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| |  ASH: Addition of Rituximab to Combination Chemotherapy Significantly Improves Treatment of Mantle Cell Lymphomas By Bruce Sylvester PHILADELPHIA, PA -- December 11, 2002 -- The addition of rituximab to combination chemotherapy both in first- and second-line treatment improves the response rates in mantle cell lymphomas (MCL) and the progression-free survival substantially, researchers from two prospective trials report. "According to the compelling results of these studies, we feel that rituximab + chemotherapy could very well become the new standard treatment for mantle cell lymphomas," said presenter and German Low Grade Lymphoma Study Group (GLSG) investigator Dr. Wolfgang Hiddemann, Professor of internal medicine, University Hospital Grosshadern, Ludwig-Maximilians-University in Munich, Germany. He presented findings here December 10th at the 44th annual meeting of the American Society of Hematology. Previous attempts to improve MCL outcomes by adjusting chemotherapy regimens have been unfruitful and MCL prognosis remains poor; remission rates are 60-70 percent and median survival is 3-5 years. However, based on clinical observations of the effect of rituximab on MCL, the GLSG launched two prospective randomized trials to study the potential value of adding rituximab to chemotherapy when compared to chemotherapy alone. Investigators recruited subjects with relapsed or refractory lymphoma (including relapsed follicular lymphoma, immunocytoma and MCL) for the first study. They compared chemotherapy consisting of fludarabine, cyclophosphamide, mitoxantrone (FCM) to fludarabine, cyclophosphamide, mitoxantrone + rituximab (R-FCM). The researchers enrolled 94 evaluable subjects, 35 of whom had MCL. "The overall response rates were 58 percent for FCM and 83 percent for R-FCM (p=0.007). In MCL patients, the difference was 65 percent versus 33 percent, respectively. Subsequent follow up revealed a higher progression-free survival for the R-FCM arm, with a median of 483 days versus 213 days (p=0.048)," the authors reported. The investigators designed the second trial to compare the first-line therapy of cyclophosphamide, adriamycin, vincristin, prednisone (CHOP) to cyclophosphamide, adriamycin, vincristin, prednisone + rituximab (R-CHOP). Like the second-line therapy study, this trial included follicular lymphomas and immunocytomas. "On the basis of 272 evaluable patients, a significant difference was observed in the overall response rate of 95 percent for R-CHOP versus 85 percent for CHOP alone (p=0.0185). Separate analysis of the 62 patients with MCL revealed an overall response rate of 97 percent versus 69 percent (p=0.004)," the authors noted. "The time to treatment failure indicates a strong tendency towards an improvement in the R-CHOP group versus CHOP alone, with an estimated median time to treatment failure of 435 days while the median is not reached in the R-CHOP group," they concluded.
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