BACKGROUND: To evaluate the efficacy and feasibility of rituximab monotherapy in Japanese patients with relapsed or refractory aggressive B-cell lymphoma. PATIENTS AND METHODS: Sixty-eight patients were treated with rituximab at 375 mg/m(2) by eight consecutive weekly infusions. Pretreatment variables affecting overall response rate (ORR) and progression-free survival (PFS) and the relationship between pharmacokinetic parameters and efficacy were analyzed. RESULTS: The ORRs of 68 enrolled patients and 57 eligible patients were 35% [95% confidence interval (CI) 24% to 48%] and 37% (95% CI 25% to 51%), respectively. Median PFS of 53 evaluable patients was 52 days, whereas time to progression of 21 eligible responders was 245 days. Mild to moderate infusion-related toxicities were observed frequently at the first infusion, but all of them were reversible. Elevated lactate dehydrogenase (LDH) and refractoriness to prior chemotherapy were unfavorable factors affecting ORR and PFS (P <0.01). Serum trough levels of rituximab and area under the concentration-time curve for responders were higher than for non-responders (P <0.05). CONCLUSIONS: Eight consecutive weekly infusions of rituximab have significant anti-lymphoma activity for relapsed or refractory aggressive B-cell lymphoma. Several pretreatment variables and serum rituximab levels are useful for predicting its efficacy.
BACKGROUND: To evaluate the efficacy and feasibility of rituximab monotherapy in Japanese patients with relapsed or refractory aggressive B-cell lymphoma. PATIENTS AND METHODS: Sixty-eight patients were treated with rituximab at 375 mg/m(2) by eight consecutive weekly infusions. Pretreatment variables affecting overall response rate (ORR) and progression-free survival (PFS) and the relationship between pharmacokinetic parameters and efficacy were analyzed. RESULTS: The ORRs of 68 enrolled patients and 57 eligible patients were 35% [95% confidence interval (CI) 24% to 48%] and 37% (95% CI 25% to 51%), respectively. Median PFS of 53 evaluable patients was 52 days, whereas time to progression of 21 eligible responders was 245 days. Mild to moderate infusion-related toxicities were observed frequently at the first infusion, but all of them were reversible. Elevated lactate dehydrogenase (LDH) and refractoriness to prior chemotherapy were unfavorable factors affecting ORR and PFS (P <0.01). Serum trough levels of rituximab and area under the concentration-time curve for responders were higher than for non-responders (P <0.05). CONCLUSIONS: Eight consecutive weekly infusions of rituximab have significant anti-lymphoma activity for relapsed or refractory aggressive B-cell lymphoma. Several pretreatment variables and serum rituximab levels are useful for predicting its efficacy.
Authors: Jeffrey A Barnes; Eric Jacobsen; Yang Feng; Arnold Freedman; Ephraim P Hochberg; Ann S LaCasce; Philippe Armand; Robin Joyce; Aliyah R Sohani; Scott J Rodig; Donna Neuberg; David C Fisher; Jeremy S Abramson Journal: Haematologica Date: 2012-11-09 Impact factor: 9.941
Authors: Carla Casulo; Julie M Vose; William Y Ho; Brad Kahl; Mark Brunvand; Andre Goy; Yvette Kasamon; Bruce Cheson; Jonathan W Friedberg Journal: Clin Immunol Date: 2014-06-11 Impact factor: 3.969
Authors: Silvia Maria Lavezzi; Jan de Jong; Martine Neyens; Paula Cramer; Fatih Demirkan; Graeme Fraser; Nancy Bartlett; Marie-Sarah Dilhuydy; Javier Loscertales; Abraham Avigdor; Simon Rule; Olga Samoilova; Andre Goy; Siddhartha Ganguly; Mariya Salman; Angela Howes; Michelle Mahler; Giuseppe De Nicolao; Italo Poggesi Journal: Pharm Res Date: 2019-05-01 Impact factor: 4.200