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Собственный опыт использования пероральной формы винорелбина
Собственный опыт использования пероральной формы винорелбина
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Аннотация
На сегодняшний день при многих онкологических заболеваниях удается достичь контроля роста опухоли благодаря успешно проводимому лечению. Пероральные препараты могут играть важную роль в этой терапевтической стратегии. Одним из таких препаратов является винорелбин.
Целью настоящего исследования было оценить токсичность и эффективность комбинаций перорального винорелбина с цитостатиками других групп у пациентов с метастатической формой рака молочной железы (мРМЖ) и немелкоклеточного рака легкого (НМРЛ).
Материалы и методы. С февраля 2008 г. по сентябрь 2011 г. 63 пациента с мРМЖ и НМРЛ (медиана возраста 55,9 года) получали винорелбин в монотерапии или в комбинации с другими цитостатиками (капецитабин, гемцитабин, карбоплатин, паклитаксел).
Результаты. У пациенток с мРМЖ, пролеченных комбинацией винорелбин + капецитабин, достигнута частичная регрессия в 7 (25,9%) случаях, стабилизация заболевания – в 12 (44,4%), частота контроля за заболеванием составила 74%. Медиана времени до прогрессирования у данной группы пациентов равна 5,0 мес.
Заключение. При проведении 1–3-й линии химиотерапии (ХТ) дублетными комбинациями с включением перорального винорелбина у пациентов с мРМЖ и НМРЛ выявлена удовлетворительная переносимость. Эффективность комбинации винорелбин + капецитабин у пациенток с мРМЖ, частота частичной регрессии составила 25,9%, уровень контроля за заболеванием – 74%. Целесообразно продолжать дальнейшее изучение комбинаций с включением перорального винорелбина.
Ключевые слова: комбинации с пероральным винорелбином, рак молочной железы, немелкоклеточный рак легкого, последовательная лучевая терапия.
Objective: to evaluate the toxicity and efficacy of combinations of oral vinorelbine and cytostatics of other groups in patients with metastatic breast cancer (MBC) and non-small cell lung cancer (NSLC).
Subjects and methods. Sixty-three patients (median age 55,9 years) with MBC and NSLC received vinorelbine alone or in combination with other cytostatics (capecitabine, gemcitabine, carboplatin, paclitaxel) in February 2008 to September 2011.
Results. The patients with MBC treated with a combination of vinorelbine + capecitabine achieved a partial remission in 7 (25,9%) cases; stabilization was noted in 12 (44,4%); the disease control rate was 74%. In this patient group, the median time to progression was equal to 5,0 months.
Conclusion. The patients with MBC and NSLC showed a satisfactory tolerance to first- to third-line chemotherapy (CT) with doublet combinations incorporating oral vinorelbine. In patients with MBC, The efficacy of the combination of vinorelbine + capecitabine was as follows: the rate of partial regression was 25,9%; that of disease control was 74%. It is reasonable to continue further investigation of combinations incorporating oral vinorelbine.
Key words: combinations with oral vinorelbine, breast cancer, non-small cell lung cancer, successive radiotherapy.
Целью настоящего исследования было оценить токсичность и эффективность комбинаций перорального винорелбина с цитостатиками других групп у пациентов с метастатической формой рака молочной железы (мРМЖ) и немелкоклеточного рака легкого (НМРЛ).
Материалы и методы. С февраля 2008 г. по сентябрь 2011 г. 63 пациента с мРМЖ и НМРЛ (медиана возраста 55,9 года) получали винорелбин в монотерапии или в комбинации с другими цитостатиками (капецитабин, гемцитабин, карбоплатин, паклитаксел).
Результаты. У пациенток с мРМЖ, пролеченных комбинацией винорелбин + капецитабин, достигнута частичная регрессия в 7 (25,9%) случаях, стабилизация заболевания – в 12 (44,4%), частота контроля за заболеванием составила 74%. Медиана времени до прогрессирования у данной группы пациентов равна 5,0 мес.
Заключение. При проведении 1–3-й линии химиотерапии (ХТ) дублетными комбинациями с включением перорального винорелбина у пациентов с мРМЖ и НМРЛ выявлена удовлетворительная переносимость. Эффективность комбинации винорелбин + капецитабин у пациенток с мРМЖ, частота частичной регрессии составила 25,9%, уровень контроля за заболеванием – 74%. Целесообразно продолжать дальнейшее изучение комбинаций с включением перорального винорелбина.
Ключевые слова: комбинации с пероральным винорелбином, рак молочной железы, немелкоклеточный рак легкого, последовательная лучевая терапия.
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Objective: to evaluate the toxicity and efficacy of combinations of oral vinorelbine and cytostatics of other groups in patients with metastatic breast cancer (MBC) and non-small cell lung cancer (NSLC).
Subjects and methods. Sixty-three patients (median age 55,9 years) with MBC and NSLC received vinorelbine alone or in combination with other cytostatics (capecitabine, gemcitabine, carboplatin, paclitaxel) in February 2008 to September 2011.
