Новые возможности улучшения продолжительности и качества жизни: эрибулин в лечении больных диссеминированным раком молочной железы
Новые возможности улучшения продолжительности и качества жизни: эрибулин в лечении больных диссеминированным раком молочной железы
Семиглазова Т.Ю., Клюге В.А., Семиглазов В.В. и др. Новые возможности улучшения продолжительности и качества жизни: эрибулин в лечении больных диссеминированным раком молочной железы. Современная Онкология. 2016; 18 (2): 27–33.
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Semiglazova T.Yu., Klyuge V.A., Semiglazov V.V. et al. New opportunities to improve of duration and quality of life: eribulin in the treatment of patients with advanced breast cancer. Journal of Modern Oncology. 2016; 18 (2): 27–33.
Новые возможности улучшения продолжительности и качества жизни: эрибулин в лечении больных диссеминированным раком молочной железы
Семиглазова Т.Ю., Клюге В.А., Семиглазов В.В. и др. Новые возможности улучшения продолжительности и качества жизни: эрибулин в лечении больных диссеминированным раком молочной железы. Современная Онкология. 2016; 18 (2): 27–33.
________________________________________________
Semiglazova T.Yu., Klyuge V.A., Semiglazov V.V. et al. New opportunities to improve of duration and quality of life: eribulin in the treatment of patients with advanced breast cancer. Journal of Modern Oncology. 2016; 18 (2): 27–33.
Начиная с 1990-х годов критерием эффективности лечения больных метастатическим/диссеминированным раком молочной железы (мРМЖ) помимо общей выживаемости становится качество жизни – физическое, социальное, психическое и эмоциональное состояние больного. До недавнего времени, в отсутствие стандартов лекарственного лечения после исчерпанных возможностей антрациклин-таксансодержащей терапии мРМЖ, выбор дальнейшей тактики основывался на отдельных нерандомизированных исследованиях и собственной интуиции онколога. Эрибулина мезилат (эрибулин) – химиотерапевтический агент, впервые подтвердивший свою эффективность в двух крупных рандомизированных исследованиях. В 1-м из них были доказаны достоверное увеличение общей выживаемости и сохранение качества жизни в общей популяции больных мРМЖ с прогрессированием заболевания после терапии, включающей антрациклиновые антибиотики и таксаны. Во 2-м исследовании было продемонстрировано преимущество эрибулина у больных с трижды негативным и люминальным В-HER2-негативным подтипами мРМЖ.
Ключевые слова: общая выживаемость, качество жизни, метастатический рак молочной железы, трижды негативный подтип, эрибулин.
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Since 1990-s the efficiency of treatment of patients with metastatic/advanced breast cancer (MBC) was started to evaluate not only by overall survival but also by quality of life which is characterized by physical, social, mental and emotional condition of the patient. As there are no standards of system treatment for MBC after anthracyclines and taxanes, choice of further tactics was based on separate randomized trials and own intuition of the oncologist until recently. Eribulin mesylate (eribulin) became the first chemotherapy agent, confirmed to be effective in two large randomized trials: in first of them a significant increase of overall survival and the preservation of quality of life were shown in population of patients with MBC progressing after treatment including anthracycline antibiotics and taxanes. In second trial advantage of the drug was registered in patients with triple negative and luminal B HER2-negative MBC subtypes.
Key words: overall survival, quality of life, metastatic breast cancer, triple negative subtype, eribulin.
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8. Belfiglio M, Fanizza C, Tinari N et al. Interuniversitario Nazionale per la Bio-Oncologia (CINBO) Meta-analysis of phase III trials of docetaxel alone or in combination with chemotherapy in metastatic breast cancer. J Cancer Res Clin Oncol 2012; 138: 221–9.
9. Lemieux J, Goodwin P, Bordeleau L et al. Quality-of-life measurement in randomized clinical trials in breast cancer: an updated systematic review (2001–2009). J Nat Cancer Inst 2011; 103: 178–231.
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12. Montazeri А. Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007. J Experim Clin Cancer Res 2008; 27: 32.
13. Eton D, Cella D, Yost K et al. A combination of distribution and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol 2004; 57: 898–910.
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15. Kuznetsov G, Towle MJ, Cheng H et al. Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389. Cancer Res 2004; 64: 5760–6.
16. Doherty MK, Morris PG. Eribulin for the treatment of metastatic breast cancer: an update on its safety and efficacy. Int J Womens Health 2015; 7: 47–58.
17. Cortes J et al. Health-related quality of life in patients with locally advanced or metastatic breast cancer treated with eribulinmesylate or capecitabine in an open-label randomized phase 3 trial. Breast Cancer Res Treat 2015; 154 (3): 509–20.
18. Kaufman PA et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2015; 33 (6): 594–601.
19. Twelves C et al. Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies. Breast Cancer Res Treat 2014; 148 (3): 553–61.
