Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Трастузумаб при метастатическом раке молочной железы, положительном по HER2-рецепторам и гормональным рецепторам
Трастузумаб при метастатическом раке молочной железы, положительном по HER2-рецепторам и гормональным рецепторам
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
• Трастузумаб – это гуманизированные моноклональные антитела IgG1, которые избирательно связываются с рецептором эпидермального фактора роста человека типа 2 (HER2), ингибируя пролиферацию и выживание клеток в HER2-зависимых опухолях.
• В рандомизированном исследовании III фазы у больных метастатическим раком молочной железы (РМЖ), положительном по HER2-рецепторам и гормональным рецепторам, в постменопаузе медиана выживаемости без прогрессирования (основной критерий эффективности) была значительно выше у больных, получавших трастузумаб внутривенно в комбинации с анастрозолом перорально, чем у больных, получавших только анастрозол перорально.
• Частота общего ответа, показатель контроля заболевания и медиана времени до прогрессирования заболевания также были значительно выше в группе комбинации трастузумаб + анастрозол, чем в группе анастрозола.
• В рандомизированном исследовании III фазы не сообщалось о новых или неожиданных нежелательных явлениях комбинированной терапии трастузумабом и анастрозолом.
• В исследовании II фазы без группы сравнения комбинации трастузумаб + летрозол у пациенток с метастатическим РМЖ, положительным по HER2-рецепторам и гормональным рецепторам, в постменопаузе большинство нежелательных явлений было легким или средней степени тяжести.
• В рандомизированном исследовании III фазы у больных метастатическим раком молочной железы (РМЖ), положительном по HER2-рецепторам и гормональным рецепторам, в постменопаузе медиана выживаемости без прогрессирования (основной критерий эффективности) была значительно выше у больных, получавших трастузумаб внутривенно в комбинации с анастрозолом перорально, чем у больных, получавших только анастрозол перорально.
• Частота общего ответа, показатель контроля заболевания и медиана времени до прогрессирования заболевания также были значительно выше в группе комбинации трастузумаб + анастрозол, чем в группе анастрозола.
• В рандомизированном исследовании III фазы не сообщалось о новых или неожиданных нежелательных явлениях комбинированной терапии трастузумабом и анастрозолом.
• В исследовании II фазы без группы сравнения комбинации трастузумаб + летрозол у пациенток с метастатическим РМЖ, положительным по HER2-рецепторам и гормональным рецепторам, в постменопаузе большинство нежелательных явлений было легким или средней степени тяжести.
Полный текст
Список литературы
1. American Cancer Society. Breast cancer facts and figures 2005-2006 [online]. Available from URL: http://www.cancer.org [Accessed 2007, Nov 30].
2. European Society for Medical Oncology. Recurrent or metastatic breast cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2007; 18 (Suppl. 2): ii9–11.
3. Plosker GL, Keam SJ. Trastuzumab: a review of its use in the management of HER2-positive metastatic and early-stage breast cancer. Drugs 2006; 66 (4): 449–75.
4. McKeage K, Perry CM. Trastuzumab: a review of its use in the treatment of metastatic breast cancer overexpressing HER2. Drugs 2002; 62 (1): 209–43.
5. Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy [online]. Available from URL: www.TheOncologist.com [Accessed 2007, Aug 8].
6. Committee for Medicinal Products for Human Use. Scientific discussion (of the extension of the indication for the use in combination with an aromatase inhitor for the treatment of patients with HER2-positive and hormone receptor positive metastatic breast cancer, not previously treated with trastuzumab) [online]. Available from URL: http://www.emea.europa.eu [Accessed 2007, Aug 10].
7. Ponzone R, Montemurro F, Maggiorotto F et al. Clinical outcome of adjuvant endocrine treatment according to PR and HER-2 status in early breast cancer. Ann Oncol 2006; 17 (11): 1631–6.
8. Schiff R, Massarweh S, Shou J et al. Breast cancer endocrine resistance: how growth factor signaling and estrogen receptor coregulators modulate response. Clin Cancer Res 2003; 9 (Suppl. 1): 447–54S.
9. Wong ZW, Isaacs C, Harris L et al. A phase II trial of letrozole and trastuzumab for ER and/or PgR and HER2 positive metastatic breast cancer [abstract no. 144]. 26th Annual San Antonio Breast Cancer Symposium; 2003 Dec 3–6; San Antonio (TX).
10. Albanell J, Codony J, Rovira A et al. Mechanism of action of anti-HER2 monoclonal antibodies: scientific update on trastuzumab and 2C4. Adv Exp Med Biol 2003; 532: 253–68.
