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Авастин в клинической химиотерапии злокачественных опухолей
Авастин в клинической химиотерапии злокачественных опухолей
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Аннотация
Авастин (бевацизумаб) – гуманизированное моноклональное антитело, обладающее выраженной антиангиогенной активностью, прицельно блокирующее сосудистый эндотелиальный фактор роста VEGF и предотвращающее его связывание с рецепторами. Хронологически Авастин является одним из первых (вторым после трастузумаба) таргетных препаратов, разрешенных для применения в клинической практике. Также он является единственным таргетным препаратом, применяемым при основных злокачественных солидных опухолях: метастатическом колоректальном раке, местно-рецидивирующем или метастатическом раке молочной железы, местно-распространенном, метастатическом или рецидивирующем неплоскоклеточном немелкоклеточном раке легкого, распространенном и/или метастатическом почечно-клеточном раке, глиобластоме (глиома 4-й степени злокачественности по классификации Всемирной организации здравоохранения) и эпителиальном раке яичника, маточной трубы и первичном раке брюшины. Таким образом, в результате многочисленных исследований Авастина в онкологии, проведенных в течение более 10 лет, Авастин можно охарактеризовать сегодня двумя словами: первый и лучший, поскольку ни один таргетный препарат не нашел столь широкого клинического применения и показаний в практической онкологии, и, более того, практически ни одно клиническое исследование Авастина не было безуспешным. Следует сказать также, что большой клинический опыт показывает относительную безопасность препарата в различных подгруппах и популяциях больных.
Ключевые слова: Авастин, ангиогенез, эндотелиальный фактор роста сосудов, таргетные препараты, колоректальный рак, рак молочной железы, немелкоклеточный рак легкого, почечно-клеточный рак, глиобластома, рак яичников, рак фаллопиевой трубы, первичный рак брюшины.
Key words: Avastin, angiogenesis, vessel endothelial growth factor, targeted agents, colorectal cancer, breast cancer, non-small cell lung cancer, renal cell cancer, glioblastoma, ovarian cancer, fallopian tube cancer, primary peritoneal cancer.
Ключевые слова: Авастин, ангиогенез, эндотелиальный фактор роста сосудов, таргетные препараты, колоректальный рак, рак молочной железы, немелкоклеточный рак легкого, почечно-клеточный рак, глиобластома, рак яичников, рак фаллопиевой трубы, первичный рак брюшины.
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Key words: Avastin, angiogenesis, vessel endothelial growth factor, targeted agents, colorectal cancer, breast cancer, non-small cell lung cancer, renal cell cancer, glioblastoma, ovarian cancer, fallopian tube cancer, primary peritoneal cancer.
Полный текст
Список литературы
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4. Kabbinavar F, Hurwitz HI, Fehrenbacher L et al. Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol 2003; 21: 60–5.
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6. Tebbutt NC, Wilson K, Gebski VJ et al. Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: Results of the Australasian Gastrointestinal Trials Group Randomized Phase III MAX Study. J Clin Oncol 2010; 28: 3191–8.
7. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: Results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007; 25: 1539–44.
8. Hurwitz H, Tebbutt NC, Kabbinavar F et al. Efficacy and Safety of Bevacizumab in Metastatic Colorectal Cancer: Pooled Analysis From Seven Randomized Controlled Trials. The Oncologist 2013; 18: 1004–12.
9. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: Results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007; 25: 1539–44.
10. Saltz LB, Clarke S, Dнaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: A randomized phase III study. J Clin Oncol 2008; 26: 2013–9.
11. Cassidy J, Saltz LB, Giantonio BJ et al. Effect of bevacizumab in older patients with metastatic colorectal cancer: Pooled analysis of four randomized studies. J Cancer Res Clin Oncol 2010; 136: 737–43.
12. Welch S, Spithoff K, Rumble RB et al. Bevacizumab combined with chemotherapy for patients with advanced colorectal cancer: A systematic review. Ann Oncol 2010; 21: 1152–62.
13. Price TJ, Zannino D, Wilson K et al. Bevacizumab is equally effective and no more toxic in elderly patients with advanced colorectal cancer: A subgroup analysis from the AGITG MAX trial: An international randomised controlled trial of capecitabine, bevacizumab, and mitomycin C. Ann Oncol 2012; 23: 1531–6.
