Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 6602
© 2006 American Society of Clinical Oncology

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Abstract

The combination of rituximab and GM-CSF in elderly patients with chronic lymphocytic leukemia (CLL)

UT M. D. Anderson Cancer Center, Houston, TX; Nichols Institute, San Juan Capistrano, CA

6602

Background: CLL is a disease found more frequently in the elderly (50% of the patients are age 70 at diagnosis). Nevertheless treatment startegies for elderly patients have not been optimized. Elderly patients are often excluded from chemotherapy programs because of fear of severe toxicities resulting from myelosuppression. Therefore, we explored the activity of rituximab in combination with GM-CSF in elderly patients with CLL. The rationale for this combination stems from in vitro data showing increased activity of rituximab when administered togheter with GM-CSF (Venugopal P. Leuk. Res.2000). Methods: Patients age 70 years, untreated or previously treated, were eligible if they had indications for treatment (NCI-WG criteria). Treatment consisted of rituximab 375 mg/m² administered weekly for 4 weeks and GM-CSF 250 mcg s.q. three times weekly for 8 weeks. In the first week GM-CSF was given on day 1 and 3 and rituximab was given on day 4. Genomic aberrations, IgV_H mutation status, ZAP-70 and CD38 expression were evaluated prospectively. Correlative studies measured changes in cell surface and soluble CD20, apoptosis and quality of life (FACT-An V4). Results: 39 patients have been enrolled, 28 are evaluable for response and 31 for toxicity. According to NCI criteria the OR rate was 61%. 7% of the patients achieved CR, 11% nodular PR and 43% PR. Thirty patients are alive and the median time to treatment failure has not been reached with a median follow up of 5 months. Toxicity attributable to GM-CSF was G1 injection site reaction observed in 16% of the patients. OR rates were higher in naive than in previously treated patients (74% vs 46%), in patients with favorable genomic features (73% vs 40%) and mutated IgV_H (89%vs 44%). No difference in OR was found in patients expressing high or low CD38 (60% vs 55%). Upregulation of surface CD20, measured 24h after the 2nd dose of GM-CSF, was observed in 3 out of 4 patients studied. Fatigue level was reduced by a mean of 7 points according to the FACT-An scale (6 patients). Conclusions: Treatment with rituximab and GM-CSF induced a high response rate with minimal toxicity in elderly patients with CLL. Priming with GM-CSF resulted in increased expression of surface CD20. This combination of rituximab and GM-CSF improved systemic symptoms such as fatigue.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Berlex Labs Berlex

Abstract presentation from the 2006 ASCO Annual Meeting