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Качество жизни – принципиальный критерий эффективности таргетной терапии метастатического HER2-положительного рака молочной железы
Семиглазова Т.Ю., Дашян Г.А., Семиглазов В.В. и др. Качество жизни – принципиальный критерий эффективности таргетной терапии метастатического HER2-положительного рака молочной железы. Современная онкология. 2015; 1: 19–24.
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Semiglazova T.Yu., Dashyan G.A., Semiglazov V.V. et al. Quality of life is the fundamental criterion of the efficacy of targeted therapy in patients with metastatic HER2-positive breast cancer. Journal of modern oncology. 2015; 1: 19–24.
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Аннотация
Начиная с 1990-х годов в клинических исследованиях накоплены уникальные данные о качестве жизни (КЖ) как об одном из принципиальных критериев эффективности лечения больных злокачественными опухолями, в том числе раком молочной железы (РМЖ). В последние десятилетия наибольший прогресс лекарственного лечения РМЖ наблюдается при HER2-положительном подтипе. Биологически направленная анти-HER2-терапия новыми препаратами (пертузумабом и T-DM1) позволяет эффективно контролировать болезнь, значимо увеличивать продолжительность жизни больных HER2-положительным РМЖ, а главное, сохранять КЖ женщин на высоком уровне. При этом оценка КЖ по опросникам – простой, надежный и высокоинформативный метод, позволяющий получить исключительно важную всестороннюю информацию о реакции больного на болезнь в зависимости от проводимого лекарственного лечения.
Ключевые слова: качество жизни, метастатический рак молочной железы, анти-HER2-таргетная терапия, T-DM1, пертузумаб.
Ключевые слова: качество жизни, метастатический рак молочной железы, анти-HER2-таргетная терапия, T-DM1, пертузумаб.
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Since the 1990s, the unique data of clinical trials has been analyzed regarding the Quality of Life (QoL) Index as a one of fundamental criteria of treatment efficacy for malignant tumors and breast cancer in particular. Last decades the highest progress was shown in the treatment of HER2-positive subtype of BC. New biological therapy with anti-HER2 targeted agents (pertuzumab and T-DM1) significantly improve overall survival in HER2-positive BC, increase disease-control rate and associated with good quality of life. QoL measurement by special Questionnaires is a simple and accurate option to evaluate the patient's reaction to disease and its treatment in detail.
Key words: quality of life, metastatic breast cancer, anti-HER2-targeted therapy, T-DM1, pertuzumab.
Полный текст
Список литературы
1. Ионова Т.И., Новик А.А., Сухонос Ю.А. Понятие качества жизни больных онкологического профиля. Онкология. 2000; 2 (1–2): 25–8. / 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]
2. Aaronson N, Cull A, Kaasa S, Sprangers M. The European Organization for Research and Treatment of Cancer (EORTC) modular approach to quality of life assessment in oncology. Int О Ment Health 1994; 23: 75–96.
3. 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 Natl Cancer Inst 2011; 103: 178–231.
4. Семиглазова Т.Ю., Семиглазов В.В., Филатова Л.В. и др. Качество жизни – важный критерий эффективности таргетной терапии метастатического поражения скелета при раке молочной железы. Опухоли женской репродуктивной системы. 2013; 1–2: 17–22. / Semiglazova T.Iu., 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. Paraskevi T. Quality of life outcomes in patients with breast cancer. Licensee PAGEPress. Italy Oncol Rev 2012; 6: e2: 7–10.
6. Osoba D, Hsu M, Copley-Merriman C et al. Stated preferences of patients with cancer for health-related quality-of-life (HRQOL) domains during treatment. Qual Life Res 2006; 15: 273–83.
7. Montazeri А. Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007. J Exper & Clin Cancer Research 2008; 27: 32.
8. 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 Epid 2004; 57: 898–910.
9. Fisher B, Osborn K, Margolese R et al. Neoplasms of the breast. Cancer med 1993; 3: 1706–74.
10. Brady M, Cella D, Mo F et al. Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument. J Clin Oncol 1997; 15: 974–86.
