Пероральная химиотерапия винорелбином при распространенном раке молочной железы: ее роль в клинической практике


DOI: https://dx.doi.org/10.18565/pharmateca.2019.7.96-101

Д.Д. Сакаева (1, 2), А.Ф. Насретдинов (1)

1) Республиканский клинический онкологический диспансер Уфа, Россия; 2) Башкирский государственный медицинский университет, кафедра фармакологии с курсом клинической фармакологии, Уфа, Россия

Обоснование. В статье рассмотрены варианты ведения пациенток с метастатическим раком молочной железы в зависимости от характеристик опухоли, состояния пациентки, наличия сопутствующей патологии. Рассмотрены преимущества и особенности пероральной химиотерапии. Описание клинического случая. Описан клинический случай применения перорального винорелбина пациентками с раком левой молочной железы в реальной клинической практике. После пяти курсов неоадъювантной полихимиотерапии, дистанционной лучевой терапии на молочную железу, мастэктомии слева, адъювантной гормонотерапии тамоксифеном в послеоперационном периоде констатировано прогрессирование заболевания. Проведено лечение пероральным винорелбином. После достижения ремиссии пациентка переведена на поддерживающую терапию фулвестрантом. Заключение. В рамках вариантов лечения интерес вызывает использование препаратов пероральной химиотерапии, таких как капецитабин и пероральный винорелбин. Последние позволяют обеспечивать контроль болезни, обладают хорошей переносимостью и уменьшают время и затраты, связанные с лечением.


Для цитирования: Сакаева Д.Д., Насретдинов А.Ф. Пероральная химиотерапия винорелбином при распространенном раке молочной железы: ее роль в клинической практике. Фарматека. 2019;26(7):96–101. DOI: https://dx.doi.org/10.18565/pharmateca.2019.7.96-101 


Литература


1. Cardosoa F., Costab A., Senkusd E., et al. 3rd ESO–ESMO international consensus guidelines for Advanced Breast Cancer (ABC 3). Ann Oncol. 2017;28–1:16–33. Doi: 10.1093/annonc/mdw544.

2. Cardosoa F., Costab A., Senkusd E., et al. 3rd ESO–ESMO international consensus guidelines for Advanced Breast Cancer (ABC 3). Breast. 2017;31:244–59. Doi: 10.1016/j.breast.2016.10.001.

3. Partridge A.H., Rumble R.B., Carey L.A., et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014;32:3307–29. Doi: 10.1200/JCO.2014.56.7479.

4. Giordano S.H., Temin S., Kirshner J.J., et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014;32:2078–99. Doi: 10.1200/JCO.2013.54.0948.

5. Finn R.S., Crown J.P., Lang I., et al. The cyclindependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): A randomised phase 2 study. Lancet. Oncol. 2015;16:25–35.

6. Seah D.S., Luis I.V., Macrae E., et al. Use and duration of chemotherapy in patients with metastatic breast cancer according to tumor subtype and line of therapy. J Natl Compr Canc Netw. 2014;12:71–80.

7. Dufresne A., Pivot X., Tournigand C., et al. Impact of chemotherapy beyond the first line in patients with metastatic breast cancer. Breast Cancer Res Treat. 2008;107:275–79.

8. Dear R.F., McGeechan K., Jenkins M.C., et al. Combination versus sequential single agent chemotherapy for metastatic breast cancer. Cochrane Database Syst Rev. 2013;12:CD008792. Doi: 10.1002/14651858.CD008792.pub2.

9. Cardoso F., Bedard P.L., Winer E.P., et al. ESO-MBC Task Force. International guidelines for management of metastatic breast cancer: Combination vs sequential single-agent chemotherapy. J Natl Cancer Inst. 2009;101:1174–81. Doi: 10.1093/jnci/djp235.

10. Findlay M., von Minckwitz G., Wardley A. Effective oral chemotherapy for breast cancer: Pillars of strength. Ann Oncol. 2008;19:212–22.

11. Liu G., Franssen E., Fitch M.I., Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997;15:110–15.

12. Schott S., Schneeweiss A., Reinhardt J., et al. Acceptance of oral chemotherapy in breast cancer patients - a survey study. BMC. Cancer. 2011;11:129. Doi: 10.1186/1471-2407-11-129.

13. Ruddy K., Mayer E., Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009;59:56–66. Doi: 10.3322/caac.20004.

14. Partridge A.H., Avorn J., Wang P.S., Winer E.P. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst. 2002;94:652–61.

