Subcutaneous Rituximab Feasible For Follicular Lymphoma

Subcutaneous administration of rituximab does not alter its efficacy or safety profile in patients with follicular lymphoma

medwireNews: Subcutaneous (SC) rituximab is effective and well tolerated for patients undergoing first-line treatment for follicular lymphoma, say SABRINA investigators who believe this may help reduce the burden of treatment for patients.

“Conventionally, rituximab is given by intravenous infusion, which can take 1·5–6 h to complete and requires monitoring throughout”, explain Andrew Davies, from the University of Southampton in the UK, and co-investigators.

“Subcutaneous administration of rituximab has been investigated as a way to deliver the clinical benefit of rituximab with reduced treatment burden and improved resource use, but without compromising efficacy or safety”, they say.

The team tested the safety and efficacy of a concentrated formulation of rituximab (120 mg/mL) that includes a recombinant human hyaluronidase designed to increase interstitial dispersion and absorption of the drug.

This “thereby allows injection of volumes otherwise too large for subcutaneous administration”, the researchers write in The Lancet Haematology.

The open-label phase III study included 410 patients with treatment-naive CD20-positive grade 1, 2 or 3a follicular lymphoma, with a good ECOG performance status and disease measurable by computed tomography or magnetic resonance imaging.

In all, 205 patients were assigned to receive sc rituximab 1400 mg every 3 weeks, alongside 6–8 cycles of CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or eight cycles of CVP (cyclophosphamide, vincristine and prednisone) chemotherapy, followed by maintenance rituximab every 8 weeks. A further 205 patients were assigned to receive standard intravenous (iv) rituximab 375 mg/m2 alongside their chemotherapy.

Overall response by the end of induction therapy was achieved by 84.4% of patients given sc rituximab and 84.9% of those given iv rituximab, with a complete response reported for 32.2% of each arm.

And after a median 37 months, progression-free survival, event-free survival and overall survival were all comparable between the sc and iv rituximab groups.

Adverse events were also similar in the sc and iv trial arms, with grade 3 or more severe side effects reported in 56% versus 55%, most commonly neutropenia. Serious adverse events were reported by 37% of the sc rituximab-treated patients and 34% of their iv counterparts, most commonly febrile neutropenia.

“Our findings from the two-stage SABRINA trial show that subcutaneous rituximab is pharmacokinetically non-inferior, and has similar efficacy and a similar safety profile to intravenous rituximab in first-line treatment of follicular lymphoma”, the team concludes.

Reference

Davies A, Merli F, Mihaljević B, et al. Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol; Advance online publication 2 May 2017. DOI: http://dx.doi.org/10.1016/S2352-3026(17)30078-9

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