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Раннее назначение эпоэтина-β предотвращает развитие тяжелой анемии у больных раком легкого, получающих химиотерапию на основе препаратов платины: анализ подгруппы клинического исследования NeoPrevent
Раннее назначение эпоэтина-β предотвращает развитие тяжелой анемии у больных раком легкого, получающих химиотерапию на основе препаратов платины: анализ подгруппы клинического исследования NeoPrevent
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Аннотация
Исследование NeoPrevent показало, что раннее назначение эпоэтина-β может предотвратить развитие тяжелой анемии у пациентов с солидными опухолями, получающих химиотерапию на основе препаратов платины. Раннее назначение эпоэтина-β целесообразно у больных раком легкого, поскольку развитие анемии (во многих случаях тяжелой) часто сопутствует этому заболеванию. Целью настоящего исследования было определение эффективности и безопасности эпоэтина-β при назначении его больным раком легкого в рамках исследования NeoPrevent. В исследование включали пациентов, у которых исходный уровень гемоглобина был ≤13 г/дл (мужчины) и ≤12 г/дл (женщины) или снизился до этих значений в ходе проведения химиотерапии на основе препаратов платины. Пациенты получали эпоэтин-β 3 раза в неделю в дозе 150 МЕ/кг до 4 нед после последнего цикла химиотерапии. Ответ на профилактическую терапию анемии определяли путем выявления доли пациентов с повышением уровня гемоглобина (>1 г/дл) и пациентов, у которых уровень гемоглобина не отклонялся от первоначального значения (±1 г/дл). Качество жизни (КЖ) оценивали с помощью линейной аналоговой шкалы. В исследование NeoPrevent были включены 255 пациентов. В статье представлены результаты анализа данных 102 больных раком легкого (немелкоклеточный рак легкого – 64%, мелкоклеточный рак легкого – 36%). Общая частота ответа на профилактическую терапию составила 90% (у 60% пациентов наблюдалось повышение уровня гемоглобина, у 30% уровень гемоглобина удерживался на первоначальном уровне). Переливание крови потребовалось только 9% пациентов. Достоверное улучшение КЖ было отмечено у пациентов с Hb-ответом (p<0,01), у остальных пациентов изменения КЧ не произошло (p≥0,578). Эпоэтин-β продемонстрировал эффективность при профилактике тяжелой анемии у больных раком легкого, получающих химиотерапию на основе препаратов платины.
Полный текст
Список литературы
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30. Crawford J, Robert F, Perry MC, Belani C, Williams D, for the Anemia Prevention in NSCLC Group. A randomized trial comparing immediate versus delayed treatment of anemia with once-weekly epoetin alfa in patients with non-small cell lung cancer scheduled to receive first-line chemotherapy. J Thoracic Oncol 2007; 2: 210–20.
31. Oberhoff C, Neri B, Amadori D et al. Recombinant human erythropoietin in the treatment of chemotherapy-induced anemia and prevention of transfusion requirement associated with solid tumors: a randomized, controlled study. Ann Oncol 1998; 9: 255–60.
32. ten Bokkel Huinink WW, de Swart CA, van Toorn DW et al. Controlled multicentre study of the influence of subcutaneous recombinant human erythropoietin on anaemia and transfusion dependency in patients with ovarian carcinoma treated with platinum-based chemotherapy. Med Oncol 1998; 15: 174–82.
33. Aapro M, Barnadas A, Leonard RC, Marangolo M. Effects of epoetin beta treatment in patients with metastatic breast cancer receiving chemotherapy. Results of the BRAVE trial. Breast Cancer Res Treat 2006; 100 (Suppl. 1): S287 (Abstract 6095).
34. Crawford J, Cella D, Cleeland CS et al. Relationship between changes in hemoglobin level and quality of life during chemotherapy in anemic cancer patients receiving epoetin alfa therapy. Cancer 2002; 95: 888–95.