14. Bendell JC, Bekaii-Saab TS, Cohn AL et al. Treatment patterns and clinical outcomes in patients with metastatic colorectal cancer initially treated with FOLFOX-bevacizumab or FOLFIRI-bevacizumab: Results from ARIES, a bevacizumab observational study. The Oncologist 2012; 17: 1486–95.
15. Arnold D, Kindler M, Petersen V et al. Bevacizumab plus chemotherapy as first-line treatment for patients with metastatic colorectal cancer: First results from a large community-based observational cohort study in Germany. Presented at: the 2010 Gastrointestinal Symposium; January 22–24, 2010; Orlando, Florida, USA.
16. Peeters M, Siena S, Tabernero J. Survival outcomes in the PRIME study for patients (pts) with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC), by baseline Eastern Cooperative Oncology Group (ECOG) performance status (PS). J Clin Oncol 2014; 32 (Suppl.): 5, Abstract 3557.
17. Rivera F. Extended RAS analysis and subsequent anti-EGFR and anti-VEGF treatment (tx) in PEAK: A first-line phase 2 study of FOLFOX6 + panitumumab (pmab) or bevacizumab (bev) in metastatic colorectal cancer (mCRC). ASCO Annual 2014; Abstract 3629.
18. Ning Y. Genetic variants of TCF7L2 and AXIN2 predict gender and tumor location-dependent clinical outcome in FIRE-3 trial: A validation study. ASCO Annual Meeting 2014; Abstract 3602.
19. Martin P, Jung S-H, Johnson J. CALGB 50803 (Alliance): A phase II trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma. J Clin Oncol 2014; 32 (Suppl.): 5, Abstract 8521.
20. Gray R, Bhattacharya S, Bowden C et al. Independent Review of E2100: A Phase III Trial of Bevacizumab Plus Paclitaxel Versus Paclitaxel in Women With Metastatic Breast Cancer. J Clin Oncol 2009; 27 (30): 4966–72.
21. Miles D, Chan A, Romieu G et al. Randomized, double-blind, placebo-controlled, phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. J Clin Oncol 2008; 26 (Suppl.): 43.
22. Robert NJ, Die´ras V, Glaspy J. RIBBON-1: Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Chemotherapy With or Without Bevacizumab for First-Line Treatment of Human Epidermal Growth Factor Receptor 2-Negative, Locally Recurrent or Metastatic Breast Cancer. J Clin Oncol 2011; 29 (10): 1252–60.
23. O’Shaughnessy J, Dieras V, Glaspy J et al. Comparison of subgroup analyses of PFS from three phase III studies of bevacizumab in combination with chemotherapy in patients with HER2-negative metastatic breast cancer (MBC). Cancer Res 2009; 69: 512, Abstract 207.
24. Miles DW, Diéras V, Cortés J et al. First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup analyses of data from 2447 patients. Ann Oncol 2014; 24 (11): 1–8.
25. Sandler A, Yi J, Dahlberg S et al. Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. J Thorac Oncol 2010; 5: 1416–23.
26. Dansin E et al. ESMO 2010.
27. Nadler E, Yu E, Ravelo A. Bevacizumab Treatment to Progression After Chemotherapy: Outcomes from a U.S. Community Practice Network. The Oncologist 2011; 16 (4): 486–96.
28. Burger RA, Brady MF, Bookman MA et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med 2011; 365: 2473–83.
29. Perren T, Swart A-M, Pfisterer J et al. A Phase 3 Trial of Bevacizumab in Ovarian Cancer N Engl J Med 2011; 365: 2484–96.
30. Aghajanian C, Blank SV, Goff BA et al: OCEANS: A randomized, double-blind, placebocontrolled phase III trial of chemotherapy with or without bevacizumab in patients with platinumsensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 2012; 30: 2039–45.
31. Pujade-Lauraine E, Hilpert F, Weber B et al. Bevacizumab Combined With Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer: The AURELIA Open-Label Randomized Phase III Trial. J Clin Oncol 2013; 54.
32. Stupp R, Hegi ME, Gilbert MR, Chakravarti A. Chemoradiotherapy in malignant glioma: standard of care and future directions. J Clin Oncol 2007; 25: 4127–36.
33. Nghiemphu PL, Liu W, Lee Y et al. Bevacizumab and chemotherapy for recurrent glioblastoma: a single-institution experience. Neurology 2009; 72: 1217–22.
34. Norden AD, Young GS, Setayesh K et al. Bevacizumab for recurrent malignant gliomas: efficacy, toxicity, and patterns of recurrence. Neurology 2008; 70: 779–87.
