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

James M Foran, Ama Z S Rohatiner, David Cunningham, Razvan A. Popescu, Philippe Solal-Celigny, Michele Ghielmini, Bertrand Coiffier, Peter W M Johnson, Christian Gisselbrecht, Felix Reyes, John A. Radford, Eric M. Bessell, Bertrand Souleau, Aziz Benzohra, T. Andrew Lister

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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/m2/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.

Original languageEnglish (US)
Pages (from-to)317-324
Number of pages8
JournalJournal of Clinical Oncology
Volume18
Issue number2
StatePublished - Jan 2000
Externally publishedYes

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Mantle-Cell Lymphoma
B-Cell Lymphoma
B-Cell Chronic Lymphocytic Leukemia
Monoclonal Antibodies
Splenic Rupture
Social Adjustment
Follicular Lymphoma
Rituximab
Intravenous Infusions
Visual Acuity
Cardiac Arrhythmias
Histology
B-Lymphocytes
Therapeutics
Drug Therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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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. / Foran, James M; Rohatiner, Ama Z S; Cunningham, David; Popescu, Razvan A.; Solal-Celigny, Philippe; Ghielmini, Michele; Coiffier, Bertrand; Johnson, Peter W M; Gisselbrecht, Christian; Reyes, Felix; Radford, John A.; Bessell, Eric M.; Souleau, Bertrand; Benzohra, Aziz; Lister, T. Andrew.

In: Journal of Clinical Oncology, Vol. 18, No. 2, 01.2000, p. 317-324.

Research output: Contribution to journalArticle

Foran, JM, Rohatiner, AZS, Cunningham, D, Popescu, RA, Solal-Celigny, P, Ghielmini, M, Coiffier, B, Johnson, PWM, Gisselbrecht, C, Reyes, F, Radford, JA, Bessell, EM, Souleau, B, Benzohra, A & Lister, TA 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, vol. 18, no. 2, pp. 317-324.
Foran, James M ; Rohatiner, Ama Z S ; Cunningham, David ; Popescu, Razvan A. ; Solal-Celigny, Philippe ; Ghielmini, Michele ; Coiffier, Bertrand ; Johnson, Peter W M ; Gisselbrecht, Christian ; Reyes, Felix ; Radford, John A. ; Bessell, Eric M. ; Souleau, Bertrand ; Benzohra, Aziz ; Lister, T. Andrew. / 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. In: Journal of Clinical Oncology. 2000 ; Vol. 18, No. 2. pp. 317-324.
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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/m2/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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T1 - 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

AU - Foran, James M

AU - Rohatiner, Ama Z S

AU - Cunningham, David

AU - Popescu, Razvan A.

AU - Solal-Celigny, Philippe

AU - Ghielmini, Michele

AU - Coiffier, Bertrand

AU - Johnson, Peter W M

AU - Gisselbrecht, Christian

AU - Reyes, Felix

AU - Radford, John A.

AU - Bessell, Eric M.

AU - Souleau, Bertrand

AU - Benzohra, Aziz

AU - Lister, T. Andrew

PY - 2000/1

Y1 - 2000/1

N2 - 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/m2/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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