11. Hudis CA. Trastuzumab: mechanism of action and use in clinical practice. N Engl J Med 2007; 357 (1): 39–51.
12. Ocana A, Cruz JJ, Pandiella A. Trastuzumab and antiestrogen therapy: focus on mechanisms of action and resistance. Am J Clin Oncol 2006; 29 (1): 90–5.
13. Mohsin SK, Weiss HL, Gutierrez MC et al. Neoadjuvant trastuzumab induces apoptosis in primary breast cancers. J Clin Oncol 2005; 23 (11): 2460–8.
14. Molina MA, Codony-Servat J, Albanell J et al. Trastuzumab (Herceptin), a humanized anti-HER2 receptor monoclonal antibody, inhibits basal and activated HER2 ectodomain cleavage in breast cancer cells. Cancer Res 2001; 61: 4744–9.
15. Izumi Y, Xu L, di Tomaso E et al. Tumour biology: herceptin acts as an anti-angiogenic cocktail. Nature 2002; 416: 279–80.
16. Yakes FM, Chinratanalab W, Ritter CA et al. Herceptin-in-duced inhibition of phosphatidylinositol-3 kinase and akt is required for antibody-mediated effects on p27, cyclin D1, and antitumour action. Cancer Res 2002; 62: 4132–41.
17. Lane H, Beuvink I, Motoyama AB et al. ErB2 potentiates breast tumor proliferation through modulation of p27Kip1-Cdk2 complex formation: receptor occupation does not determine growth dependency. Mol Cell Biol 2000; 20 (9): 3210–23.
18. Lane HA, Motoyama A, Beuvink I et al. Modulation of p27/Cdk2 complex formation through 4D5-mediated inhibition of HER2 receptor signaling. Ann Oncol 2001; 12 (Suppl. 1): S21–2.
19. Valabrega G, Montemurro F, Aglietta M. Trastuzumab: mechanism of action, resistance and future perspectives in HER2-overexpressing breast cancer. Ann Oncol 2007; 18 (6): 977–84.
20. Gennari R, Menard S, Fagnoni F et al. Pilot study of the mechanism of action of preoperative trastuzumab in patients with primary operable breast tumors overexpressing HER2. Clin Cancer Res 2004; 10 (17): 5650–5.
21. HerceptinR ?(trastuzumab) prescribing information. San Francisco (CA): Genentech Inc., 2006 Nov.
22. Carter P, Presta L, Gorman CM et al. Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc Natl Acad Sci USA 1992; 89: 4285–9.
23. Nahta R, Takahashi T, Ueno NT et al. P27kip1 down-regulation is associated with trastuzumab resistance in breast cancer cells. Cancer Res 2004; 64: 3981–6.
24. Nagata Y, Lan K-H, Zhou X et al. PTEN activation contributes to tumor inhibition by trastuzumab, and loss of PTEN predicts trastuzumab resistance in patients. Cancer Cell 2004 Aug; 6: 117–27.
25. Lu Y, Zi X, Pollak M et al. Molecular mechanisms underlying IGF-I-induced attenuation of the growth-inhibitory activity of protrastuzumab (herceptin) on SKBR3 breast cancer cells. Int J Cancer 2004; 108: 334–41.
26. Valabrega G, Montemurro F, Sarotto I et al. TGF??expressionimpairs trastuzumab-induced HER2 downregulation. Oncogene 2005; 24: 3002–10.
27. Harris K, Washington CB, Lieberman J-F. A population pharmacokinetic (PK) model for trastuzumab (Herceptin) and implications for clinical dosing [abstract no. 488; plus poster]. 38th Annual Meeting of the American Society of Clinical Oncology; 2002; Orlando (FL).
28. Cobleigh MA, Vogel CL, Tripathy D et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999; 17 (9): 2639–48.
29. Baselga J, Carbonell X, Castaneda-Soto NJ et al. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J Clin Oncol 2005; 23 (10): 2162–71.
30. Leyland-Jones B, Gelmon K, Ayoub JP et al. Pharmacokinetics, safety, and efficacy of trastuzumab administered every three weeks in combination with paclitaxel. J Clin Oncol 2003; 21 (21): 3965–71.
31. European Medicines Agency. Herceptin: summary of product characteristics [online]. Available from URL: http://www.emea.europa.eu [Accessed 2007 Aug 8].
