterial d 6 ( 2.7) 1 ( 0.5) 4 ( 1.8) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0)
Bacteremia d
Herpes zoster c d
Sepsis*
c d @
5 ( 2.2) 0 ( 0.0) 4 ( 1.8) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0)
11 ( 4.9) 10 ( 4.5) 3 ( 1.3) 2 ( 0.9) 29 ( 9.9) 25 ( 8.9) 6 ( 2.0) 2 ( 0.7)
2 ( 0.9) 1 ( 0.5) 0 ( 0.0) 0 ( 0.0) 6 ( 2.0) 1 ( 0.4) 4 ( 1.4) 1 ( 0.4)
Gastrointestinal disorders
Diarrhea 122 ( 54.5) 83 ( 37.6) 22 ( 9.8) 17 ( 7.7) 114 ( 38.9) 34 ( 12.1) 7 ( 2.4) 0 ( 0.0)
Nausea e 33 ( 14.7) 22 ( 10.0) 16 ( 7.1) 10 ( 4.5) 31 ( 10.6) 28 ( 10.0) 0 ( 0.0) 0 ( 0.0)
17 ( 7.6) 12 ( 5.4) 8 ( 3.6) 5 ( 2.3) 16 ( 5.5) 15 ( 5.4) 1 ( 0.3) 0 ( 0.0)
12 ( 5.4) 8 ( 3.6) 0 ( 0.0) 0 ( 0.0) 37 ( 12.6) 25 ( 8.9) 2 ( 0.7) 0 ( 0.0)
8 ( 3.6) 7 ( 3.2) 1 ( 0.4) 4 ( 1.8) 31 ( 10.6) 15 ( 5.4) 1 ( 0.3) 1 ( 0.4)
0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 20 ( 6.8) 12 ( 4.3) 1 ( 0.3) 0 ( 0.0)
Vomiting
Constipation
e
Abdominal pain e
Abdominal pain upper
e
General disorders and administration site conditions
Asthenia 0 ( 0.0) 1 ( 0.5) 0 ( 0.0) 0 ( 0.0) 87 ( 29.7) 53 ( 18.9) 10 ( 3.4) 2 ( 0.7)
Fatigue 51 ( 22.8) 30 ( 13.6) 21 ( 9.4) 9 ( 4.1) 31 ( 10.6) 15 ( 5.4) 3 ( 1.0) 0 ( 0.0)
Pyrexia e 17 ( 7.6) 10 ( 4.5) 2 ( 0.9) 2 ( 0.9) 60 ( 20.5) 26 ( 9.3) 1 ( 0.3) 0 ( 0.0)
9 ( 4.0) 4 ( 1.8) 0 ( 0.0) 0 ( 0.0) 31 ( 10.6) 21 ( 7.5) 0 ( 0.0) 0 ( 0.0)
71 ( 31.7) 48 ( 21.7) 11 ( 4.9) 5 ( 2.3) 22 ( 7.5) 17 ( 6.1) 3 ( 1.0) 0 ( 0.0)
9 ( 4.0) 4 ( 1.8) 3 ( 1.3) 0 ( 0.0) 21 ( 7.2) 25 ( 8.9) 2 ( 0.7) 0 ( 0.0)
Skin and subcutaneous tissue disorders
Dry skin e
Rash
Pruritus
(continued)