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Режимы на основе Таксотера® в терапии HER-2-позитивного рака молочной железы
Режимы на основе Таксотера® в терапии HER-2-позитивного рака молочной железы
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Аннотация
Доцетаксел (Таксотер®) высокоэффективен при раке молочной железы, а комбинация доцетаксела с трастузумабом представляет собой безопасную альтернативу антрациклинсодержащим режимам терапии HER-2-позитивной формы заболевания. Доклинические исследования показали синергизм трастузумаба и доцетаксела в отличие от паклитаксела, характеризующегося только аддитивным взаимодействием с трастузумабом.
Несмотря на отсутствие прямых сравнительных рандомизированных исследований, непрямой анализ продемонстрировал более высокую эффективность комбинации доцетаксел/трастузумаб по сравнению с режимом паклитаксел/трастузумаб при метастатическом HER-2+ раке молочной железы. Добавление капецитабина к комбинации доцетаксел/трастузумаб достоверно увеличивало выживаемость без прогрессирования болезни, однако не влияло на частоту ответов и общую выживаемость больных. Добавление карбоплатина к доцетакселу с трастузумабом не улучшало результаты лечения в отличие от комбинации паклитаксел/трастузумаб.
В адъювантной терапии раннего HER-2-позитивного рака молочной железы обоснованно могут использоваться последовательный антрациклинсодержащий режим доксорубицин/циклофосфамид, затем доцетаксел/трастузумаб (АС-ТН) или безантрациклиновая комбинация доцетаксел/карбоплатин/трастузумаб (ТСН), которая характеризуется сравнимой эффективностью и долгосрочной безопасностью при меньшем числе курсов.
Ключевые слова: доцетаксел (Таксотер®), трастузумаб, рак молочной железы.
Despite the fact that there are no prospective randomized studies the indirect analysis showed that the docetaxel/trastuzumab combination is more effective than paclitaxel/trastuzumab combination. The addition of capecitabine to the docetaxel/trastuzumab combination increased progression free survival, however it did not show a significant difference in the response rate and overall survival. The addition of carboplatin to the docetaxel/trastuzumab combination did not improve the effectiveness of treatment, but the combination of carboplatin/paclitaxel/trastuzumab was proven to be more effective, than paclitaxel/trastuzumab.
Both treatment regimens (consisting docetaxel plus trastuzumab following doxorubicin and cyclophosphamide or consisting docetaxel, carboplatin and trastuzumab) might be used in adjuvant chemotherapy of patients with HER-2-positive early breast cancer.
Key words: docetaxel (Taxotere®), trastuzumab, breast cancer.
Несмотря на отсутствие прямых сравнительных рандомизированных исследований, непрямой анализ продемонстрировал более высокую эффективность комбинации доцетаксел/трастузумаб по сравнению с режимом паклитаксел/трастузумаб при метастатическом HER-2+ раке молочной железы. Добавление капецитабина к комбинации доцетаксел/трастузумаб достоверно увеличивало выживаемость без прогрессирования болезни, однако не влияло на частоту ответов и общую выживаемость больных. Добавление карбоплатина к доцетакселу с трастузумабом не улучшало результаты лечения в отличие от комбинации паклитаксел/трастузумаб.
В адъювантной терапии раннего HER-2-позитивного рака молочной железы обоснованно могут использоваться последовательный антрациклинсодержащий режим доксорубицин/циклофосфамид, затем доцетаксел/трастузумаб (АС-ТН) или безантрациклиновая комбинация доцетаксел/карбоплатин/трастузумаб (ТСН), которая характеризуется сравнимой эффективностью и долгосрочной безопасностью при меньшем числе курсов.
Ключевые слова: доцетаксел (Таксотер®), трастузумаб, рак молочной железы.
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Despite the fact that there are no prospective randomized studies the indirect analysis showed that the docetaxel/trastuzumab combination is more effective than paclitaxel/trastuzumab combination. The addition of capecitabine to the docetaxel/trastuzumab combination increased progression free survival, however it did not show a significant difference in the response rate and overall survival. The addition of carboplatin to the docetaxel/trastuzumab combination did not improve the effectiveness of treatment, but the combination of carboplatin/paclitaxel/trastuzumab was proven to be more effective, than paclitaxel/trastuzumab.
Both treatment regimens (consisting docetaxel plus trastuzumab following doxorubicin and cyclophosphamide or consisting docetaxel, carboplatin and trastuzumab) might be used in adjuvant chemotherapy of patients with HER-2-positive early breast cancer.
Key words: docetaxel (Taxotere®), trastuzumab, breast cancer.
