Rituximab Plus Chlorambucil As First-Line Treatment for Chronic Lymphocytic Leukemia: Final Analysis of an Open-Label Phase II Study
| Autor: | Christopher Pocock, Donald Milligan, Stephan Oertel, Paul Moreton, Andrew R. Pettitt, Hazem A. Sayala, Abraham M. Varghese, George A Follows, John G. Gribben, David Oscier, Andy C. Rawstron, Daniel B. Kennedy, Dena Cohen, Amit Nathwani, Peter Hillmen, Claire Dearden |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Chronic lymphocytic leukemia Population Phases of clinical research Comorbidity Gastroenterology Antibodies Monoclonal Murine-Derived immune system diseases hemic and lymphatic diseases Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans education Aged Aged 80 and over education.field_of_study Chlorambucil business.industry ORIGINAL REPORTS Middle Aged medicine.disease Leukemia Lymphocytic Chronic B-Cell Surgery Fludarabine Leukemia Treatment Outcome Oncology Female Rituximab business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 32:1236-1241 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2013.49.6547 |
| Popis: | Purpose 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/m2 on day 1, cycle one, and 500 mg/m2 thereafter) plus chlorambucil (10 mg/m2/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. Results 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. Conclusion 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|