Место пегилированного липосомального доксорубицина в терапии метастатического рака молочной железы
Аннотация
Обзор посвящен исследованиям пегилированного липосомального доксорубицина (ПЛД) при метастатическом раке молочной железы (мРМЖ), включая монотерапию 1-й линии, «поддерживающую» терапию, комбинации с другими цитостатиками, режимы с трастузумабом при HER-2-позитивном подварианте, а также «терапию спасения» при интенсивно предлеченных формах заболевания. Показано, что ПЛД не уступает обычным антрациклинам по эффективности и значительно превосходит их по безопасности, особенно у больных с высоким риском кардиальных осложнений; отсутствие кумулятивной токсичности и предельно допустимой дозы позволяет проводить терапию до прогрессирования, использовать препарат в качестве «поддержки», а также эффективно и безопасно комбинировать ПЛД с трастузумабом при HER-2-позитивном мРМЖ. Клиническая польза от назначения ПЛД не зависит от чувствительности к обычным антрациклинам. Препарат является также важной опцией лечения таксан-рефрактерного мРМЖ.
Список литературы
1. American Cancer Society. Cancer Facts & Figures 2011. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acsp c-029771.pdf.
2. Fossati R., Confalonieri C., Torri V. et al. Cytotoxic and hormonal treatment of metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women. J Clin Oncol 1998;16(10):3439–60.
3. O’Shaughnessy J., Miles D., Vukelja S. et. al. Superior survival with capecitabine plus docetaxel combination therapy in anthracyclinepretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002;20(12):2812–23.
4. Albain K.S., Nag S., Calderillo-Ruiz G. et al. Global phase III study of gemcitabine plus paclitaxel (GT) vs. paclitaxel (T) as frontline therapy for metastatic breast cancer (MBC): First report of overall survival. Proc ASCO 2004;23:5. Abstract 510.
5. Martin M., Ruiz A., Muñoz M. et al. Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. Lancet Oncol 2007;8(3):219–25. DOI: 10.1016/S1470-2045(07)70041-4.
6. Cardoso F., Bedard P.L., Winer E.P. et al. International guidelines for management of metastatic breast cancer: combination vs sequential single-agent chemotherapy. J Natl Cancer Inst 2009;101(17):1174–81. DOI: 10.1093/jnci/djp235.
7. Cardoso F., Costa A., Norton L. et al. ESOESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol 2014;25(10):1871–88. DOI: 10.1093/annonc/ mdu385.
8. NCCN Guidelines Version 3.2013, Invasive Breast Cancer BINV-20. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
9. Karamouzis M.V., Ioannidis G., Rigatos G. Quality of life in metastatic breast cancer patients under chemotherapy or supportive care: a singleinstitution comparative study. Eur J Cancer Care (Engl) 2007;16(5):433–8. DOI:10.1111/j.1365-2354.2006.00771.x.
10. Tutt A, Ellis P., Kilbum L. et al. The TNT trial: A randomized phase III trial of carboplatin (C) compared with docetaxel (D) for patients with metastatic or recurrent locally advanced triple negative or BRCA1/2 breast cancer (CRUK/07/012). SABCS 2014. Abstract S3-01.
11. Piccart-Gebhart M.J., Burzykowski T., Buyse M. et al. Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer. J Clin Oncol 2008;26(12):1980–6. DOI: 10.1200/ JCO.2007.10.8399.
12. Falkson G., Gelman R.S., Pandya K.J. et al. Eastern Cooperative Oncology Group randomized trials of observation versus maintenance therapy for patients with metastatic breast cancer in complete remission following induction treatment. J Clin Oncol 1998;16(5):1669–76.
13. Gennari A., Stockler M., Puntoni M. et al. Duration of chemotherapy for metastatic breast cancer: a systematic review and meta-analysis of randomized clinical trials. J Clin Oncol 2011;29(16):2144–9. DOI: 10.1200/JCO.2010.31.5374.
14. O’Brien M.E.R., Wigler N., Inbar M. et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCI (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004;15(3):440–9.
15. Каприн А.Д., Старинский В.В., Петрова Г.В. Злокачественные новообразования в России в 2014 году (заболеваемость и смертность). М.: 2016. С. 13. [Kaprin A.D., Starinskiy V.V., Petrova G.V. Malignant neoplasms in Russia in 2014 (morbidity and mortality). Moscow, 2014. P. 13. (In Russ.)].
16. Smorenburg C.H., de Groot S.M., van Leeuwen-Stok A.E. et al. A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer: results of the OMEGA study of the Dutch Breast Cancer Group BOOG. Ann Oncol 2014;25(3):599–605. DOI: 10.1093/ annonc/mdt588.
