Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-Hodgkin's lymphoma and mantle cell lymphoma:: results of a randomised phase III trial (OSHO# 19)

被引:90
作者
Herold, M
Schulze, A
Niederwieser, D
Franke, A
Fricke, HJ
Richter, P
Freund, M
Ismer, B
Dachselt, K
Boewer, C
Schirmer, V
Weniger, J
Pasold, R
Winkelmann, C
Klinkenstein, C
Schulze, M
Arzberger, H
Bremer, K
Hahnfeld, S
Schwarzer, A
Müller, C
Müller, C
机构
[1] HELIOS Klinikum Erfurt GmbH, Med Klin 2, Bereich Hamatol Onkol, D-99089 Erfurt, Germany
[2] Univ Klinikum Leipzig, Leipzig, Germany
[3] Univ Klinikum Magdeburg, Magdeburg, Germany
[4] Univ Klinikum Jena, Jena, Germany
[5] Univ Klinikum Rostock, Rostock, Germany
[6] St Hedwig Krankenhaus, Berlin, Germany
[7] Vogtlandklin Plauen, Plauen, Germany
[8] Gemeinschaftspraxis Hamatol Onkol, Erfurt, Germany
[9] Klinikum Ernst Von Bergmann, Potsdam, Germany
[10] Bezirkskrankenhaus Wittenberg, Wittenberg, Germany
[11] Med Zentrum, Frankfurt, Germany
[12] Bezirkskrankenhaus Zittau, Zittau, Germany
[13] Gemeinschaftspraxis Hamatol Onkol, Meissen, Germany
[14] Augusta Krankenanstalt, Bochum, Germany
[15] Gemeinschaftspraxis hamatol Onkol, Jena, Germany
[16] Gemeinschaftspraxis hamatol Onkol, Leipzig, Germany
[17] Gemeinschaftspraxis hamatol Onkol, Arnstadt, Germany
[18] Katholisches Krankenhaus, Erfurt, Germany
关键词
bendamustine; cyclophosphamide; indolent; non-Hodgkin's lymphoma; prednisone; vincristine; mantle cell lymphoma;
D O I
10.1007/s00432-005-0023-2
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: The purpose of this study was to compare the efficacy and toxicity of bendamustine, vincristine+prednisone (BOP) with a standard regimen of cyclophosphamide, vincristine+prednisone ( COP) in patients with previously untreated advanced indolent non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma. Methods: A total of 164 patients with follicular lymphoma (grade 1/2), mantle cell lymphoma or lymphoplasmacytic lymphoma (immunocytoma) was randomised to treatment with vincristine 2 mg (day 1) and prednisone 100 mg/m(2) (days 1-5) + bendamustine 60 mg/m(2) (days 1-5) or + cyclophosphamide 400 mg/m(2) (days 1-5) for a total of eight 21-day cycles. Results: The rate of complete remission was 22% with BOP and 20% with COP. The projected 5-year survival rate was 61% with BOP and 46% with COP. The BOP-associated 5-year survival advantage almost reached significance in the subgroup of patients who responded to therapy (74% vs. 56%; P=0.05), and did reach significance in responders who did not receive interferon maintenance therapy (70% vs. 47%; P=0.03). Toxicity was acceptable in both treatment groups, although alopecia and leucopenia were more severe with COP. Conclusions: Bendamustine can efficaciously and safely replace cyclophosphamide, as used in standard COP therapy, for the treatment of patients with indolent NHL and mantle cell lymphoma. Long-term survival data suggest a clinically significant benefit for patients treated with BOP.
引用
收藏
页码:105 / 112
页数:8
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