15. Goodin S., Griffith N., Chen B., et al. Safe handling of oral chemotherapeutic agents in clinical practice: Recommendations from an international pharmacy panel. J Oncol Pract. 2011;7:7–12.

16. Blum J.L., Barrios C.H., Feldman N., et al. Pooled analysis of individual patient data from capecitabine monotherapy clinical trials in locally advanced or metastatic breast cancer. Breast Cancer Res Treat. 2012;136:777–88. Doi: 10.1007/s10549-012-2288-x.

17. Aapro M., Finek J. Oral vinorelbine in metastatic breast cancer: A review of current clinical trial results. Cancer Treat Rev. 2012;38:120–26. Doi: 10.1016/j.ctrv.2011.05.005.

18. Oostendorp L.J., Stalmeier P.F., Donders A.R., et al. Efficacy and safety of palliative chemotherapy for patients with advanced breast cancer pretreated with anthracyclines and taxanes: A systematic review. Lancet. Oncol. 2011;12:1053–61. Doi: 10.1016/S1470-2045(11)70045-6.

19. O’Shaughnessy J.A., Kaufmann M., Siedentopf F.,et al. Capecitabine monotherapy: Review of studies in first-line HER-2-negative metastatic breast cancer. Oncologist. 2012;17:476–84. Doi: 10.1634/theoncologist.2011-0281.

20. O’Shaughnessy J.A., Blum J., Moiseyenko V., et al. Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol. 2001;12:1247–54.

21. Stockler M.R., Harvey V.J., Francis P.A., et al. Capecitabine versus classical cyclophosphamide, methotrexate, and fluorouracil as first-line chemotherapy for advanced breast cancer. J Clin Oncol. 2011;29:4498–504. Doi: 10.1200/JCO.2010.33.9101.

22. Kaufmann M., Maass N., Costa S.D., et al. First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active: Results of the MONICA trial. Eur J Cancer. 2010;46:3184–91. Doi: 10.1016/j.ejca.2010.07.009.

23. Robert N.J., Diéras V., Glaspy J., et al. RIBBON-1: Randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011;29:1252–60. Doi: 10.1200/JCO.2010.28.0982.

24. Sparano J.A., Vrdoljak E., Rixe O., et al. Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J. Clin. Oncol. 2010;28:3256–63. Doi: 10.1200/JCO.2009.24.4244.

25. Talbot D.C., Moiseyenko V., Van Belle S., et al. Randomised, phase II trial comparing oral capecitabine (Xeloda) with paclitaxel in patients with metastatic/advanced breast cancer pretreated with anthracyclines. Br J Cancer. 2002;86:1367–72.

26.

27. Miller K.D., Chap L.I., Holmes F.A., et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005;23:792–99.

28. Reichardt P., Von Minckwitz G., Thuss-Patience P.C., et al. Multicenter phase II study of oral capecitabine (Xeloda®) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol. 2003;14:1227–33.

29. Blum J.L., Jones S.E., Buzdar A.U., et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999;17:485–93.

30. Blum J.L., Dieras V., Lo Russo P.M., et al. Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer. 2001;92:1759–68.

31. Freyer G., Delozier T., Lichinister M., et al. Phase II study of oral vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol. 2003;21:35–40.

32. Amadori D., Koralewski P., Tekiela A., et al. Efficacy and safety of navelbine oral (NBVO) in first line metastatic breast cancer. Eur J Cancer. 2001;37(6):Abstract 713.

33. Bartsch R., Pluschnig U., Wenzel C., et al. Oral vinorelbine in metastatic breast cancer: The Vienna experience. Ann Oncol. 2008;19(8):Abstract 160.

34. Blancas I., Morales S., Diaz N., et al. Efficacy and safety of oral vinorelbine in first or second-line metastatic breast cancer. J Clin Oncol. 2010;28(15):Abstract 1090.

35. Mansour M., Haddad N. Phase II study of single agent oral vinorelbine as a first line chemotherapy for metastatic breast cancer patients previously treated with adjuvant anthracyclines and/or taxanes. Proc 21st International Congress on Anti Cancer Treatment. 2010. Abstract 627.

36. Steger G.G., Dominguez A., Switsers O., et al. Phase II study evaluating oral vinorelbine as a single-agent as first-line chemotherapy for metastatic breast cancer patients with bone metastases (NORBREAST-228 Trial): First efficacy results. Ann Oncol. 2014;25(4):Abstract 403P.

