DALTON DE ALENCAR FISCHER CHAMONE

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    Maintenance with rituximab is not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIB MAXIMA study
    (2012) 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.
    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.
  • article 29 Citação(ões) na Scopus
    Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study
    (2014) WITZENS-HARIG, Mathias; FOA, Robin; ROCCO, Alice Di; HAZEL, Guy van; CHAMONE, Dalton F. A.; ROWE, Jacob M.; ARCAINI, Luca; PODDUBNAYA, Irina; HO, Anthony D.; IVANOVA, Valentina; VRANOVSKY, Andrej; THURLEY, Dan; OERTEL, Stephan
    Previous randomized trials have demonstrated that rituximab maintenance (R-maintenance) can prolong time to progressive disease in patients with follicular lymphoma (FL). The phase IIIb MAXIMA study (NCT00430352) was a large prospective evaluation of R-maintenance in a daily care setting. The primary objective was safety. Secondary objectives included progression-free survival, overall survival, time to next lymphoma treatment, and partial response (PR) to complete response/unconfirmed (CR/CRu) conversion rate. Patients (n = 545) with first-line or relapsed FL who responded to 8 cycles of rituximab-based induction received R-maintenance every 2 months for 2 years. At study entry, 380 patients had CR or CRu, and 165 had PR. The median age was 57.0 years. The most common non-hematologic adverse events (AEs, excluding infusion-related reactions) were cough (9.9 % of patients), fatigue (7.5 %), nasopharyngitis (7.1 %), back pain (6.5 %), diarrhea (6.9 %), arthralgia (6.0 %), headache and hypertension (5.2 % each), and pyrexia (5.1 %). The majority of AEs were grade 1 or 2. Grade 3, 4, and 5 infections occurred in 21 (3.9 %), 2 (0.4 %), and 1 (0.2 %) patient, respectively. Fifty-one hematologic AEs occurred in 6.6 % (n = 35) of patients. Grade 3/4 prolonged neutropenia and hypogammaglobulinemia occurred in 13 (2.4 %) and 5 (0.9 %) patients, respectively. All cases of prolonged neutropenia or hypogammaglobulinemia were manageable and resolved. Fast infusion did not alter the safety profile. Efficacy was comparable with results from previous trials. R-maintenance is safe in a daily care setting for patients with first-line or relapsed FL.
  • article 0 Citação(ões) na Scopus
    Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study (vol 93, pg 1717, 2014)
    (2014) WITZENS-HARIG, Mathias; FOA, Robin; ROCCO, Alice Di; HAZEL, Guy van; CHAMONE, Dalton F. A.; ROWE, Jacob M.; ARCAINI, Luca; PODDUBNAYA, Irina; HO, Anthony D.; IVANOVA, Valentina; VRANOVSKY, Andrej; THURLEY, Dan; OERTEL, Stephan