Randomised, phase III trial of epoetin-Β to treat chemotherapy-induced anaemia according to the EU regulation

British Journal of Cancer

Volumn 105, Issue 9, 2011, Pages 1267-1272

  Fujisaka, Y ^a,i   Sugiyama, T ^b   Saito, H ^c   Nagase, S ^d   Kudoh, S ^e   Endo, M ^f   Sakai, H ^g   Ohashi, Y ^h   Saijo, N ⁱ  

^a OSAKA MEDICAL COLLEGE HOSPITAL   (Japan)

^b IWATE MEDICAL UNIVERSITY   (Japan)

^c AICHI CANCER CENTER HOSPITAL   (Japan)

^d TOKYO MEDICAL UNIVERSITY   (Japan)

^e OSAKA CITY UNIVERSITY HOSPITAL   (Japan)

^f SHIZUOKA CANCER CENTER   (Japan)

^g SAITAMA CANCER CENTER   (Japan)

^h UNIVERSITY OF TOKYO   (Japan)

ⁱ KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

chemotherapy induced anaemia; erythropoietin; survival

Indexed keywords

ANTINEOPLASTIC AGENT; HEMOGLOBIN; PLACEBO; RECOMBINANT ERYTHROPOIETIN;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AGED; ANEMIA; ANOREXIA; ARTICLE; BLOOD PRESSURE; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CHEMOTHERAPY INDUCED ANEMIA; CONSTIPATION; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ERYTHROCYTE TRANSFUSION; FEMALE; HEMOGLOBIN BLOOD LEVEL; HUMAN; LEUKOPENIA; LUNG EMBOLISM; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; OVARY CANCER; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT DURATION;

ADULT; AGED; ANEMIA; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BLOOD TRANSFUSION; ERYTHROPOIETIN; FEMALE; GENITAL NEOPLASMS, FEMALE; HEMOGLOBINS; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; PLACEBOS; QUALITY OF LIFE; RECOMBINANT PROTEINS;

EID: 80054973811     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2011.395     Document Type: Article

References (31)

