The safety and effectiveness of Rituxan were evaluated in three, randomized, active-controlled, open-label, multicenter studies with a collective enrollment of 1854 patients. Patients with previously untreated diffuse large B-cell NHL received Rituxan in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

Study 6

A total of 632 patients aged ≥ 60 years with B-cell NHL Grade F, G, or H by the International Working Formulation classification or DLBCL (including primary mediastinal B-cell lymphoma) in the REAL classification were randomized in a 1:1 ratio to treatment with CHOP or R-CHOP. Patients were given 6 or 8, 21 day cycles of CHOP. Patients in the R-CHOP arm also received 4 or 5 doses of Rituxan 375 mg/m² on Days -7 and -3 (prior to Cycle 1), and 48-72 hours pre-Cycle 3, pre-Cycle 5, and pre-Cycle 7 for patients receiving 8 cycles of CHOP induction. The main outcome measure of the study was progression-free survival, defined as the time from randomization to the first of progression, relapse or death. Responding patients underwent a second randomization to receive Rituxan or no further therapy.

Among all enrolled patients, 62% had centrally confirmed DLBCL histology, 73% had Stage III-IV disease, 56% had IPI scores ≥ 2, 86% had ECOG performance status of < 2, 57% had elevated LDH levels, and 30% had two or more extranodal disease sites involved. Efficacy results are presented in Table 4. These results reflect a statistical approach which allows for an evaluation of Rituxan administered in the induction setting that excludes any potential impact of Rituxan given after the second randomization.

Analysis of results after the second randomization in Study 6 demonstrates that for patients randomized to R-CHOP, additional Rituxan exposure beyond induction was not associated with further improvements in progression free survival or overall survival.

Study 7

A total of 399 patients with DLBCL, aged ≥ 60 years, were randomized in a 1:1 ratio to receive CHOP or R-CHOP induction. All patients received up to 8, 3-week cycles of CHOP induction; patients in the R-CHOP arm received Rituxan 375 mg/m² on Day 1 of each cycle. The main outcome measure of the study was event free survival, defined as the time from randomization to relapse, progression, change in therapy or death from any cause. Among all enrolled patients, 80% had stage III or IV disease, 60% of patients had an age-adjusted IPI ≥ 2, 80% had ECOG performance status scores < 2, 66% had elevated LDH levels, and 52% had extranodal involvement in at least two sites. Efficacy results are presented in Table 4.

Study 8

A total of 823 patients with DLBCL, aged 18-60 years, were randomized in a 1:1 ratio to receive an anthracycline-containing chemotherapy regimen alone or in combination with Rituxan. The main outcome measure of the study was time to treatment failure, defined as time from randomization to the earliest of progressive disease, failure to achieve a complete response, relapse or death. Among all enrolled patients, 28% had Stage III-IV disease, 100% had IPI scores of ≤ 1, 99% had ECOG performance status of < 2, 29% had elevated LDH levels, 49% had bulky disease and 34% had extranodal involvement. Efficacy results are presented in Table 4.

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