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Пегилированный липосомальный доксорубицин в монотерапии больных метастатическим раком молочной железы
Пегилированный липосомальный доксорубицин в монотерапии больных метастатическим раком молочной железы
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Аннотация
Антрациклины и таксаны являются одними из наиболее эффективных препаратов в терапии метастатического рака молочной железы (МРМЖ). Однако частое применение антрациклинов и таксанов в адъювантном режиме, приводящее к появлению кумулятивных побочных эффектов, включая кардиотоксичность, в значительной степени ограничивает их возможности в терапии МРМЖ. На сегодняшний день режимы, содержащие трастузумаб, все чаще используются в адъювантной терапии. Трастузумаб также обладает неблагоприятным профилем кардиологической безопасности. Все это является основанием для разработки новых эффективных и безопасных препаратов для лечения больных МРМЖ. Пегилированный липосомальный доксорубицин (ПЛД) является хорошей альтернативой традиционным антрациклинам в терапии ряда пациенток с МРМЖ. Клинические исследования III фазы свидетельствуют, что ПЛД и традиционный доксорубицин обладают приблизительно одинаковой эффективностью в терапии больных МРМЖ. При этом профиль кардиологической безопасности ПЛД является значительно более благоприятным. Гематологические побочные эффекты, тошнота/рвота и алопеция также значительно чаще встречаются у пациенток, получающих традиционный доксорубицин. При использовании ПЛД наиболее часто диагностируемыми побочными эффектами являются ладонно-подошвенный синдром и стоматит. Результаты исследований II и III фаз свидетельствуют о целесообразности проведения монотерапии ПЛД у тех больных, у которых МРМЖ был выявлен после адъювантной терапии антрациклинами, а также у больных, получивших ранее несколько линий химиотерапии, рефрактерных к таксанам, пациенток с кардиологическими факторами риска (гипертоническая болезнь и лучевая терапия), пожилых пациенток, а также у больных, у которых была выявлена острая токсичность, вызванная применением традиционного доксорубицина (например, алопеция).
Полный текст
Список литературы
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14. O'Brien MER, Wigler N, Inbar M et al. CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Аnn Oncol 2004; 15: 440–9.
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29. Keller AM, Mennel RG, Georgoulias VA et al. Randomized phase III trial of pegylated liposomaldoxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer. J Clin Oncol 2004; 22: 3893–901.
30. Alba E, Ruiz-Borrego M, Martin M et al. Prolongation of TTP by maintenance therapy with PLD in a multicenter phase III randomized trial following standard chemotherapy for MBC: GEICAM 2001–01 study. J Clin Oncol 2007; 25 (18 Suppl.): 1007.
31. Allen TM, Martin FJ. Advantages of liposomal delivery systems for anthracyclines. Semin Oncol 2004; 31 (Suppl. 13): 5–15.
32. Conley BA, Egorin MJ, Whitacre MY et al. Phase I and pharmacokinetic trial of liposome-encapsulated doxorubicin. Cancer Chemother Pharmacol 1993; 33: 107–12.
33. Vail DM, Amantea MA, Colbern GT et al. Pegylated liposomal doxorubicin: prof of principle using preclinical animal models and pharmacokinetic studies. Semin Oncol 2004; 31 (Suppl. 13): 16–35.
34. Gabizon A, Shmeeda H, Barenholz Y. Pharmacokinetics of pegylated liposomal doxorubicin: review of animal and human studies. Clin Pharmacokinet 2003; 42: 419–36.
35. Symon Z, Peyser A, Tzemach D et al. Selective delivery of doxorubicin to patients with breast carcinoma metastases by stealth liposomes. cancer 1999; 86: 72–8.
2. Thigpen JT. Innovations in anthracycline therapy: overview. Community Oncol 2005; 2 (Suppl. 1): 3–7.
3. Swain S, Whaley FS, Ewer MS. Congestive heart failure in patients treated with doxorubicin: a retrospective analysis of three trials. Cancer 2003; 97: 2869-79.
4. Von Hoff D, Layard M, Basa P et al. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med 1979; 91: 710–7.
5. Praga C, Trave F, Petroccione A. Anthracycline-induced cardiotosicity and its relevance in cancer treatment. In: Nimmo WS, Tucker GT, editors. Clinical measurement in drug evaluation. London: Wolfe Publishing; 1991; 132–42.
6. Ryberg M, Mielsen D, Skovsgaard T et al. Epirubicin cardiotoxicity: an analysis of 469 patients with metastatic breast cancer. J Clin Oncol 1998; 16: 3502–8.
7. Orditura M, Quaglia F, Morgillo T et al. Pegylated liposomal doxorubicin: pharmacologic and clinical evidence of potent antitumor activity with reduced anthracycline-induced cardiotoxicity [review]. Oncol Rep 2004; 12: 549–56.
8. Singal P, Iliskovic N. Doxorubicin induced cardiomyopathy. N Engl J Med 1998; 339: 900–5.
9. Pai VB, Nahata MC. Cardiotoxicity of chemotherapeutic agents, incidence, treatment and prevention. Drug Saf 2000; 22: 263–302.
