Hillmen, Peter and Gribben, John G and Follows, George A and Milligan, Donald and Sayala, Hazem A and Moreton, Paul and Oscier, David G and Dearden, Claire E and Kennedy, Daniel B and Pettitt, Andrew R and Nathwani, Amit and Varghese, Abraham and Cohen, Dena and Rawstron, Andy and Oertel, Stephan and Pocock, Christopher F E (2014) Rituximab plus chlorambucil as first-line treatment for chronic lymphocytic leukemia: Final analysis of an open-label phase II study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 32 (12). pp. 1236-41. ISSN 1527-7755. This article is accessible to all HEFT staff and students via NHS Evidence www.evidence.nhs.uk by using their Athens login IDsFull text not available from this repository.
Most patients with chronic lymphocytic leukemia (CLL) are elderly and/or have comorbidities that may make them ineligible for fludarabine-based treatment. For this population, chlorambucil monotherapy is an appropriate therapeutic option; however, response rates with chlorambucil are low, and more effective treatments are needed. This trial was designed to assess how the addition of rituximab to chlorambucil (R-chlorambucil) would affect safety and efficacy in patients with CLL.
PATIENTS AND METHODS
Patients with first-line CLL were treated with rituximab (375 mg/m(2) on day 1, cycle one, and 500 mg/m(2) thereafter) plus chlorambucil (10 mg/m(2)/d all cycles; day 1 through 7) for six 28-day cycles. For patients not achieving complete response (CR), six additional cycles of chlorambucil alone could be administered. The primary end point of the study was safety.
A total of 100 patients were treated with R-chlorambucil, with a median follow-up of 30 months. Median age of patients was 70 years (range, 43 to 86 years), with patients having a median of seven comorbidities. Hematologic toxicities accounted for most grade 3/4 adverse events reported, with neutropenia and lymphopenia both occurring in 41% of patients and leukopenia in 23%. Overall response rates were 84%, with CR achieved in 10% of patients. Median progression-free survival was 23.5 months; median overall survival was not reached.
These results compare favorably with previously published results for chlorambucil monotherapy, suggesting that the addition of rituximab to chlorambucil may improve efficacy with no unexpected adverse events. R-chlorambucil may improve outcome for patients who are ineligible for fludarabine-based treatments.
|Additional Information:||This article is accessible to all HEFT staff and students via NHS Evidence www.evidence.nhs.uk by using their Athens login IDs|
|Subjects:||WH Haemic and lymphatic systems. Haematology|
|Divisions:||Planned IP Care > Oncology and Clinical Haematology|
|Depositing User:||Mrs Yolande Brookes|
|Date Deposited:||18 Aug 2014 14:08|
|Last Modified:||18 Aug 2014 14:08|
Actions (login required)