37. Tubiana-Mathieu N., Bougnoux P., Becquart D., et al. Alloral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: An International Phase II Trial. Br. J. Cancer. 2009;101:232–37. Doi: 10.1038/sj.bjc.6605156.

38. Nolè F., Crivellari D., Mattioli R., et al. Phase II study of an all-oral combination of vinorelbine with capecitabine in patients with metastatic breast cancer. Cancer Chemother Pharmacol. 2009;64:673–80. Doi: 10.1007/s00280-008-0915-3.

39. Campone M., Dobrovolskaya N., Tjulandin S., et al. A three-arm randomized phase II study of oral vinorelbine plus capecitabine versus oral vinorelbine and capecitabine in sequence versus docetaxel plus capecitabine in patients with metastatic breast cancer previously treated with anthracyclines. Breast J. 2013;19:240–49. Doi: 10.1111/tbj.12098.

40. Tawfik H., Rostom Y., Elghazaly H. All-oral combination of vinorelbine and capecitabine as first-line treatment in HER2/Neu-negative metastatic breast cancer. Cancer Chemother Pharmacol. 2013;71:913–19. Doi: 10.1007/s00280-013-2082-4.

41. Finek J., Holubec L. Jr., Svoboda T., et al. A phase II trial of oral vinorelbine and capecitabine in anthracycline pretreated patients with metastatic breast cancer. Anticancer Res. 2009;29:667–70.

42. Delcambre C., Veyret C., Levy C., et al. A phase I/II study of capecitabine combined with oral vinorelbine as first or second line therapy in locally advanced or metastatic breast cancer. Breast Cancer Res Treat. 2005;94(67):Abstract 1081.

43. Jones A., O’Brien M., Sommer H., et al. Phase II study of oral vinorelbine in combination with capecitabine as second line chemotherapy in metastatic breast cancer patients previously treated with anthracyclines and taxanes. Cancer Chemother Pharmacol. 2010;65:755–63. Doi: 10.1007/s00280-009-1081-y.

44. Lorusso V., Spada M., Giampaglia M., et al. Oral vinorelbine plus capecitabine (oral vincap) combination in patients with advanced breast cancer (ABC). A phase II study of the GOIM (Gruppo Oncologico dell’Italia Meridionale). Ann Oncol. 2006;17:vii15–7.

45. von Minckwitz G., du Bois A., Schmidt M., et al. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: A german breast group 26/breast international group 03-05 study. J Clin Oncol. 2009;27:1999–2006. Doi: 10.1200/JCO.2008.19.6618.

46. Cameron D., Casey M., Press M., et al. A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: Updated efficacy and biomarker analyses. Breast Cancer Res Treat. 2008;112:533–43. Doi: 10.1007/s10549-007-9885-0.

47. Burstein H.J., Keshaviah A., Baron A.D., et al. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study. Cancer. 2007;110:965–72.

48. Andersson M., Lidbrink E., Bjerre K., et al. Phase III randomized study comparing docetaxel plus trastuzumab with vinorelbine plus trastuzumab as first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer: The HERNATA study. J Clin Oncol. 2011;29:264–71. Doi: 10.1200/JCO.2010.30.8213.

49. Bergen E., Berghoff A.S., Rudas M., et al. Taxanes plus trastuzumab compared to oral vinorelbine plus trastuzumab in HER2- overexpressing metastatic breast cancer. Breast Care (Basel). 2014;9:344–48. Doi: 10.1159/000368330.

50. Andersson M., Lopez-Vega J.M., Petit T., et al. Interim safety and efficacy of pertuzumab, trastuzumab and vinorelbine for first-line (1L) treatment of patients (pts) with HER2-positive locally advanced or metastatic breast cancer (MBC). Ann Oncol. 2014;25(4):Abstract 361PD.


Об авторах / Для корреспонденции


Автор для связи: Д.Д. Сакаева, д.м.н., зам. главного врача по химиотерапии, Республиканский клинический онкологический диспансер, Уфа, Россия; e-mail: d_sakaeva@mail.ru; Адрес: 450054, Россия, Уфа, пр-кт Октября, 73/1


ORCID:
Д.Д. Сакаева https://orcid.org/000-0003-4341-6017 
А.Ф. Насретдинов https://orcid.org/0000-0001-8340-7962 


Похожие статьи


Бионика Медиа