11. 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.
12. 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.
13. Cella D, Wang M, Wagner L, Miller K. Survival-adjusted health related quality of life (HRQL) among patients with metastatic breast cancer receiving paclitaxel plus bevacizumab vs. paclitaxel alone: results from Eastern Cooperative Oncology Group Study 2100 (E2100). Breast Cancer Res Treat 2011; 130: 855–61.
14. Walker M, Hasan M, Yim Y et al. Retrospective study of the effect of disease progression on patient reported outcomes in HER-2 negative metastatic breast cancer patients. Health Qual Life Outcomes 2011; 9: 46.
15. Corey-Lisle P, Peck R, Mukhopadhyay P et al. Q-TWiST analysis of ixabepilone in combination with capecitabine on quality of life in patients with metastatic breast cancer. Cancer 2012; 118: 461–8.
16. Sherrill B, Di Leo A, Amonkar M et al. Quality-of-life and quality-adjusted survival (Q-TWiST) in patients receiving lapatinib in combination with paclitaxel as first-line treatment for metastatic breast cancer. Curr Med Res Opin 2010; 26: 767–75.
17. Zhou X, Cella D, Cameron D et al. Lapatinib plus capecitabine vs. capecitabine alone for HER2+ (ErbB2+) metastatic breast cancer: quality-of-life assessment. Breast Cancer Res Treat 2009; 117: 577–89.
18. Rugo H, Brammer M, Zhang F et al. Effect of trastuzumab on health-related quality of life in patients with HER2-positive metastatic breast cancer: data from three clinical trials. Clin Breast Cancer 2010; 10: 288–93.
19. Мерабишвили В.М. Эпидемиология и выживаемость больных раком молочной железы. Вопр. онкологии. 2013; 59 (3): 314–9. / Merabishvili V.M. Epidemiologiia i vyzhivaemost' bol'nykh rakom molochnoi zhelezy. Vopr. onkologii. 2013; 59 (3): 314–9. [in Russian]
20. Семиглазов В.Ф., Палтуев Р.М., Семиглазова Т.Ю. и др. Опухоли репродуктивной системы. М.: Рекламно-издательская группа МегаПро, 2013. / Semiglazov V.F., Paltuev R.M., Semiglazova T.Iu. i dr. Opukholi reproduktivnoi sistemy. M.: Reklamno-izdatel'skaia gruppa MegaPro, 2013. [in Russian]
21. Baselga J, Cortes J, Kim S et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012; 366: 109–19.
22. Swain S, Cortes J, Semiglazov V et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomized, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2013; 14: 461–71.
23. Cortés J, Baselga J, Im Y.-H. Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer. Ann Oncol 2013; 24 (10): 2630–5.
24. Verma S, Miles D, Gianni L et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012; 367: 1783–91. Erratum in N Engl J Med 2013; 368: 2442.
25. Welslau М, Dieras V, Sohn J-H. Patient-Reported Outcomes From EMILIA, a Randomized Phase 3 Study of Trastuzumab Emtansine (T-DM1) Versus Capecitabine and Lapatinib in Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Breast Cancer. Cancer 2014; p. 642–51.
2. Aaronson N, Cull A, Kaasa S, Sprangers M. The European Organization for Research and Treatment of Cancer (EORTC) modular approach to quality of life assessment in oncology. Int О Ment Health 1994; 23: 75–96.
3. 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 Natl Cancer Inst 2011; 103: 178–231.
4. Семиглазова Т.Ю., Семиглазов В.В., Филатова Л.В. и др. Качество жизни – важный критерий эффективности таргетной терапии метастатического поражения скелета при раке молочной железы. Опухоли женской репродуктивной системы. 2013; 1–2: 17–22. / Semiglazova T.Iu., 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. Paraskevi T. Quality of life outcomes in patients with breast cancer. Licensee PAGEPress. Italy Oncol Rev 2012; 6: e2: 7–10.
6. Osoba D, Hsu M, Copley-Merriman C et al. Stated preferences of patients with cancer for health-related quality-of-life (HRQOL) domains during treatment. Qual Life Res 2006; 15: 273–83.
