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European phase II study of rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantle-cell lymphoma, immunocytoma, and small B-cell lymphocytic lymphoma

European phase II study of rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantle-cell lymphoma, immunocytoma, and small B-cell lymphocytic lymphoma
European phase II study of rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantle-cell lymphoma, immunocytoma, and small B-cell lymphocytic lymphoma
PURPOSE: Mantle-cell lymphoma (MCL), immunocytoma (IMC), and small B-cell lymphocytic lymphoma (SLL) are B-cell malignancies that express CD20 and are incurable with standard therapy. A multicenter phase II study was conducted to assess the toxicity and the overall response rates (RR) and complete response (CR) rates to rituximab (chimeric anti-CD20 monoclonal antibody). PATIENTS AND METHODS: Between January 1997 and January 1998, 131 patients with newly diagnosed MCL (MCL1; n = 34) and previously treated MCL (MCL2; n = 40), IMC (n = 28), and SLL (n = 29) received rituximab 375 mg/m(2)/wk for 4 weeks via intravenous infusion. Restaging studies were performed 1 and 2 months after treatment. An analysis of the duration of response was conducted in December 1998. RESULTS: Eleven patients were unassessable, including one who died of splenic rupture after the first infusion. The RR among the 120 assessable patients was 30% (36 of 120 patients). The RR by histology was as follows: MCL1, 38%; MCL2, 37%; IMC, 28%; and SLL, 14%. Ten patients, all with MCL, achieved CR. The median duration of response in MCL was 1.2 years. Immediate side effects were common and usually responded to adjustments in the infusion rate. There were 31 episodes of infection after treatment; most cases were mild. Cardiac arrhythmia and ophthalmologic side effects occurred in 10 and nine patients, respectively, including one case of severe loss of visual acuity. CONCLUSION: Single-agent rituximab has moderate activity in MCL and IMC but only limited activity in SLL. The duration of response in MCL was similar to that previously reported in follicular lymphoma. Its use in combination with cytotoxic chemotherapy to increase the CR rate is warranted in MCL and IMC.
1527-7755
317-324
Foran, J. M.
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Rohatiner, A.Z.
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Cunningham, D.
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Popescu, R. A.
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Solal-Celigny, P.
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Ghielmini, M.
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Coiffier, B.
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Johnson, Peter W.M.
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Gisselbrecht, C.
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Reyes, F.
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Radford, J. A.
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Bessell, E. M.
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Souleau, B.
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Benzohra, A.
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Lister, T. A.
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Foran, J. M.
41bf3074-618f-464d-9412-043ed89d3267
Rohatiner, A.Z.
6555b742-d414-4fcb-908f-f43b6de8b71a
Cunningham, D.
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Popescu, R. A.
257e3d8b-d33d-4b2d-80cb-89545d3dbbf9
Solal-Celigny, P.
d8092bde-1381-40e9-855f-11cf90bb2344
Ghielmini, M.
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Coiffier, B.
2760ae53-a2aa-45a3-93be-3375cf82eb9b
Johnson, Peter W.M.
3f6068ce-171e-4c2c-aca9-dc9b6a37413f
Gisselbrecht, C.
0889fc96-7d28-49dc-8c75-25361e8e2c8c
Reyes, F.
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Radford, J. A.
c376f5ef-2c39-4c31-8b34-75c0ae19085c
Bessell, E. M.
73bcaa4e-d91b-4d5b-b7f3-3fae8feaac66
Souleau, B.
a9d853ed-eb15-4563-ab03-0333aac09d80
Benzohra, A.
cb0b6de5-a0c3-4962-b50b-eb2c67397550
Lister, T. A.
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Foran, J. M., Rohatiner, A.Z., Cunningham, D., Popescu, R. A., Solal-Celigny, P., Ghielmini, M., Coiffier, B., Johnson, Peter W.M., Gisselbrecht, C., Reyes, F., Radford, J. A., Bessell, E. M., Souleau, B., Benzohra, A. and Lister, T. A. (2000) European phase II study of rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantle-cell lymphoma, immunocytoma, and small B-cell lymphocytic lymphoma. Journal of Clinical Oncology, 18 (2), 317-324.

Record type: Article

Abstract

PURPOSE: Mantle-cell lymphoma (MCL), immunocytoma (IMC), and small B-cell lymphocytic lymphoma (SLL) are B-cell malignancies that express CD20 and are incurable with standard therapy. A multicenter phase II study was conducted to assess the toxicity and the overall response rates (RR) and complete response (CR) rates to rituximab (chimeric anti-CD20 monoclonal antibody). PATIENTS AND METHODS: Between January 1997 and January 1998, 131 patients with newly diagnosed MCL (MCL1; n = 34) and previously treated MCL (MCL2; n = 40), IMC (n = 28), and SLL (n = 29) received rituximab 375 mg/m(2)/wk for 4 weeks via intravenous infusion. Restaging studies were performed 1 and 2 months after treatment. An analysis of the duration of response was conducted in December 1998. RESULTS: Eleven patients were unassessable, including one who died of splenic rupture after the first infusion. The RR among the 120 assessable patients was 30% (36 of 120 patients). The RR by histology was as follows: MCL1, 38%; MCL2, 37%; IMC, 28%; and SLL, 14%. Ten patients, all with MCL, achieved CR. The median duration of response in MCL was 1.2 years. Immediate side effects were common and usually responded to adjustments in the infusion rate. There were 31 episodes of infection after treatment; most cases were mild. Cardiac arrhythmia and ophthalmologic side effects occurred in 10 and nine patients, respectively, including one case of severe loss of visual acuity. CONCLUSION: Single-agent rituximab has moderate activity in MCL and IMC but only limited activity in SLL. The duration of response in MCL was similar to that previously reported in follicular lymphoma. Its use in combination with cytotoxic chemotherapy to increase the CR rate is warranted in MCL and IMC.

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Published date: January 2000

Identifiers

Local EPrints ID: 157811
URI: https://eprints.soton.ac.uk/id/eprint/157811
ISSN: 1527-7755
PURE UUID: 3fa2f3e1-9b56-491c-b594-b32871cfb132
ORCID for Peter W.M. Johnson: ORCID iD orcid.org/0000-0003-2306-4974

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Date deposited: 16 Jun 2010 13:44
Last modified: 06 Jun 2018 12:57

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Contributors

Author: J. M. Foran
Author: A.Z. Rohatiner
Author: D. Cunningham
Author: R. A. Popescu
Author: P. Solal-Celigny
Author: M. Ghielmini
Author: B. Coiffier
Author: C. Gisselbrecht
Author: F. Reyes
Author: J. A. Radford
Author: E. M. Bessell
Author: B. Souleau
Author: A. Benzohra
Author: T. A. Lister

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