20. Schwartzberg L et al. Quality of life in patients receiving first-line eribulin mesylate for HER2 – locally recurrent or MBC [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9–13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015; 75 (9 Suppl): Abstract nr P5-17-02.
21. Aaronson NK, Ahmedzai S, Bergman B et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365–76.
22. Osoba D, Zee B, Pater J et al. Psychometric properties and responsiveness of the EORTC quality of Life Questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer. Qual Life Res 1994; 3: 353–64.
23. Sprangers MA, Groenvold M, Arraras JI et al. The European Organization for research and treatment of cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol 1996; 14: 2756–68.
24. EORTC Manual http://www.eortc.be/qol/files/SCManualQLQ-C30.pdf.-2001
25. Martínez E, Zamora P, Servitja S et al. Cascade study: epidemyological analysis of current natural history and treatment patterns of metastatic breast cancer in Spain. Eisai Inc. 2015.
26. Kikuchi Y, Shirakawa K, Kanauchi H et al. A retrospective multicenter observation study about comparative analysis on efficacy of eribulin mesylate with taxane regimens (including combination with bevacizumab) in metastatic breast cancer patients. 2015.
27. Fabi A, Moscetti L, Ciccarese M et al. Eribulin in heavily pretreated metastatic breast cancer patients and clinical/biological feature correlations: impact on the practice. Future oncology. 2015.
28. Velikova G, Hudgens S, Forsythe A et al. Health-related quality of life (HRQoL) and disease symptoms in patients with locally advanced or metastatic breast cancer (MBC) treated with eribulin or capecitabine in a post anthracycline and taxane setting. 2015.
29. Di Maio M, Gallo C, Leighl N et al. Lymptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol 2015; 33: 910–5.
30. Basch E et al. The missing voice of patients in drug-safety reporting. N Engl J Med 2010; 362: 865–9.
31. Basch E, Reeve B, Mitchell S et al. Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 2014; 106.
32. Brettschneider C, Luhmann D, Raspe H et al. Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA). GMS Health Technol Assess 2011; 7: Doc01.
33. Reed E, Simmonds P, Haviland J et al. Quality of life and experience of care in women with metastatic breast cancer: a cross-sectional survey. J Pain Symptom Manage 2011; 43: 747–58.
34. Ballatori E, Roila F et al. Impact of nausea and vomiting on quality of life in cancer patients during chemotherapy. Health Qual Life Outcomes 2003; 1: 46.
________________________________________________
1. Cardoso F et al. Locally recurrent or metastatic breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2015; 22: vi25–vi30.
2. Howlader N, Noone A, Krapcho M et al. SEER Cancer Statistics Review 1975-2010.http://www.seer.cancer.gov/archive/csr/1975_2010/results_merged/sect_04_breast.pdf.-2013.
3. Semiglazov V.F., Paltuev R.M., Semiglazova T.Yu. i dr. Opukholi reproduktivnoi sistemy. M.: Reklamno-izdatel'skaia gruppa MegaPro, 2013. [in Russian]
4. Semiglazova T.Yu., Semiglazov V.V., Filatova L.V. i dr. Kachestvo zhizni – vazhnyi kriterii effektivnosti targetnoi terapii metastaticheskogo porazheniia skeleta pri rake molochnoi zhelezy. Opukholi zhenskoi reproduktivnoi sistemy. 2013; 1–2: 17–22. [in Russian]
5. Semiglazov V.V., Zhabina A.S., Osipov M.A. i dr. Kachestvo zhizni – printsipial'nyi kriterii effektivnosti targetnoi terapii metastaticheskogo HER2-polozhitel'nogo raka molochnoi zhelezy. Journal of Modern Oncology. 2015; 17 (1): 19–24. [in Russian]
6. Ionova T.I., Novik A.A., Sukhonos Iu.A. Poniatie kachestva zhizni bol'nykh onkologicheskogo profilia. Onkologiia. 2000; 2 (1–2): 25–8. [in Russian]
7. Greenberg P, Hortobagyi G, Smith T et al. Long-term follow-up of patients complete remission following combination chemotherapy for metastatic breast cancer. J Clin Oncol 1996; 14: 2197–205.
8. Belfiglio M, Fanizza C, Tinari N et al. Interuniversitario Nazionale per la Bio-Oncologia (CINBO) Meta-analysis of phase III trials of docetaxel alone or in combination with chemotherapy in metastatic breast cancer. J Cancer Res Clin Oncol 2012; 138: 221–9.
9. Lemieux J, Goodwin P, Bordeleau L et al. Quality-of-life measurement in randomized clinical trials in breast cancer: an updated systematic review (2001–2009). J Nat Cancer Inst 2011; 103: 178–231.
10. Howlader N, Noone A, Krapcho M et al. SEER Cancer Statistics Review, 1975–2010.http://www.seer.cancer.gov/archive/csr/1975_2010/results_merged/sect_04_breast.pdf.