17. Alba E., Ruiz-Borrego M., Margeli M. et al. Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study. Breast Cancer Res Treat 2010;122(1):169–76. DOI: 10.1007/s10549-010-0860-9.
18. Sparano J.A., Makhson A.N., Semiglazov V.F. et al. Pegylated liposomal doxorubicin plus docetaxel significantly improves time to progression without additive cardiotoxicity compared with docetaxel monotherapy in patients with advanced breast cancer previously treated with neoadjuvant-adjuvant antracycline therapy: results from a randomized phase III study. J Clin Oncol 2009;27(27):4522– 9. DOI: 10.1200/JCO.2008.20.5013.
19. Kurtz J.E., Rousseau F., Meyer N. et al. Phase II trial of pegylated liposomal doxorubicin- cyclophosphamide combination as first-line chemotherapy in older metastatic breast cancer patients. Oncology 2007;73(3–4): 210–4. DOI: 10.1159/000127411.
20. Trudeau M.E., Clemons M.J., Provencher L. et al. Phase II multicenter trial of anthracycline rechallenge with pegylated liposomal doxorubicin plus cyclophosphamide for first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines. J Clin Oncol 2009;27(35):5906–10. DOI: 10.1200/ JCO.2009.22.7504.
21. Verill M.W., Lee J., Cameron D.A. et al. Anglo-Celtic IV: first results of a UK National Cancer Research Network randomized phase III pharmacogenetic trial of weekly compared to 3 weekly paclitaxel in patients with locally advanced or metastatic breast cancer (ABC). Proc Am Soc Clin Oncol 2007;25:33s. Abstract LBA1005.
22. Seidman A., Berry D., Cirrincione C. et al. CALGB 9840: Phase III study of weekly (w) paclitaxel via 1-hour (h) infusion versus standard (S) 3 h infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER-2 positive metastatic breast cancer and randomized for T in HER-2 normal MBC. Proc ASCO 2004;22:6s. Abstract 512.
23. Leonardi V., Palmisano V., Pepe A. et al. Weekly pegylated liposomal doxorubicin and paclitaxel in patients with metastatic breast carcinoma: a phase II study. Oncol Lett 2010;1(4):749–53. DOI: 10.3892/ol_00000131.
24. Seidman A.D., Brufsky A., Ansari R.H. et al. Phase III trial of gemcitabine plus docetaxel (GD) compared to capecitabine plus docetaxel (CD) with planned crossover to the alternate single agent in metastatic breast cancer (MBC). J Clin Oncol 2009;27(suppl):15s. Abstract 1000.
25. Rivera E., Valero V., Arun B. et al. Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer. J Clin Oncol 2003;21(17):3249–54. DOI: 10.1200/ JCO.2003.03.111.
26. Adamo V., Lorusso V., Rossello R. et al. Pegylated liposomal doxorubicin and gemcitabine in front-line treatment of recurrent/ metastatic breast cancer: a multicenter phase II study. Br J Cancer 2008;98(12):1916–21. DOI: 10.1038/sj.bjc.6604409.
27. Fabi A., Ferretti G., Papaldo P. et al. Pegylated liposomal doxorubicin in combination with gemcitabine: a phase II study in anthracycline-nave and anthracycline pretreated metastatic breast cancer. Cancer Chemother Pharmacol 2006;57(5):615–23. DOI: 10.1007/ s00280-005-0116-2.
28. Franchina T., Adamo B., Ricciardi G.R. et al. Activity of pegylated liposomal doxorubicin in combination with gemcitabine in triple negative breast cancer with skin involvement: two case reports. Cancer Biol Ther 2012;13(7):472–6. DOI: 10.4161/cbt.19593.
29. Slamon D.J., Clark G.M., Wong S.G. et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/ neu oncogene. Science 1987;235(4785):177–82.
30. Slamon D.J., Godolphin W., Jones L.A. et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989;244(4905):707–12.
31. Gunnarsdottir K., Jensen M.B., Zahrieh D. et al. CEF is superior to CMF for tumors with topoisomerase II 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):S46. Abstract 1023.
32. 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(16):2428–36. DOI: 10.1200/JCO.2005.02.9264.
33. Knoop A.S., 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(30):7483–90. DOI: 10.1200/JCO.2005.11.007.
34. Coon J.S., Marcus E., Gupta-Burt S. et al. Amplification and overexpression of topoisomerase II predict response to anthracycline-based therapy in locally advanced breast cancer. Clin Cancer Res 2002;8(4):1061–7.
