Sie sind bereits registriert?
Loggen Sie sich mit Ihrem Universimed-Benutzerkonto ein:
Sie sind noch nicht registriert?
Registrieren Sie sich jetzt kostenlos auf universimed.com und erhalten Sie Zugang zu allen Artikeln, bewerten Sie Inhalte und speichern Sie interessante Beiträge in Ihrem persönlichen Bereich zum späteren Lesen. Ihre Registrierung ist für alle Unversimed-Portale gültig. (inkl. allgemeineplus.at & med-Diplom.at)
Rituximab Monotherapy for Previously Untreated Follicular Lymphoma: Which Approach Is Better?
Patients with asymptomatic, low-tumor-burden follicular lymphoma (FL) can be managed by a watch-and-wait strategy or, as shown in several clinical trials, by single-agent intravenous (IV) rituximab; this second approach has the intent of delaying time to disease progression and cytotoxic chemotherapy. Investigators now report a phase 3, multicenter, randomized trial comparing industry-supplied rituximab IV with subcutaneously administered rituximab in 202 patients with previously untreated FL (stage II–IV; grade 1, 2, or 3a) and with low tumor burden by GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria.
The two treatment arms were IV rituximab 375 mg/m2 weekly for 4 weeks or a subcutaneous regimen, which started with one IV rituximab dose, then fixed-dose subcutaneous (1400 mg) weekly for 3 more weeks, and finally maintenance bimonthly subcutaneous rituximab through month 9. The progression-free survival (primary endpoint) at 4 years was significantly better with subcutaneous than with IV rituximab (58.1% vs. 41.2%; hazard ratio, 0.585). Using Lugano criteria (which includes restaging positron-emission tomography/computed tomography and bone marrow biopsy), the overall response rate was significantly better with subcutaneous than IV rituximab (73% vs. 52%), as was the complete response rate (59% vs. 36%). The groups did not differ on 4-year overall survival (95%–97%) or time to next lymphoma treatment. Toxicities were as expected and did not differ between study arms. In exploratory analyses, higher rituximab area-under-the-curve (AUC) serum levels during the first 3 months of therapy correlated with better outcomes and with subcutaneous rituximab.
The finding of higher AUC levels likely reflects the higher rituximab doses in the subcutaneous group; the authors suggest that these patients may have limited benefit from maintenance therapy. Shared patient-provider decision making between observation and rituximab approaches remains appropriate for low-tumor-burden FL. If rituximab is chosen, subcutaneous rituximab should be preferred over IV given the better outcomes and patient convenience.
Cartron G et al.
Title: Randomized phase III trial evaluating subcutaneous rituximab for the first-line treatment of low-tumor burden follicular lymphoma: Results of a LYSA study.
Source: J Clin Oncol 2023 Jul 1; [e-pub]. (Abstract/FREE Full Text)