CLINICAL NEWS
er their chronic GVHD was improving, stable, or worsening on a 7-point
Likert scale)
Of the 575 patients included in the observational trial, 451 had evaluations at six
months, and 307 of those patients had no
recurrent malignancy or prior treatment
change.
At three months, clinician-reported,
patient-reported, and 2014 NIH-calculated
response was associated with longer subsequent FFS, but not with NRM or OS. For
FFS:
• Clinician-reported response:
HR=0.34 (95% CI 0.22-0.52); p<0.001
• Patient-reported response: overall
p<0.001
• NIH-calculated response: HR=0.60
(95% CI 0.41-0.89); p=0.01
• NIH-calculated response: HR=0.58
(95% CI 0.42-0.80); p=0.001
At six months, clinician-reported and
2014 NIH-calculated response was associated with higher subsequent FFS (but not
NRM):
Clinician-reported response also predicted longer OS (HR=0.55; 95% CI
0.36-0.85; p=0.007).
Dr. Palmer and colleagues also tested
whether changes in individual organ
assessments, laboratories, or patient-reported symptoms were predictive of FFS,
• Clinician-reported response:
HR=0.61 (95% CI 0.44-0.85); p=0.004
T:7”
Table 6: Grade 3/4 Adverse Reactions Reported in ≥2% Patients
and With a ≥1% Difference in Proportion of Patients Between the
REVLIMID/dexamethasone and Placebo/dexamethasone groups
System Organ Class/ Preferred Term REVLIMID/Dex# Placebo/Dex#
(N=353)
(N=350)
n (%)
n (%)
Eye Disorders
Cataract
6 (1.7)
1 (0.3)
Cataract Unilateral
5 (1.4)
0 (0.0)
Psychiatric Disorder
Depression
10 (2.8)
6 (1.7)
Venous and Arterial Thromboembolism [see Boxed Warning, Warnings
and Precautions (5.4)]
Deep vein thrombosis (DVT) was reported as a serious (7.4%) or severe
(8.2%) adverse drug reaction at a higher rate in the REVLIMID/dexamethasone
group compared to 3.1 % and 3.4% in the placebo/dexamethasone group,
respectively in the 2 studies in patients with at least 1 prior therapy with
discontinuations due to DVT adverse reactions reported at comparable rates
between groups. In the NDMM study, DVT was reported as an adverse
reaction (all grades: 10.3%, 7.2%, 4.1%), as a serious adverse reaction
(3.6%, 2.0%, 1.7%), and as a Grade 3/4 adverse reaction (5.6%, 3.7%,
2.8%) in the Rd Continuous, Rd18, and MPT Arms, respectively.
Discontinuations and dose reductions due to DVT adverse reactions were
reported at comparable rates between the Rd Continuous and Rd18 Arms
(both <1%). Interruption of REVLIMID treatment due to DVT adverse
reactions was reported at comparable rates between the Rd Continuous
(2.3%) and Rd18 (1.5%) arms.
Pulmonary embolism (PE) was reported as a serio \