7. Montazeri А. Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007. J Exper & Clin Cancer Research 2008; 27: 32.
8. 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 Epid 2004; 57: 898–910.
9. Fisher B, Osborn K, Margolese R et al. Neoplasms of the breast. Cancer med 1993; 3: 1706–74.
10. Brady M, Cella D, Mo F et al. Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument. J Clin Oncol 1997; 15: 974–86.
11. 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.
12. 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.
13. Cella D, Wang M, Wagner L, Miller K. Survival-adjusted health related quality of life (HRQL) among patients with metastatic breast cancer receiving paclitaxel plus bevacizumab vs. paclitaxel alone: results from Eastern Cooperative Oncology Group Study 2100 (E2100). Breast Cancer Res Treat 2011; 130: 855–61.
14. Walker M, Hasan M, Yim Y et al. Retrospective study of the effect of disease progression on patient reported outcomes in HER-2 negative metastatic breast cancer patients. Health Qual Life Outcomes 2011; 9: 46.
15. Corey-Lisle P, Peck R, Mukhopadhyay P et al. Q-TWiST analysis of ixabepilone in combination with capecitabine on quality of life in patients with metastatic breast cancer. Cancer 2012; 118: 461–8.
16. Sherrill B, Di Leo A, Amonkar M et al. Quality-of-life and quality-adjusted survival (Q-TWiST) in patients receiving lapatinib in combination with paclitaxel as first-line treatment for metastatic breast cancer. Curr Med Res Opin 2010; 26: 767–75.
17. Zhou X, Cella D, Cameron D et al. Lapatinib plus capecitabine vs. capecitabine alone for HER2+ (ErbB2+) metastatic breast cancer: quality-of-life assessment. Breast Cancer Res Treat 2009; 117: 577–89.
18. Rugo H, Brammer M, Zhang F et al. Effect of trastuzumab on health-related quality of life in patients with HER2-positive metastatic breast cancer: data from three clinical trials. Clin Breast Cancer 2010; 10: 288–93.
19. Мерабишвили В.М. Эпидемиология и выживаемость больных раком молочной железы. Вопр. онкологии. 2013; 59 (3): 314–9. / Merabishvili V.M. Epidemiologiia i vyzhivaemost' bol'nykh rakom molochnoi zhelezy. Vopr. onkologii. 2013; 59 (3): 314–9. [in Russian]
20. Семиглазов В.Ф., Палтуев Р.М., Семиглазова Т.Ю. и др. Опухоли репродуктивной системы. М.: Рекламно-издательская группа МегаПро, 2013. / Semiglazov V.F., Paltuev R.M., Semiglazova T.Iu. i dr. Opukholi reproduktivnoi sistemy. M.: Reklamno-izdatel'skaia gruppa MegaPro, 2013. [in Russian]
21. Baselga J, Cortes J, Kim S et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012; 366: 109–19.
22. Swain S, Cortes J, Semiglazov V et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomized, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2013; 14: 461–71.
23. Cortés J, Baselga J, Im Y.-H. Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer. Ann Oncol 2013; 24 (10): 2630–5.
24. Verma S, Miles D, Gianni L et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012; 367: 1783–91. Erratum in N Engl J Med 2013; 368: 2442.
25. Welslau М, Dieras V, Sohn J-H. Patient-Reported Outcomes From EMILIA, a Randomized Phase 3 Study of Trastuzumab Emtansine (T-DM1) Versus Capecitabine and Lapatinib in Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Breast Cancer. Cancer 2014; p. 642–51.
________________________________________________
1. 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]
2. Aaronson N, Cull A, Kaasa S, Sprangers M. The European Organization for Research and Treatment of Cancer (EORTC) modular approach to quality of life assessment in oncology. Int О Ment Health 1994; 23: 75–96.
3. 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 Natl Cancer Inst 2011; 103: 178–231.
4. Semiglazova T.Iu., 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. Paraskevi T. Quality of life outcomes in patients with breast cancer. Licensee PAGEPress. Italy Oncol Rev 2012; 6: e2: 7–10.
