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Роль nab-паклитаксела в лечении больных метастатическим раком молочной железы
Роль nab-паклитаксела в лечении больных метастатическим раком молочной железы
Фролова М.А. Роль nab-паклитаксела в лечении больных метастатическим раком молочной железы. Современная Онкология. 2016; 18 (3): 33–37.
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Аннотация
Nab-паклитаксел представляет собой наночастицу паклитаксела, связанную с альбумином. В отличие от стандартных таксанов (паклитаксел, доцетаксел), в составе nab-паклитаксела отсутствуют растворители, что снижает риск развития реакций гиперчувствительности и других побочных явлений. При использовании nab-паклитаксела не требуется проведения премедекации глюкокортикоидами и антигистаминными препаратами. Кроме того, в ряде экспериментов было показано, что применение nab-паклитаксела позволяет создать более высокую концентрацию препарата в опухоли. В статье освещены основные исследования применения nab-паклитаксела в различных дозах и режимах введения при метастатическом раке молочной железы. Приведен возможный алгоритм оптимального режима введения nab-паклитаксела для различных клинических ситуаций.
Ключевые слова: метастатический рак молочной железы, таксаны, nab-паклитаксел.
Key words: metastatic breast cancer, taxanes, nab-paclitaxel.
Ключевые слова: метастатический рак молочной железы, таксаны, nab-паклитаксел.
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Key words: metastatic breast cancer, taxanes, nab-paclitaxel.
Полный текст
Список литературы
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13. Sahenk Z, Barohn R, New P et al. Taxol neuropathy. Arch Neurol 1994; 51: 72–729.
14. Gradishar WJ, Tjulandin S, Davidson N et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 2005; 23: 7794–803.
15. Gradishar WJ, Krasnojon D, Cheporov S et al. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol 2009; 27: 3611–9.
16. Gradishar W, Krasnojon D, Cheporov S et al. Phase II Trial of Nab-Paclitaxel Compared With Docetaxel as First-Line Chemotherapy in Patients With Metastatic Breast Cancer: Final Analysis of Overall Survival. Clin Breast Cancer 2012; 12 (5): 313–21.
17. Mirtsching B, Cosgriff T, Harker G et al. A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer. Clin Breast Cancer 2011; 11: 121–8.
18. Rugo HS, Barry WT, Moreno-Aspitia A et al. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance).
J Clin Oncol 2015; 20; 33 (21): 2361–9.
19. Ibrahim NK, Samuels B, Page R et al. Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer. J Clin Oncol 2005; 23: 6019–26.
20. Blum JL, Savin MA, Edelman G et al. Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer 2007; 7: 850–6.
21. Aapro M, Tjulandin S, Bhar P, Gradishar W. Weekly nabpaclitaxel is safe and effective in ≥65 years old patients with metastatic breast cancer: a post-hoc analysis. Breast 2011; 20: 468–74.
22. Timoney JP, McGuffy D, DeRitis D et al. Incidence of hypersensitivity reactions (HSRs) to albumin-bound paclitaxel (ABI) in patients (pts) with a history of HSR to cremophor-based paclitaxel (P). ASCO Meeting Abstracts 2011; 29: 2566.
23. Munck A. Glucocorticoid inhibition of glucose uptake by peripheral tissues: old and new evidence, molecular mechanisms, and physiological significance. Perspect Biol Med 1971; 14: 265–9.
24. Abraxane prescribing information. 2012.
25. Ando M, Watanabe T, Nagata K et al. Efficacy of Docetaxel 60 mg/m2 in Patients With Metastatic Breast Cancer According to the Status of Anthracycline Resistance. J Clin Oncol 2001; 19 (2): 336–42.
26. Arpino G, Marme F, Cortes J et al. Tailoring the dosing schedule of nab-paclitaxel in metastatic breastcancer according to patient and disease characteristics: Recommendations from a panel of experts. Crit Rev Oncol Hematol 2015 Oct 28. [Epub ahead of print].
2. Goldspeil BR. Guidelines for administration. In: Paclitaxel in Cancer Treatment, McGuire WP and Rowinsky EK (eds). New York: Marcel Dekker Inc, 1995; p. 175–86.
3. Ten Tije AJ, Verweij J, Loos WJ, Sparreboom A. Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin Pharmacokinet 2003; 42: 665–85.
4. Weiss RB, Donehower RC, Wiernik PH et al. Hypersensitivity reactions from taxol. J Clin Oncol 1990; 8: 1263–68.
5. Foote MA. Using nanotechnology to improve the characteristics of antineoplastic drugs: Improved characteristics of nab-paclitaxel compared with solvent-based paclitaxel. Biotechnol Ann Review 2007; 13: 345–57.
