title: Prospective, randomized, controlled, and open study in primarily inoperable, stage III non-small cell lung cancer (NSCLC) patients given sequential radiochemotherapy with or without epoetin alfa.
abstract: OBJECTIVE
  Induction chemotherapy is associated with anemia in non-small cell lung cancer (NSCLC) patients undergoing radiotherapy. This randomized, open-label study compared the effect of sequential radiochemotherapy (RCHT) versus RCHT + epoetin alfa (RCHT + EPO), with respect to 2-year overall survival (OS).
  
  
  METHODS
  Patients ⩾18 years received sequential RCHT; one arm also received EPO (chemotherapy day 1, when Hb<12 g/dL). Kaplan-Meier analysis with log-rank test, and Cox-regression methods were performed.
  
  
  RESULTS
  Of the 385 patients randomized (RCHT + EPO: n = 195; RCHT: n = 190), 78 (RCTH + EPO: 46 [23.6%]; RCHT: 32 [16.8%]) were anemic at baseline. Two-year OS was higher in RCHT + EPO-treated versus RCHT-treated (28.5% [95% CI: 22.2-35.1%] versus 20.6% [95% CI: 15.1-26.8%] [p = 0.2278]), and requirement for RBC transfusion was lower (24/195 [12.3%] versus 61/190 [32.1%]). In anemic (baseline) patients (post hoc analysis), median survival was shorter in RCTH-treated (212 days) versus RCHT + EPO-treated (343 days) (Hazard ratio = 1.62 [95% CI: 0.99-2.63], p = 0.0525). Adverse events were documented in 72.7% (RCHT + EPO: 75.0%; RCHT: 70.5%) patients, and thrombovascular events (TVEs) in 45 patients (RCHT + EPO: 16.7%; RCHT: 7.9%; p = 0.0099).
  
  
  CONCLUSIONS
  A statistically non-significant trend for 2-year OS was observed in a sub-group of EPO-treated NSCLC-patients with baseline anemia, although this trend was not maintained in the overall population with inoperable NSCLC.
authors.affiliation: Ruprecht Karl University, Heidelberg, Germany. Electronic address: Juergen.Debus@med.uni-heidelberg.de.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Debus
authors.affiliation: Thoraxklinik, Heidelberg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Drings
authors.affiliation: Acromion GmbH, Frechen, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Baurecht
authors.affiliation: Medical Affairs, Janssen-Cilag GmbH, Neuss, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Angermund
mesh_terms: D000368:Aged; D000740:Anemia / Q000139:chemically induced* / Q000209:etiology / Q000517:prevention & control; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001803:Blood Transfusion / Q000706:statistics & numerical data; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D014747:Vinblastine; D000068817:Epoetin Alfa; D002945:Cisplatin; D000077235:Vinorelbine
keywords: Anemia; Chemotherapy; Epoetin alfa; Hemoglobin; Non-small cell lung cancer