1. Aapro M, Leonard RC, Barnadas A, Marangolo M, Untch M, Malamos N, Mayordomo J, Reichert D, Pedrini JL, Ukarma L, Scherhag A, Burger HU (2008a) Effect of once-weekly epoetin beta on survival in patients with metastatic breast cancer receiving anthracy-cline-and/or taxane-based chemotherapy: results of the Breast Cancer-Anemia and the Value of Erythropoietin (BRAVE) study. J Cin Oncol 26: 592-598 (Pubitemid 351264353)
2. Aapro M, Scherhag A, Burger HU (2008b) Effect of treatment with epoetin-beta on survival, tumour progression and thromboembolic events in patients with cancer: an updated meta-analysis of 12 randomised controlled studies including 2301 patients. Br J Cancer 99: 14-22 (Pubitemid 351920217)
3. Bennett CL, Silver SM, Djulbegovic B, Samaras AT, Blau CA, Gleason KJ, Barnato SE, Elverman KM, Courtney DM, McKoy JM, Edwards BJ, Tigue CC, Raisch DW, Yarnold PR, Dorr DA, Kuzel TM, Tallman MS, Trifilio SM, West DP, Lai SY, Henke M (2008) Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia. JAMA 299: 914-924 (Pubitemid 351397066)
4. Bohlius J, Schmidlin K, Brillant C, Schwarzer G, Trelle S, Seidenfeld J, Zwahlen M, Clarke M, Weingart O, Kluge S, Piper M, Rades D, Steensma DP, Djulbegovic B, Fey MF, Ray-Coquard I, Machtay M, Moebus V, Thomas G, Untch M, Schumacher M, Egger M, Engert A (2009a) Recombinant human erythropoiesis- stimulating agents and mortality in patients with cancer: a meta-analysis of randomized trials. Lancet 373: 1532-1542
5. Bohlius J, Schmidlin K, Brillant C, Schwarzer G, Trelle S, Seidenfeld J, Zwahlen M, Clarke M, Weingart O, Kluge S, Piper M, Rades D, Steensma DP, Djulbegovic B, Fey MF, Ray-Coquard I, Machtay M, Moebus V, Thomas G, Untch M, Schumacher M, Egger M, Engert A (2009b) Recombinant human erythropoiesis- stimulating agents and mortality in patients with cancer: a meta-analysis of randomized trials. Erratum in Lancet 374: 28
6. Bohlius J, Wilson J, Seidenfeld J, Piper M, Schwarzer G, Sandercock J, Trelle S, Weingart O, Bayliss S, Djulbegovic B, Bennett CL, Langensiepen S, Hyde C, Engert A (2006) Recombinant human erythropoietins and cancer patients: up-dated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst 98: 708-714 (Pubitemid 43821788)
7. ̈ Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P (2007) EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer 43: 258-270 (Pubitemid 46127840)
8. Boogaerts M, Coiffier B, Kainz C, the Epoetin b QOL Working Group (2003) Impact of epoetin b on quality of life in patients with malignant disease. Br J Cancer 88: 988-995 (Pubitemid 36560764)
9. Fandrey J, Dicato M (2009) Examining the involvement of erythropoiesis-stimulating agents in tumor proliferation (erythropoietin receptors, receptor binding, signal transduction), angiogenesis, and venous thromboembolic events. Oncologist 14(Suppl 1): 34-42. Review
10. Fujisaka Y, Tamura T, Ohe Y, Kunitoh H, Sekine I, Yamamoto N, Nokihara H, Horiike A, Kodama T, Saijo N (2006) Pharmacokinetics and pharmacodynamics of weekly epoetin beta in lung cancer patients. Jpn J Clin Oncol 36: 477-482 (Pubitemid 44592674)
11. Hedenus M, Adriansson M, Miguel JS, Kramer MHH, Schipperus MR, Juvonen E, Taylor K, Belch A, Altés A, Martinelli G, Watson D, Matcham J, Rossi G, Littlewood TJ, on behalf of the Darbepoetin Alfa 20000161 Study Group (2003) Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double-blind, placebo-controlled study. Br J Haematol 122: 394-403 (Pubitemid 36951623)
12. Henke M, Laszig R, Rübe C, Schäfer U, Haase KD, Schilcher B, Mose S, Beer KT, Burger U, Dougherty C, Frommhold H (2003) Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet 362: 1255-1260 (Pubitemid 37324251)
13. Iconomou G, Koutras A, Rigopoulos A, Vagenakis AG, Kalofonos HP (2003) Effect of recombinant human erythropoietin on quality of life in cancer patients receiving chemotherapy: results of a randomized, controlled trial. J Pain Symptom Manage 25: 512-518 (Pubitemid 36629274)
14. Juneja V, Keegan P, Gootenberg JE, Rothmann MD, Shen YL, Lee KY, Weiss KD, Pazdur R (2008) Continuing reassessment of the risks of erythropoiesis- stimulating agents in patients with cancer. Clin Cancer Res 14: 3242-3247
15. Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K, for the Japanese Gynecologic Oncology Group (2009) Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet 374: 1331-1338
16. Leyland-Jones B, Semiglazov V, Pawlicki M, Pienkowski T, Tjulandin S, Manikhas G, Makhson A, Roth A, Dodwell D, Baselga J, Biakhov M, Valuckas K, Voznyi E, Liu X, Vercammen E (2005) Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study. J Clin Oncol 23: 5960-5972
