CLINICAL NEWS
Literature Scan
Continued from page 65
intravenously every 2 months for 3 years; n=120) or
the observation arm (n=120).
At data cutoff (July 1, 2015), the median follow-up
from randomization was 50.2 months (range = 46.4-
54.2 months). Eighty-three patients in the rituximab
cohort had received the scheduled three-year course
of therapy; among patients who stopped rituximab,
the most common reasons were disease progression
(n=16) or neutropenia (n=9).
“[The study results]
show the efficacy of
a cytarabine-based
induction regimen
free of anthracycline
or alkylating agents ...”
—STEVEN LE GOUILL, MD, PhD
Serious infections following AHCT were reported
in four patients in each cohort (related to spondylitis,
pyelonephritis, septicemia, and varicella in the
rituximab cohort and septicemia, cellulitis, meningitis,
and severe pneumonia in both lungs in the observation
group). The most frequent grade 3/4 adverse event in
both cohorts was neutropenia.
Incidence of progressive disease and death appeared
to be lower in the rituximab group (16 and 13 patients,
respectively) than in the observation group (37 and
24 patients). Lymphoma was the major cause of death
in each group (8 in the rituximab cohort and 16 in
the observation cohort), whereas the development
of a secondary cancer led to three patient deaths in
the rituximab cohort and one patient death in the
observation group.
After four courses of R-DHAP induction, the overall
response rate was 89 percent, with a complete response
rate of 77 percent. Starting from randomization, the
median event-free survival (EFS; primary endpoint) was
not reached in either cohort. The median progression-
free survival (PFS) and overall survival (OS) were also
not reached in either group.
Four-year EFS, PFS, and OS rates for patients who
received maintenance therapy versus those who did not
were:
• EFS: 79% (95% CI 70-86) vs. 61% (95% CI 50-70;
p=0.001)
• PFS: 83% (95% CI 73-88) vs. 64% (95% CI 55-73;
p<0.001)
• OS: 89% (95% CI 81-94) vs. 80% (95% CI 72-88;
p=0.04)
Patients who received rituximab maintenance had a
significantly lower risk of disease progression, relapse,
death, rituximab allergy, or severe infection, compared
with patients receiving no maintenance therapy (hazard
ratio = 0.46; 95% CI 0.28-0.74; p=0.002).
Among the 11 patients who received R-CHOP prior
to randomization, four were assigned to the rituximab
group: One had disease progression and died, and three
were alive at the time of analysis. The other seven were
randomized to the observation cohort: Four relapsed
but were alive at analysis, and three died.
For the 59 patients who did not undergo
randomization, the median PFS was 11 months (95% CI
6.4-28.0), and the median OS was 30.6 months (95% CI
12.3-44.6).
“Maintenance therapy with rituximab after R-DHAP
induction therapy, followed by R-BEAM consolidation
therapy, prevented relapses and was associated with
a low risk of major infection,” the authors concluded,
adding that the study results “show the efficacy
of a cytarabine-based induction regimen free of
anthracycline or alkylating agents in patients with this
condition.”
Because the study included only patients who
received rituximab maintenance therapy after R-DHAP
induction therapy, followed by R-BEAM consolidation
therapy, the study’s findings are limited to this
population, the authors noted. “Whether maintenance
therapy with rituximab improves outcomes in patients
who are treated with other regimens is unknown.”
The study also did not measure immunoglobulin
levels to determine the degree and duration of
immunosuppression with this treatment approach.
The study was supported by Roche and Amgen. ●
The authors report no financial conflicts.
REFERENCE
Le Gouill S, Thieblemont C, Oberic L. Rituximab after autologous stem-cell transplantation in mantle-
cell lymphoma. N Engl J Med. 2017;377:1250-60.
ASH | Job Center
®
Find a match for
your career
aspirations
Designed with job seekers in mind, the ASH
Job Center allows users to search through the
latest career opportunities with ease, save job
listings of interest, and post resumes online.
Start your search today at
www.hematology.org/jobcenter.
ASH Job Center ad ACN 9-5x4-75.indd 1
68
ASH Clinical News
American Society of Hematology
Helping hematologists conquer blood diseases worldwide.
8/28/17 3:37 PM
November 2017