Randomized trial of ofatumumab and bendamustine vs ofatumumab, bendamustine, and bortezomib in previously untreated patients with high-risk follicular lymphoma: CALGB 50904 (Alliance)
Cancer Jun 13, 2019
Blum KA, et al. - In patients with untreated, high-risk follicular lymphoma (FL), who were enrolled in this multicenter, randomized phase 2 trial, researchers assessed complete responses (CRs), efficacy, and safety with ofatumumab and bendamustine and with ofatumumab, bendamustine, and bortezomib. They randomly assigned patients with grade 1 to 3a FL and either a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2 with 1 lymph node >6 cm or an FLIPI score of 3 to 5, to receive ofatumumab, bendamustine, and maintenance ofatumumab (arm A) or to receive ofatumumab, bendamustine, bortezomib, and maintenance ofatumumab and bortezomib (arm B). In patients with high-risk FL, no improvement was seen in CR rates, progression-free survival, and overall survival in relation to addition of bortezomib to ofatumumab and bendamustine. Despite similar grade 3 to 4 toxicities, more patients who received bortezomib needed dose modifications and early discontinuation.
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