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Prepublished online as a Blood First Edition Paper on July 3, 2003; DOI 10.1182/blood-2002-11-3496.
Submitted November 21, 2002
Accepted May 29, 2003
Clinical activity of rituximab in extranodal marginal zone B-cell lymphoma of MALT type
Annarita Conconi, Giovanni Martinelli, Catherine Thieblemont, Andres J M Ferreri, Liliana Devizzi, Fedro Peccatori, Maurilio Ponzoni, Ennio Pedrinis, Stefania Dell'Oro, Virginio Filipazzi, Pierre-Yves Dietrich, Alessandro M Gianni, Bertrand Coiffier, Franco Cavalli, and Emanuele Zucca*
Division of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland
Hematology Unit, Division of Internal Medicine, Department of Medical Sciences and IRCAD, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy
Division of Hematology-Oncology, European Institute of Oncology, Milan, Italy
Division of Hematology, Centre Hospitalier Lyon Sud, Lyon, France
Department of Radiochemotherapy, San Raffaele Hospital, Scientific Institute, Milan, Italy
Division of Medical Oncology C, Istituto Nazionale Tumori, Milan, Italy
Department of Pathology, San Raffaele Hospital, Scientific Institute, Milan, Italy
Istituto Cantonale di Patologia, Locarno, Switzerland
UO Oncologia Medica, Ospedale Luigi Sacco, Milan, Italy
Division d'oncologie, Hopital Cantonal, Geneva, Switzerland
* Corresponding author; email: ielsg{at}ticino.com.
The clinical activity of rituximab has been evaluated in a phase II study in both untreated and relapsed 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, extragastric in 20. Eleven patients had previously been treated with chemotherapy. At study entry 12 patients had Ann Arbor stage IE, 3 stage IIE and 20 stage IV disease. The overall response rate was 73% (95%CI: 56%-87%), with 15 complete responses and 10 partial responses, and the response rate was significantly higher in the chemotherapy-naive patients who had a 87% response rate compared to the 45% of the untreated patients (p=0.03). The median response duration was 10.5 months. At a median follow-up of 15 months, 9 patients relapsed (26%). The median time to treatment failure was 14.2 months in the whole series but it was significantly longer (22 vs. 12 months) in the chemotherapy-naive patients in comparison with those who had prior chemotherapy (p=0.001). 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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