G-CSF Increases Disease-Free Survival in Standard-Risk Acute Myeloid Leukemia

Laurie Barclay, MD

August 20, 2003

Aug. 20, 2003 -- Priming with granulocyte colony stimulating factor (G-CSF) before chemotherapy increased disease-free survival but not overall survival in acute myeloid leukemia (AML), according to the results of a multicenter randomized trial published in the Aug. 21 issue of the New England Journal of Medicine. Patients with standard-risk AML benefitted whereas those with poor prognosis did not.

"Sensitization of leukemic cells with hematopoietic growth factors may enhance the cytotoxicity of chemotherapy in AML," write Bob Lowenberg, MD, and colleagues from the Dutch-Belgian Hemato-Oncology (HOVON) Cooperative Group and the Swiss Group for Clinical Cancer Research.

In this study, 640 patients (age range, 18-60 years) with AML received cytarabine plus idarubicin (cycle 1) and cytarabine plus amsacrin (cycle 2) with or without G-CSF.

After induction chemotherapy, response rates were similar in both groups. After a median follow-up of 55 months, rate of disease-free survival at four years was 42% in the G-CSF group and 33% in the no-GSF group ( P = .02). Relative risk of relapse in the G-CSF group was 0.77 (95% confidence interval [CI], 0.61 - 0.99; P = .04). Overall survival was not significantly different between groups.

G-CSF was not associated with improved outcome in the subgroup of patients with an unfavorable prognosis. However, the subgroup of patients (72%) with standard-risk AML fared better with G-CSF therapy. Overall four-year survival was 45% for those in the G-CSF group compared with 35% for those who did not receive G-CSF (relative risk of death, 0.75; 95% CI, 0.59 - 0.95; P = .02). Disease-free survival was 45% for those in the G-CSF group compared with 33% for those who did not receive G-CSF (relative risk, 0.70; 95% CI, 0.55 - 0.90; P = .006).

Although the authors recommend additional studies of G-CSF priming in specific subgroups of patients and regimens of combination therapy, they suggest that "chemotherapy and sensitization of leukemia cells by hematopoietic growth factors is a plausible strategy for reducing the risk of relapse in patients with AML."

In an accompanying editorial, Charles A. Schiffer, MD, from Wayne State University in Detroit, Michigan, agrees that "additional studies seem warranted before priming with growth factors (G-CSF or others) in younger patients with standard-risk AML becomes standard care. In particular, it would be important to identify more specifically which patients may (or may not) benefit from such an approach."

Aventis supported this study.

N Engl J Med. 2003;349:727-729, 743-752

Reviewed by Gary D. Vogin, MD

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