Purpose: A prospective Phase II trial was carried out to evaluate the effectiveness of erythropoietin in improving or maintaining performance status as determined by the Karnofsky performance status (KPS) score and hemoglobin (Hb) levels in lung cancer patients treated with concurrent chemoradiation (CH-RT).
Methods and materials: A total of 51 patients with lung cancer (11 with small-cell, limited stage and 40 with non-small-cell disease, 17 with Stage IIIA and 23 with Stage IIIB), who underwent three different concurrent CH-RT protocols were enrolled. Baseline Hb and KPS values were recorded, as were the nadir Hb and KPS values before concurrent CH-RT. The final Hb and KPS values were recorded the last week of concurrent CH-RT. An Hb level of <or=11 g/dL before concurrent CH-RT was required before receiving erythropoietin. Prognostic factors for KPS improvement and survival were assessed by univariate and multivariate studies.
Results: Of the 51 patients, 47 (92.3%) were men (mean age 63.6 years, range 40-75). The median baseline KPS score was 80, and the mean baseline Hb was 12.2 +/- 1.76 g/dL (range 9-16.9). The mean nadir and final Hb value was 9.98 +/- 0.67 g/dL (range 8.6-11) and 11.33 +/- 1.59 g/dL (range 6.9-14.4), respectively. A significant increase was seen in the Hb and KPS score (p <0.05) in the final measurements. Differences were found between the final and nadir Hb in the predictive value for differences in performance status (p = 0.001). On univariate study, pathologic findings (p = 0.0234), weight loss (p = 0.0049), baseline Hb (p = 0.0057), and final Hb improvement (p = 0.0237) were prognostic factors for survival. Nadir Hb (p = 0.027), final Hb improvement (p = 0.0069), pathologic findings (p = 0.0006), and weight loss (p = 0.0001) had significant prognostic value for survival in multivariate analysis.
Conclusion: In this study, erythropoietin appears to have a significant, beneficial impact on the KPS and Hb of patients undergoing concurrent CH-RT.