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

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

来源：

JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY | 2006年 / 132卷 / 02期

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

页码：105 / 112

页数：8

共 25 条

[11] KARNEKAL S, 2004, P AACR, P45
[12] LENNERT K, 1990, HISTOPATHOLOGIE NONH, P15
[13] Leoni LM, 2003, BLOOD, V102, p640A
[14] LEONI LM, 2004, P AACR, P45
[15] NIEMEYER C, 2004, P AACR, P45
[16] POTSCHER C, 2000, AKT ONKOL, V109, P3
[17] RUFFERT K, 1989, Z KLIN MED, V44, P671
[18] RUFFERT K, 1999, ANN ONCOL, V10, P125
[19] Rummel MJ, 2005, J CLIN ONCOL, V23, p576S
[20] Bendamustine hydrochloride activity against doxorubicin-resistant human breast carcinoma cell lines
Strumberg, D
Harstrick, A
Doll, K
Hoffmann, B
Seeber, S
[J]. ANTI-CANCER DRUGS, 1996, 7 (04) : 415 - 421

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