Double-blind randomized control trial of the effect of recombinant human erythropoietin on chemotherapy-induced anemia in patients with non-small cell lung cancer.
BACKGROUND
We studied the clinical effect of recombinant human erythropoietin (r-huEPO) on anemia induced by two courses of cisplatin-based chemotherapy in patients with non-small cell lung cancer (NSCLC).


METHODS
Seventy-two patients with NSCLC were randomized into three groups, receiving 100, or 200 IU/kg of r-huEPO, or placebo. The r-huEPO and placebo were administered subcutaneously three times a week for 6 weeks, starting 2 weeks after the initiation of chemotherapy.


RESULTS
In the 53 evaluable patients, hemoglobin (Hb) levels at the nadir after the second cycle of chemotherapy were significantly elevated compared with the nadir after the first cycle in both r-huEPO treated groups, while this level was decreased in the placebo group. Hb levels at the end of the second course of chemotherapy (week 8) in both r-huEPO groups were higher than that in the placebo groups. No adverse drug reaction attributable to r-huEPO was observed. Serum erythropoietin levels after the administration of r-huEPO were higher than those after placebo administration.


CONCLUSIONS
r-huEPO had an effect in preventing anemia in patients with NSCLC who had cisplatin-based chemotherapy.
Kunikane
H
H
Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama 240-8555, Japan. kunikane@courante.plala.or.jp
Watanabe
K
K
Fukuoka
M
M
Saijo
N
N
Furuse
K
K
Ikegami
H
H
Ariyoshi
Y
Y
Kishimoto
S
S
D000740:Anemia / Q000097:blood / Q000139:chemically induced / Q000517:prevention & control*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001803:Blood Transfusion; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000188:drug therapy*; D002945:Cisplatin / Q000009:adverse effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000009:adverse effects*; D011994:Recombinant Proteins; D016896:Treatment Outcome; D014751:Vindesine / Q000009:adverse effects*
D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D016685:Mitomycin; D002945:Cisplatin; D014751:Vindesine