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Эффективность препарата трабектедин в монотерапии и комбинированных режимах в терапии распространенного рака яичника
Эффективность препарата трабектедин в монотерапии и комбинированных режимах в терапии распространенного рака яичника
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Аннотация
Учитывая высокую частоту рецидивирования эпителиального рака яичника (РЯ) после радикального лечения, необходимо совершенствование терапевтического подхода к его лечению. Новый препарат морского происхождения трабектедин показал высокую эффективность как в монотерапии, так и в комбинированных режимах с различными цитостатиками в терапии рецидивов РЯ, чувствительных к препаратам платины. Рандомизированное исследование OVA-301 показало наибольшую пользу применения комбинации трабектедина с пегилированным липосомальным доксорубицином в подгруппе больных с частично платиночувствительными рецидивами РЯ. Приемлемый токсический профиль препарата, представленный в основном нейтропенией и транзиторным повышением уровня трансаминаз, делает его перспективным для дальнейшего изучения.
Ключевые слова: рак яичника, трабектедин, пегилированный липосомальный доксорубицин.
Key words: ovarian cancer, trabectedin, pegylated liposomal doxorubicin.
Ключевые слова: рак яичника, трабектедин, пегилированный липосомальный доксорубицин.
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Key words: ovarian cancer, trabectedin, pegylated liposomal doxorubicin.
Полный текст
Список литературы
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2. Чиссов В.И., Старинский В.В., Петрова Г.В. Злокачественные заболевания в России в 2011 г. (заболеваемость и смертность). М., 2013.
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5. D'Incalci M, Galmarini CM. A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther 2010; 9 (8): 2157–63.
6. Valoti G, Nicoletti MI, Pellegrino A et al. Ecteinascidin-743, a new marine natural product with potent antitumor activity on human ovarian carcinoma xenografts. Clin Cancer Res 1998; 4: 1977–83.
7. Hendriks HR, Fiebig HH, Giavazzi R et al. High antitumor activity of ET-743 against human tumor xenografts from melanoma, non-small-cell lung and ovarian cancer. Ann Oncol 1999; 10: 1233–40.
8. Sessa C, de Braud F, Perotti A et al. Trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails. J Clin Oncol 2005; 20: 1867–74.
9. Krasner CN, McMeekin DS, Chan S et al. A phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Br J Cancer 2007; 97 (12): 1618–24.
10. Del Campo JM, Roszak A, Bidzinski M et al. Phase II randomized study of trabectedin given as two different every 3 weeks dose schedules (1,5 mg/m2 24h or 1,3 mg/m2 3h) to patients with relapsed, platinum-sensitive, advanced ovarian cancer. Ann Oncol 2009; 20: 1794–802.
11. Del Campo JM, Sessa C, Krasner CN et al. Trabectedin as single agent in relapsed advanced ovarian cancer: results from a retrospective pooled analysis of three phase II trials. Med Oncol 2013; 30: 435.
12. Ferradina G, Salutari V, Vincenzi B et al. Trabectedin as single agent in the salvage treatment of heavily treated ovarian cancer patients: A retrospective, multicenter study. Gynecol Oncol 2013; 130 (3): 505–10.
13. Petru E, Kolovetsiou V, Idris T. Prolonged response to trabectedin in a patient with ovarian carcinosarcoma refractory to adjuvant platinum-taxane. J Solid Tumors 2013; 3 (3).
14. Monk BJ, Herzog T, Kaye S et al. A randomized phase III study of trabectedin with pegylated liposomal doxorubicin versus PLD in relapsed, recurrent ovarian cancer. Proceedings of the 33rd Annual Meeting of the European Society of Medical Oncology. Stockholm 2008. Abstr. LBA3.
15. Monk BJ, Dalton H, Benjamin I, Tanović A. Trabectedin as a new chemotherapy option in the treatment of relapsed platinum sensitive ovarian cancer. Curr Pharm Des 2012; 18 (25): 3754–69.
16. Sehouli J, Alfaro V, González-Martín A. Trabectedin plus pegylated liposomal doxorubicin in the treatment of patients with partially platinum-sensitive ovarian cancer: current evidence and future perspectives. Ann Oncol 2012; 23 (3): 556–62.