Полный текст
Список литературы
1. Gunnarsdottir K, Jensen M-B, Zahrieh D et al. CEF is superior to CMF for tumors with topoisomerase IIα-gene alterations: a STEPP (subpopulation treatment effect pattern plot) analysis on Danish breast cancer cooperative group study 89D. Breast Cancer Res Treat 2006; 100 (Suppl. 1): 46. Abstr. 1023.
2. Tanner M, Isola J, Wiklund T et al. Topoisomerase II-gene amplification predicts favorable treatment response to tailored and dose-escalated anthracycline-based adjuvant chemotherapy in HER-2/neu-amplified breast cancer: Scandinavian Breast Group Trial 9401. J Clin Oncol 2006; 24: 2428–36.
3. Knoop AS, Knudsen H, Balslev E et al. Retrospective analysis of topoisomerase IIa-amplifications and deletions as predictive markers in primary breast cancer patients randomly assigned to cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, epirubicin, and fluorouracil. Danish Breast Cancer Cooperative Group. J Clin Oncol 2005; 23: 7483–90.
4. Coon JS, Marcus E, Gupta-Burt S et al. Amplification and overexpression of topoisomerase IIa predict response to anthracycline-based therapy in locally advanced breast cancer. Clin Cancer Res 2002; 8: 1061–7.
5. Slamon DJ, Mackey J, Robert N et al. Role of anthracycline based therapy in the adjuvant treatment of breast cancer: efficacy analysis determined by molecular subtypes of the disease. Breast Cancer Res Treat 2007; 106 (Suppl. 1): 5. Abstr. 13.
6. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plays a monoclonal antibody against HER-2 for metastatic breast cancer that overexpresses HER-2. N Engl J Med 2001; 334: 783–92.
7. Pergam MD, Konecny GE, O’Callaghan C et al. Rational combinations of trastusumab with chemotherapeutic drugs used in the treatment of human breast cancer. J Natl Cancer Inst 2004; 96: 739–49.
8. Pergam MD, Hsu S, Lewis G et al. Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers. Oncogene 1999; 18: 2241–51.
9. Marty M, Cognetti F, Maraninchi D et al. Randomized Phase II Trial of the Efficacy and Safety of Trastuzumab Combined With Docetaxel in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Administered As First-Line Treatment: The M77001 Study Group. J Clin Oncol 2005; 23: 4265–74.
10. O’Shaughnessy J, Miles D, Vukelja S et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002; 20 (12): 2812–23.
11. Wardley A, Antón-Torres A, Pivot X et al. Evaluation of trastuzumab, docetaxel and capecitabine as first-line therapy for HER2-positive locally advanced or metastatic breast cancer. SABCS 2007, Breast Cancer Res and Treat 2007; 106 (Suppl. 1): 33. Abstr. 309.
12. Pegram MD, Pienkowski T, Northfelt DW et al. Results of two open-label, multicenter phase II studies of docetaxel, platinum salts and trastuzumab in HER-2-positive advanced breast cancer. J Natl Cancer Inst 2004; 96: 759–69.
13. Slamon DJ, Yeon CH, Pienkowski T et al. Survival analysis from two open-label non-randomized phase II trials of trastuzumab (H) combined with docetaxel (T) and platinum’s (C, cisplatin or carboplatin) (TCH) in women with HER-2+ advanced breast cancer (ABC). J Clin Oncol 2004; 22: 642.
14. Pegram M, Forbes J, Pienkowski T et al. BCIRG007: First overall survival analysis of randomized phase III trial of trastuzumab plus docetaxel with or without carboplatin as first line therapy in HER-2 amplified metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2007; 1 (25): 18. Abstr. LBA100.
15. Robert N, Leyland-Jones B, Asmar L et al. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2006; 24: 2786–92.
16. Raff JP, Rajdev L, Malik U et al. Phase II study of weekly docetaxel alone or in combination with trastuzumab in patients with metastatic breast cancer. Clin Breast Cancer 2004; 4: 420–7.
17. Tedesco KL, Thor AD, Johnson DH et al. Docetaxel combined with trastuzumab is an active regimen in HER-2 3-overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer: A multiinstitutional phase II trial. J Clin Oncol 2004; 22: 1071–7.
18. Esteva FJ, Valero V, Booser D et al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20: 1800–8.
19. Piccart-Gebhart MJ, Procter M, Leyland-Jones et al. Trastuzumab after Adjuvant Chemotherapy in HER-2-Positive Breast Cancer. N Engl M J Med 2005; 353: 1659–72.
20. Perez EA, Romond EH, Suman VJ et al. Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patients with HER-2-positive breast cancer. JCO, 2007, ASCO Annual Meeting Proceedings (Post-Meeting Edition); 25 (Suppl. 20): 512.
