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Blood, 1 January 2001, Vol. 97, No. 1, pp. 101-106
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Rituximab (anti-CD20 monoclonal antibody) as single first-line
therapy for patients with follicular lymphoma with a low tumor
burden: clinical and molecular evaluation
Philippe Colombat,
Gilles Salles,
Nicole Brousse,
Pitahey Eftekhari,
Piere Soubeyran,
Vincent Delwail,
Eric Deconinck,
Corinne Haïoun,
Charles Foussard,
Catherine Sebban,
Astasia Stamatoullas,
Noël Milpied,
François Boué,
Bruno Taillan,
Pierre Lederlin,
Albert Najman,
Catherine Thièblemont,
François Montestruc,
Anne Mathieu-Boué,
Aziz Benzohra, and
Philippe Solal-Céligny
From CHU Bretonneau, Tours; Centre Hospitalier
Lyon-Sud, Pierre-Benite; Hôpital Necker, Hôpital St Louis,
and Hôpital Saint-Antoine, Paris; Institut Bergonie, Bordeaux;
CHU La Milètrie, Poitiers; Hôpital J. Minjoz, Besancon;
Hôpital Henri Mondor, Creteil; CHU Angers, Angers; Centre
Léon Berard, Lyon; Centre Henri Becquerel, Rouen; CHU Hôtel
Dieu, Nantes; Hôpital Antoine Beclère, Clamart;
Hôpital de Larchet, Nice; CHU Nancy-Brabois,
Vandoeuvre-les-Nancy; Produits Roche Neuilly-sur-Seine; Centre Jean
Bernard, Le Mans, France.
The clinical activity of rituximab, a chimeric monoclonal antibody
which binds to the CD20 antigen, was evaluated as a single first-line
therapy for patients with follicular non-Hodgkin lymphoma (NHL). Fifty
patients with follicular CD20+ NHL and a low tumor burden
were analyzed for clinical and molecular responses. They received 4 weekly infusions of rituximab at a dose of 375 mg/m2. The
response rate a month after treatment (day 50) was 36 of 49 (73%),
with 10 patients in complete remission, 3 patients in complete
remission/unconfirmed, and 23 patients in partial remission. Ten
patients had stable disease, and the disease progressed in 3 patients. One of 13 (8%) patients in complete remission, 9 of 23 (39%) patients in partial remission, and 5 of 10 (50%) patients with
stable disease exhibited disease progression during the first year.
Within the study population, 32 patients were initially informative for
polymerase chain reaction (PCR) data on bcl-2-JH rearrangement. On day 50, 17 of 30 patients (57%) were negative for
bcl-2-JH rearrangement in peripheral blood, and 9 of 29 (31%) were negative in bone marrow; a significant association was
observed between molecular and clinical responses
(P < .0001). At month 12, 16 of 26 patients (62%) were
PCR negative in peripheral blood. These results indicate that early
molecular responses can be sustained for up to 12 months and that this
response is highly correlated with progression-free survival. Rituximab
has a high clinical activity and a low toxicity and induces a high
complete molecular response rate in patients with follicular lymphoma
and a low tumor burden.
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G. Cartron, L. Dacheux, G. Salles, P. Solal-Celigny, P. Bardos, P. Colombat, and H. Watier
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O. W. Press, J. P. Leonard, B. Coiffier, R. Levy, and J. Timmerman
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