Results. The patients with MBC treated with a combination of vinorelbine + capecitabine achieved a partial remission in 7 (25,9%) cases; stabilization was noted in 12 (44,4%); the disease control rate was 74%. In this patient group, the median time to progression was equal to 5,0 months.
Conclusion. The patients with MBC and NSLC showed a satisfactory tolerance to first- to third-line chemotherapy (CT) with doublet combinations incorporating oral vinorelbine. In patients with MBC, The efficacy of the combination of vinorelbine + capecitabine was as follows: the rate of partial regression was 25,9%; that of disease control was 74%. It is reasonable to continue further investigation of combinations incorporating oral vinorelbine.
Key words: combinations with oral vinorelbine, breast cancer, non-small cell lung cancer, successive radiotherapy.
Полный текст
Список литературы
1. Liu G, Franssen E, Fitch MI et al. Patients preferences for oral vs. intravenous palliative chemotherapy. J Clin Oncol 1997; 15: 110–5.
2. Binet S, Chaineau E, Fellous A et al. Immunofluorescence study of the action of navelbine, vincristine on mitotic and axonal microtubules. Int J Cancer 1990; 46: 262–6.
3. Marty M, Fumoleau P, Adenis A et al. Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumors. Ann Oncol 2001; 12: 1643–9.
4. Varoli P, Nguyen L, Tranchard B et al. A simultaneous oral/intravenous population pharmacokinetics model for vinorelbine. Eur J Clin Pharmacol 2002; 58: 467–76.
5. Dipierre A, Chastang Cl, Quoix E et al. Vinorelbine versus vinorelbine plus cisplatin in advanced NSCLC: a randomized trial. Ann of Oncol 1994; 5: 37–42.
6. Le Chevalier T. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin vs. vinorelbine alone in advanced non-small cell lung cancer: a results of a European multicenter trial including 612 patients. J Clin Oncol 1994; 12 (12): 360–7.
7. Crawford J, O’Rourke M, Schiller JH et al. Randomized trial of the vinorelbine compared with fluorouracil plus leucovorin on patients with stage IV NSCLC. J Clin Oncol 1996; 14 (10): 2774–84.
8. Fumoleau P, Delgao FM, Delozier T et al. Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 1993; 11: 1245–332.
9. Garcia-Gonde J et al. Phase II trial of weekly in vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 1994; 5: 854–7.
10. Bruno S, Lira-Peurto V, Mickiewicz F et al. Phase II trial with navelbine in the treatment of advanced breast cancer patients. Ann Oncol 1992; 3 (1): 126–9.
11. Weber B, Vogel C, Jones et al. Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 1995; 13: 2722–30.
12. Romero A, Rabinovitch MG, Vallero C. Vinorelbine as first line chemotherapy for metastatic breast carcinoma. J Clin Oncol 1994; 12: 336–41.
13. Terenziani M, Demicheli R, Brambilla C et al. Vinorelbine: an active, non-cross-resistant drug in advanced breast cancer – results from a phase II study. Breast Cancer Research Treatment 1996; 39: 285–91.
14. Vogel C, O’Rourke M, Winer et al. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years old. Ann Oncol 1999; 10: 397–402.
15. Gligorov J, Beerblock K, Selle F et al. Capecitabine and oral vinorelbine in metastatic breast cancer: preliminary experience. Proc Am Soc Clin Oncol 2003; 22. Abstr. 351.
16. Anton A, Lluch A, Casado A et al. Phase I–II study of oral vinorelbine (NVBO) and capecitabine (X) in metastatic breast cancer (MBC): results of the phase I trial. J Clin Oncol 2008; 26 (15s): 67s. Abstr. 1105.
17. Gil-Delgado M, Rocher M, Boostandoost E, Khayat D. First step of oral vinorelbine and capecitabine combination in advanced breast cancer patients: feasibility study. J Clin Oncol 2008; 26: 1135 (15s).
18. Delcambre C, Veyret C, Levy C et al. A phase I–II study of capecitabine (Xeloda®) combined with oral vinorelbine as first- or second-line therapy on locally advanced or metastatic breast cancer (MBC). Proc San Antonio Breast Cancer Symposium 2005. Abstr. 1081.
19. Kellokumpu-Lehtinen PL, Sunela K, Lehtinen I et al. Finished Breast Cancer Group. A phase I study of an all oral combination of vinorelbine/capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and/or taxanes. Clin Breast Cancer 2006; 17: 401–5.
20. Nole F, Catania C, Sanna G et al. Dose-finding and pharmacokinetic study of an all oral combination regimen of oral vinorelbine and capecitabine for patients with metastatic breast cancer. Ann Oncol 2006; 17: 322–9.
21. Finek J, Holubec L Jr, Svoboda T et al. A phase II trial of oral vinorelbine and capecitabine in antracycline pretreated patients with metastatic breast cancer. Anticancer Res 2009; 29 (2): 667–70.
22. Nole F, Grivellari 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 (4): 673–80.
23. Tubiana-Mathieu N, Bougnoux P, Becquart D et al. All oral 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 (2): 232–7.
24. 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 (4): 755–63.