35. Slamon D.J., 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):S5. Abstract 13.
36. Keefe D.L. Trastuzumab-associated cardiotoxicity. Cancer 2002;95(7):1592–1600.
37. Christodoulou C., Kostopoulos I., Kalofonos H.P. et al. Trastuzumab combined with pegylated liposomal doxorubicin in patients with metastatic breast cancer. Oncology 2009;76(4):275–85. DOI: 10.1159/000207504.
38. Kim E., Gaiotti D.A., Volm M.D. et al. Reversible cardiotoxicity from pegylated liposomal doxorubicin plus trastuzumab: results from 2 prospective studies. Breast Cancer Res Treat 2004;88:S204. Abstract 5058.
39. Andreopoulou E., Gaiotti D., Kim E. et al. Feasibility and cardiac safety of pegylated liposomal doxorubicin plus trastuzumab in heavily pretreated petients with recurrent HER2-overexpressing metastatic breast cancer. Clin Breast Cancer 2007;7(9):690–6. DOI: 10.3816/CBC.2007.n.028.
40. Chia S., Clemons M., Martin L.A. et al. Pegylated liposomal doxorubicin and trastuzumab in HER-2 overexpressing metastatic breast cancer: a multicenter phase II trial. J Clin Oncol 2006;24(18):2773– 8. DOI: 10.1200/ JCO.2005.03.8331.
41. Stickeler E., Klar M., Watermann D. et al. Pegylated liposomal doxorubicin and trastuzumab in HER2/neu positive metastatic breast cancer: a multicenter phase II trial. Breast Cancer Res Treat 2009;117(3):591–8. DOI: 10.1007/s10549-008-0306-9.
42. Wolff A.C., Wang M., Li H. et al. Phase II trial of pegylated liposomal doxorubicin plus docetaxel with and without trastuzumab in metastatic breast cancer: Eastern Cooperative Oncology Group trial E3198. Breast Cancer Res Treat 2010;121(1):111–20. DOI: 10.1007/ s10549-010-0838-7.
43. Martin M., Sánchez-Rovira P., Muños M. et al. Pegylated liposomal doxorubicin in combination with cyclophosphamide and trastuzumab in HER2-positive metastatic breast cancer patients: efficacy and cardiac safety from the GEICAM/2004-05 study. Ann Oncol 2011;22(12):2591–6. DOI: 10.1093/annonc/mdr024.
44. Pivot X., Asmar L., Buzdar A.U. et al. A unified definition of clinical anthracycline resistance breast cancer. Br J Cancer 2000;82(3):529–34. DOI: 10.1054/ bjoc.1999.0958.
45. Andre F., Bachelot Th.D., Campone M. et al. Array CGH and DNA sequencing to personalize targeted treatment of metastatic breast cancer (MBC) patients (pts): A prospective multicentric trial (SAFIR01). ASCO 2013. Abstract 511.
46. Le Tourneau Ch., Delord J.P., Goncalves A. et al. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open- label, proof-ofconcept, randomised, controlled phase 2 trial. Lancet Oncol 2015;16(13):1324–34. DOI: 10.1016/S1470-2045(15)00188-6.
47. 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(4):792–99. DOI: 10.1200/JCO.2005.05.098.
48. Keller A., Mennel R.G., Georgoulias V.A. et al. Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer. J Clin Oncol 2004;22(19):3893–901. DOI: 10.1200/ JCO.2004.08.157.
49. Krell J. What is the evidence for rechallenging with anthracyclines or taxanes in metastatic breast cancer? A review of the data. J Clin Oncol 2009;27(15S). Abstract 1072.
50. Al-Batran S., Scholz M., Jäger E. Anthracycline-rechallenge using pegylated liposomal doxorubicin (PLD) in previously treated patients with metastatic breast cancer (MBC): A meta-analysis using pooled individual data from four prospective trials. J Clin Oncol 2009;27(15S). Abstract 1047.
51. Al-Batran S.E., Gunter M., Pauligk C. et al. Anthracycline rechallenge using pegylated liposomal doxorubicin in patients with metastatic breast cancer: a pooled analysis using individual data from four prospective trials. Br J Cancer 2010;103(10):1518–23. DOI: 10.1038/sj. bjc.6605961.
Для цитирования:
Артамонова Е.В. Место пегилированного липосомального доксорубицина в терапии метастатического рака молочной железы. Опухоли женской репродуктивной системы. 2016;12(2):35-45. https://doi.org/10.17650/1994-4098-2016-12-2-35-45
For citation:
Artamonova E.V. Place of pegylated liposomal doxorubicin in the therapy of metastatic breast cancer. Tumors of female reproductive system. 2016;12(2):35-45. (In Russ.) https://doi.org/10.17650/1994-4098-2016-12-2-35-45
Просмотров: 309
Послать статью по эл. почте 