Subcutaneous Compared to Intravenous Administration of Rituximab Plus CHOP in Patients with Diffuse Large B-Cell Lymphoma — a Study By the Polish Lymphoma Research Group

Background

Fixed-dose ready-to-use subcutaneous formulation of rituximab (R^--SC) is a simpler and faster option for delivery of rituximab. compared to intravenous infusion (R-IV). Results from the phase 3 SABRINA study showed that R-SC had comparable pharmacokinetics, efficacy and safety to R-IV in patients with follicular lymphoma (FL) (Davies A et al. Lancet 2017;4:272). R-SC was approved in Poland for treatment of patients with Diffuse Large B-cell lymphoma (DLBCL) and FL in January 2017. Given the conclusive data on R-SC efficacy and safety in DLBCL patients are pending, we conducted a retrospective evaluation of DLBCL patients treated at Polish Research Lymphoma Group sites. We evaluated efficacy and safety of R-SC with CHOP (R-SC-CHOP) compared with control R-IV-CHOP group.

Methods

29 patients with DLBCL NOS (anaplastic variant in 2 patients) who completed R-SC-CHOP therapy were identified. The first R administration was always intravenous and subsequent R cycles were SC (7 out of 29 patients received up to 3 consecutive R-IV). R-SC was administered in abdominal wall over the time up to 10 minutes. 144 doses of R-SC-CHOP were administered, the median (range) 5 (3-7). The median age (range) in R-SC-CHOP group at diagnosis was 60 (24-87), 10 (34%) patients were male, R-IPI : 0 - 3 pts (10%), 1-2 - 17 pts (59%), 3-5 - 9 pts (31%). Control group consisted of 20 consecutive patients treated with R-IV-CHOP between January and May 2016. The median age (range) at diagnosis was 65 (41-86), 11 (55%) patients were male, R-IPI : 0 - 1 pt (5%), 1-2 - 15 pts (75%), 3-5 - 4 pts (20%). Diagnosis of DLBCL or FL was done by local pathologists.

Results

Overall (ORR) and complete (CR) response rate was 93% (27/29) andof 76% (22/29) in R-SC-CHOP group, and 95 % (19/20) and 80% (16/20) in R-IV-CHOP group, respectively. PET/CT was done in 16 R-SC-CHOP patients and in 12 R-IV-CHOP patients. All PET/CT scans were negative at the end of therapy. One patient in R-IV-CHOP group had disease progression after one year of follow-up. There were no deaths. Three grade 2 infusion related reactions during R-IV administration were reported. One case of injection-related skin reaction occurred in 1 out of 144 R-SC injections.

Conclusion

This preliminary data confirms similar efficacy and safety of R-SC-CHOP compared to R-IV-CHOP in patients with DLBCL. R-SC-CHOP is safe with low incidence of adverse events, and generally preferred by the patients and providers.