21. Slamon DJ, Eiermann W, Robert N et al. Phase III trial comparing AC-T with AC-TH and with TCH in the adjuvant treatment of HER-2 positive early breast cancer patients: second interim efficacy analysis. SABCS 2006. Abstr. 209.
22. Joensuu H, Kellokumpu-Lehtinen PL, Bono P. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006; 354: 809–20.
23. Romond EH, Perez RK, Bryant J et al. Trastuzumab plus adjuvant chemotherapy for operable HER-2-positive breast cancer. N Engl J Med 2005; 353: 1673–84.
24. Viani GA, Afonao SL, Stefano EJ et al. Adjuvant trastuzumab in the treatment of her-2-positive early breast cancer: A metaanalysis of published randomized trials. BMC Cancer 2007; 7: 153.
25. Slamon D, Mackey J, Robert N et al. Phase III Trial Comparing AC-T with AC-TH and with TCH in the adjuvant treatment of HER-2-positive early breast cancer patients: BCIRG 006 study. SABS 2005. Abstr. 1.
26. Slamon D, Eiermann W, Robert N. BCIRG006: 2nd interim analysis phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC≥T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC≥TH) with docetaxel, carboplatin and trastuzumab (TCH) in Her-2/neu positive early breast cancer patients. 29th Annual San Antonio Breast Cancer Symposium. San Antonio, TX 2006. Abstr. LBA 52.
27. Slamon D, Eiermann W, Robert N et al. Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (ACT) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (ACTH) with docetaxel, carboplatin and trastuzumab (TCH) in HER-2/neu positive early breast cancer patients: BCIRG006 study. Cancer Res 2009; 69 (Suppl.): 500. Abstr. 62.
28. Joensuu H, Kellokumpu-Lehtinen PL, Bono P et al. Adjuvant docetaxel or vinorelbine with or without trastusumab for breast cancer. NEJM 2006; 354: 809–20.
29. Perez E, Romond E, Suman V et al. Updated results of the combined analysis of NCCTG №9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patients with HER-2-positive breast cancer. J Clin Oncol 2007; 25 (Suppl. 18): 6. Abstr. 512.
30. Perez EA, Suman VJ, Davidson NE et al. Results of chemotherapy alone, with sequential or concurrent addition of 52 weeks of trastuzumab in the NCCTG N9831 HER-2-positive adjuvant breast cancer trial. SABCS 2009. Abstr. 80.
2. Tanner M, Isola J, Wiklund T et al. Topoisomerase II-gene amplification predicts favorable treatment response to tailored and dose-escalated anthracycline-based adjuvant chemotherapy in HER-2/neu-amplified breast cancer: Scandinavian Breast Group Trial 9401. J Clin Oncol 2006; 24: 2428–36.
3. Knoop AS, Knudsen H, Balslev E et al. Retrospective analysis of topoisomerase IIa-amplifications and deletions as predictive markers in primary breast cancer patients randomly assigned to cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, epirubicin, and fluorouracil. Danish Breast Cancer Cooperative Group. J Clin Oncol 2005; 23: 7483–90.
4. Coon JS, Marcus E, Gupta-Burt S et al. Amplification and overexpression of topoisomerase IIa predict response to anthracycline-based therapy in locally advanced breast cancer. Clin Cancer Res 2002; 8: 1061–7.
5. Slamon DJ, Mackey J, Robert N et al. Role of anthracycline based therapy in the adjuvant treatment of breast cancer: efficacy analysis determined by molecular subtypes of the disease. Breast Cancer Res Treat 2007; 106 (Suppl. 1): 5. Abstr. 13.
6. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plays a monoclonal antibody against HER-2 for metastatic breast cancer that overexpresses HER-2. N Engl J Med 2001; 334: 783–92.
7. Pergam MD, Konecny GE, O’Callaghan C et al. Rational combinations of trastusumab with chemotherapeutic drugs used in the treatment of human breast cancer. J Natl Cancer Inst 2004; 96: 739–49.
8. Pergam MD, Hsu S, Lewis G et al. Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers. Oncogene 1999; 18: 2241–51.
9. Marty M, Cognetti F, Maraninchi D et al. Randomized Phase II Trial of the Efficacy and Safety of Trastuzumab Combined With Docetaxel in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Administered As First-Line Treatment: The M77001 Study Group. J Clin Oncol 2005; 23: 4265–74.
10. O’Shaughnessy J, Miles D, Vukelja S et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002; 20 (12): 2812–23.
11. Wardley A, Antón-Torres A, Pivot X et al. Evaluation of trastuzumab, docetaxel and capecitabine as first-line therapy for HER2-positive locally advanced or metastatic breast cancer. SABCS 2007, Breast Cancer Res and Treat 2007; 106 (Suppl. 1): 33. Abstr. 309.
