Anemia response and safety to epoetin-beta treatment in patients with neoadjuvant therapy prior to primary digestive tract tumor surgery

Cancer Chemother Pharmacol. 2010 Aug;66(3):567-73. doi: 10.1007/s00280-009-1197-0. Epub 2009 Dec 12.

Abstract

Purpose: Anemia is common during anticancer treatment. This study aimed to evaluate the response and safety of treatment with epoetin-beta (EB) in patients with neoadjuvant therapy prior to primary digestive tract tumor surgery.

Patients and methods: In this open-label, single-arm study, patients (n = 22) with hemoglobin (Hb) levels below 11 g/dl who received epoetin-beta 450 IU/kg (30,000 IU) weekly until the hemoglobin level reached 12 g/dl.

Results: After treatment with EB, a mean absolute increment of 2.6 g/dl was attained. The mean hemoglobin values during the study were pretreatment 10.1 g/dl, half-way through treatment 12.3 g/dl, 4 weeks after concomitant radiochemotherapy 12.7 g/dl, the week prior to surgery 12.5 g/dl, and after surgery 10.9 g/dl. No patient required transfusion before or after surgery. The probability or risk of postoperative complications was 27.3%, and included one rectovaginal fistula, one parastomal hernia, one case of ileus and two surgical wound infections. In this series, downstaging was observed in 81.8% of patients, and downsizing in 90.9%. Most interestingly, histopathological complete response rate was achieved by 18.2%.

Conclusions: Epoetin-beta (EB) treatment in our series of patients with digestive malignancies subjected to neoadjuvant radiochemotherapy proved effective and safe, avoiding the need for transfusion during surgery.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anemia / drug therapy*
  • Anemia / etiology
  • Cohort Studies
  • Combined Modality Therapy
  • Erythropoietin / adverse effects
  • Erythropoietin / therapeutic use*
  • Female
  • Gastrointestinal Neoplasms / pathology
  • Gastrointestinal Neoplasms / therapy*
  • Hematinics / adverse effects
  • Hematinics / therapeutic use*
  • Hemoglobins / metabolism
  • Humans
  • Male
  • Middle Aged
  • Neoadjuvant Therapy / methods*
  • Postoperative Complications / etiology
  • Prospective Studies
  • Recombinant Proteins
  • Treatment Outcome

Substances

  • Hematinics
  • Hemoglobins
  • Recombinant Proteins
  • epoetin beta
  • Erythropoietin