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Alemtuzumab plus chemotherapy prolonged PFS in high-risk CLL
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The addition of the CD52 monoclonal antibody alemtuzumab to front-line fludarabine and cyclophosphamide extended PFS in patients with high-risk chronic lymphocytic leukemia, according to phase 3 study results.
The analysis included 272 patients with high-risk disease features such as unmutated IGHV, 17p or 11q deletions, or trisomy 12.
Treatment consisted of six 28-day cycles. Researchers randomly assigned 139 patients 40 mg/m2 daily fludarabine (Fludara, Genzyme) plus 250 mg/m2 daily cyclophosphamide on days 1 through 3. The other 133 patients received the chemotherapy regimen plus 30 mg alemtuzumab (Campath, Ilex Pharmaceuticals) on day 1.
Overall, the alemtuzumab combination significantly prolonged 3-year PFS (53% vs. 37%; P=.01).
Researchers did not observe a significant OS benefit among all patients treated with alemtuzumab (P=.28); however, results of a post-hoc analysis indicated more patients aged younger than 65 years assigned alemtuzumab achieved 3-year OS compared with those assigned chemotherapy alone (85% vs. 76%; P=.035).
More patients assigned alemtuzumab demonstrated a response (88% vs. 78%; P=.036) and achieved bone marrow minimal residual disease-negative complete remission (64% vs. 43%; P=.016).
Opportunistic infections were 2.5 times more common in the alemtuzumab arm (P=.002). However, researchers noted low-doses of the regimen did not increase treatment-related mortality (3.8% vs. 4.3%).
“Our low-dose approach probably represents the most feasible balance in fludarabine and cyclophosphamide-based immunochemotherapy with alemtuzumab, and clearly illustrates the limitations of the use of this antibody due to immunosuppression,” the researchers wrote. “Despite these limitations, this and other trials confirm the value of this antibody in CLL and even though other compounds, e.g. Burton’s kinase inhibitors are emerging with promising activity in high-risk CLL, alemtuzumab should keep its place in the CLL armamentarium and may even be combined with such emerging new drugs.”
Disclosure: The study was funded by Schering and Genzyme. The researchers report no relevant financial disclosures.
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