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Rituximab/Hyper-CVAD Achieves High Complete Responses in Aggressive Mantle Cell Lymphoma

Rituximab/Hyper-CVAD Achieves High Complete Responses in Aggressive Mantle Cell Lymphoma

HOUSTON—In patients 65 years or younger with untreated mantle cell
lymphoma (MCL), adding rituximab (Rituxan) to the
hyper-CVAD/methotrexate/cytarabine (Ara-C) regimen produced high complete
remission rates and failure-free survival rates equivalent to those reported
for hyper-CVAD followed by stem cell transplants.

Results of a trial testing rituximab plus hyperfractionated
cyclophosphamide, doxorubicin, vincristine, and dexamethasone (R-HCVAD)
without stem cell transplant were presented at the Annual Meeting of The
American Society of Hematology by Jorge Romaguera, MD, of The University of
Texas M. D. Anderson Cancer Center. Dr. Romaguera cautioned that the data
for patients under 65, "while very encouraging, are preliminary, and
longer follow-up is warranted to assure this promising therapeutic outcome
is sustained."

R-HCVAD also produced high complete remission rates in patients older
than 65 with untreated aggressive MCL. In those patients, "the rate of
complete remission has improved significantly when compared with CHOP
(cyclophosphamide [Cytoxan, Neosar], doxorubicin HCl, vincristine [Oncovin],
prednisone)," Dr. Romaguera noted. "The complete remission rate in
patients over 65 was also significantly better than that of 68% reported
with hyper-CVAD without rituximab. The failure-free survival rate for this
subgroup, however, has not improved comparably and new approaches are
needed."

Modifying the Regimen

This trial built on a previous one using the hyper-CVAD regimen that
included stem cell transplants in patients younger than 66. That trial
produced a complete response rate of 100% and prolonged failure-free and
overall survival. Eight patients that were eligible for stem cell transplant
and did not receive it, but completed six to eight cycles of hyper-CVAD had
comparable failure-free survival rates.

The new trial used the hyper-CVAD regimen with two modifications: (1)
rituximab at 375 mg/m² was added on day 1 of each cycle; and (2) stem cell
transplants were not done for patients achieving complete remission within
six courses of treatment.

The study included only untreated patients with aggressive MCL.
"Other criteria were standard, including adequate organ function,
unless the abnormalities were due to lymphoma," Dr. Romaguera
explained. "Patients who were pregnant, had positive HIV status, or
presented central nervous system lymphoma were excluded." There was no
age limit.

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