title: A new dose-intense epoetin alfa regimen effective in anemic cancer patients receiving chemotherapy: an open-label, non randomized, pilot study.
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.
  
  
  METHODS
  
  
  
  METHODS
  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.
  
  
  METHODS
  Twenty-nine anemic (Hb< or =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<0.0001), reaching 10.68 g/dl on day 15 (p<0.0001). On days 22 and 29, the mean Hb levels increased to 10.93 and 11.05 g/dl, (p=0.002 and 0.033, respectively). No patient received blood transfusions. The global mean increase of Hb level was 1.64 g/dl (basal to d 29). It was defined as a major response: an increase of Hb levels > 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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Medical Oncology, University Campus Bio-Medico, Rome, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Santini
authors.forename: Bruno
authors.initials: B
authors.lastname: Vincenzi
authors.forename: Annalisa
authors.initials: A
authors.lastname: La Cesa
authors.forename: Vladimir
authors.initials: V
authors.lastname: Virzi
authors.forename: Francesca
authors.initials: F
authors.lastname: Navajas
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Malafarina
authors.forename: Giordano
authors.initials: G
authors.lastname: Dicuonzo
authors.forename: Roberto
authors.initials: R
authors.lastname: Cassandro
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Esposito
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Montesarchio
authors.forename: Angela M
authors.initials: AM
authors.lastname: Groeger
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tonini
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010865:Pilot Projects; D011990:Receptors, Transferrin / Q000097:blood; D011994:Recombinant Proteins; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D006397:Hematinics; D006454:Hemoglobins; D011990:Receptors, Transferrin; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa