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Blood, Vol. 92 No. 6 (September 15), 1998:
pp. 1927-1932
Rituximab (Anti-CD20 Monoclonal Antibody) for the Treatment of
Patients With Relapsing or Refractory Aggressive Lymphoma: A
Multicenter Phase II Study
B. Coiffier,
C. Haioun,
N. Ketterer,
A. Engert,
H. Tilly,
D. Ma,
P. Johnson,
A. Lister,
M. Feuring- Buske,
J.A. Radford,
R. Capdeville,
V. Diehl, and
F. Reyes
From the Service d'Hématologie, Centre Hospitalier Lyon-Sud,
Pierre-Bénite, France; the Service d'Hématologie,
Hôpital Henri-Mondor, Créteil, France; the Klinik 1 fur
Innere Medezin, Üniversität zu Köln, Köln,
Germany; the Service d'Hématologie, Centre Henri
Bécquerel, Rouen, France; the Department of Hematolgy, Royal
North Shore Hospital, St Leonards, Australia; the Cancer Research
Building, St James University Hospital, Leeds, UK; the Department of
Medical Oncology, St Bartholomew's Hospital, London, UK; the Zentrum
fur Innere Medizin, Abt. Hematologie und Onkologie, August
Universität, Göttingen, Germany; the CRC Department of
Medical Oncology, University of Manchester, Manchester, UK; and
Hoffman-La Roche, Basel, Switzerland.
Rituximab, a chimeric monoclonal antibody that binds specifically to
the CD20 antigen, induced objective responses in 50% of patients with
low-grade or follicular B-cell lymphoma. Because most nonfollicular
B-cell lymphomas also express the CD20 antigen, we conducted a phase II
study to evaluate the efficacy and tolerability of this new agent in
patients with more aggressive types of lymphoma. Patients with diffuse
large B-cell lymphoma (DLCL), mantle cell lymphoma (MCL), or other
intermediate- or high-grade B-cell lymphomas according to the Working
Formulation were included in this prospective randomized phase II study
if they were in first or second relapse, if they were refractory to
initial therapy, if they progressed after a partial response to initial
therapy, or if they were elderly (age >60 years) and not previously
treated. The patients received 8 weekly infusions of rituximab at the
dose of 375 mg/m2 in arm A or one infusion of 375 mg/m2 followed by 7 weekly infusions of 500 mg/m2 in arm B. Patients were evaluated 2 months after the
last rituximab infusion. Fifty-four patients were randomized from 9 centers in Europe and Australia (28 in arm A and 26 in arm B). A total
of 5 complete responses (CR) and 12 partial responses (PR) were
observed among the 54 enrolled patients, with no difference between the two doses. In an intent-to-treat analysis, the CR rate was 9% (CI95%, 3% to 20%) and the PR rate was 22%
(CI95%, 12% to 36%), for an overall response rate of
31% (CI95%, 20% to 46%). An analysis of prognostic
factors showed that response rates were lower in patients with
refractory disease, patients with lymphoma not classified as DLCL, and
patients with a tumor larger than 5 cm in diameter. DLCL and MCL
patients had response rates of 37% and 33%, respectively. The median
time to progression exceeded 246 days for the 17 responding patients.
The most frequently reported adverse events were related to an infusion
syndrome and were mild: 19% of the patients had a grade 3 related
adverse event, slightly more in arm B, and only 1 patient had a grade 4 related adverse event in arm A. Two patients (3.7%)
withdrew from treatment because of severe adverse events, one patient
in each arm. In this first trial of rituximab in DLCL and MCL, patients
experienced a significant clinical activity with a low toxicity.
Rituximab has significant activity in DLCL and MCL patients and should
be tested in combination with chemotherapy in such patients.
© 1998 by The American Society of Hematology.
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