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Annals of Oncology 13:928-943, 2002
© 2002 European Society for Medical Oncology

Factors affecting toxicity, response and progression-free survival in relapsed patients with indolent B-cell lymphoma and mantle cell lymphoma treated with rituximab: a Japanese phase II study

T. Igarashi1, Y. Kobayashi2, M. Ogura3, T. Kinoshita4, T. Ohtsu1, Y. Sasaki1, Y. Morishima3, T. Murate4, M. Kasai5, N. Uike6, M. Taniwaki7, Y. Kano8, K. Ohnishi9, Y. Matsuno2, S. Nakamura3, S. Mori10, Y. Ohashi11 and K. Tobinai2,+

1Hematology and Oncology Division, National Cancer Center Hospital East, Kashiwa; 2Hematology Division and Clinical Laboratory Division, National Cancer Center Hospital, Tokyo; 3Department of Hematology and Chemotherapy and Department of Pathology, Aichi Cancer Center Hospital, Nagoya; 4First Department of Internal Medicine, Nagoya University School of Medicine, Nagoya; 5Department of Internal Medicine, Sapporo Hokuyu Hospital, Sapporo; 6Division of Hematology, National Kyushu Cancer Center, Fukuoka; 7Third Department of Internal Medicine, Kyoto Prefectural University of Medicine, Kyoto; 8Division of Hematology, Tochigi Cancer Center Hospital, Utsunomiya; 9Third Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu; 10Department of Pathology, Institute of Medical Science, University of Tokyo, Tokyo; 11Biostatistics Sciences, School of Health Science and Nursing Biostatistics, University of Tokyo, Tokyo, Japan

Received 3 September 2001; revised 5 December 2001; accepted 9 January 2002.

Abstract

Background

The aim of the study was to determine factors affecting the toxicity and efficacy of rituximab monotherapy in relapsed patients with indolent B-cell lymphoma and mantle cell lymphoma (MCL).

Patients and methods

A total of 90 patients were enrolled and treated with rituximab infusions at 375 mg/m2 once weekly for 4 weeks. Central pathology review revealed that histologically, 81 patients had indolent B-cell lymphoma or MCL: 59 with follicular lymphoma, 17 with MCL, four with marginal zone lymphoma and one with lymphoplasmacytoid lymphoma. Of these, four were ineligible due to violation of other eligibility criteria. Pre-treatment variables affecting toxicities were analyzed for all 90 patients, and those affecting response and progression-free survival (PFS) were analyzed for 77 eligible patients with confirmed indolent B-cell lymphoma or MCL. The relationship between serum rituximab levels and efficacy was also analyzed for 66 eligible patients.

Results

Hematological toxicities (grade >=3) occurred more frequently in females (P <0.05), and thrombocytopenia and leukopenia were more frequent in patients with high lactate dehydrogenase (LDH) levels (P <0.05). Non-hematological toxicities (grade >=2) were more frequent in patients with extranodal disease or bone marrow involvement. The overall response rate (ORR) in patients receiving one prior chemotherapy regimen was higher than those receiving two or more regimens (P <0.05). The median PFS was shorter in MCL patients, in those with extranodal disease, or in those receiving two or more prior chemotherapy regimens (P <0.01). The PFS intervals of patients with higher serum rituximab levels (>=70 µg/ml) immediately before the third infusion were longer than in other patients (P <0.01).

Conclusions

Several prognostic factors and serum rituximab levels are useful for predicting the toxicity and efficacy of rituximab monotherapy.

Key words: indolent B-cell lymphoma, mantle cell lymphoma, prognostic factor, rituximab, serum level


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