ASH News Daily 2013 - Day 3 - (Page B-14)
Page B-14
ASH News Daily
Monday, December 9, 2013
®
career-development
awardS
Scholar Award
«« From Page B-8
Loretta Nastoupil, MD
Dr. Nastoupil received her MD
from the University of Texas Southwestern Medical Center at Dallas.
She completed her residency in internal medicine at Barnes-Jewish
hospital and Washington University and her fellowship in hematology and medical oncology at
Emory University. She
endeavors focused on
is currently an assistant
comparative effectiveprofessor in the departness research in both
ment of Lymphoma/
follicular and diffuse
Myeloma at the Univerlarge B-cell lymphoma
sity of Texas MD Ander(DLBCL). Her goals
son Cancer Center. Her
were to identify dismain areas of interest
parities in outcomes
are clinical research inin an attempt to imvolving genomic factors
prove the delivery of
that predict outcomes
care and outcomes for
for poor-risk patients
patients with lymLoretta Nastoupil, MD phoma. Through her
with lymphoma.
Under the outstandcollaboration with Dr.
ing mentorship of Dr. Christopher Flowers, they identified racial disR. Flowers at Emory University, Dr. parities among DLBCL in the early
Nastoupil refined her keen inter- adoption of chemoimmunotheraest in lymphoma. Early research py and in the biologic subtypes of
both the potential benefit of lenalidomide and the risk of second primary
malignancies when considering treatment with lenalidomide.
6 ADVERSE REACTIONS
The following adverse reactions are described in detail in other labeling
sections:
Because clinical trials are conducted under widely varying conditions,
adverse reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in practice.
6.3 Clinical Trials Experience in Mantle Cell Lymphoma
In the MCL trial, a total of 134 patients received at least 1 dose of
REVLIMID. Their median age was 67 (range 43-83) years, 128/134 (96%)
were Caucasian, 108/134 (81%) were males and 82/134 (61%) had
duration of MCL for at least 3 years.
Table 7 summarizes the most frequently observed adverse reactions
regardless of relationship to treatment with REVLIMID. Across the 134
patients treated in this study, median duration of treatment was 95 days
(1-1002 days). Seventy-eight patients (58%) received 3 or more cycles of
therapy, 53 patients (40%) received 6 or more cycles, and 26 patients
(19%) received 12 or more cycles. Seventy-six patients (57%) underwent
at least one dose interruption due to adverse events, and 51 patients (38%)
underwent at least one dose reduction due to adverse events. Twenty-six
patients (19%) discontinued treatment due to adverse events.
Table 7: Incidence of Adverse Reactions (≥10%) or Grade 3 / 4 AE
(in at least 2 patients) in Mantle Cell Lymphoma
All AEs1
(N=134)
Grade 3/4 AEs2
(N=134)
n (%)
n (%)
General disorders and administration site conditions
Fatigue
45 (34)
Pyrexia$
31 (23)
Edema peripheral
21 (16)
Asthenia$
19 (14)
General physical health deterioration
3 (2)
Gastrointestinal disorders
Diarrhea$
42 (31)
Nausea$
40 (30)
Constipation
21 (16)
Vomiting$
16 (12)
Abdominal pain$
13 (10)
Musculoskeletal and connective tissue disorders
Back pain
18 (13)
Muscle spasms
17 (13)
Arthralgia
11 (8)
Muscular weakness$
8 (6)
Respiratory, thoracic and mediastinal disorders
Cough
38 (28)
Dyspnea$
24 (18)
Pleural Effusion
10 (7)
Hypoxia
3 (2)
Pulmonary embolism
3 (2)
Respiratory distress$
2 (1)
Oropharyngeal pain
13 (10)
Infections and infestations
Pneumonia@ $
19 (14)
Upper respiratory tract infection
17 (13)
Cellulitis$
3 (2)
Bacteremia$
2 (1)
Staphylococcal sepsis$
2 (1)
Urinary tract infection$
5 (4)
»» SCHOLAR AWARD Page B-16
Table 7: Incidence of Adverse Reactions (≥10%) or Grade 3 / 4 AE
(in at least 2 patients) in Mantle Cell Lymphoma
All AEs1
(N=134)
Grade 3/4 AEs2
(N=134)
n (%)
System Organ Class/Preferred Term
* Neutropenia and thrombocytopenia [see Boxed Warnings, Warnings
and Precautions (5.3)]
* Deep vein thrombosis and pulmonary embolism [see Boxed
Warnings, Warnings and Precautions (5.4)]
* Allergic Reactions [see Warnings and Precautions (5.5)]
* Tumor lysis syndrome [see Warnings and Precautions (5.6)]
* Tumor flare reactions [see Warnings and Precautions (5.7)]
* Hepatotoxicity [see Warnings and Precautions (5.8)]
* Second Primary Malignancies [see Warnings and Precautions (5.9)]
System Organ Class/Preferred Term
DLBCL. This provided the platform
for her current research: exploring
racial differences in genes differentially mutated in activated B-celllike DLBCL and developing novel
treatment strategies.
