| Abstract: |
Purpose Chronic lymphocytic leukemia (CLL) is a disease of the elderly, yet few clinical trials include a significant number of older patients, and outcomes after specific therapies can be different depending on age. Patients and Methods We examined patients enrolled onto successive first-line CALGB CLL trials to determine whether efficacy of regimens varied by age, focusing on ideal chemotherapy choice and benefit of immunotherapy addition to chemotherapy in older patients. Regimens included chlorambucil, fludarabine, fludarabine plus rituximab (FR), fludarabine with consolidation alemtuzumab, and FR with consolidation alemtuzumab. Results A total of 663 patients were evaluated for response, progression-free survival (PFS), and overall survival (OS) by age group. Interaction effects of fludarabine versus chlorambucil by age group (PFS, P = .046; OS, P = .006) showed that among patients younger than 70 years, PFS and OS was improved with fludarabine over chlorambucil (PFS: hazard ratio [HR] = 0.6, 95% CI, 0.5 to 0.8; OS: HR = 0.7, 95% CI, 0.5 to 0.9), but not in older adults (PFS, HR = 1.0, 95% CI, 0.6 to 1.7; OS: HR = 1.5, 95% CI, 0.9 to 2.3). In contrast, FR improved outcomes relative to fludarabine, irrespective of age (PFS: HR = 0.6, 95% CI, 0.4 to 0.7; OS: HR = 0.7, 95% CI, 0.5 to 0.9). Alemtuzumab consolidation did not provide benefit over similar regimens without alemtuzumab (P > .20), irrespective of age. Conclusion These data support the use of chlorambucil as an acceptable treatment for many older patients with CLL and suggest rituximab is beneficial regardless of age. These findings bear relevance to both routine care of CLL patients 70 years and older and also future clinical trials in this population. © 2012 by American Society of Clinical Oncology. |
| Keywords: |
adult; cancer chemotherapy; cancer survival; treatment outcome; treatment response; aged; aged, 80 and over; disease-free survival; middle aged; retrospective studies; unclassified drug; major clinical study; overall survival; fludarabine; clinical trials as topic; comparative study; disease free survival; rituximab; methodology; antineoplastic agent; cancer immunotherapy; progression free survival; antineoplastic combined chemotherapy protocols; randomized controlled trials as topic; age factors; retrospective study; groups by age; age; monoclonal antibody; confidence interval; immunology; immunotherapy; drug derivative; aging; multivariate analysis; hazard ratio; kaplan meier method; chronic lymphatic leukemia; leukemia, lymphocytic, chronic, b-cell; multicenter studies as topic; alemtuzumab; chlorambucil; vidarabine; randomized controlled trial (topic); clinical trial (topic); kaplan-meier estimate; multicenter study (topic); antibodies, monoclonal, murine-derived; antibodies, monoclonal, humanized; fludarabine plus rituximab
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| Notes: |
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- "Export Date: 21 May 2013"
- "CODEN: JCOND"
- ": Chemicals/CASalemtuzumab, 216503-57-0; chlorambucil, 305-03-3; fludarabine, 21679-14-1; rituximab, 174722-31-7; vidarabine, 2006-02-2, 5536-17-4; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal, Murine-Derived; Chlorambucil, 305-03-3; Vidarabine, 5536-17-4; alemtuzumab; fludarabine, P2K93U8740; rituximab"
- "Source: Scopus"
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