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|Title:||Maintenance with rituximab is not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIB MAXIMA study|
|Authors:||WITZENS-HARIG, M.; ROCCO, A. Di; HAZEL, G. van; CHAMONE, D.; RUFFERT, K.; ROWE, J.; ARCAINI, L.; PODDUBNAYA, I.; HO, A.; IVANOVA, V.; VRANOWSKY, A.; OERTEL, S.; THURLEY, D.; FOA, R.|
|Citation:||ONKOLOGIE, v.35, suppl.6, p.46-46, 2012|
|Abstract:||Clinical trial data support the efficacy of rituximab maintenance therapy, following rituximab-based chemoimmunotherapy, in patients with follicular lymphoma (FL). With safety as its primary objective, this phase IIIB study (clinicaltrials.gov identifier: NCT00430352) was the first large prospective evaluation of rituximab maintenance in clinical practice. Patients (n = 534) with first-line or relapsed FL who responded to ≥8 cycles of rituximab-based induction therapy (anthracycline 62%, alkylator 21%, purine analog 8%, rituximab monotherapy 5%, other 4%) received twelve 2-monthly rituximab infusions for 2 years. Overall, 422 infections occurred in 193 (36.1%) patients, most commonly nasopharyngitis (7.1%), bronchitis (4.7%), sinusitis (4.3%), upper respiratory tract infection (3.9%), and influenza (3.7%); and were grade 3/4/5 in 21 (3.9%), 2 (0.4%) and 1 (0.2%) patient(s), respectively. Fifty-one hematologic adverse events occurred in 35 (6.6%) patients, most commonly neutropenia (n = 18; 3.4%; grade 3 or 4 in 13 patients; 2.4%). Grade 3 or 4 hypogammaglobulinemia occurred in 5 (0.9%) patients. Rates and types of infections were similar in patients with or without prolonged neutropenia or hypogammaglobulinemia. Rituximab maintenance every 2 months for 2 years is not associated with uncommon or severe infections in clinical practice in FL. Prolonged neutropenia and hypogammaglobulinamia are rare, manageable events.|
|Appears in Collections:||Comunicações em Eventos - FM/MCM|
Comunicações em Eventos - HC/ICHC
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