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Title: Rituximab Effective With Minimal Toxicity in Patients With Relapsed or Refractory Hairy Cell Leukaemia: Presented at NHL

"Rituximab Effective With Minimal Toxicity in Patients With Relapsed or Refractory Hairy Cell Leukaemia: Presented at NHL"

By Chris Berrie PRAGUE, CZECH REPUBLIC -- September 14, 2004 -- Rituximab has significant efficacy and minimal toxicity in patients with hairy cell leukemia (HCL) that are relapsed and refractory to 2-chlorodeoxyadenosine (2-CDA), according to a phase 2 study by the Swiss Group for Clinical Cancer Research (SAKK). The research was presented here September 12th at The Role of Immunotherapy in NHL: Optimising Treatment Outcomes, sponsored by Roche. "HCL is a rare disease; however, most of these patients require treatment because of progressive pancytopaenia and splenomegaly," said Reinhard Zenhäusern, MD, clinical investigator, Institute of Medical Oncology, Inselspital Bern, Bern, Switzerland. Thus, over the last 20 years, the treatment for HCL has progressed from splenectomy, through interferon-alpha, to the purine analogues, such as pentostatin and the present treatment of choice, 2-CDA. However, along with the 85% complete response (CR) rates with 2-CDA, some 30% of patients relapse within 3 to 4 years. SAKK undertook this study (SAKK 31/98) on the basis of rituximab efficacy in relapsed low-grade leukaemias and the presence of CD20 on lymphocytes of mature B-cell lymphoma and leukaemia. Twenty-six patients with relapsed (36%) or progressive (64%) HCL after treatment with 2-CDA were recruited. The possibly rituximab-related death (respiratory and cardiac failure) of 1 patient after the first infusion left 25 for evaluation. The median age of these patients was 58 years (range, 38-83), 80% were male, and 96% had classical HCL, with 1 having a prolymphocytic HCL subtype. Previous treatments were splenectomy in 16%, 36% had received interferon-alpha, and 8% had received chemotherapy other than 2-CDA. Rituximab was given in 4 courses of 375 mg/m[² IV at weekly intervals. Among the 22 evaluable patients, 32% achieved a complete response, with an overall response rate of 68%. The median relapse-free survival was 15.9 months, and the median duration of remission was 21.2 months. The most common grade 3/4 adverse event was leukopaenia/neutropaenia, which occurred in 40% of patients after the first infusion, 28% after the second, 24% after the third, and 16% after the fourth. There was also a second death (from gastrointestinal bleeding) that occurred 12 weeks after the fourth rituximab infusion, although this was considered not to be treatment related.

Dr. Zenhäusern concluded that rituximab appears to be a good therapeutic option for patients with HCL, while noting that "the schedule for the optimal dose for rituximab has to be clarified, and special attention should be given to patients with underlying cardiac disease."

[Presentation title: Rituximab in Patients With Hairy Cell Leukaemia Relapsing After Treatment With 2-chlorodeoxyadenosine. Abstract 416]

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