6. Desai N, Trieu V, Yao Z et al. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of Cremophor-free, albumin-bound paclitaxel, ABI-007, compared with Cremophor-based paclitaxel. Clin Cancer Res 2006; 12: 1317–24.
7. Sparreboom A, van Zuylen L, Brouwer E et al. Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications. Cancer Res 1999; 59: 1454–57.
8. Hawkins M, Desai N, Soon-Shiong P. Rationale, Preclinical Support, and Clinical Proof-of-Concept for Formulating Water-insoluble Therapeutics as Albumin-stabilized Nanoparticles: Experience with Paclitaxel. AACR 2003. Poster.
9. Price KS and Castells MC. Taxol reactions. Allergy Asthma Proc 2002; 23: 205–08.
10. Kloover JS, den Bakker MA, Gelderblom H et al. Fatal outcome of a hypersensitivity reaction to paclitaxel: a critical review of premedication regimens. Br J Cancer 2004; 90: 304–5.
11. Postma TJ, Vermorken JB, Liefting AJM et al. Paclitaxel-induced neuropathy. Ann Oncol 1995; 6: 489–94.
12. Boer HH, Moorer-van Delft CM, Muller LJ et al. Ultrastructural neuropathologic effects of taxol on neurons of the freshwater snail Lymnaea stagnalis. J Neurooncol 1995; 25: 49–57.
13. Sahenk Z, Barohn R, New P et al. Taxol neuropathy. Arch Neurol 1994; 51: 72–729.
14. Gradishar WJ, Tjulandin S, Davidson N et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 2005; 23: 7794–803.
15. Gradishar WJ, Krasnojon D, Cheporov S et al. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol 2009; 27: 3611–9.
16. Gradishar W, Krasnojon D, Cheporov S et al. Phase II Trial of Nab-Paclitaxel Compared With Docetaxel as First-Line Chemotherapy in Patients With Metastatic Breast Cancer: Final Analysis of Overall Survival. Clin Breast Cancer 2012; 12 (5): 313–21.
17. Mirtsching B, Cosgriff T, Harker G et al. A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer. Clin Breast Cancer 2011; 11: 121–8.
18. Rugo HS, Barry WT, Moreno-Aspitia A et al. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance).
J Clin Oncol 2015; 20; 33 (21): 2361–9.
19. Ibrahim NK, Samuels B, Page R et al. Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer. J Clin Oncol 2005; 23: 6019–26.
20. Blum JL, Savin MA, Edelman G et al. Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer 2007; 7: 850–6.
21. Aapro M, Tjulandin S, Bhar P, Gradishar W. Weekly nabpaclitaxel is safe and effective in ≥65 years old patients with metastatic breast cancer: a post-hoc analysis. Breast 2011; 20: 468–74.
22. Timoney JP, McGuffy D, DeRitis D et al. Incidence of hypersensitivity reactions (HSRs) to albumin-bound paclitaxel (ABI) in patients (pts) with a history of HSR to cremophor-based paclitaxel (P). ASCO Meeting Abstracts 2011; 29: 2566.
23. Munck A. Glucocorticoid inhibition of glucose uptake by peripheral tissues: old and new evidence, molecular mechanisms, and physiological significance. Perspect Biol Med 1971; 14: 265–9.
24. Abraxane prescribing information. 2012.
25. Ando M, Watanabe T, Nagata K et al. Efficacy of Docetaxel 60 mg/m2 in Patients With Metastatic Breast Cancer According to the Status of Anthracycline Resistance. J Clin Oncol 2001; 19 (2): 336–42.
26. Arpino G, Marme F, Cortes J et al. Tailoring the dosing schedule of nab-paclitaxel in metastatic breastcancer according to patient and disease characteristics: Recommendations from a panel of experts. Crit Rev Oncol Hematol 2015 Oct 28. [Epub ahead of print].
2. Goldspeil BR. Guidelines for administration. In: Paclitaxel in Cancer Treatment, McGuire WP and Rowinsky EK (eds). New York: Marcel Dekker Inc, 1995; p. 175–86.
3. Ten Tije AJ, Verweij J, Loos WJ, Sparreboom A. Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin Pharmacokinet 2003; 42: 665–85.
4. Weiss RB, Donehower RC, Wiernik PH et al. Hypersensitivity reactions from taxol. J Clin Oncol 1990; 8: 1263–68.
5. Foote MA. Using nanotechnology to improve the characteristics of antineoplastic drugs: Improved characteristics of nab-paclitaxel compared with solvent-based paclitaxel. Biotechnol Ann Review 2007; 13: 345–57.