Dr. Nastoupil is extremely honored to receive an ASH Scholar
Award. She acknowledges her outstanding training programs and her
colleagues who have contributed
to her achievements. She would
particularly like to thank her mentor Dr. Christopher Flowers for his
continued encouragement, guidance, and example.
n (%)
Skin and subcutaneous tissue disorders
Rash +
30 (22)
2 (1)
Pruritus
23 (17)
1 (<1)
Blood and lymphatic system disorders
Neutropenia
65 (49)
58 (43)
Thrombocytopenia% $
48 (36)
37 (28)
Anemia$
41 (31)
15 (11)
Leukopenia$
20 (15)
9 (7)
Lymphopenia
10 (7)
5 (4)
Febrile neutropenia$
8 (6)
8 (6)
Metabolism and nutrition disorders
Decreased appetite
19 (14)
1 (<1)
Hypokalemia
17 (13)
3 (2)
Dehydration$
10 (7)
4 (3)
Hypocalcemia
4 (3)
2 (1)
Hyponatremia
3 (2)
3 (2)
Renal and urinary disorders
Renal failure$
5 (4)
2 (1)
Vascular disorders
Hypotension@ $
9 (7)
4 (3)
Deep vein thrombosis$
5 (4)
5 (4)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor flare
13 (10)
0
Squamous cell carcinoma of skin$
4 (3)
4 (3)
Investigations
Weight decreased
17 (13)
0
1-MCL trial AEs - All treatment emergent AEs with ≥10% of subjects
2-MCL trial Grade 3/4 AEs - All treatment-emergent Grade 3/4 AEs in 2 or
more subjects
$-MCL trial Serious AEs - All treatment-emergent SAEs in 2 or more
subjects
9 (7)
3 (2)
0
4 (3)
2 (1)
@ - AEs where at least one resulted in a fatal outcome
% - AEs where at least one was considered to be Life Threatening (if the
outcome of the event was death, it is included with death cases)
# - All PTs under SOC of Infections except for rare infections of Public
Health interest will be considered listed
8 (6)
1 (<1)
1 (<1)
1 (<1)
5 (4)
+ - All PTs under HLT of Rash will be considered listed
The following adverse events which have occurred in other indications and
not described above have been reported (5-10%) in patients treated with
REVLIMID monotherapy for mantle cell lymphoma.
General disorders and administration site conditions: Chills
Musculoskeletal and connective tissue disorders: Pain in extremity
Nervous system disorders: Dysguesia, headache, neuropathy peripheral
Infections and infestations: Respiratory tract infection, sinusitis,
nasopharyngitis
Skin and subcutaneous tissue disorders: Dry skin, night sweats
2 (1)
1 (<1)
2 (1)
2 (1)
The following serious adverse events not described above and reported in
2 or more patients treated with REVLIMID monotherapy for mantle cell
lymphoma.
1 (<1)
8 (6)
2 (1)
2 (1)
2 (1)
2 (1)
0
Respiratory, Thoracic and Mediastinal Disorders: Chronic obstructive
pulmonary disease
Infections and Infestations: Clostridium difficile colitis, sepsis
Neoplasms benign, malignant and unspecified (incl cysts and polyps):
Basal cell carcinoma
Cardiac Disorder: Supraventricular tachycardia
12 (9)
0
2 (1)
2 (1)
2 (1)
2 (1)
(continued)
Cosmos Communications
K
6.4 Postmarketing Experience
The following adverse drug reactions have been identified from the
worldwide post-marketing experience with REVLIMID: Allergic conditions
(angioedema, SJS, TEN), tumor lysis syndrome (TLS) and tumor
flare reaction (TFR), pneumonitis, hepatic failure, including fatality,
toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, and mixed
cytolytic/cholestatic hepatitis and transient abnormal liver laboratory tests.
Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate their frequency
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