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Токсичность трабектединсодержащих комбинаций в терапии различных злокачественных новообразований
Токсичность трабектединсодержащих комбинаций в терапии различных злокачественных новообразований
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Аннотация
Противоопухолевая активность трабектедина в качестве монотерапии различных солидных опухолей (саркомы мягких тканей, рак яичника, рак молочной железы, меланома) способствовала изучению лекарственных комбинаций на его основе. В исследованиях I фазы осуществлялся поиск оптимальных доз и режимов введения трабектедина в сочетании с другими цитостатиками. В настоящем обзоре рассмотрены аспекты клинического применения и токсического профиля трабектедина и его комбинаций, включая довольно редкое осложнение – рабдомиолиз, а также приведен собственный опыт его использования.
Ключевые слова: трабектедин, токсичность, рабдомиолиз.
Key words: trabectedin, toxicity, rhabdomyolysis.
Ключевые слова: трабектедин, токсичность, рабдомиолиз.
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Key words: trabectedin, toxicity, rhabdomyolysis.
Полный текст
Список литературы
1. 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.
2. 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.
3. Hendriks HR, Fiebig HH, Giavazzi R et al. High antitumor activity of ET743 against human tumor xenografts from melanoma, non-small-cell lung and ovarian cancer. Ann Oncol 1999; 10: 1233–40.
4. Cesne A, Yovine A, Blay JY et al. A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials. Invest New Drugs 2012; 30: 1193–202.
5. Twelves C, Hoekman K, Bowman A et al. Phase I and pharmacokinetic study of Yondelis (ecteinascidin-743, ET-743) administreted as on infusion over 1h or 3h every 21 days in patients with solid tumors. Eur J Cancer 2003; 39: 1842–51.
6. McMeekin S, del Campo JM, Colombo N et al. Trabectedin in relapsed advanced ovarian cancer (ROC): A pooled analysis of three phase II studies. ASCO Meeting Abstr 2007; 25 (Suppl. 18): 5579.
7. 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.
8. 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.
9. Campo Del JM, Roszak A, Bidzinski M et al. Phase II randomized study of trabectedin given as 2 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.
10. 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.
11. Sessa C, Gallerani E, Conte Del 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 29: 2011 (Suppl; abstr. 2517).
12. 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.
13. Gore L, Rivera E, Lavalee K et al. Phase I combination study of trabectedin (T) and capecitabine (C) in patients with advanced malignancies. J Clin Oncol 2006; 24 (Suppl. 18S): 2079.
14. Messersmith WA, Jimeno A, Ettinger D et al. Phase I trial of weekly trabectedin (ET-743) and gemcitabine in patients with advanced solid tumors. Cancer Chemoter Pharmacol 2008; 63: 181–8.
15. Sessa C, Perotti A, Noberasco C et al. Phase I clinical and pharmacokinetic study of trabectedin and doxorubicin in advanced soft tissue sarcoma and breast cancer. Eur J Cancer 2009; 45 (7): 1153–61.
16. 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.
17. Papadopoulos KP, Chu Q, Patnaik A et al. Phase I pharmacokinetics (PK) study of sequential paclitaxel and trabectedin every 2 weeks in patients with advanced solid tumors. J Clin Oncol 2006. ASCO Ann Meeting Proceedings (part I) 2006; 24 (18): 2029.
18. Poveda A, Kaye SB, Herzog T et al. Correlation RNA expression of DNA repair genes with clinical outcomes of advanced ovarian cancer (OC) pts treated with pegylated liposomal doxorubicin (PLD) vs trabectedin (T) + PLD in the ET-743-OVA-301 clinical trial. Eur J Cancer Suppl 2009; 7: 451.
19. Romero I, Colombo N, Kaye SB et al. Tolerability of long-term use of trabectedin (Tr) in combination with pegylated liposomal doxorubicin (PLD) in patients (pts) with relapsed ovarian cancer (ROC). J Clin Oncol 2010; 28: 15. Abstr. 5121.
20. Monk BJ, Dalton H, Benjamin I et al. Trabectedin as a new chemotherapy option in the treatment of relapsed platinum sensitive ovarian cancer. Curr Pharm Des 2012; 18 (25): 3754–69.
21. Grosso F, D´Incalci M, Cartoafa M et al. A comprehensive safety analysis confirms rhabdomyolysis as an uncommon adverse reaction in patients treated with trabectedin. Cancer Chemother Pharmacol 2012; 69 (6): 1557–65.
22. Chatzizisis YS, Misirli G, Hatzitolios AI et al. The syndrome of rhabdomyolysis: complications and treatment. Eur J Intern Med 2008; 19: 568–74.
23. Khan FY. Rhabdomyolysis: a review of the literature. Neth J Med 2009; 67: 272–83.
24. Cesne Le A, Yovine A, Blay JY et al. A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials. Invest New Drugs 2012; 30: 1193–202.