32. Kaufman B, Mackey J, Clemens M et al. Trastuzumab plus anastrozole prolongs progression-free survival in postmenopausal women with HER2-positive, hormone-dependent metastatic breast cancer [abstract no. LBA2]. Ann Oncol 2006; 17 (Suppl. 9): i.
33. Mackey JR, Kaufman B, Clemens M et al. Trastuzumab prolongs progression-free survival in hormone-dependent and HER2-positive metastatic breast cancer [abstract; plus slide presentation at the 29th Annual San Antonio Breast Cancer Symposium 2006 Dec 14–17]. Breast Cancer Res Treat 2006; 100 (Suppl. 1): S5–6.
34. Marcom PK, Isaacs C, Harris L et al. The combination of letrozole and trastuzumab as first or second-line biological therapy produces durable responses in a subset of HER2 positive and ER positive advanced breast cancers. Breast Cancer Res Treat 2007; 102 (1): 43–9.
35. Clemens M, Kaufman B, Mackey J et al. Trastuzumab [HerceptinR] plus anastrozole may prolong overall survival in post-menopausal women with HER2-positive, hormone-dependent metastatic breast cancer: results of a post hoc analysis from the TAnDEM study [poster]. ASCO Breast Cancer Symposium; 2007 Sept 7–8; San Francisco (CA).
36. Suter TM, Procter M, van Veldhuisen DJ et al. Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol 2007; 25: 3859–65.
2. European Society for Medical Oncology. Recurrent or metastatic breast cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2007; 18 (Suppl. 2): ii9–11.
3. Plosker GL, Keam SJ. Trastuzumab: a review of its use in the management of HER2-positive metastatic and early-stage breast cancer. Drugs 2006; 66 (4): 449–75.
4. McKeage K, Perry CM. Trastuzumab: a review of its use in the treatment of metastatic breast cancer overexpressing HER2. Drugs 2002; 62 (1): 209–43.
5. Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy [online]. Available from URL: www.TheOncologist.com [Accessed 2007, Aug 8].
6. Committee for Medicinal Products for Human Use. Scientific discussion (of the extension of the indication for the use in combination with an aromatase inhitor for the treatment of patients with HER2-positive and hormone receptor positive metastatic breast cancer, not previously treated with trastuzumab) [online]. Available from URL: http://www.emea.europa.eu [Accessed 2007, Aug 10].
7. Ponzone R, Montemurro F, Maggiorotto F et al. Clinical outcome of adjuvant endocrine treatment according to PR and HER-2 status in early breast cancer. Ann Oncol 2006; 17 (11): 1631–6.
8. Schiff R, Massarweh S, Shou J et al. Breast cancer endocrine resistance: how growth factor signaling and estrogen receptor coregulators modulate response. Clin Cancer Res 2003; 9 (Suppl. 1): 447–54S.
9. Wong ZW, Isaacs C, Harris L et al. A phase II trial of letrozole and trastuzumab for ER and/or PgR and HER2 positive metastatic breast cancer [abstract no. 144]. 26th Annual San Antonio Breast Cancer Symposium; 2003 Dec 3–6; San Antonio (TX).
10. Albanell J, Codony J, Rovira A et al. Mechanism of action of anti-HER2 monoclonal antibodies: scientific update on trastuzumab and 2C4. Adv Exp Med Biol 2003; 532: 253–68.
11. Hudis CA. Trastuzumab: mechanism of action and use in clinical practice. N Engl J Med 2007; 357 (1): 39–51.
12. Ocana A, Cruz JJ, Pandiella A. Trastuzumab and antiestrogen therapy: focus on mechanisms of action and resistance. Am J Clin Oncol 2006; 29 (1): 90–5.
13. Mohsin SK, Weiss HL, Gutierrez MC et al. Neoadjuvant trastuzumab induces apoptosis in primary breast cancers. J Clin Oncol 2005; 23 (11): 2460–8.
14. Molina MA, Codony-Servat J, Albanell J et al. Trastuzumab (Herceptin), a humanized anti-HER2 receptor monoclonal antibody, inhibits basal and activated HER2 ectodomain cleavage in breast cancer cells. Cancer Res 2001; 61: 4744–9.
15. Izumi Y, Xu L, di Tomaso E et al. Tumour biology: herceptin acts as an anti-angiogenic cocktail. Nature 2002; 416: 279–80.
16. Yakes FM, Chinratanalab W, Ritter CA et al. Herceptin-in-duced inhibition of phosphatidylinositol-3 kinase and akt is required for antibody-mediated effects on p27, cyclin D1, and antitumour action. Cancer Res 2002; 62: 4132–41.
