title: Erythropoietin treatment under polychemotherapy in patients with gynecologic malignancies: a prospective, randomized, double-blind placebo-controlled multicenter study.
abstract: In order to examine the influence of erythropoietin (rHuEPO) on serum hemoglobin levels, transfusion requirements, and quality of life in patients with gynecologic malignancies under polychemotherapy and chronic tumor anemia (hemoglobin <11 g/dl), we performed a prospective, randomized, double-blinded placebo-controlled clinical trial. Between October 1992 and October 1993, 35 patients from 5 gynecologic departments were entered into this trial. Inclusion criteria were hemoglobin level <11 g/dl, ferritin level >29 ng/ml, stool negative for occult blood, and life expectancy for more than 3 months. Patients received either 150 U/kg body wt rHuEPO (Erypo by Cilag-Janssen) sc three times a week for 12 weeks (n = 23) or a placebo (n = 12). If the hemoglobin levels of the 4th, 8th, or 12th week were >2 g/dl above the baseline value and/or >12 g/dl, the patient was classified as a responder. Patients who required blood transfusions (hemoglobin <8 g/dl, erythrocytes <3 x 10(6)/ml, or clinical symptoms of anemia) were classified as nonresponders. A nonvalidated quality of life questionnaire was completed by the patient at the beginning of the treatment and then every fourth week before receiving chemotherapy. In the rHuEPO group 56.6% of the patients responded to the treatment (chi2 = 10.79, P = 0.001) and only 5 patients (21.7%) required blood transfusions, whereas 8 of 12 patients in the placebo group (66.6%) had to be transfused (chi2 = 6.81, P = 0.009). Quality of life did not differ significantly between the rHuEPO group and the placebo group of patients. Within the rHuEPO group those patients that responded showed a significant increase in physical activity after response in comparison to the preresponsive phase (P = 0.02, paired t test). We therefore concluded that rHuEPO significantly increases serum hemoglobin levels and decreases transfusions requirements while maintaining quality of life in patients with gynecological malignancies who are undergoing polychemotherapy.
authors.affiliation: Department of Gynecologic Endocrinology, University of Vienna, Austria.
authors.forename: Ch
authors.initials: Ch
authors.lastname: Kurz
authors.forename: Ch
authors.initials: Ch
authors.lastname: Marth
authors.forename: G
authors.initials: G
authors.lastname: Windbichler
authors.forename: M
authors.initials: M
authors.lastname: Lahousen
authors.forename: M
authors.initials: M
authors.lastname: Medl
authors.forename: N
authors.initials: N
authors.lastname: Vavra
authors.forename: P
authors.initials: P
authors.lastname: Sevelda
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced* / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001803:Blood Transfusion / Q000706:statistics & numerical data; D004311:Double-Blind Method; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000150:complications / Q000188:drug therapy*; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D014594:Uterine Neoplasms / Q000150:complications / Q000188:drug therapy*
chemical_list: D011994:Recombinant Proteins; D004921:Erythropoietin