Efficacy and safety of rituximab in the treatment of B cells non-Hodgkin lymphoma

EXECUTIVE ABSTRACT

Strength of Recommendations: Weak in favor of the technology

Technology: Rituximab Indication: B cell Non-Hodgkin lymphoma (NHL), CD20 positive.

Characterization of the technology: Rituximab targets a specific protein known as CD20 on the surface of B-cells resulting in cell death.

Question: Is rituximab more effective and safer than conventional induction or maintenance treatment for patients with indolent and aggressive B cell NHL?

Search and analysis of scientific evidence: We searched The Cochrane Library, Centre for Reviews and Dissemination, Tripdatabase, Medline and LILACS databases aiming to find systematic reviews and randomized clinical trials (RCT) comparing treatment containing rituximab versus rituximab free regimens for the treatment of B- cell NHL. Health Technology Assessments (HTA) were searched on the websites of national and international agencies. Quality of the evidence and strength of recommendation were evaluated using the GRADE system.

Summary of results of selected studies: After full reading, we selected 13 systematic reviews, eight RCT and six HTA publications. There were benefits of increased overall survival in two to five years with a higher incidence of serious adverse events, such as granulocytopenia and leucopenia, which did not appear to lead to increased infections or mortality rates. The primary studies included in systematic reviews had important methodological limitations that have reduced the quality of the evidence.

Recommendations: The recommendations refer to patients older than 18 years, HIV-negative, with B-cell NHL, CD20 positive. In line with the Decree SAS / MS No. 621 of July 5, 2012, the use of rituximab is recommended in combination with CHOP chemotherapy as first-line treatment for aggressive NHL diffuse large B-cell stages II-IV. Rituximab is also recommended in combination with CHOP regimen as second-line treatment. For patients with follicular NHL indolent stage III or IV, rituximab is recommended i) in combination with chemotherapy for patients previously treated or not, ii) alone for maintenance in the patients who responded to treatment after second-line chemotherapy.

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