11. Amado F, Lourenço MT, Deheinzelin D. Metastatic breast cancer: do current treatments improve quality of life? A prospective study. Sao Paulo Med J 2006; 124: 203–7.
12. Montazeri А. Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007. J Experim Clin Cancer Res 2008; 27: 32.
13. Eton D, Cella D, Yost K et al. A combination of distribution and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol 2004; 57: 898–910.
14. Perry S, Kowalski T, Chang C. Quality of life assessment in women with breast cancer: benefits, acceptability and utilization. Health Qual Life Outcomes 2007; 5: 24–38.
15. Kuznetsov G, Towle MJ, Cheng H et al. Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389. Cancer Res 2004; 64: 5760–6.
16. Doherty MK, Morris PG. Eribulin for the treatment of metastatic breast cancer: an update on its safety and efficacy. Int J Womens Health 2015; 7: 47–58.
17. Cortes J et al. Health-related quality of life in patients with locally advanced or metastatic breast cancer treated with eribulinmesylate or capecitabine in an open-label randomized phase 3 trial. Breast Cancer Res Treat 2015; 154 (3): 509–20.
18. Kaufman PA et al. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2015; 33 (6): 594–601.
19. Twelves C et al. Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies. Breast Cancer Res Treat 2014; 148 (3): 553–61.
20. Schwartzberg L et al. Quality of life in patients receiving first-line eribulin mesylate for HER2 – locally recurrent or MBC [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9–13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015; 75 (9 Suppl): Abstract nr P5-17-02.
21. Aaronson NK, Ahmedzai S, Bergman B et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365–76.
22. Osoba D, Zee B, Pater J et al. Psychometric properties and responsiveness of the EORTC quality of Life Questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer. Qual Life Res 1994; 3: 353–64.
23. Sprangers MA, Groenvold M, Arraras JI et al. The European Organization for research and treatment of cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol 1996; 14: 2756–68.
24. EORTC Manual http://www.eortc.be/qol/files/SCManualQLQ-C30.pdf.-2001
25. Martínez E, Zamora P, Servitja S et al. Cascade study: epidemyological analysis of current natural history and treatment patterns of metastatic breast cancer in Spain. Eisai Inc. 2015.
26. Kikuchi Y, Shirakawa K, Kanauchi H et al. A retrospective multicenter observation study about comparative analysis on efficacy of eribulin mesylate with taxane regimens (including combination with bevacizumab) in metastatic breast cancer patients. 2015.
27. Fabi A, Moscetti L, Ciccarese M et al. Eribulin in heavily pretreated metastatic breast cancer patients and clinical/biological feature correlations: impact on the practice. Future oncology. 2015.
28. Velikova G, Hudgens S, Forsythe A et al. Health-related quality of life (HRQoL) and disease symptoms in patients with locally advanced or metastatic breast cancer (MBC) treated with eribulin or capecitabine in a post anthracycline and taxane setting. 2015.
29. Di Maio M, Gallo C, Leighl N et al. Lymptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol 2015; 33: 910–5.
30. Basch E et al. The missing voice of patients in drug-safety reporting. N Engl J Med 2010; 362: 865–9.
31. Basch E, Reeve B, Mitchell S et al. Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 2014; 106.
32. Brettschneider C, Luhmann D, Raspe H et al. Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA). GMS Health Technol Assess 2011; 7: Doc01.
33. Reed E, Simmonds P, Haviland J et al. Quality of life and experience of care in women with metastatic breast cancer: a cross-sectional survey. J Pain Symptom Manage 2011; 43: 747–58.
34. Ballatori E, Roila F et al. Impact of nausea and vomiting on quality of life in cancer patients during chemotherapy. Health Qual Life Outcomes 2003; 1: 46.
1 ФГБУ НИИ онкологии им. Н.Н.Петрова Минздрава России. 197758, Россия, Санкт-Петербург, пос. Песочный, ул. Ленинградская, д. 68;
2 ГБОУ ВПО Северо-Западный государственный медицинский университет им. И.И.Мечникова Минздрава России. 191015, Россия, Санкт-Петербург, ул. Кирочная, д. 41;
3 ГБОУ ВПО Первый Санкт-Петербургский государственный медицинский университет им. акад. И.П.Павлова Минздрава России. 197022, Россия, Санкт-Петербург, ул. Льва Толстого, д. 6/8
*tsemiglazova@mail.ru
1 N.N.Petrov Research Institute of Oncology of the Ministry of Health of the Russian Federation. 197758, Russian Federation, Saint Petersburg, pos. Pesochnyi, ul. Leningradskaia, d. 68;
2 I.I.Mechnikov State Northwestern Medical University of the Ministry of Health of the Russian Federation. 191015, Russian Federation, Saint Petersburg, ul. Kirochnaia, d. 41;
3 I.M.Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation. 197022, Russian Federation, Saint Petersburg, ul. L'va Tolstogo, d. 6/8
*tsemiglazova@mail.ru