Semi-extended, six weekly rituximab infusions in pre-treated advanced low-grade B cell XXXX : a phase II study.

@entity1 @entity137 @entity1503 @entity74 @entity1893
Either four or eight weekly rituximab infusions in relapsed or refractory low-grade or follicular B cell @entity1893 ( @entity1893 ) are well tolerated and efficacious. This phase II trial investigated the safety and efficacy of six weekly rituximab doses in chemotherapeutically pre-treated relapsed or refractory low-grade @entity1893 @entity1 . Sixty-eight @entity1 (median age 64 years) received six i.v. rituximab infusions 375 mg/m2 weekly. All @entity1 had received one or more prior therapies (median 2; range 1-18). Forty-two @entity1 had @entity74 and were evaluated for @entity137 and efficacy; 12 of these required re-treatment with six weekly rituximab infusions. Twenty-six @entity1 received rituximab as remission consolidation therapy and were assessed for @entity137 only. No @entity1 discontinued because of adverse events. Most adverse events were National Cancer Institute grade 1 (2-9%) or 2 (3-5%) and usually occurred during the first infusion. No @entity1503 were observed. Overall response rate was 59% (median time to response 2 weeks) and 10 of 12 re-treated @entity1 responded. Median time to progression for all @entity1 was 14 months and for responders 21 months. More than half the 42 @entity1 evaluated for efficacy and more than 70% of the 25 responding @entity1 still survived longer than 3 years after treatment. The safety profile and efficacy achieved in this study compare favorably with those seen with four or eight weekly doses in pre-treated low-grade @entity1893 .