17. Poveda A, Vergote I, Tjulandin S et al. Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6–12 months) subpopulation of OVA-301 phase III randomized trial. Ann Oncol 2010.
18. Mabuchi S, Hisamatsu T, Kawase C et al. The activity of Trabectedin as a single agent or in combination with Everolimus for clear cell carcinoma of the ovary. Clin Cancer Res 2011; 17: 4462–73.
19. Takano M, Ikeda Y, Kudoh K et al. Complete remission of recurrent ovarian clear cell carcinoma by chemotherapy with bevacizumab, trabectedin and oxaliplatin. J Obstet Gynaecol Res 2013; 39 (4): 872–5.
20. Bevacizumab and Trabectedin ± Carboplatin in Advanced Ovarian Cancer Clinical Trials. Identifier: NCT01735071. Mario Negri Institute for Pharmacol Research 2013. Mario Negri Institute for Pharmacological Research. Collaborators: Pharma Mar, Hoffmann-La Roche.
21. Monk BJ, Sill M, Walker JL et al. Activity of docetaxel plus trabectedin in reccurent or persistent ovarian and primary peritoneal cancer: A phase II study of the Gynecologic Oncology Group (GOG). J Clin Oncol 2010; 28 (Suppl. 15): 5046.
22. Sessa C, Cresta S, Noberasco C et al. Phase I clinical and pharmacokinetic study of trabectedin and cisplatin in solid tumors. Eur J Cancer 2009; 45: 2116–22.
23. Sessa C, Gallerani E, Del Conte G et al. Phase I dose-finding study of trabectedin (T) in combination with cisplatin (C) in patients (pts) with advanced solid tumors. J Clin Oncol 2011; 29. Abstr. 2517.
24. Vidal L, Garcia-Martin M, Tan S et al. Phase I combination study of trabectedin and carboplatin in patients with advanced solid tumors. Ann Oncol 2010; 15 (Suppl. 3): 102–1.
25. Черкасова М.В., Хохлова С.В., Лимарева С.В. и др. Токсичность трабектединсодержащих комбинаций в терапии различных злокачественных новообразований. Соврем. онкология. 2013; 2 (15): 46–50.
2. Чиссов В.И., Старинский В.В., Петрова Г.В. Злокачественные заболевания в России в 2011 г. (заболеваемость и смертность). М., 2013.
3. Урманчеева А.Ф., Мешкова И.Е. Вопросы эпидемиологии и диагностики рака яичников. Практич. онкология. 2000; 4: 7–13.
4. David-Cordonnier MH, Gajate C, Olmea O et al. DNA and non-DNA targets in the mechanism of action of the antitumor drug trabectedin. Chem Biol 2005; 12: 1201–10.
5. D'Incalci M, Galmarini CM. A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther 2010; 9 (8): 2157–63.
6. Valoti G, Nicoletti MI, Pellegrino A et al. Ecteinascidin-743, a new marine natural product with potent antitumor activity on human ovarian carcinoma xenografts. Clin Cancer Res 1998; 4: 1977–83.
7. Hendriks HR, Fiebig HH, Giavazzi R et al. High antitumor activity of ET-743 against human tumor xenografts from melanoma, non-small-cell lung and ovarian cancer. Ann Oncol 1999; 10: 1233–40.
8. Sessa C, de Braud F, Perotti A et al. Trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails. J Clin Oncol 2005; 20: 1867–74.
9. Krasner CN, McMeekin DS, Chan S et al. A phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens. Br J Cancer 2007; 97 (12): 1618–24.
10. Del Campo JM, Roszak A, Bidzinski M et al. Phase II randomized study of trabectedin given as two different every 3 weeks dose schedules (1,5 mg/m2 24h or 1,3 mg/m2 3h) to patients with relapsed, platinum-sensitive, advanced ovarian cancer. Ann Oncol 2009; 20: 1794–802.
11. Del Campo JM, Sessa C, Krasner CN et al. Trabectedin as single agent in relapsed advanced ovarian cancer: results from a retrospective pooled analysis of three phase II trials. Med Oncol 2013; 30: 435.