6. Desai N, Trieu V, Yao Z et al. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of Cremophor-free, albumin-bound paclitaxel, ABI-007, compared with Cremophor-based paclitaxel. Clin Cancer Res 2006; 12: 1317–24.
7. Sparreboom A, van Zuylen L, Brouwer E et al. Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications. Cancer Res 1999; 59: 1454–57.
8. Hawkins M, Desai N, Soon-Shiong P. Rationale, Preclinical Support, and Clinical Proof-of-Concept for Formulating Water-insoluble Therapeutics as Albumin-stabilized Nanoparticles: Experience with Paclitaxel. AACR 2003. Poster.
9. Price KS and Castells MC. Taxol reactions. Allergy Asthma Proc 2002; 23: 205–08.
10. Kloover JS, den Bakker MA, Gelderblom H et al. Fatal outcome of a hypersensitivity reaction to paclitaxel: a critical review of premedication regimens. Br J Cancer 2004; 90: 304–5.
11. Postma TJ, Vermorken JB, Liefting AJM et al. Paclitaxel-induced neuropathy. Ann Oncol 1995; 6: 489–94.
12. Boer HH, Moorer-van Delft CM, Muller LJ et al. Ultrastructural neuropathologic effects of taxol on neurons of the freshwater snail Lymnaea stagnalis. J Neurooncol 1995; 25: 49–57.
13. Sahenk Z, Barohn R, New P et al. Taxol neuropathy. Arch Neurol 1994; 51: 72–729.
14. Gradishar WJ, Tjulandin S, Davidson N et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 2005; 23: 7794–803.
15. Gradishar WJ, Krasnojon D, Cheporov S et al. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol 2009; 27: 3611–9.
16. Gradishar W, Krasnojon D, Cheporov S et al. Phase II Trial of Nab-Paclitaxel Compared With Docetaxel as First-Line Chemotherapy in Patients With Metastatic Breast Cancer: Final Analysis of Overall Survival. Clin Breast Cancer 2012; 12 (5): 313–21.
17. Mirtsching B, Cosgriff T, Harker G et al. A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer. Clin Breast Cancer 2011; 11: 121–8.
18. Rugo HS, Barry WT, Moreno-Aspitia A et al. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance).
J Clin Oncol 2015; 20; 33 (21): 2361–9.
19. Ibrahim NK, Samuels B, Page R et al. Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer. J Clin Oncol 2005; 23: 6019–26.
20. Blum JL, Savin MA, Edelman G et al. Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer 2007; 7: 850–6.
21. Aapro M, Tjulandin S, Bhar P, Gradishar W. Weekly nabpaclitaxel is safe and effective in ≥65 years old patients with metastatic breast cancer: a post-hoc analysis. Breast 2011; 20: 468–74.
22. Timoney JP, McGuffy D, DeRitis D et al. Incidence of hypersensitivity reactions (HSRs) to albumin-bound paclitaxel (ABI) in patients (pts) with a history of HSR to cremophor-based paclitaxel (P). ASCO Meeting Abstracts 2011; 29: 2566.
23. Munck A. Glucocorticoid inhibition of glucose uptake by peripheral tissues: old and new evidence, molecular mechanisms, and physiological significance. Perspect Biol Med 1971; 14: 265–9.
24. Abraxane prescribing information. 2012.
25. Ando M, Watanabe T, Nagata K et al. Efficacy of Docetaxel 60 mg/m2 in Patients With Metastatic Breast Cancer According to the Status of Anthracycline Resistance. J Clin Oncol 2001; 19 (2): 336–42.
26. Arpino G, Marme F, Cortes J et al. Tailoring the dosing schedule of nab-paclitaxel in metastatic breastcancer according to patient and disease characteristics: Recommendations from a panel of experts. Crit Rev Oncol Hematol 2015 Oct 28. [Epub ahead of print].
________________________________________________
2. Goldspeil BR. Guidelines for administration. In: Paclitaxel in Cancer Treatment, McGuire WP and Rowinsky EK (eds). New York: Marcel Dekker Inc, 1995; p. 175–86.
3. Ten Tije AJ, Verweij J, Loos WJ, Sparreboom A. Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin Pharmacokinet 2003; 42: 665–85.
4. Weiss RB, Donehower RC, Wiernik PH et al. Hypersensitivity reactions from taxol. J Clin Oncol 1990; 8: 1263–68.
5. Foote MA. Using nanotechnology to improve the characteristics of antineoplastic drugs: Improved characteristics of nab-paclitaxel compared with solvent-based paclitaxel. Biotechnol Ann Review 2007; 13: 345–57.