25. Cervellin G, Comelii I, Lippi G. Rhabdomyolysis: historical background, clinical, diagnostic and therapeutic features. Clin Chem Lab Med 2010; 48 (6): 749–56.
2. 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.
3. Hendriks HR, Fiebig HH, Giavazzi R et al. High antitumor activity of ET743 against human tumor xenografts from melanoma, non-small-cell lung and ovarian cancer. Ann Oncol 1999; 10: 1233–40.
4. Cesne A, Yovine A, Blay JY et al. A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials. Invest New Drugs 2012; 30: 1193–202.
5. Twelves C, Hoekman K, Bowman A et al. Phase I and pharmacokinetic study of Yondelis (ecteinascidin-743, ET-743) administreted as on infusion over 1h or 3h every 21 days in patients with solid tumors. Eur J Cancer 2003; 39: 1842–51.
6. McMeekin S, del Campo JM, Colombo N et al. Trabectedin in relapsed advanced ovarian cancer (ROC): A pooled analysis of three phase II studies. ASCO Meeting Abstr 2007; 25 (Suppl. 18): 5579.
7. 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.
8. 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.
9. Campo Del JM, Roszak A, Bidzinski M et al. Phase II randomized study of trabectedin given as 2 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.
10. 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.
11. Sessa C, Gallerani E, Conte Del 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 29: 2011 (Suppl; abstr. 2517).
12. 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.
13. Gore L, Rivera E, Lavalee K et al. Phase I combination study of trabectedin (T) and capecitabine (C) in patients with advanced malignancies. J Clin Oncol 2006; 24 (Suppl. 18S): 2079.
14. Messersmith WA, Jimeno A, Ettinger D et al. Phase I trial of weekly trabectedin (ET-743) and gemcitabine in patients with advanced solid tumors. Cancer Chemoter Pharmacol 2008; 63: 181–8.
15. Sessa C, Perotti A, Noberasco C et al. Phase I clinical and pharmacokinetic study of trabectedin and doxorubicin in advanced soft tissue sarcoma and breast cancer. Eur J Cancer 2009; 45 (7): 1153–61.
16. 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.
17. Papadopoulos KP, Chu Q, Patnaik A et al. Phase I pharmacokinetics (PK) study of sequential paclitaxel and trabectedin every 2 weeks in patients with advanced solid tumors. J Clin Oncol 2006. ASCO Ann Meeting Proceedings (part I) 2006; 24 (18): 2029.
18. Poveda A, Kaye SB, Herzog T et al. Correlation RNA expression of DNA repair genes with clinical outcomes of advanced ovarian cancer (OC) pts treated with pegylated liposomal doxorubicin (PLD) vs trabectedin (T) + PLD in the ET-743-OVA-301 clinical trial. Eur J Cancer Suppl 2009; 7: 451.
19. Romero I, Colombo N, Kaye SB et al. Tolerability of long-term use of trabectedin (Tr) in combination with pegylated liposomal doxorubicin (PLD) in patients (pts) with relapsed ovarian cancer (ROC). J Clin Oncol 2010; 28: 15. Abstr. 5121.
20. Monk BJ, Dalton H, Benjamin I et al. Trabectedin as a new chemotherapy option in the treatment of relapsed platinum sensitive ovarian cancer. Curr Pharm Des 2012; 18 (25): 3754–69.
21. Grosso F, D´Incalci M, Cartoafa M et al. A comprehensive safety analysis confirms rhabdomyolysis as an uncommon adverse reaction in patients treated with trabectedin. Cancer Chemother Pharmacol 2012; 69 (6): 1557–65.
22. Chatzizisis YS, Misirli G, Hatzitolios AI et al. The syndrome of rhabdomyolysis: complications and treatment. Eur J Intern Med 2008; 19: 568–74.
23. Khan FY. Rhabdomyolysis: a review of the literature. Neth J Med 2009; 67: 272–83.
24. Cesne Le A, Yovine A, Blay JY et al. A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials. Invest New Drugs 2012; 30: 1193–202.
25. Cervellin G, Comelii I, Lippi G. Rhabdomyolysis: historical background, clinical, diagnostic and therapeutic features. Clin Chem Lab Med 2010; 48 (6): 749–56.
Авторы
М.В.Черкасова1, С.В.Хохлова2, С.В.Лимарева2, Н.Ф.Орел1, 2, В.А.Горбунова2, И.В.Поддубная1, Н.В.Любимова2
1 ГБОУ ДПО Российская медицинская академия последипломного образования Минздрава РФ, Москва
2 ФГБУ РОНЦ им. Н.Н.Блохина РАМН, Москва
1 ГБОУ ДПО Российская медицинская академия последипломного образования Минздрава РФ, Москва
2 ФГБУ РОНЦ им. Н.Н.Блохина РАМН, Москва
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