17. Littlewood TJ, Bajetta E, Nortier JWR, Vercammen E, Rapoport B, for the Epoetin Alfa Study Group (2001) Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: results of a randomized, double-blind, placebo-controlled trial. J Clin Oncol 19: 2865-2874 (Pubitemid 32538196)
18. Ludwig H, Belle SV, Barrett-Lee P, Birgegard G, Bokemeyer C, Gascón P, Kosmidis P, Krzakowski M, Nortier J, Olmi P, Schneider M, Schrijvers D (2004) The European Cancer Anaemia Survey (ECAS): a large multi national, prospective survey defining the prevalence, incidence, and treatment of anaemia in cancer patients. Eur J Cancer 40: 2293-2306 (Pubitemid 39348881)
19. Minton O, Richardson A, Sharpe M, Hotopf M, Stone P (2010) Drug therapy for the management of cancer-related fatigue. Cochrane Database Syst Rev: CD006704
20. Morishima Y, Ogura M, Yoneda S, Sakai H, Tobinai K, Nishiwaki Y, Minami H, Hotta T, Ezaki K, Ohe Y, Yokoyama A, Tsuboi M, Mori K, Watanabe K, Ohashi Y, Hirashima K, Saijo N, Japan Erythropoietin Study Group (2006) Once-weekly epoetin-beta improves hemoglobin levels in cancer patients with chemotherapy-induced anemia: a randomized, double-blind, dose-finding study. Jpn J Cin Oncol 36: 655-661 (Pubitemid 44697560)
21. Nakagawa K, Ozaki T, Satoh T, Miyazaki M, Akashi Y, Terashima M, Fujisaka Y, Tamura T, Fukuoka M, Saijo N (2007) Epoetin beta subcutaneous administration to lung cancer patients with anemia; results of pharmacokinetics/ pharmacodynamics study. Jpn J LungCancer 47: 313-322 (Pubitemid 47535614)
22. Ohe Y, Ohashi Y, Kubota K, Tamura T, Nakagawa K, Negoro S, Nishiwaki Y, Saijo N, Ariyoshi Y, Fukuoka M, for the FACS Cooperative Group (2007) Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and ciaplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan. Ann Oncol 18: 317-323 (Pubitemid 46323100)
23. ̈ Osterborg A, Brandberg Y, Molostova V, Iosava G, Abdulkadyrov K, Hedenus M, Messinger D, for the Epoetin Beta Hematology Study Group (2002) Randomized, double-blind, placebo-controlled trial of recombi-nant human erythropoietin, epoetin beta, in hematologic malignancies. J Clin Oncol 20: 2486-2494 (Pubitemid 34525734)
24. Overgaard J, Hoff C, Hansen HS, Specht L, Overgaard M, Grau C, Andersen E, Johansen J, Andersen L, Evensen J (2007) Randomized study of the importance of novel erythropoiesis stimulating protein (Aranesp) for the effect of radiotherapy in patients with primary squamous cell carcinoma of the head and neck (HNSCC)-the Danish Head and Neck Cancer Group DAHANCA 10 randomized trial. Eur J Cancer 5(Suppl): 7
25. Smith Jr RE, Aapro MS, Ludwig H, Pintér T, Simakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA (2008) Darbepoetin alfa for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol 26: 1040-1050
26. Suzuki Y, Tokuda Y, Fujiwara Y, Minami H, Ohashi Y, Saijo N (2008) Weekly epoetin beta maintains hemoglobin levels and improves quality of life in patients with non-myeloid malignancies receiving chemotherapy. Jpn J Cin Oncol 38: 214-221 (Pubitemid 351419746)
27. Thomas G, Ali S, Hoebers FJP, Darcy KM, Rodgers WH, Patel M, Abulafia O, Lucci III JA, Begg AC (2008) Phase III trial to evaluate the efficacy of maintaining hemoglobin levels above 12.0 g/dl with erythropoietin vs above 10.0 g/dl without erythropoietin in anemic patients receiving concurrent radiation and cisplatin for cervical cancer. Gynecol Oncol 108: 317-325
28. Tonelli M, Hemmelgarn B, Reiman T, Manns B, Reaume MN, Lloyd A, Wiebe N, Klarenbach S (2009) Benefits and harms of erythropoiesis-stimulating agents for anemia related to cancer: a meta-analysis. CMAJ 180: E62-E71
29. Tsuboi M, Ezaki K, Tobinai K, Ohashi Y, Saijo N (2009) Weekly administration of epoetin beta for chemotherapy-induced anemia in cancer patients: results of a multicenter, phase III, randomized, double-blind, placebo-controlled study. Jpn J Clin Oncol 39: 163-168
30. Wright JR, Ung YC, Julian JA, Pritchard KI, Whelan TJ, Smith C, Szechtman B, Roa W, Mulroy L, Rudinskas L, Gagnon B, Okawara GS, Levine MN (2007) Randomized, double-blind, placebo-controlled trial of erythropoietin in non-small-cell lung cancer with disease-related anemia. J Clin Oncol 25: 1027-1032 (Pubitemid 46596751)
31. Yoshimura A, Kobayashi K, Fumimoto H, Fujiki Y, Eremenco S, Kudoh S (2004) Cross-cultural validation of the Japanese Functional Assessment of Cancer Therapy-Anemia (FACT-An). J Nippon Med Sch 71: 314-322 (Pubitemid 39469724)