title: Erythropoietin treatment in chemotherapy-induced anemia in previously untreated advanced esophagogastric cancer patients.
abstract: BACKGROUND
  The impact of erythropoiesis-stimulating agents in chemotherapy-induced anemia has been a constant topic of debate over recent years. We prospectively assessed the efficacy of epoetin beta (Epo-b) in improving hemoglobin (Hb) levels and outcome in patients within an open label, randomized clinical phase II trial with advanced or metastatic gastric/esophagogastric cancer.
  
  
  METHODS
  Previously untreated patients were randomized to receive 3-weekly cycles of capecitabine (1000 mg/m(2) bid) for 14 days plus on day 1 either irinotecan 250 mg/m(2) or cisplatin 80 mg/m(2). Epo-b (30000 IU once weekly) was initiated in patients with Hb <11 g/dl and continued until Hb ≥12 g/dl was reached. If after 4 weeks the Hb increase was <0.5 g/dl, Epo-b was increased to 30000 IU, twice weekly.
  
  
  RESULTS
  Of 118 patients enrolled, 32 received Epo-b treatment; of these, 65 % achieved an increase in Hb levels of at least 2 g/dl, with 74 % achieving the target Hb of ≥12 g/dl. Within the study population, patients receiving Epo-b showed better overall survival (median 14.5 vs. 8.0 months, P = 0.056) as well as a significantly improved disease control rate (78 vs. 55 %, P = 0.025). Patients in the irinotecan group profited significantly (P < 0.05) in terms of progression-free survival and overall survival under Epo-b treatment (median 6.5 vs 4.1 months and median 15.4 vs 8.4 months, respectively).
  
  
  CONCLUSIONS
  Epo-b was effective in raising Hb levels in patients with advanced esophagogastric cancer. Patients receiving Epo-b had a significantly increased response to chemotherapy and a clear trend to improved survival.
authors.affiliation: 1st Medical Department, Johannes-Gutenberg University Mainz, Langenbeckstr.1, 55101, Mainz, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Thomaidis
authors.forename: Arndt
authors.initials: A
authors.lastname: Weinmann
authors.forename: Martin
authors.initials: M
authors.lastname: Sprinzl
authors.forename: Stephan
authors.initials: S
authors.lastname: Kanzler
authors.forename: Jochen
authors.initials: J
authors.lastname: Raedle
authors.forename: Matthias
authors.initials: M
authors.lastname: Ebert
authors.forename: Carl Cristoph
authors.initials: CC
authors.lastname: Schimanski
authors.forename: Peter Robert
authors.initials: PR
authors.lastname: Galle
authors.forename: Thomas
authors.initials: T
authors.lastname: Hoehler
authors.forename: Markus
authors.initials: M
authors.lastname: Moehler
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D004943:Esophagogastric Junction; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin