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Blood, 15 October 2003, Vol. 102, No. 8, pp. 2741-2745.
Prepublished online as a Blood First Edition Paper on July 3, 2003; DOI 10.1182/blood-2002-11-3496.
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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Clinical activity of rituximab in extranodal marginal zone B-cell lymphoma of MALT type
Annarita Conconi,
Giovanni Martinelli,
Catherine Thiéblemont,
Andrés J. M. Ferreri,
Liliana Devizzi,
Fedro Peccatori,
Maurilio Ponzoni,
Ennio Pedrinis,
Stefania Dell'Oro,
Giancarlo Pruneri,
Virginio Filipazzi,
Pierre-Yves Dietrich,
Alessandro M. Gianni,
Bertrand Coiffier,
Franco Cavalli, and
Emanuele Zucca
From the Oncology Institute of Southern Switzerland, Division of Medical Oncology, Bellinzona, Switzerland; Hematology Unit, Division of Internal Medicine, Department of Medical Sciences and IRCAD,AmedeoAvogadro University of Eastern Piedmont, Novara, Italy; Division of Hematology-Oncology, European Institute of Oncology, Milan, Italy; Service d'Hématologie Centre Hospitalier Lyon Sud, Lyon, France; Department of Radiochemotherapy, San Raffaele H Scientific Institute, Milan, Italy; Division of Medical Oncology C, Istituto Nazionale Tumori, Milan, Italy; Department of Pathology, San Raffaele H Scientific Institute, Milan, Italy; Istituto Cantonale di Patologia, Locarno, Switzerland; Division of Pathology, European Institute of Oncology, Milan, Italy; UO Oncologia Medica, Ospedale Luigi Sacco, Milan, Italy; and Division d'oncologie, Hopital Cantonal, Génève, Switzerland.
The clinical activity of rituximab has been evaluated in a phase 2 study in both untreated and relapsed mucosa-associated lymphoid tissue (MALT) lymphomas. Treatment consisted of 4 standard (375 mg/m2) weekly doses. Thirty-five patients were enrolled, and 34 completed the treatment program. The primary lymphoma location was stomach in 15 patients, and extragastric in 20. Eleven patients had previously been treated with chemotherapy. At study entry 12 patients had Ann Arbor stage IE, 3 had stage IIE, and 20 had stage IV disease. The overall response rate was 73% (95% confidence interval, 56%-87%), with 15 complete responses and 10 partial responses, and the response rate was significantly higher in the chemotherapy-naive patients, who had an 87% response rate compared with 45% of the previously treated patients (P = .03). The median response duration was 10.5 months. At a median follow-up of 15 months, 9 patients (26%) relapsed. The median time to treatment failure was 14.2 months in the whole series, but it was significantly longer (22 versus 12 months) in the chemotherapynaive patients compared with those who had prior chemotherapy (P = .001). Most adverse events were of mild to moderate severity with no grade 4 toxicity. This study indicates that rituximab is safe with significant activity in MALT lymphomas.
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