e researchers identified 5,510 women age 65 and older who were diagnosed with breast cancer and treated with chemotherapy between 1991 and 1999. A total of 906 (16%) were treated with at least one course of G-CSF (832), GM-CSF (29), or both (49). Among these 906 patients, 16 (1.77%) developed AML or MDS; among the 4,604 women who didn't get growth factor treatment, 48 (1.04%) developed one of the diseases. The authors calculated that women who received GM-CSF or G-CSF had twice the risk of developing AML or MDS as women not treated with the growth factors.

"Our study demonstrates that the elevated risk of AML or MDS associated with adjuvant chemotherapy may be further increased by the concurrent use of growth factors," the authors write. "It is unclear if the growth factors cause an increased risk or if the requirements for their use cause an increased risk; however, the absolute overall risk appeared to be small, even among the elderly patients we studied. Nevertheless, if further research confirms this finding, this risk should be factored into clinical decisions with regard to the use of growth factors."

In an editorial, Ivo P. Touw, Ph.D., and Marijke Bontenbal, of the Erasmus University Medical Center Rotterdam in the Netherlands, review the possible biologic mechanisms for the increased risk, and point out that growth factor use has increased in recent years. They also note that the benefits of adjuvant chemotherapy for breast cancer may far outweigh any risk of a second cancer. "In clinical practice, … the benefits of adjuvant chemotherapy are of a different order of magnitude than the risk of secondary MDS or AML," they write. "Furthermore, given all the unknown factors, associations could be found that have no causal relationship. The evidence for a potential role of G-CSF in the onset of AML/MDS, derived from only a few retrospective studies, thus has to be qualified as hypothesis generating rather than conclusive."

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