ASH Clinical News ACN_4.3_FULL-ISSUE-DIGITAL | Page 39

CLINICAL NEWS
group (low, low-intermediate, high-
intermediate, or high) and randomized
1:1 to receive R-CHOP (n=103; median
age = 61 years; range = 22-85 years) or
bortezomib plus R-CHOP (VR-CHOP;
n=103; median age = 65 years; range =
20-83 years). Dosing in each cycle was: and 11 (12%) in the VR-CHOP cohort
died (HR=0.75; 90% CI 0.38-1.45) during
follow-up. The two-year OS rates were
88.4 percent and 93.0 percent, respectively
(HR=0.75; 90% CI 0.38-1.45; p=0.763).
Again, two-year OS rates were similar
regardless of disease stage:
• rituximab 375 mg/m 2 intravenously
(IV) on day 1 • 79.2% for high-intermediate vs. 92.1%
for high (HR=0.62; 90% CI 0.25-1.42;
p=0.638)
• cyclophosphamide 750 mg/m 2 IV
on day 1
“The similarity of these rates for
R-CHOP and VR-CHOP suggest that
prolonged follow-up of patients ... is
unlikely to reveal a difference.”
—JOHN P. LEONARD, MD
• doxorubicin 50 mg/m 2 IV on day 1
• vincristine 1.4 mg/m 2 (maximum of
2 mg) IV on day 1
• prednisone 100 mg orally on days
1-5
• bortezomib 1.3 mg/m 2 IV on days
1 and 4
One-hundred patients receiving R-
CHOP and 101 receiving VR-CHOP
were included in the safety analysis.
Common grade ≥3 adverse events
(AEs) included neutropenia (53% vs.
49%, respectively), thrombocytope-
nia (13% vs. 29%), anemia (7% vs.
15%), leukopenia (26% vs. 25%), and
neuropathy (1% vs. 5%). Serious AEs
occurred in 31 percent of R-CHOP–
treated patients and 34 percent of VR-
CHOP–treated patients. Four patients
(4%) discontinued R-CHOP and six
(6%) discontinued VR-CHOP.
Two patients in each cohort died:
one from treatment-related septic
shock in the R-CHOP group and the
other from acute cardiopulmonary
arrest in the VR-CHOP group.
Progression-free survival (PFS;
primary endpoint) was evaluable in
183 patients with centrally confirmed
non-GCB DLBCL who received
one or more study doses: 91 in the
R-CHOP cohort and 92 in the VR-
CHOP cohort.
After a median follow-up of 34.3
months in the R-CHOP cohort and
34.4 months in the VR-CHOP cohort
(ranges not provided), median PFS
was not reached in either group. Two-
year PFS rates were 77.6 percent and
82.0 percent, respectively, and were
similar across disease risk group:
• 65.1% for high-intermediate vs.
72.4% for high (hazard ratio [HR] =
0.67; 90% CI 0.34-1.29)
• 90.0% for low vs. 88.9% for low-
intermediate (HR=0.85; 90% CI
0.35-2.10)
Median overall survival (OS) was
also not reached in either cohort: 14
patients (15%) in the R-CHOP cohort
ASHClinicalNews.org
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References: 1. Franchini M, Mannucci PM. The history of hemophilia. Semin Thromb Hemost. 2014;40:571-576. 2. Peyvandi F, Garagiola I, Young G. The past and future
of haemophilia: diagnosis, treatments, and its complications. Lancet. 2016;388:187-197. 3. Lenting PJ, van Mourik JA, Mertens K. The life cycle of coagulation factor VIII in
view of its structure and function. Blood. 1998;92(11):3983-3996. 4. Antovic A, Mikovic D, Elezovic I, Zabczyk M, Hutenby K, Antovic JP. Improvement of fibrin clot structure
after factor VIII injection in haemophilia A patients treated on demand. Thromb Haemost. 2013;111(4):656-661. 5. Hvas AM, Sørensen HT, Norengaard L, Christiansen K,
Ingerslev J, Sørensen B. Tranexamic acid combined with recombinant factor VIII increases clot resistance to accelerated fibrinolysis in severe hemophilia A. J Thromb Haemost.
2007;5:2408-2414.
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