摘要

BACKGROUND: Monoclonal antibodies may be used more effectively in combination A previous study of intravenous (IV) bolus alemtuzumab plus rituximab in patients with chronic lymphocytic leukemia (CLL) recurrence produced a response rate of 54% after a 4-week treatment period METHODS: To optimize dose, schedule, and route of alemtuzumab, a study was designed exploring continuous intravenous infusion (CIV) followed by subcutaneous (SC) alemtuzumab together with weekly IV rituximab in patients with previously treated CLL. RESULTS: Data from 40 patients with a median age of 59 years, and a median of 3 prior regimens (range, 1-8 regimens) were evaluable Approximately 64% of patients were fludarabine-refractory Seven patients (18%) achieved a complete response (CR), 4 (10%) a nodular partial response (nPR), and 10 (25%) a partial response for an overall response rate of 53% Of 11 major responses (CR, nPR), 8 occurred after cycle 1. Response rates were highest in blood (94%), followed by liver/spleen (82%), bone marrow (68%), and lymph nodes (51%) The combination did not generate unexpected toxicities Cytomegalovirus (CMV) reactivations occurred in 6 patients (15%) and responded well to anti-CMV therapy High titers of anti-idiotype antibodies after SC alemtuzumab were demonstrated in 1 patient, but remained without clinical sequelae CONCLUSIONS: The combination of CIV/SC alemtuzumab plus rituximab has activity in some patients with recurrent/refractory CLL and maximum response is achieved after 1 cycle (4 weeks) in 73% of patients Further exploration in other settings of CLL together with accompanying pharmacokinetic studies is recommended. Cancer 2010;116:2360-5.

  • 出版日期2010-5-15