35. Henry DH. Epoetin alfa for the treatment of cancer- and chemotherapy-related anaemia: product review and update. Expert Opin Pharmacother 2005; 6: 295–310.
36. Straus DJ, Testa MA, Sarokhan BJ et al. Quality-of-life and health benefits of early treatment of mild anaemia. Cancer 2006; 107: 1909–17.
37. Barrett-Lee PJ, Ludwig H, Birgeg?ard G et al. European Cancer Anaemia Survey Advisory Board and Participating Centers. Independent risk factors for anemia in cancer patients receiving chemotherapy: results from the European Cancer Anaemia Survey. Oncology 2006; 70: 34–48.
38. Wright JR, Ung YC, Julian JA et al. Randomized, double-blind, placebo-controlled trial of erythropoietin in non-small-cell lung cancer with diseaserelated anemia. J Clin Oncol 2007; 25: 1027–32.
39. Henke M, Laszig R, Rube C et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet 2003; 362: 1255–60.
40. Leyland-Jones B, Semiglazov V, Pawlicki M et al. 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 2005; 23: 5960–72.
41. Overgaard J. Study of the importance of novel erythropoiesis stimulating protein (AranespR) for the effect of radiotherapy in patients with primary squamous cell carcinoma of the head and neck. Interim analysis of the DAHANCA 10 study; 1 December 2006 [available from http://www.dahanca.dk/get media file.php?mediaid=125].
42. Glaspy J, Smith R, Aapro M et al. Results from a Phase III, randomized, double-blind, placebocontrolled study of darbepoetin alfa for the treatment of anemia in patients not receiving chemotherapy or radiotherapy [Abstract]. In: Breakthroughs in clinical research: phase III clinical plenary session. 98th annual meeting of the American Association for Cancer Research, AACR. 2007 [Abstract nr LB-3].
43. http://wwwext.amgen.com/media/media pr detail.jsp?year=2007&releaseID=987476 [accessed on 22 May 2007].
44. Bohlius J, Wilson J, Seidenfeld J et al. Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst 2006; 98: 708–14.
45. Coiffier B, Boogaerts M, Aapro M et al. Effect of treatment with epoetin beta on thromboembolic events in anemic patients with cancer: a meta-analysis. Support Care Cancer 2006; 4: 49–55.
2. Ludwig H, Van Belle S, Barrett-Lee P et al. The European Cancer Anaemia Survey (ECAS): a large, multinational, prospective survey defining the prevalence, incidence, and treatment of anaemia in cancer patients. Eur J Cancer 2004; 40: 2293–306.
3. Cella D. Factors influencing quality of life in cancer patients: anemia and fatigue. Semin Oncol 1998; 25 (Suppl. 7): 43–6.
4. Harper P, Mor`ere J-F. Assessing anaemia and fatigue: putting theory into practice. Curr Med Res Opin 2006; 22(Suppl. 4): S1–4.
5. Tanaka K, Akechi T, Okuyama T et al. Impact of dyspnea, pain, and fatigue on daily life activities in ambulatory patients with advanced lung cancer. J Pain Symptom Manage 2002; 23: 417–23.
6. Mor`ere J-F. Role of epoetin in the management of anaemia in patients with lung cancer. Lung Cancer 2004; 46: 149–56.
7. Caro JJ, Salas M, Ward A, Goss G. Anemia as an independent prognostic factor for survival in patients with cancer: a systematic, quantitative review. Cancer 2001; 91: 2214–1.
8. Albain KS, Crowley JJ, LeBlanc M, Livingston RB. Survival determinants in extensive-stage non-small-cell lung cancer: the Southwest Oncology Group experience. J Clin Oncol 1991; 9: 1618–26.
9. MacRae R, Shyr Y, Johnson D, Choy H. Declining hemoglobin during chemoradiotherapy for locally advanced non-small cell lung cancer is significant. Radiother Oncol 2002; 64: 37–40.