6. Desai N, Trieu V, Yao Z et al. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of Cremophor-free, albumin-bound paclitaxel, ABI-007, compared with Cremophor-based paclitaxel. Clin Cancer Res 2006; 12: 1317–24.
7. Sparreboom A, van Zuylen L, Brouwer E et al. Cremophor EL-mediated alteration of paclitaxel distribution in human blood: clinical pharmacokinetic implications. Cancer Res 1999; 59: 1454–57.
8. Hawkins M, Desai N, Soon-Shiong P. Rationale, Preclinical Support, and Clinical Proof-of-Concept for Formulating Water-insoluble Therapeutics as Albumin-stabilized Nanoparticles: Experience with Paclitaxel. AACR 2003. Poster.
9. Price KS and Castells MC. Taxol reactions. Allergy Asthma Proc 2002; 23: 205–08.
10. Kloover JS, den Bakker MA, Gelderblom H et al. Fatal outcome of a hypersensitivity reaction to paclitaxel: a critical review of premedication regimens. Br J Cancer 2004; 90: 304–5.
11. Postma TJ, Vermorken JB, Liefting AJM et al. Paclitaxel-induced neuropathy. Ann Oncol 1995; 6: 489–94.
12. Boer HH, Moorer-van Delft CM, Muller LJ et al. Ultrastructural neuropathologic effects of taxol on neurons of the freshwater snail Lymnaea stagnalis. J Neurooncol 1995; 25: 49–57.
13. Sahenk Z, Barohn R, New P et al. Taxol neuropathy. Arch Neurol 1994; 51: 72–729.
14. Gradishar WJ, Tjulandin S, Davidson N et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol 2005; 23: 7794–803.
15. Gradishar WJ, Krasnojon D, Cheporov S et al. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol 2009; 27: 3611–9.
16. Gradishar W, Krasnojon D, Cheporov S et al. Phase II Trial of Nab-Paclitaxel Compared With Docetaxel as First-Line Chemotherapy in Patients With Metastatic Breast Cancer: Final Analysis of Overall Survival. Clin Breast Cancer 2012; 12 (5): 313–21.
17. Mirtsching B, Cosgriff T, Harker G et al. A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer. Clin Breast Cancer 2011; 11: 121–8.
18. Rugo HS, Barry WT, Moreno-Aspitia A et al. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance).
J Clin Oncol 2015; 20; 33 (21): 2361–9.
19. Ibrahim NK, Samuels B, Page R et al. Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer. J Clin Oncol 2005; 23: 6019–26.
20. Blum JL, Savin MA, Edelman G et al. Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer 2007; 7: 850–6.
21. Aapro M, Tjulandin S, Bhar P, Gradishar W. Weekly nabpaclitaxel is safe and effective in ≥65 years old patients with metastatic breast cancer: a post-hoc analysis. Breast 2011; 20: 468–74.
22. Timoney JP, McGuffy D, DeRitis D et al. Incidence of hypersensitivity reactions (HSRs) to albumin-bound paclitaxel (ABI) in patients (pts) with a history of HSR to cremophor-based paclitaxel (P). ASCO Meeting Abstracts 2011; 29: 2566.
23. Munck A. Glucocorticoid inhibition of glucose uptake by peripheral tissues: old and new evidence, molecular mechanisms, and physiological significance. Perspect Biol Med 1971; 14: 265–9.
24. Abraxane prescribing information. 2012.
25. Ando M, Watanabe T, Nagata K et al. Efficacy of Docetaxel 60 mg/m2 in Patients With Metastatic Breast Cancer According to the Status of Anthracycline Resistance. J Clin Oncol 2001; 19 (2): 336–42.
26. Arpino G, Marme F, Cortes J et al. Tailoring the dosing schedule of nab-paclitaxel in metastatic breastcancer according to patient and disease characteristics: Recommendations from a panel of experts. Crit Rev Oncol Hematol 2015 Oct 28. [Epub ahead of print].
Авторы
М.А.Фролова*
ФГБУ Российский онкологический научный центр им. Н.Н.Блохина Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*drfrolova@yandex.ru
N.N.Blokhin Russian Cancer Research Center of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23
*drfrolova@yandex.ru
ФГБУ Российский онкологический научный центр им. Н.Н.Блохина Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*drfrolova@yandex.ru
________________________________________________
N.N.Blokhin Russian Cancer Research Center of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23
*drfrolova@yandex.ru
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