Hemoglobin increase in advanced/metastatic lung cancer patients receiving multicycle chemotherapy and weekly darbepoetin alfa: An initial ongoing experience

Abstract

8250 Background: Recombinant human erythropoietin (rHuEpo) is efficient in treating chemotherapy-induced anemia, increasing mean hemoglobin (Hgb) levels by 1 g/dl at 4 weeks (w) (Gabrilove, JCO 2001). Darbepoetin alfa, a novel erythropoiesis stimulating protein, has a lower receptor-binding affinity than rHuEPO, due to its higher sialic acid-containing carbohydrate content, but a longer serum half-life, that should confer it a greater and faster in vivo potency at 2 and 4 w (Egrie, Exp Hematol 2003). Aim of this ongoing study was to evaluate whether in the treatment of anemic lung cancer patients, darbepoetin alfa had the same efficacy as that expected from rHuEpo. Methods:From July till October 2003, 24 patients with advanced-metastatic NSCLC receiving chemo- (22 pts) or radiotherapy (2 pts), mean age 64 yrs, ECOG 0–1, were treated for treatment-induced anemia with darbepoetin alfa, 150 mcg/w s.c. for 4 w. The treatment was started at Hgb levels ≤10.5 g/dl, or at Hgb >10.5 g/dl, but with a Hgb reduction ≥1.5 g/dl after the beginning of chemotherapy. Hgb response was assessed at 2 and 4 w of treatment. Results:Mean Hgb change was 0.54 g/dl and 1.14 g/dl at 2 and 4 w respectively. Eight/24 and 13/24 pts had a Hgb increase ≥1 g/dl at 2 and 4 w respectively, while 6/24 pts had a major response, with an increase ≥2g/dl at 4 w. Twenty-two patients were therefore stratified according to the schedule of chemotherapy they were receiving (platinum- vs non-platinum-based [59% vs 41%], oral vs i.v. [27% vs 73%]) and to pre-treatment vs no-pre-treatment with rHuEPO (27% vs 73%), and then correlated with the response to darbepoetin therapy (t-test). No statistical differences between the groups were observed. Conclusions: Compared with data from historical studies, in our cluster of patients darbepoetin alfa was equiactive with rHuEpo at 4 weeks, showing a similar rate of early responses at 2 w. Moreover, no significant differences in response were observed for those patients who were receiving less anemia-inducing treatments, such as non-platinum-based therapy or oral therapy (vinorelbine 4 pts, ZD-1839 2 pts). No significant financial relationships to disclose.