Written in Blood
“Due to the long-time course of
chronic GVHD, standard endpoints such
as overall survival (OS) and non-relapse
mortality (NRM) require longer-term
follow-up than might be desired in most
early-phase chronic GVHD trials,” Jeanne
Palmer, MD, from the Division of Hematology/Oncology at Mayo Clinic in Scottsdale, Arizona, and colleagues wrote. Dr.
Palmer and co-authors sought to identify
measurements at three or six months that
could predict subsequent long-term OS,
NRM, and failure-free survival (FFS).
FFS, defined as continued disease-free
survival without the addition of a new
systemic immunosuppressive medication,
is “easy to document … but also has the
disadvantage of relying on the clinician’s
treatment approach, which is subject to
bias and variation in management styles,”
the authors noted.
In this trial, overall response was measured in three ways:
• National Institutes of Health-calculated response according to both the
2005 and 2014 Consensus Criteria
algorithms, which use changes in skin,
mouth, eye, lungs, joints, gastrointestinal, and liver measures to assign
patients to the categories of complete
response (CR), partial response (PR),
stable disease (SD), and progressive
disease (PD)
• Clinician-reported response of CR,
PR, SD, and PD as reported on clinician-completed surveys
• Patient-reported response (i.e., wheth-
T:7”
without a dose reduction, 50% in the REVLIMID/dexamethasone
treatment group had at least one additional dose interruption with or
without a dose reduction compared to 21% in the placebo/dexamethasone
treatment group. Most adverse reactions and Grade 3/4 adverse reactions
were more frequent in patients who received the combination of
REVLIMID/dexamethasone compared to placebo/dexamethasone.
Table 5: Adverse Reactions Reported in ≥5% of Patients and with a
≥2% 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 (%)
Tables 5, 6, and 7 summarize the adverse reactions reported for
REVLIMID/dexamethasone and placebo/dexamethasone groups.
Metabolism and nutrition disorders
Anorexia
Hypokalemia
Hypocalcemia
Appetite Decreased
Dehydration
Hypomagnesemia
Investigations
Weight Decreased
Eye disorders
Blurred vision
Vascular disorders
Deep vein thrombosis%
Hypertension
Hypotension
55 (15.6)
48 (13.6)
31 (8.8)
24 (6.8)
23 (6.5)
24 (6.8)
34 (9.7)
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