title: Effects of anemia correction with epoetin beta in patients receiving radiochemotherapy for advanced cervical cancer.
abstract: Patients with cervical cancer frequently suffer from anemia. This two-stage, adaptive-design study investigated the effect of anemia correction with epoetin beta on treatment outcomes. Patients with stage IIB-IVA cervical cancer received radiochemotherapy (RCT) and were randomized to epoetin 150 IU/kg three times weekly (n = 34) or standard care (control; n = 40) for up to 12 weeks. Primary end point for stage 1 aimed to establish a correlation between anemia correction and treatment failure (no complete response or relapsing within 6 months after RCT initiation) as a proof of concept before moving into stage 2. Secondary end points included progression/relapse-free survival, overall survival, response to RCT, hemoglobin (Hb) response, and safety. Median baseline Hb was 11.4 and 11.6 g/dL in epoetin and control groups, respectively. At treatment end point, median Hb increased by 1.3 g/dL with epoetin, but decreased by 0.7 g/dL in the control group (P < 0.0001). No significant correlation between Hb increase and treatment failure was demonstrated. There were no significant differences between epoetin and control groups in progression/relapse-free survival (29.4% vs 32.5% patients with events; P = 0.96), overall survival (23.5% vs 12.5% patients with events; P = 0.22) or overall complete response (53% vs 58%; P = 0.86). Adverse events were well matched between groups. This study shows that epoetin beta rapidly, effectively, and safely increases Hb levels in patients with cervical cancer receiving RCT. No positive correlation of Hb increase and improvement in clinical outcomes could be demonstrated.
authors.affiliation: Department of Gynecology, Martin Luther University Halle-Wittenberg, Halle, Germany.
authors.forename: H-G
authors.initials: HG
authors.lastname: Strauss
authors.forename: G
authors.initials: G
authors.lastname: Haensgen
authors.forename: J
authors.initials: J
authors.lastname: Dunst
authors.forename: C R W
authors.initials: CR
authors.lastname: Hayward
authors.forename: H-U
authors.initials: HU
authors.lastname: Burger
authors.forename: A
authors.initials: A
authors.lastname: Scherhag
authors.forename: H
authors.initials: H
authors.lastname: Koelbl
mesh_terms: D000328:Adult; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D007279:Injections, Subcutaneous; D016015:Logistic Models; D008875:Middle Aged; D009367:Neoplasm Staging; D011336:Probability; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D011994:Recombinant Proteins; D012016:Reference Values; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin