Publikation

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)

Wissenschaftlicher Artikel/Review - 01.10.2005

Bereiche
PubMed
DOI

Zitation
Ghielmini M, Cerny T, Wernli M, Ketterer N, Lohri A, Stahel R, Martinelli G, Fey M, Cogliatti S, Léger-Falandry C, Leoncini-Franscini L, Salles G, Rufibach K, Schmitz S. 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). Annals of oncology : official journal of the European Society for Medical Oncology / ESMO 2005; 16:1675-82.
Art
Wissenschaftlicher Artikel/Review (Englisch)
Zeitschrift
Annals of oncology : official journal of the European Society for Medical Oncology / ESMO 2005; 16
Veröffentlichungsdatum
01.10.2005
ISSN (Druck)
0923-7534
Seiten
1675-82
Kurzbeschreibung/Zielsetzung

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.