Use of Hematopoietic Growth Factors and Risk of Thromboembolic and Pulmonary Toxicities in Elderly Patients with Advanced Ovarian Cancer.

Objective: To evaluate the risk of thromboembolic and pulmonary toxicities associated with hematopoietic growth factor (HGF) use (i.e., erythropoietin-stimulating agent [ESA] and/or colony-stimulating factor [CSF]) in a community-dwelling cohort of elderly patients with advanced ovarian cancer.

Methods: We studied 8,188 women, 65 years and older from the Surveillance, Epidemiology and End Results-Medicare linked database, diagnosed from January 1, 2000 to December 31, 2009. Patients were categorized into five groups: no chemotherapy and no ESA/CSF (n = 2,616), chemotherapy but no ESA/CSF (n = 1,854), ESA only (n = 1,313), CSF only (n = 743), and ESA + CSF (n = 1,662). We reported the cumulative incidence of toxicities for 2, 6, and greater than 6 months, and the incidence density for the overall follow-up. Cox-proportional hazards regression was performed to determine risk of toxicities.

Results: Of the 5,572 patients receiving chemotherapy, 66.7% (n = 3,718) received HGF supportive treatment, 29.8% received ESA + CSF, 23.6% received ESA only, and 13.3% received CSF only. Patients who received chemotherapy and also ESA + CSF had a 14.1% cumulative incidence of thromboembolic event (TEE) at 6 months of follow-up compared with 8.0% in those who received chemotherapy without growth factor and 3.2% in those with neither chemotherapy nor growth factor. Those with chemotherapy who received ESA + CSF had a significantly higher risk of TEE (adjusted hazard ratio, 1.22; 95% confidence interval, 1.01-1.47) as compared with patients with chemotherapy and no ESA/CSF, although patients aged 85 years and older may experience up to a five-fold increased risk. The risk of pulmonary toxicities did not significantly differ by HGF use.

Conclusions: An increased risk of TEEs was observed in elderly patients with ovarian cancer who received ESA + CSF. The risk-benefit ratio for administering HGF should be carefully evaluated, especially among those 85 years and older.