10. Glimelius B, Linne T, Hoffman K et al. Epoetin beta in the treatment of anemia in patients with advanced gastrointestinal cancer. J Clin Oncol 1998; 16: 434–40.
11. ЕOsterborg A, Brandberg Y, Molostova V et al. Randomized, double-blind, placebo-controlled trial of recombinant human erythropoietin, epoetin beta, in hematologic malignancies. J Clin Oncol 2002; 20: 2486–94.
12. Boogaerts M, Coiffier B, Kainz C. Epoetin b QOL Working Group. Impact of epoetin _ on quality of life in patients with malignant disease. Br J Cancer 2003; 88: 988–95.
13. Bogdanos J, Karamanolakis D, Milathianakis K et al. Epoetin beta (NeoRecormon®) corrects anaemia in patients with hormonerefractory prostate cancer and bone metastases. Anticancer Res 2004; 24: 1957–61.
14. Boogaerts M, Oberhoff C, ten Bokkel Huinink W et al. Epoetin beta (NeoRecormonR) therapy in patients with solid tumours receiving platinum and non-platinum chemotherapy: a meta analysis. Anticancer Res 2006; 26: 479–84.
15. Pirker R, Lehnert M, Minar W. Once-weekly epoetin beta (30,000 IU) in anemic patients with lung cancer receiving chemotherapy. Lung Cancer 2007; 55: 89–94.
16. Kunikane H, Watanabe K, Fukuoka M et al. Double-blind randomized control trial of the effect of recombinant human erythropoietin on chemotherapy-induced anemia in patients with non-small cell lung cancer. Int J Clin Oncol 2001; 6: 296–301.
17. de Castro J, Ordґo?nez A, Isla D et al. Early intervention with epoetin beta prevents severe anaemia in patients with solid tumours receiving platinumbased chemotherapy: results of the NeoPrevent study. Cancer Chemother Pharmacol 2007; 59: 35–42.
18. Henry DH, Brooks Jr BJ, Case Jr DC et al. Recombinant human erythropoietin therapy for anemic cancer patients receiving cisplatin chemotherapy. Cancer J Sci Am 1995; 1: 252–60.
19. Thatcher N, De Campos ES, Bell DR et al. 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.
20. Barrett-Lee PJ, Bailey NP, O’Brien ME, Wager E. Large-scale UK audit of blood transfusion requirements and anaemia in patients receiving cytotoxic chemotherapy. Br J Cancer 2000; 82: 93–7.
21. Allain JP. Transfusion risks of yesterday and of today. Transfus Clin Biol 2003; 10: 1–5.
22. Currie CJ, Patel TC, McEwan P, Dixon S. Evaluation of the future supply and demand for blood products in the United Kingdom National Health Service. Transfus Med 2004; 14: 19–24.
23. Stainsby D, Jones H, Asher D et al. Serious hazards of transfusion: a decade of hemovigilance in the UK. Transfus Med Rev 2006; 20: 273–82.
24. Cornes P, Coiffier B, Zambrowski J-J. Erythropoietic therapy for the treatment of anemia in patients with cancer: a valuable clinical and economic option. Curr Med Res Opin 2007; 23: 357–68.
25. Bokemeyer C, Aapro MS, Courdi A et al. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer 2007; 43: 258–70.
26. de Campos E, Radford J, Steward W et al. Clinical and in vitro effects of recombinant human erythropoietin in patients receiving intensive chemotherapy for small-cell lung cancer. J Clin Oncol 1995; 13: 1623–31.
27. Lee JS. The use of erythropoietin in radiation oncology. Cancer Control 1998; 5 (Suppl. 1): 33–40.
28. Dunphy FR, Harrison BR, Dunleavy TL et al. Erythropoietin reduces anemia and transfusions: a randomized trial with or without erythropoietin during chemotherapy. Cancer 1999; 86: 1362–7.