12. Pegram MD, Pienkowski T, Northfelt DW et al. Results of two open-label, multicenter phase II studies of docetaxel, platinum salts and trastuzumab in HER-2-positive advanced breast cancer. J Natl Cancer Inst 2004; 96: 759–69.
13. Slamon DJ, Yeon CH, Pienkowski T et al. Survival analysis from two open-label non-randomized phase II trials of trastuzumab (H) combined with docetaxel (T) and platinum’s (C, cisplatin or carboplatin) (TCH) in women with HER-2+ advanced breast cancer (ABC). J Clin Oncol 2004; 22: 642.
14. Pegram M, Forbes J, Pienkowski T et al. BCIRG007: First overall survival analysis of randomized phase III trial of trastuzumab plus docetaxel with or without carboplatin as first line therapy in HER-2 amplified metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2007; 1 (25): 18. Abstr. LBA100.
15. Robert N, Leyland-Jones B, Asmar L et al. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2006; 24: 2786–92.
16. Raff JP, Rajdev L, Malik U et al. Phase II study of weekly docetaxel alone or in combination with trastuzumab in patients with metastatic breast cancer. Clin Breast Cancer 2004; 4: 420–7.
17. Tedesco KL, Thor AD, Johnson DH et al. Docetaxel combined with trastuzumab is an active regimen in HER-2 3-overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer: A multiinstitutional phase II trial. J Clin Oncol 2004; 22: 1071–7.
18. Esteva FJ, Valero V, Booser D et al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20: 1800–8.
19. Piccart-Gebhart MJ, Procter M, Leyland-Jones et al. Trastuzumab after Adjuvant Chemotherapy in HER-2-Positive Breast Cancer. N Engl M J Med 2005; 353: 1659–72.
20. Perez EA, Romond EH, Suman VJ et al. Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patients with HER-2-positive breast cancer. JCO, 2007, ASCO Annual Meeting Proceedings (Post-Meeting Edition); 25 (Suppl. 20): 512.
21. Slamon DJ, Eiermann W, Robert N et al. Phase III trial comparing AC-T with AC-TH and with TCH in the adjuvant treatment of HER-2 positive early breast cancer patients: second interim efficacy analysis. SABCS 2006. Abstr. 209.
22. Joensuu H, Kellokumpu-Lehtinen PL, Bono P. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006; 354: 809–20.
23. Romond EH, Perez RK, Bryant J et al. Trastuzumab plus adjuvant chemotherapy for operable HER-2-positive breast cancer. N Engl J Med 2005; 353: 1673–84.
24. Viani GA, Afonao SL, Stefano EJ et al. Adjuvant trastuzumab in the treatment of her-2-positive early breast cancer: A metaanalysis of published randomized trials. BMC Cancer 2007; 7: 153.
25. Slamon D, Mackey J, Robert N et al. Phase III Trial Comparing AC-T with AC-TH and with TCH in the adjuvant treatment of HER-2-positive early breast cancer patients: BCIRG 006 study. SABS 2005. Abstr. 1.
26. Slamon D, Eiermann W, Robert N. BCIRG006: 2nd interim analysis phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC≥T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC≥TH) with docetaxel, carboplatin and trastuzumab (TCH) in Her-2/neu positive early breast cancer patients. 29th Annual San Antonio Breast Cancer Symposium. San Antonio, TX 2006. Abstr. LBA 52.
27. Slamon D, Eiermann W, Robert N et al. Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (ACT) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (ACTH) with docetaxel, carboplatin and trastuzumab (TCH) in HER-2/neu positive early breast cancer patients: BCIRG006 study. Cancer Res 2009; 69 (Suppl.): 500. Abstr. 62.
28. Joensuu H, Kellokumpu-Lehtinen PL, Bono P et al. Adjuvant docetaxel or vinorelbine with or without trastusumab for breast cancer. NEJM 2006; 354: 809–20.
29. Perez E, Romond E, Suman V et al. Updated results of the combined analysis of NCCTG №9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patients with HER-2-positive breast cancer. J Clin Oncol 2007; 25 (Suppl. 18): 6. Abstr. 512.
30. Perez EA, Suman VJ, Davidson NE et al. Results of chemotherapy alone, with sequential or concurrent addition of 52 weeks of trastuzumab in the NCCTG N9831 HER-2-positive adjuvant breast cancer trial. SABCS 2009. Abstr. 80.
Авторы
Е.В.Артамонова
Российский онкологический научный центр им. Н.Н.Блохина РАМН, Москва
Oncology Scientific Center of RAMS named after N.N. Blokhin, Moscow
Российский онкологический научный центр им. Н.Н.Блохина РАМН, Москва
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Oncology Scientific Center of RAMS named after N.N. Blokhin, Moscow
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