6. Osoba D, Hsu M, Copley-Merriman C et al. Stated preferences of patients with cancer for health-related quality-of-life (HRQOL) domains during treatment. Qual Life Res 2006; 15: 273–83.
7. Montazeri А. Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007. J Exper & Clin Cancer Research 2008; 27: 32.
8. 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 Epid 2004; 57: 898–910.
9. Fisher B, Osborn K, Margolese R et al. Neoplasms of the breast. Cancer med 1993; 3: 1706–74.
10. Brady M, Cella D, Mo F et al. Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument. J Clin Oncol 1997; 15: 974–86.
11. 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.
12. 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.
13. Cella D, Wang M, Wagner L, Miller K. Survival-adjusted health related quality of life (HRQL) among patients with metastatic breast cancer receiving paclitaxel plus bevacizumab vs. paclitaxel alone: results from Eastern Cooperative Oncology Group Study 2100 (E2100). Breast Cancer Res Treat 2011; 130: 855–61.
14. Walker M, Hasan M, Yim Y et al. Retrospective study of the effect of disease progression on patient reported outcomes in HER-2 negative metastatic breast cancer patients. Health Qual Life Outcomes 2011; 9: 46.
15. Corey-Lisle P, Peck R, Mukhopadhyay P et al. Q-TWiST analysis of ixabepilone in combination with capecitabine on quality of life in patients with metastatic breast cancer. Cancer 2012; 118: 461–8.
16. Sherrill B, Di Leo A, Amonkar M et al. Quality-of-life and quality-adjusted survival (Q-TWiST) in patients receiving lapatinib in combination with paclitaxel as first-line treatment for metastatic breast cancer. Curr Med Res Opin 2010; 26: 767–75.
17. Zhou X, Cella D, Cameron D et al. Lapatinib plus capecitabine vs. capecitabine alone for HER2+ (ErbB2+) metastatic breast cancer: quality-of-life assessment. Breast Cancer Res Treat 2009; 117: 577–89.
18. Rugo H, Brammer M, Zhang F et al. Effect of trastuzumab on health-related quality of life in patients with HER2-positive metastatic breast cancer: data from three clinical trials. Clin Breast Cancer 2010; 10: 288–93.
19. Merabishvili V.M. Epidemiologiia i vyzhivaemost' bol'nykh rakom molochnoi zhelezy. Vopr. onkologii. 2013; 59 (3): 314–9. [in Russian]
20. Semiglazov V.F., Paltuev R.M., Semiglazova T.Iu. i dr. Opukholi reproduktivnoi sistemy. M.: Reklamno-izdatel'skaia gruppa MegaPro, 2013. [in Russian]
21. Baselga J, Cortes J, Kim S et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012; 366: 109–19.
22. Swain S, Cortes J, Semiglazov V et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomized, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2013; 14: 461–71.
23. Cortés J, Baselga J, Im Y.-H. Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer. Ann Oncol 2013; 24 (10): 2630–5.
24. Verma S, Miles D, Gianni L et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012; 367: 1783–91. Erratum in N Engl J Med 2013; 368: 2442.
25. Welslau М, Dieras V, Sohn J-H. Patient-Reported Outcomes From EMILIA, a Randomized Phase 3 Study of Trastuzumab Emtansine (T-DM1) Versus Capecitabine and Lapatinib in Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Breast Cancer. Cancer 2014; p. 642–51.
Авторы
Т.Ю.Семиглазова*1, 2, Г.А.Дашян1, В.В.Семиглазов3, А.С.Жабина1, М.А.Осипов1, З.С.Котова1, В.В.Клименко1, 2, П.В.Криворотько1, 2, В.Ф.Семиглазов1, 2
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 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 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 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
________________________________________________
T.Yu.Semiglazova*1, 2, G.A.Dashyan1, V.V.Semiglazov3, A.S.Zhabina1, M.A.Osipov1, Z.S.Kotova1, V.V.Klimenko1, 2, P.V.Krivorotko1, 2, V.F.Semiglazov1, 2
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
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