Double-blind randomized control trial of the effect of recombinant human erythropoietin on chemotherapy-induced anemia in patients with non-small cell lung cancer

Int J Clin Oncol. 2001 Dec;6(6):296-301. doi: 10.1007/s10147-001-8031-y.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Anemia / blood
  • Anemia / chemically induced
  • Anemia / prevention & control*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Blood Transfusion
  • Carcinoma, Non-Small-Cell Lung / blood
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Cisplatin / adverse effects*
  • Double-Blind Method
  • Drug Administration Schedule
  • Erythropoietin / therapeutic use*
  • Female
  • Hemoglobins / metabolism
  • Humans
  • Lung Neoplasms / blood
  • Lung Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Mitomycin / adverse effects*
  • Recombinant Proteins
  • Treatment Outcome
  • Vindesine / adverse effects*

Substances

  • Hemoglobins
  • Recombinant Proteins
  • Erythropoietin
  • Mitomycin
  • Cisplatin
  • Vindesine

Supplementary concepts

  • MiPE protocol
  • VDA-P protocol