12. Ferradina G, Salutari V, Vincenzi B et al. Trabectedin as single agent in the salvage treatment of heavily treated ovarian cancer patients: A retrospective, multicenter study. Gynecol Oncol 2013; 130 (3): 505–10.
13. Petru E, Kolovetsiou V, Idris T. Prolonged response to trabectedin in a patient with ovarian carcinosarcoma refractory to adjuvant platinum-taxane. J Solid Tumors 2013; 3 (3).
14. Monk BJ, Herzog T, Kaye S et al. A randomized phase III study of trabectedin with pegylated liposomal doxorubicin versus PLD in relapsed, recurrent ovarian cancer. Proceedings of the 33rd Annual Meeting of the European Society of Medical Oncology. Stockholm 2008. Abstr. LBA3.
15. Monk BJ, Dalton H, Benjamin I, Tanović A. Trabectedin as a new chemotherapy option in the treatment of relapsed platinum sensitive ovarian cancer. Curr Pharm Des 2012; 18 (25): 3754–69.
16. Sehouli J, Alfaro V, González-Martín A. Trabectedin plus pegylated liposomal doxorubicin in the treatment of patients with partially platinum-sensitive ovarian cancer: current evidence and future perspectives. Ann Oncol 2012; 23 (3): 556–62.
17. Poveda A, Vergote I, Tjulandin S et al. Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6–12 months) subpopulation of OVA-301 phase III randomized trial. Ann Oncol 2010.
18. Mabuchi S, Hisamatsu T, Kawase C et al. The activity of Trabectedin as a single agent or in combination with Everolimus for clear cell carcinoma of the ovary. Clin Cancer Res 2011; 17: 4462–73.
19. Takano M, Ikeda Y, Kudoh K et al. Complete remission of recurrent ovarian clear cell carcinoma by chemotherapy with bevacizumab, trabectedin and oxaliplatin. J Obstet Gynaecol Res 2013; 39 (4): 872–5.
20. Bevacizumab and Trabectedin ± Carboplatin in Advanced Ovarian Cancer Clinical Trials. Identifier: NCT01735071. Mario Negri Institute for Pharmacol Research 2013. Mario Negri Institute for Pharmacological Research. Collaborators: Pharma Mar, Hoffmann-La Roche.
21. Monk BJ, Sill M, Walker JL et al. Activity of docetaxel plus trabectedin in reccurent or persistent ovarian and primary peritoneal cancer: A phase II study of the Gynecologic Oncology Group (GOG). J Clin Oncol 2010; 28 (Suppl. 15): 5046.
22. Sessa C, Cresta S, Noberasco C et al. Phase I clinical and pharmacokinetic study of trabectedin and cisplatin in solid tumors. Eur J Cancer 2009; 45: 2116–22.
23. Sessa C, Gallerani E, Del Conte G et al. Phase I dose-finding study of trabectedin (T) in combination with cisplatin (C) in patients (pts) with advanced solid tumors. J Clin Oncol 2011; 29. Abstr. 2517.
24. Vidal L, Garcia-Martin M, Tan S et al. Phase I combination study of trabectedin and carboplatin in patients with advanced solid tumors. Ann Oncol 2010; 15 (Suppl. 3): 102–1.
25. Черкасова М.В., Хохлова С.В., Лимарева С.В. и др. Токсичность трабектединсодержащих комбинаций в терапии различных злокачественных новообразований. Соврем. онкология. 2013; 2 (15): 46–50.
Авторы
М.В.Черкасова1, С.В.Хохлова2, С.В.Лимарева2, И.Я.Базаева2, Н.Ф.Орел1, 2, В.А.Горбунова2, И.В.Поддубная1
1 ГБОУ ДПО Российская медицинская академия последипломного образования Минздрава России
2 ФГБУ РОНЦ им. Н.Н.Блохина РАМН
1 ГБОУ ДПО Российская медицинская академия последипломного образования Минздрава России
2 ФГБУ РОНЦ им. Н.Н.Блохина РАМН
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