Annals of Oncology Advance Access originally published online on July 19, 2005
Annals of Oncology 2005 16(10):1675-1682; doi:10.1093/annonc/mdi320
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© 2005 European Society for Medical Oncology
Single agent rituximab in patients with follicular or mantle cell lymphoma: clinical and biological factors that are predictive of response and event-free survival as well as the effect of rituximab on the immune system: a study of the Swiss Group for Clinical Cancer Research (SAKK)
1 Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland; 2 Istituto Europeo di Oncologia, Milano, Italy; 3 Centre Hospitalier Lyon-Sud, Lyon, France
* Correspondence to: Dr M. Ghielmini, Oncology Institute of Southern Switzerland, Ospedale San Giovanni 6500 Bellinzona. Tel: +41-91-811-79-15; Fax +41-91-811-79-16; E-mail: mghielmini{at}ticino.com
Background: Predictive factors of rituximab efficacy and its effect on the immune system are still not defined.
Patients and methods: Three hundred and six patients with follicular or mantle cell lymphoma received four weekly doses of rituximab (induction) and no further treatment (arm A) or four more doses at 2-month intervals (arm B).
Results: Response rate to induction was 44%. Independent predictive factors for response were disease bulk <5 cm, follicular histology, normal hemoglobin and low lymphocyte count. Factors associated with event-free survival (EFS) were having responded to induction, having received not more than one line of therapy, Ann Arbor stage I–III, high lymphocyte count, disease bulk <5 cm, Fc-gamma receptor genotype VV and receiving prolonged treatment. B cells were suppressed by treatment but recovered after a median of 12 months in arm A and 18 months in arm B. The median IgM level after 1 year was normal in arm A but was decreased to 73% of baseline in arm B. We observed 24 serious adverse events, equally distributed between arms. Ten patients receiving induction only and six patients receiving prolonged treatment developed a second tumor.
Conclusions: We defined the characteristics predicting response and EFS to rituximab. Prolonged treatment results in longer EFS at the cost of a longer reduction in B cell and IgM levels, but without additional clinical toxicity.
Key words:
rituximab, predictive factors, toxicity, Fc-
receptor, follicular lymphoma, mantle cell lymphoma
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