RITUXAN IN COMBINATION WITH CHOP OR OTHER ANTHRACYCLINE-BASED CHEMOTHERAPY IMPROVED OUTCOMES IN PREVIOUSLY UNTREATED DLBCL

*Patients in the R-CHOP arm received RITUXAN 375 mg/m2 on Day 1 of each cycle.

RITUXAN + CHOP IMPROVED EVENT-FREE SURVIVAL IN FIRST-LINE DLBCL 1

  • R-CHOP improved overall survival by 26% vs CHOP alone at 5-year median follow-up (58% with R-CHOP vs 46% with CHOP alone) 1,9
In The ECOG-4494 Trial 1
  • In a multicenter, open-label study, 632 patients (age ≥60 years) with previously untreated DLBCL were randomized to receive R-CHOP or CHOP alone
  • Patients received 6 or 8 cycles of CHOP, each cycle lasting 21 days. All patients in the R-CHOP arm received 4 doses of RITUXAN 375 mg/m2 on Days −7 and −3 (prior to Cycle 1) and 48−72 hours prior to Cycles 3 and 5. Patients who received 8 cycles of CHOP also received RITUXAN prior to Cycle 7
    • 62% of the study population had centrally confirmed DLBCL histology
    • 73% had stage III or IV disease
    • 56% had IPI scores ≥2
    • 86% had ECOG performance status of <2
    • 57% had elevated LDH levels
    • 30% had extranodal involvement in at least 2 sites
  • R-CHOP improved median PFS by 94% (3.1 years vs 1.6 years) vs CHOP alone (primary endpoint: HR: 0.69; P<0.05)
  • At 2 years, OS was improved to 74% from 63% with R-CHOP vs CHOP alone (HR: 0.72; P<0.05)
In The MInT Trial 1
  • In a multicenter, open-label study, 823 patients (age 18–60 years) with previously untreated DLBCL were randomized to receive 8 cycles of either R-CHEMO or CHEMO alone
    • 28% of the study population had stage III or IV disease
    • 100% had IPI scores of ≤1
    • 99% had ECOG performance status of <2
    • 29% had elevated LDH levels
    • 49% had bulky disease
    • 34% had extranodal involvement
  • The median time to treatment failure (primary endpoint) could not be reliably estimated. Time to treatment failure was defined as progressive disease, failure to achieve a complete response, relapse, or death
  • R-CHEMO reduced the risk of treatment failure by 55% vs CHEMO alone (HR: 0.45; P<0.05)
  • 2-year OS was 95% for R-CHEMO vs 86% for CHEMO alone (HR: 0.40; P<0.05)

CHEMO: Approximately 44% of trial patients in both study arms received CHOEP (CHOP + etoposide), 49% received CHOP, 4% received MACOP-B (methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin), and 4% received PMitCEBO (prednisolone, mitoxantrone, cyclophosphamide, etoposide, bleomycin, and vincristine). 2

SELECT IMPORTANT SAFETY INFORMATION

RITUXAN IN COMBINATION WITH CHOP CHEMOTHERAPY FOR DLBCL

  • Detailed safety data collection was primarily limited to Grade 3 and 4 adverse reactions and serious reactions. In studies of elderly patients with DLBCL, the following adverse reactions, regardless of severity, were reported more frequently (≥5%) in patients ≥60 years of age receiving R-CHOP as compared with CHOP alone: pyrexia (56% vs. 46%), lung disorder (31% vs. 24%), cardiac disorder (29% vs. 21%), and chills (13% vs. 4%)
  • A review of cardiac toxicity determined that supraventricular arrhythmias or tachycardia accounted for most of the difference in cardiac disorders (4.5% for R-CHOP vs. 1.0% for CHOP)
  • The following Grade 3 or 4 adverse reactions occurred more frequently among patients in the R-CHOP arm compared with those in the CHOP arm: thrombocytopenia (9% vs. 7%) and lung disorder (6% vs. 3%). Other Grade 3 or 4 adverse reactions reported more frequently among patients receiving R-CHOP were viral infection, neutropenia, and anemia

R=RITUXAN; CHOP=cyclophosphamide, doxorubicin, vincristine, and prednisone; OS=overall survival; GELA=Groupe d'Etude des Lymphomes de l'Adulte; LNH=Lymphome Non Hodgkinien; ECOG=Eastern Cooperative Oncology Group; MInT=MabThera® (rituximab) International Trial.

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