Author(s): ,
Pieternella Lugtenburg
Department of Hematology,Erasmus MC Cancer Institute,Rotterdam,Netherlands
Antonio Rueda
Department of Oncology,E.P. Hospital Costa del Sol,Marbella,Spain
Irit Avivi
Division of Hematology,Tel Aviv Sourasky Medical Center,Tel Aviv,Israel
Arnon Nagler
Department of Hematology,Chaim Sheba Medical Center,Tel Hashomer,Israel
Jean-Pierre Marolleau
Department of Clinical Hematology,University Hospital of Amiens,Amiens,France
Monica Tani
Hematology Unit,S. Maria Delle Croci Hospital,Ravenna,Italy
Henriette Berenschot
Department of Internal Medicine,Albert Schweitzer Hospital,Dordrecht,Netherlands
Stuart Osborne
Biometrics,F. Hoffmann-La Roche Ltd,Basel,Switzerland
Rodney Smith
Pharmaceuticals Division,F. Hoffmann-La Roche Ltd,Basel,Switzerland
Michael Pfreundschuh
Department of Internal Medicine I,University Hospital of Saarland,Homburg,Germany
EHA Learning Center. Lugtenburg E. Jun 13, 2015; 103114
Disclosure(s): Erasmus MC Cancer Institute
Dr. Elly Lugtenburg
Dr. Elly Lugtenburg

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Abstract: S483

Type: Oral Presentation

Presentation during EHA20: From 13.06.2015 16:15 to 13.06.2015 16:30

Location: Room A7

Subcutaneous rituximab (RSC) offers improved patient (pt) convenience and healthcare resource savings versus intravenous R (RIV), with similar efficacy and safety outcomes in the SABRINA study in follicular lymphoma (FL). RSC is approved in Europe and other countries for use in FL and diffuse large B-cell lymphoma (DLBCL).

To confirm the efficacy and safety of RSC versus RIV plus CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) for the treatment of DLBCL.

The open-label, randomised MABEASE study (NCT01649856) investigated the efficacy of RSC versus RIV plus CHOP in untreated DLBCL. Pts were randomised 2:1 to receive RSC (RIV 375 mg/m2 cycle 1; RSC 1400 mg fixed dose cycles 2–8) or RIV (RIV 375 mg/m2 cycles 1–8), plus 6 or 8 cycles of CHOP every 14 or 21 days. Responses (complete response [CR], unconfirmed CR [CRu], partial response [PR], progressive disease [PD]) were determined by investigator assessment (Cheson 1999 criteria). Administration-related reactions (ARRs) were defined as R-related adverse events (AEs) that occurred ≤24 hours of administration. The primary endpoint was response rate at end of treatment (EOT). Safety was a secondary endpoint.

In total, 576 pts were randomised (RSC n=381; RIV n=195; intent-to-treat [ITT] population); baseline characteristics were balanced between arms. A total of 572 pts (RSC n=378; RIV n=194) received ≥1 dose of R. Nine RSC pts discontinued after cycle 1, due to AE (n=5), withdrawn consent (n=2), PD and protocol violation (both n=1); as both arms received RIV during cycle 1, these pts were included in the RIV arm for safety analyses (RSC n=369; RIV n=203). At EOT (RSC n=342; RIV n=177), response rates were similar between arms in the ITT population overall (RSC 52%; RIV 51%) and when pts were stratified by age (~50% for all groups; Table). AE rates were comparable between the RSC and RIV arms overall (92% vs 91%) and during cycle 1 (61% vs 64%); the most common AE overall was neutropaenia (RSC 36%; RIV 33%). During cycles 2–8, RSC and RIV pts had similar rates of grade ≥3 AEs (53% vs 50%) and serious AEs (SAEs; 34% vs 31%); the most frequent grade ≥3 AE was neutropaenia (RSC 22%; RIV 20%) and the most common SAE was febrile neutropaenia (RSC 11%; RIV 6%). ARR rates were similar between RSC and RIV pts overall (28%/arm), during cycle 1 (11% vs 14%) and cycles 2–8 (22% vs 20%). From cycle 2–8, the most common ARR by System Organ Class (SOC) was general disorders and administrative site conditions (RSC 10%; RIV 4%). Rates of grade ≥3 ARRs was similar between arms overall (2% vs 5%), during cycle 1 (0% vs 2%) and cycles 2–8 (2% vs 4%); from cycles 2–8, the most common grade ≥3 ARR by SOC was blood and lymphatic system disorders (RSC 1%; RIV 3%). In total, 52% (RSC) and 54% (RIV) of pts had R-related AEs; the most frequent R-related AE was neutropaenia (RSC 14%; RIV 16%). Overall, 8% (RSC) and 9% (RIV) of pts discontinued R due to AEs, most commonly infections (RSC 2%; RIV 3%). In total, 63 pts (11%) died (RSC 10%; RIV 13%). AEs led to death in 6% (RSC) and 7% (RIV) of pts, most commonly due to infections (2%/arm).

RSC and RIV plus CHOP had similar efficacy and safety outcomes in previously untreated DLBCL. RSC offers convenience for pts and efficient utilisation of healthcare resources.

Keyword(s): CHOP, Diffuse large B cell lymphoma, Rituximab

Session topic: Optimization and innovation in treating aggressive lymphomas
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