Accelerated Delivery of Rituximab Is Safe on an Out-Patient Basis.

Abstract

Abstract Aim A prospective study to determine the safety of the accelerated delivery of rituximab. Methods A pilot study investigating the safety of the accelerated delivery of rituximab was commenced in September 2004. First doses of rituximab were delivered as per prescribing guidelines. Patients without infusion related toxicity were eligible for accelerated rituximab in second or subsequent infusions. In the first 4 patients the infusion was administered at 100mg/hr, increasing to 400mg/hr after 15 minutes in the absence of a reaction. All subsequent patients commenced the infusion at 400mg/hr. All patients received premedication with paracetamol, promethazine and hydrocortisone unless contra-indicated. Patients with a previous grade III/IV infusion related toxicity were excluded. Results 23 patients have been enrolled to date. Data is available for 62 infusions - median 3 infusions per patient (range: 1–6). Median age was 64 years (range: 28–85). 65% of patients were male. Diagnoses included non-Hodgkin’s Lymphoma - 20 patients (Diffuse Large Cell Lymphoma - 8, Follicular Lymphoma - 9, Mantle Cell Lymphoma - 1, Lymphoplasmacytic Lymphoma - 2), Immune Thrombocytopenic Purpura - 2 and Dermatomyositis-1. 44% of patients received single agent rituximab and 56% received it in combination with chemotherapy. The median dose of rituximab was 700mg (range: 600–800mg). There were 2 adverse events with no grade III/IV infusion related toxicity. One patient experienced grade I hypothermia. A second patient experienced grade II fevers and rigors which required interruption of the infusion. The patient was subsequently found to have pneumonia. The infusion was completed without further incident. Excluding data from the latter patient, median infusion time was 1 hour and 55 minutes and 76% of infusions were completed within 2 hours. Conclusion For second or subsequent infusions, the accelerated delivery of rituximab is safe and well tolerated allowing shorter outpatient stays and improving the efficiency of resource utilisation. The study has been extended to include patients with bulky lymphoma and Chronic Lymphocytic Leukaemia.