10. Seidman A, Hudis C, Pierri MK et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002; 20: 1215–21.
11. Kim C, Bryant J, Horne Z et al. Trastuzumab sensitivity of breast cancer with co-amplification of HER2 and cMYC suggests pro-apoptotic function of dysregulated cMYC in vivo. Breast Cancer Res treat 2005; 94 (Suppl. 1): S6.
12. Pritchard KI, Shepherd LE, O'Malley FP et al. for the Nqational Cancer Institute of Canada Clinical trials Group. HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med 2006; 354: 2103–11.
13. Park JW. Liposome-based drug delivery in breast cancer treatment. Breast Cancer Res 2002; 4: 95–9.
14. O'Brien MER, Wigler N, Inbar M et al. CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Аnn Oncol 2004; 15: 440–9.
15. Batist G, Ramakrishnan G, Rao CS et al. Reduced cardiotoxicity and preserved antitumor efficacy of liposome-encapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer. J Clin Oncol 2001; 19: 1444–54.
16. 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: 2773–8.
17. Wiliams G, Cortazar P, Pazdur R. Developing drugs to decrease the toxicity of chemotherapy. J Clin Oncol 2001; 19: 3439–41.
18. National Comprehensive Cancer Network website. clinical practice guidelines in oncology: breast cancer v.2.2006. available at: http://www.nccn.org/professionals/physician_gls/PDF/breast.pdf. Accessed August 1; 2006.
19. Ranson MR, Carmichael J, O'Byrne K et al. Treatment of advanced cancer with sterically stabilized liposomal doxorubicin: results of a multicenter phase II trial. J Clin Oncol 1997; 15: 3185–91.
20. Lyass O, Uziely B, Ben-Yosef R et al. correlation of toxicity with pharmacokinetics of pegylated liposomal doxorubicin (Doxil) in metastatic breast carcinoma. Cancer 2000; 89: 1037–47.
21. Coleman RE, Biganzoli L, Canney P et al. A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993). Eur J Cancer 2006; 42: 882–7.
22. Al-Batran S-E, Meerpohl HG, von Minckwitz G et al. Reduced incidence of severe palmar-plantar erythrodysesthesia and muccositis in a prospective multicenter phase II trial with pegylated liposomal doxorubicin at 40 gm/m2 every 4 weeks in previously treated patients with metastatic breast cancer. Oncology 2006; 70: 141–6.
23. Mlineritsch B, Mayer P, Rass C et al. Phase II study of single-agent pegylated liposomal doxorubicin HCl (PLD) in metastatic breast cancer after first-line treatment failure. Onkologie 2004; 27: 441–6.
24. Al-Batran SE, Bischoff J, von Munckwitz G et al. The clinical benefit of pegylated liposomal doxorubicin in patients with metastatic breast cancer previously treated with conventional anthracyclines: a multicentre phase II trial. Br J Cancer 2006; 94: 1615–20.
25. Rivera E, Valero V, Esteva FJ et al. Lack of activity of stealth liposomal doxorubicin in the treatment of patients with anthracycline-resistant breast cancer. Cancer Chemother Pharmacol 2002; 49: 299–302.
26. Rose PG. Pegylated liposomal doxorubicin: optimizing the dosing schedule in ovarian cancer. Oncologist 2005; 10: 205–14.
27. Chan S, Friedrichs K, Noel D et al., for the 303 study Group. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 199; 17: 2341–54.
28. Yardley DA, Shipley DM, Greco FA et al. Phase II randomized trial of pegylated liposomal doxorubicin versus weekly docetaxel with subsequent crossover as first-line chemotherapy for metastatic breast cancer. poster presentation at the 27th Annual San Antonio Breast Cancer Symposium, December 8-11, 2004. Poster 5057.
29. Keller AM, Mennel RG, Georgoulias VA et al. Randomized phase III trial of pegylated liposomaldoxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer. J Clin Oncol 2004; 22: 3893–901.
30. Alba E, Ruiz-Borrego M, Martin M et al. Prolongation of TTP by maintenance therapy with PLD in a multicenter phase III randomized trial following standard chemotherapy for MBC: GEICAM 2001–01 study. J Clin Oncol 2007; 25 (18 Suppl.): 1007.
31. Allen TM, Martin FJ. Advantages of liposomal delivery systems for anthracyclines. Semin Oncol 2004; 31 (Suppl. 13): 5–15.
32. Conley BA, Egorin MJ, Whitacre MY et al. Phase I and pharmacokinetic trial of liposome-encapsulated doxorubicin. Cancer Chemother Pharmacol 1993; 33: 107–12.
33. Vail DM, Amantea MA, Colbern GT et al. Pegylated liposomal doxorubicin: prof of principle using preclinical animal models and pharmacokinetic studies. Semin Oncol 2004; 31 (Suppl. 13): 16–35.
34. Gabizon A, Shmeeda H, Barenholz Y. Pharmacokinetics of pegylated liposomal doxorubicin: review of animal and human studies. Clin Pharmacokinet 2003; 42: 419–36.
35. Symon Z, Peyser A, Tzemach D et al. Selective delivery of doxorubicin to patients with breast carcinoma metastases by stealth liposomes. cancer 1999; 86: 72–8.
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