17. Lane H, Beuvink I, Motoyama AB et al. ErB2 potentiates breast tumor proliferation through modulation of p27Kip1-Cdk2 complex formation: receptor occupation does not determine growth dependency. Mol Cell Biol 2000; 20 (9): 3210–23.
18. Lane HA, Motoyama A, Beuvink I et al. Modulation of p27/Cdk2 complex formation through 4D5-mediated inhibition of HER2 receptor signaling. Ann Oncol 2001; 12 (Suppl. 1): S21–2.
19. Valabrega G, Montemurro F, Aglietta M. Trastuzumab: mechanism of action, resistance and future perspectives in HER2-overexpressing breast cancer. Ann Oncol 2007; 18 (6): 977–84.
20. Gennari R, Menard S, Fagnoni F et al. Pilot study of the mechanism of action of preoperative trastuzumab in patients with primary operable breast tumors overexpressing HER2. Clin Cancer Res 2004; 10 (17): 5650–5.
21. HerceptinR ?(trastuzumab) prescribing information. San Francisco (CA): Genentech Inc., 2006 Nov.
22. Carter P, Presta L, Gorman CM et al. Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc Natl Acad Sci USA 1992; 89: 4285–9.
23. Nahta R, Takahashi T, Ueno NT et al. P27kip1 down-regulation is associated with trastuzumab resistance in breast cancer cells. Cancer Res 2004; 64: 3981–6.
24. Nagata Y, Lan K-H, Zhou X et al. PTEN activation contributes to tumor inhibition by trastuzumab, and loss of PTEN predicts trastuzumab resistance in patients. Cancer Cell 2004 Aug; 6: 117–27.
25. Lu Y, Zi X, Pollak M et al. Molecular mechanisms underlying IGF-I-induced attenuation of the growth-inhibitory activity of protrastuzumab (herceptin) on SKBR3 breast cancer cells. Int J Cancer 2004; 108: 334–41.
26. Valabrega G, Montemurro F, Sarotto I et al. TGF??expressionimpairs trastuzumab-induced HER2 downregulation. Oncogene 2005; 24: 3002–10.
27. Harris K, Washington CB, Lieberman J-F. A population pharmacokinetic (PK) model for trastuzumab (Herceptin) and implications for clinical dosing [abstract no. 488; plus poster]. 38th Annual Meeting of the American Society of Clinical Oncology; 2002; Orlando (FL).
28. Cobleigh MA, Vogel CL, Tripathy D et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999; 17 (9): 2639–48.
29. Baselga J, Carbonell X, Castaneda-Soto NJ et al. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J Clin Oncol 2005; 23 (10): 2162–71.
30. Leyland-Jones B, Gelmon K, Ayoub JP et al. Pharmacokinetics, safety, and efficacy of trastuzumab administered every three weeks in combination with paclitaxel. J Clin Oncol 2003; 21 (21): 3965–71.
31. European Medicines Agency. Herceptin: summary of product characteristics [online]. Available from URL: http://www.emea.europa.eu [Accessed 2007 Aug 8].
32. Kaufman B, Mackey J, Clemens M et al. Trastuzumab plus anastrozole prolongs progression-free survival in postmenopausal women with HER2-positive, hormone-dependent metastatic breast cancer [abstract no. LBA2]. Ann Oncol 2006; 17 (Suppl. 9): i.
33. Mackey JR, Kaufman B, Clemens M et al. Trastuzumab prolongs progression-free survival in hormone-dependent and HER2-positive metastatic breast cancer [abstract; plus slide presentation at the 29th Annual San Antonio Breast Cancer Symposium 2006 Dec 14–17]. Breast Cancer Res Treat 2006; 100 (Suppl. 1): S5–6.
34. Marcom PK, Isaacs C, Harris L et al. The combination of letrozole and trastuzumab as first or second-line biological therapy produces durable responses in a subset of HER2 positive and ER positive advanced breast cancers. Breast Cancer Res Treat 2007; 102 (1): 43–9.
35. Clemens M, Kaufman B, Mackey J et al. Trastuzumab [HerceptinR] plus anastrozole may prolong overall survival in post-menopausal women with HER2-positive, hormone-dependent metastatic breast cancer: results of a post hoc analysis from the TAnDEM study [poster]. ASCO Breast Cancer Symposium; 2007 Sept 7–8; San Francisco (CA).
36. Suter TM, Procter M, van Veldhuisen DJ et al. Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol 2007; 25: 3859–65.
Авторы
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.