A new dose-intense epoetin alfa regimen effective in anemic cancer patients receiving chemotherapy: An open-label, non randomized, pilot study

Daniele Santini, Bruno Vincenzi, Annalisa La Cesa, Vladimir Virzi, Francesca Navajas, Vincenzo Malafarina, Giordano Dicuonzo, Roberto Cassandro, Vincenzo Esposito, Vincenzo Montesarchio, Angela M. Groeger, Giuseppe Tonini

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Chronic anemia is a well-recognized complication of both cancer and cytotoxic treatments and is associated with symptoms (e.g., fatigue, dyspnea) that may induce or exacerbate functional deterioration. The use of recombinant human erythropoetin (rHuEPO epoetin alfa) clearly increased haemoglobin (Hb) levels, decreased transfusion needs and allowed recovery of quality of life in anemic cancer patients (pts) undergoing chemotherapy (CT). The purpose of this open-label, non randomized, pilot study was to assess the safety and efficacy of an intensive 19-day epoetin alfa treatment in anemic patients with solid tumors receiving chemotherapy. Patients and Methods: Treatment: patients received a single induction s.c. dose of epoetin alfa 40,000 IU day 1 and twice a dose of 10,000 IU s.c. (8:00 a.m.- 8:00 p.m.) on days 3, 5, 8, 10, 12, 15, 17 and 19. The total dose of epoetin alfa per patient was 200,000 IU. Iron supplementation: 125 mg i.v. days and 8. Soluble transferrin receptor (sTfR) levels were performed on days 1,8 and 15. This epoetin induction regimen was not followed by an epoetin maintenance therapy. Patients: Twenty-nine anemic (Hb ≤ 11.5 g/dL) pts with non myeloid malignancies undergoing CT were included in the study. Results: At baseline the mean Hb level was 9.41 g/dl. On day 8, the mean Hb level increased to 10.07 g/dl (p 1.5 g/dl. A rate of 62% (18/29 patients) of major responses was observed on day 21. Moreover, 25/29 patients (86.2%) presented an increase of Hb levels > 1 g/dl after 21 days. On days 8 and 15, the mean sTfR levels had increased significantly (p=0.021 and 0.001, respectively). The increase of mean sTfR level after 15 days correlated significantly with the increase of mean Hb level in the first two weeks of epoetin therapy (p=0.05). Epoetin alfa has been well tolerated so far in the study. Conclusion: The results of the present study suggest that an induction dose of 40,000 IU of epoetin alfa, followed by 8 maintenance doses of 20,000 IU each, may improve the standard response in terms of both time to response and Hb increase. Moreover, the Hb levels seemed to increase after epoetin therapy discontinuation (d22-29).

Original languageEnglish
Pages (from-to)669-674
Number of pages6
JournalAnticancer Research
Volume25
Issue number1 B
Publication statusPublished - Jan 2005

Keywords

  • Anemia
  • Epoetin alfa

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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