Study 2

In a multicenter, single-arm study, 37 patients with relapsed or refractory, low-grade NHL received 375 mg/m² of Rituxan weekly for 8 doses. Results are summarized in Table 2. (See ADVERSE REACTIONS: Risk Factors Associated with Increased Rates of Adverse Events.)

Bulky Disease, Weekly for 4 Doses

In pooled data (Study 1 and 3) from multiple studies of Rituxan, 39 patients with relapsed or refractory, bulky disease (single lesion > 10 cm in diameter), low-grade NHL received 375 mg/m² of Rituxan weekly for 4 doses. Results are summarized in Table 2.^{16, 17} (For information on the higher incidence of Grade 3 and 4 adverse events, see ADVERSE REACTIONS: Risk Factors Associated with Increased Rates of Adverse Events.)

Retreatment Weekly for 4 Doses

Study 3

In a multicenter, single-arm study, 60 patients received 375 mg/m² of Rituxan weekly for 4 doses.¹⁸ All patients had relapsed or refractory, low-grade or follicular B-cell NHL and had achieved an objective clinical response to Rituxan administered 3.8-35.6 months (median 14.5 months) prior to retreatment with Rituxan. Of these 60 patients, 55 received their second course of Rituxan, 3 patients received their third course and 2 patients received their second and third courses of Rituxan in this study. Results are summarized in Table 2.

Previously Untreated, Follicular, CD-20 Positive, B-Cell NHL

Study 4

A total of 322 patients with previously untreated follicular NHL were randomized (1:1) to receive up to eight 3-week cycles of CVP chemotherapy alone (CVP) or in combination with Rituxan 375 mg/m² on Day 1 of each cycle (R-CVP) in an open-label, multicenter study. The main outcome measure of the study was progression-free survival (PFS) defined as the time from randomization to the first of progression, relapse or death.

Twenty-six percent of the study population was > 60 years of age, 99% had Stage III or IV disease, and 50% had an International Prognostic Index (IPI) score ≥ 2. Of the 289 patients with available histologic material for review, 95% had a centrally-confirmed diagnosis of follicular (REAL follicular grade 1, 2 and 3) NHL. The results for PFS as determined by a blinded, independent assessment of progression are presented in Table 3. The point estimates may be influenced by the presence of informative censoring. The PFS results based on investigator assessment of progression were similar to those obtained by the independent review assessment.

Table 3
Efficacy Results in Study 4

Previously Untreated, Low-Grade, CD-20 Positive, B-Cell NHL

Study 5

A total of 322 patients with previously untreated low-grade, B-cell NHL (IWF Grades A, B or C) who did not progress after 6 or 8 cycles of CVP chemotherapy were enrolled in an open-label, multicenter, randomized trial. Patients were randomized (1:1) to receive Rituxan, 375 mg/m² IV infusion, once weekly for 4 doses every 6 months for up to 16 doses or no further therapeutic intervention. The main outcome measure of the study was progression-free survival defined as the time from randomization to progression, relapse or death. Thirty-seven percent of the study population was > 60 years of age, 99% had Stage III or IV disease, and 63% had an IPI score ≥ 2. Among the 237 patients for whom histologic material was available for review, 201 patients (85%) had centrally confirmed IWF Grade A, B or C NHL.

There was a reduction in the risk of progression, relapse, or death (hazard ratio estimate in the range of 0.36 to 0.49) for patients randomized to Rituxan as compared to those who received no additional treatment.

Diffuse Large B-Cell NHL (DLBCL)

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