В представленном обзоре обсуждаются рандомизированные исследования III фазы, посвященные применению доцетаксела в адъювантной терапии больных раком молочной железы без метастазов в лимфоузлах. Показано, что включение препарата в программы адъювантного лечения пациенток группы N0, но с наличием хотя бы одного из факторов высокого риска рецидива заболевания достоверно улучшает выживаемость.
This review discusses III phase randomized trials of docetaxel used in the adjuvant therapy of patients with breast cancer without lymph node involvement. Incorporation of the drug into adjuvant treatment programs for N0 group patients, but with at least one high risk factor for recurrent cancer, significantly improves survival.
Key words: N0 breast cancer, adjuvant therapy, docetaxel.
1. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-027766.pd.... GLOBOCAN 2008 (IARC) – Section of Cancer Information 2011; p. 3–7.
2. Стенина М.Б., Фролова М.А. Рак молочной железы: наиболее важные научные события и выводы последних лет. Практическая онкология. 2011; 12 (1): 6–11.
3. Злокачественные новообразования в России в 2009 году (заболеваемость и смертность). Под ред. В.И.Чиссова, В.В.Старинского, Г.В.Петровой. М., 2011.
4. Saphner T, Tormey DC, Gray R. Annual hazard rates of recurrence for breast cancer after primary therapy. J Clin Oncol 1996; 14: 2738–46.
5. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365: 1687–717.
6. Goldhirsch A, Wood WC, Coates AS et al. Strategies for subtypes-dealing with the diversity of breast cancer: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2011. Ann Oncol 2011; 22: 1736–47.
7. Peto R. Метаанализ EBCTCG. The worldwide overview: New results for systemic adjuvant therapy. SABCS 2007, San Antonio, TX (Plenary lecture 1).
8. Jones S, Holmes F, O'Shaughnessy J et al. Extended follow-up and analysis by age of the US Oncology Adjuvant trial 9735: docetaxel/cyclophosphamide is associated with an overall survival benefit compared to doxorubicin/cyclophosphamide and is well-tolerated in women 65 or older. Breast Cancer Res Treat 2007; 106 (Suppl. 1): S5 (Abstr.12).
9. Martin M, Pienkowsky T, Mackey J et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 352 (22): 2302–12.
10. Martin M, Lluch A, Seguí M A et al. Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol 2006; 17: 1205–12.
11. Hayes DF, Thor AD, Dressler LG et al. HER2 and Response to Paclitaxel in Node-Positive Breast Cancer. NEJM 2007; 357: 1496–506.
12. Roche H, Fumoleau P, Spielmann M et al. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. JCO 2006; 24 (36): 5664–71.
13. Jones SE, Holmes FA, O’Shaughnessy J et al. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicine and cyclophosphamide: 7-year follow-up of US Oncology Research Trial 9735. J Clin Oncol 2009; 27: 1177–83.
14. Jones SE, Savin MA, Holmes FA et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol 2006; 24: 5381–7.
15. Sparano JA, Wang M, Martino S et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 2008; 358: 1663–71.
16. SEER Cancer statistics. Fast stats by cancer site, 2000–2006. (http://seer.cancer.gov./faststats/selections.php?series=cancer) – по состоянию на 15 декабря 2011г. (http://seer.cancer.gov./statfacts/html/breast.html) по состоянию на 15 декабря 2011 г.
17. Martin M, Lluch A, Segui MA et al. Doxorubicin in combination with fluorouracil and cyclophosphamide (i.v. FAC regimen, day 1, 21) versus methotrexate in combination with fluorouracil and cyclophosphamide (i.v. CMF regimen, day 1, 21) as adjuvant chemotherapy for operable breast cancer: a study by the GEICAM Group. Ann Oncol 2003; 14: 833–42.
18. Martin M, Lluch A, Segui MA et al. Toxicity and health-related quality of life in breast cancer patients receiving adjuvan docetaxel, doxorubicin, cyclophosphamide (ТАС) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol 2006; 17: 1205–12.
19. Martin M, Pienkowski T, Mackey J et al. TAC versus FAC as adjuvant chemotherapy for high-risk node-negative breast cancer: results of the GEICAM 9805 trial. Ann Oncol 2008; 19 (Suppl. 8): viii 77; Abstr. 1830.
20. Martin M, Segui MA, Anton A et al. Adjuvant docetaxel for high-risk, node-negative breast cancer. N Engl J Med 2010; 363: 2200–10.
21. Jones S, Holmes F, O'Shaughnessy J. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US Oncology research trial 9735. J Clin Oncol 2009; 27 (8): 1177–83.
22. 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 HER2-positive adjuvant breast cancer trial. SABCS 2009; Abstr. 80.
23. Perez E, Romond E, Suman V et al. Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patients with HER2-positive breast cancer. J Clin Oncol 2007; 25 (Suppl. 18): 6s; Abstr. 512.
24. Slamon D, Mackey J, Robert N. Role of antracycline-based therapy in the adjuvant treatment of breast cancer: efficacy analyses determined by molecular subtypes of the disease. SABS 2006; Abstr. 13.
Авторы
Е.В.Артамонова
Российский онкологический научный центр им. Н.Н.Блохина РАМН, Москва