25. Kowalski DM, Krzakowski MJ, Zajda K et al. Oral vinorelbine (NVBo) at 3-weekly flat-dose intakes (FDI) as single agent or with cisplatin (CDDP) concomitantly with thoracic radiotherapy (RT) in stage III NSCLC: Escalation-dose phase I trial results. ASCO Meeting. Abstr. 2011, abstr. 7045.
26. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457–81.
2. Binet S, Chaineau E, Fellous A et al. Immunofluorescence study of the action of navelbine, vincristine on mitotic and axonal microtubules. Int J Cancer 1990; 46: 262–6.
3. Marty M, Fumoleau P, Adenis A et al. Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumors. Ann Oncol 2001; 12: 1643–9.
4. Varoli P, Nguyen L, Tranchard B et al. A simultaneous oral/intravenous population pharmacokinetics model for vinorelbine. Eur J Clin Pharmacol 2002; 58: 467–76.
5. Dipierre A, Chastang Cl, Quoix E et al. Vinorelbine versus vinorelbine plus cisplatin in advanced NSCLC: a randomized trial. Ann of Oncol 1994; 5: 37–42.
6. Le Chevalier T. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin vs. vinorelbine alone in advanced non-small cell lung cancer: a results of a European multicenter trial including 612 patients. J Clin Oncol 1994; 12 (12): 360–7.
7. Crawford J, O’Rourke M, Schiller JH et al. Randomized trial of the vinorelbine compared with fluorouracil plus leucovorin on patients with stage IV NSCLC. J Clin Oncol 1996; 14 (10): 2774–84.
8. Fumoleau P, Delgao FM, Delozier T et al. Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 1993; 11: 1245–332.
9. Garcia-Gonde J et al. Phase II trial of weekly in vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 1994; 5: 854–7.
10. Bruno S, Lira-Peurto V, Mickiewicz F et al. Phase II trial with navelbine in the treatment of advanced breast cancer patients. Ann Oncol 1992; 3 (1): 126–9.
11. Weber B, Vogel C, Jones et al. Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 1995; 13: 2722–30.
12. Romero A, Rabinovitch MG, Vallero C. Vinorelbine as first line chemotherapy for metastatic breast carcinoma. J Clin Oncol 1994; 12: 336–41.
13. Terenziani M, Demicheli R, Brambilla C et al. Vinorelbine: an active, non-cross-resistant drug in advanced breast cancer – results from a phase II study. Breast Cancer Research Treatment 1996; 39: 285–91.
14. Vogel C, O’Rourke M, Winer et al. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years old. Ann Oncol 1999; 10: 397–402.
15. Gligorov J, Beerblock K, Selle F et al. Capecitabine and oral vinorelbine in metastatic breast cancer: preliminary experience. Proc Am Soc Clin Oncol 2003; 22. Abstr. 351.
16. Anton A, Lluch A, Casado A et al. Phase I–II study of oral vinorelbine (NVBO) and capecitabine (X) in metastatic breast cancer (MBC): results of the phase I trial. J Clin Oncol 2008; 26 (15s): 67s. Abstr. 1105.
17. Gil-Delgado M, Rocher M, Boostandoost E, Khayat D. First step of oral vinorelbine and capecitabine combination in advanced breast cancer patients: feasibility study. J Clin Oncol 2008; 26: 1135 (15s).
18. Delcambre C, Veyret C, Levy C et al. A phase I–II study of capecitabine (Xeloda®) combined with oral vinorelbine as first- or second-line therapy on locally advanced or metastatic breast cancer (MBC). Proc San Antonio Breast Cancer Symposium 2005. Abstr. 1081.
19. Kellokumpu-Lehtinen PL, Sunela K, Lehtinen I et al. Finished Breast Cancer Group. A phase I study of an all oral combination of vinorelbine/capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and/or taxanes. Clin Breast Cancer 2006; 17: 401–5.
20. Nole F, Catania C, Sanna G et al. Dose-finding and pharmacokinetic study of an all oral combination regimen of oral vinorelbine and capecitabine for patients with metastatic breast cancer. Ann Oncol 2006; 17: 322–9.
21. Finek J, Holubec L Jr, Svoboda T et al. A phase II trial of oral vinorelbine and capecitabine in antracycline pretreated patients with metastatic breast cancer. Anticancer Res 2009; 29 (2): 667–70.
22. Nole F, Grivellari 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 (4): 673–80.
23. Tubiana-Mathieu N, Bougnoux P, Becquart D et al. All oral 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 (2): 232–7.
24. 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 (4): 755–63.
25. Kowalski DM, Krzakowski MJ, Zajda K et al. Oral vinorelbine (NVBo) at 3-weekly flat-dose intakes (FDI) as single agent or with cisplatin (CDDP) concomitantly with thoracic radiotherapy (RT) in stage III NSCLC: Escalation-dose phase I trial results. ASCO Meeting. Abstr. 2011, abstr. 7045.
26. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457–81.
Авторы
Н.Ю.Добровольская, С.А.Большакова, Ю.М.Бычков, Р.Д.Квиникадзе, Ю.А.Понкратова
ФГБУ Российский научный центр рентгенорадиологии Минздрава РФ, Москва
ФГБУ Российский научный центр рентгенорадиологии Минздрава РФ, Москва
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