29. Portalone L, Altieri AM, Antilli A et al. Preventative epoetin a (EPO) use in the treatment of advanced nsclc: an AIPO oncology study group multicenter trial. Eur J Cancer 2001; 37 (Suppl. 6): S56 (Abstract 196).
30. Crawford J, Robert F, Perry MC, Belani C, Williams D, for the Anemia Prevention in NSCLC Group. A randomized trial comparing immediate versus delayed treatment of anemia with once-weekly epoetin alfa in patients with non-small cell lung cancer scheduled to receive first-line chemotherapy. J Thoracic Oncol 2007; 2: 210–20.
31. Oberhoff C, Neri B, Amadori D et al. Recombinant human erythropoietin in the treatment of chemotherapy-induced anemia and prevention of transfusion requirement associated with solid tumors: a randomized, controlled study. Ann Oncol 1998; 9: 255–60.
32. ten Bokkel Huinink WW, de Swart CA, van Toorn DW et al. Controlled multicentre study of the influence of subcutaneous recombinant human erythropoietin on anaemia and transfusion dependency in patients with ovarian carcinoma treated with platinum-based chemotherapy. Med Oncol 1998; 15: 174–82.
33. Aapro M, Barnadas A, Leonard RC, Marangolo M. Effects of epoetin beta treatment in patients with metastatic breast cancer receiving chemotherapy. Results of the BRAVE trial. Breast Cancer Res Treat 2006; 100 (Suppl. 1): S287 (Abstract 6095).
34. Crawford J, Cella D, Cleeland CS et al. Relationship between changes in hemoglobin level and quality of life during chemotherapy in anemic cancer patients receiving epoetin alfa therapy. Cancer 2002; 95: 888–95.
35. Henry DH. Epoetin alfa for the treatment of cancer- and chemotherapy-related anaemia: product review and update. Expert Opin Pharmacother 2005; 6: 295–310.
36. Straus DJ, Testa MA, Sarokhan BJ et al. Quality-of-life and health benefits of early treatment of mild anaemia. Cancer 2006; 107: 1909–17.
37. Barrett-Lee PJ, Ludwig H, Birgeg?ard G et al. European Cancer Anaemia Survey Advisory Board and Participating Centers. Independent risk factors for anemia in cancer patients receiving chemotherapy: results from the European Cancer Anaemia Survey. Oncology 2006; 70: 34–48.
38. Wright JR, Ung YC, Julian JA et al. Randomized, double-blind, placebo-controlled trial of erythropoietin in non-small-cell lung cancer with diseaserelated anemia. J Clin Oncol 2007; 25: 1027–32.
39. Henke M, Laszig R, Rube C et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet 2003; 362: 1255–60.
40. Leyland-Jones B, Semiglazov V, Pawlicki M et al. 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 2005; 23: 5960–72.
41. Overgaard J. Study of the importance of novel erythropoiesis stimulating protein (AranespR) for the effect of radiotherapy in patients with primary squamous cell carcinoma of the head and neck. Interim analysis of the DAHANCA 10 study; 1 December 2006 [available from http://www.dahanca.dk/get media file.php?mediaid=125].
42. Glaspy J, Smith R, Aapro M et al. Results from a Phase III, randomized, double-blind, placebocontrolled study of darbepoetin alfa for the treatment of anemia in patients not receiving chemotherapy or radiotherapy [Abstract]. In: Breakthroughs in clinical research: phase III clinical plenary session. 98th annual meeting of the American Association for Cancer Research, AACR. 2007 [Abstract nr LB-3].
43. http://wwwext.amgen.com/media/media pr detail.jsp?year=2007&releaseID=987476 [accessed on 22 May 2007].
44. Bohlius J, Wilson J, Seidenfeld J et al. Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst 2006; 98: 708–14.
45. Coiffier B, Boogaerts M, Aapro M et al. Effect of treatment with epoetin beta on thromboembolic events in anemic patients with cancer: a meta-analysis. Support Care Cancer 2006; 4: 49–55.
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