HX575, recombinant human epoetin alfa, for the treatment of chemotherapy-associated symptomatic anaemia in patients with solid tumours

Onkologie

Volumn 32, Issue 4, 2009, Pages 168-174

  Weigang Köhler, Karin ^a   Vetter, Andrea ^b   Thyroff Friesinger, Ursula ^b  

^a KLINIKUM NÜRNBERG   (Germany)

^b Sandoz Biopharmaceuticals   (Germany)

Author keywords

Chemotherapy; Epoetin alfa; Erythropoiesis; Haemoglobin; Reticulocytes

Indexed keywords

ANTINEOPLASTIC AGENT; HEMOGLOBIN; HX 575; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; APPETITE DISORDER; ARTICLE; ASTHENIA; BLOOD TRANSFUSION; BREATHING DISORDER; CANCER CHEMOTHERAPY; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EDEMA; EMBOLISM; FEMALE; FEVER; GASTROINTESTINAL MOTILITY DISORDER; GASTROINTESTINAL PAIN; HEART ARREST; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HEART VENTRICLE ARRHYTHMIA; HUMAN; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; NAUSEA AND VOMITING; NEOPLASM; NEUROLOGIC DISEASE; PAIN; PERITONEAL DISEASE; RANDOMIZED CONTROLLED TRIAL; RETICULOCYTE; RETROPERITONEAL DISEASE; SOLID TUMOR; STOMACH PARESIS; THROMBOSIS;

ADULT; AGED; AGED, 80 AND OVER; ANEMIA; ANTINEOPLASTIC AGENTS; EPOETIN ALFA; FEMALE; GERMANY; HEMATINICS; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; SINGLE-BLIND METHOD; TREATMENT OUTCOME;

EID: 65349147154     PISSN: 0378584X     EISSN: None     Source Type: Journal    
DOI: 10.1159/000200783     Document Type: Article

References (21)

1. Groopman JE, Itri LM: Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst 1999;91:1616-1634.
2. Abels RI: Use of recombinant human erythropoietin in the treatment of anemia in patients who have cancer. Semin Oncol 1992;19(3 suppl 8):29-35.
3. Skillings JR, Sridhar FG, Wong C, Paddock L: The frequency of red cell transfusion for anemia in patients receiving chemotherapy. A retrospective cohort study. Am J Clin Oncol 1993;16:22-25.
4. Witzig TE, Silberstein PT, Loprinzi CL, Sloan JA, Novotny PJ, Mailliard JA, Rowland KM, Alberts SR, Krook JE, Levitt R, Morton RF: Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy. J Clin Oncol 2005;23:2606-2617.
5. Gabrilove JL, Cleeland CS, Livingston RB, Sarokhan B, Winer E, Einhorn LH: Clinical evaluation of once-weekly dosing of epoetin alfa in chemotherapy patients: improvements in hemoglobin and quality of life are similar to three-times-weekly dosing. J Clin Oncol 2001;19:2875-2882.
6. Abels R: Erythropoietin for anemia in cancer patients. Eur J Cancer 1993;29A(suppl 2):S2-S8.
7. Markham A, Bryson HM: Epoetin alfa. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in nonrenal applications. Drugs 1995;49:232-254.
8. Dunn CJ, Wagstaff AJ: Epoetin alfa. A review of its clinical efficacy in the management of anemia associated with renal failure and chronic disease and its use in surgical patients. Drugs Aging 1995;7:131-156.
9. Rizzo JD, Somerfield MR, Hagerty JS, Seidenfeld J, Bohlius J, Bennett CL, Cella DF, Djulbegovic B, Goode MJ, Jakubowski AA, Rarick MU, Regan DH, Lichtin AE; American Society of Clinical Oncology; American Society of Hematology: Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/ American Society of Hematology Clinical Practice Guideline Update. J Clin Oncol 2008;26:132-149.
10. National Institute for Clinical Excellence (NICE): Anaemia management in chronic kidney disease. National clinical guideline for management in adults and children. www.nice.org.uk/nicemedia/ pdf/Anaemia-Management-full-guideline. pdf; accessed on April 30, 2008.
11. Public Assessment Report (EPAR) for Authorised Medicinal Products in Human Use: Product Information Binocrit-H-C-725-II-01; accessed at: www. emea.europa.eu/humandocs/PDFs/EPAR/binocrit/ H-725-PI-en.pdf on 16 October, 2008.
12. Study 2003-29-INJ-9 'Randomized, double-blind, multicenter, parallel-group, equivalence study to evaluate the efficacy and safety of HX575 vs. Erypo® for the treatment of anemia in hemodialysis patients', European Public Assessment Report (EPAR) for Authorised Medicinal Products in Human Use: Epoetin alfa Hexal H-C-726, scientific discussion. www.emea.europa.eu/ humandocs/Humans/ EPAR/epoetinalfahexal/epoetinalfahexal.htm; accessed on 2 April, 2008.
13. Glaspy J, Bukowski R, Steinberg D, Taylor C, Tchekmedyian S, Vadhan-Raj S: Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J Clin Oncol 1997;15:1218-1234.
14. Oberhoff C, Krumeich B, Petry KU, Rebmann U, Nowrousian MR, Kasper C, Voigtmann R, Karthaus M, Merkle E, Gallasch W, Quarder O, Schindler AE: Effekt von rekombinantem humanen Erythropoetin auf den Transfusionsbedarf und die Hämoglobinkonzentration bei Patienten mit soliden Tumoren und chemotherapie-induzierter Anämie. Tumordiagn u Ther 2000;21:15-25.
15. Thatcher N, De Campos ES, Bell DR, Steward WP, Varghese G, Morant R, Vansteenkiste JF, Rosso R, Ewers SB, Sundal E, Schatzmann E, Stocker H: Epoetin alpha prevents anaemia and reduces transfusion requirements in patients undergoing primarily platinum-based chemotherapy for small cell lung cancer. Br J Cancer 1999;80:396-402.
16. Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E: Measuring fatigue and other anemiarelated symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage 1997;13:63-74.
17. Cella D: The Functional Assessment of Cancer Therapy-Anemia (FACT-An) scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol 1997;34(suppl 2):13-19.
18. Henke M: Erythropoetin in the treatment of cancer. Onkologie 2005;28:181-182.
19. Vaupel P, Dunst J, Engert A, Fandrey J, Feyer P, Freund M, Jelkmann W: Effects of recombinant human erythropoietin (rHuEPO) on tumor control in patients with cancer-induced anemia. Onkologie 2005;28:216-221.
20. Henke M, Mattern D, Pepe M, Bézay C, Weissenberger C, Werner M, Pajonk F: Do erythropoietin receptors on cancer cells explain unexpected clinical findings? J Clin Oncol 2006;24:4708-4713.
21. Nissenson AR, Swan SK, Lindberg JS, Soroka SD, Beatey R, Wang C, Picarello N, McDermott- Vitak A, Maroni BJ: Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients. Am J Kidney Dis 2002;40:110-118.