35. Pope WB, Lai A, Nghiemphu P et al. MRI in patients with high-grade gliomas treated with bevacizumab and chemotherapy. Neurology 2006; 66: 1258–60.
36. Stark VV. Bevacizumab (Avastin) and CPT-11 (Camptosar) in the treatment of relapsed malignant glioma (abstract). Neurooncology 2005;7: 369.
37. Yung WK, Albright RE, Olson J et al. A phase II study of temozolomide vs procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer 2000; 83: 588–93.
38. Wagner SA, Desjardins A, Reardon DA, et al. Update on survival from the original phase II trial of bevacizumab and irinotecan in recurrent malignant gliomas (abstract). J Clin Oncol 2008; 26: 2021.
39. Vredenburgh JJ, Desjardins A, Herndon 2nd JE et al. Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. Clin Cancer Res 2007; 13: 1253–9.
40. Vredenburgh JJ, Desjardins A, Herndon 2nd JE et al. Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. J Clin Oncol 2007; 25: 4722–9.
41. Cloughesy TF, Prados MD, Mikkelsen T et al. A phase II, randomized, non-comparative clinical trial of the effect of bevacizumab (BV) alone or in combination with irinotecan (CPT) on 6-month progression free survival (PFS6) in recurrent, treatment-refractory glioblastoma (GBM) (abstract). J Clin Oncol 2008; 26: 2010b.
42. Kreisl TN, Kim L, Moore K et al. Phase II trial of single-agent bevacizumab followed by bevacizumab and irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol 2009; 27: 740–5.
2. Saltz LB, Clarke S, Dнaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: A randomized phase III study. J Clin Oncol 2008; 26: 2013–9.
3. Guan ZZ, Xu JM, Luo RC et al. Efficacy and safety of bevacizumab plus chemotherapy in Chinese patients with metastatic colorectal cancer: A randomized phase III ARTIST trial. Chin J Cancer 2011; 30: 682–9.
4. Kabbinavar F, Hurwitz HI, Fehrenbacher L et al. Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer. J Clin Oncol 2003; 21: 60–5.
5. Kabbinavar FF, Schulz J, McCleod M et al. Addition оf bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: Results of a randomized phase II trial. J Clin Oncol 2005; 23: 3697–705.
6. Tebbutt NC, Wilson K, Gebski VJ et al. Capecitabine, bevacizumab, and mitomycin in first-line treatment of metastatic colorectal cancer: Results of the Australasian Gastrointestinal Trials Group Randomized Phase III MAX Study. J Clin Oncol 2010; 28: 3191–8.
7. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: Results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007; 25: 1539–44.
8. Hurwitz H, Tebbutt NC, Kabbinavar F et al. Efficacy and Safety of Bevacizumab in Metastatic Colorectal Cancer: Pooled Analysis From Seven Randomized Controlled Trials. The Oncologist 2013; 18: 1004–12.
9. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: Results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007; 25: 1539–44.
10. Saltz LB, Clarke S, Dнaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: A randomized phase III study. J Clin Oncol 2008; 26: 2013–9.
11. Cassidy J, Saltz LB, Giantonio BJ et al. Effect of bevacizumab in older patients with metastatic colorectal cancer: Pooled analysis of four randomized studies. J Cancer Res Clin Oncol 2010; 136: 737–43.
12. Welch S, Spithoff K, Rumble RB et al. Bevacizumab combined with chemotherapy for patients with advanced colorectal cancer: A systematic review. Ann Oncol 2010; 21: 1152–62.
13. Price TJ, Zannino D, Wilson K et al. Bevacizumab is equally effective and no more toxic in elderly patients with advanced colorectal cancer: A subgroup analysis from the AGITG MAX trial: An international randomised controlled trial of capecitabine, bevacizumab, and mitomycin C. Ann Oncol 2012; 23: 1531–6.
14. Bendell JC, Bekaii-Saab TS, Cohn AL et al. Treatment patterns and clinical outcomes in patients with metastatic colorectal cancer initially treated with FOLFOX-bevacizumab or FOLFIRI-bevacizumab: Results from ARIES, a bevacizumab observational study. The Oncologist 2012; 17: 1486–95.
15. Arnold D, Kindler M, Petersen V et al. Bevacizumab plus chemotherapy as first-line treatment for patients with metastatic colorectal cancer: First results from a large community-based observational cohort study in Germany. Presented at: the 2010 Gastrointestinal Symposium; January 22–24, 2010; Orlando, Florida, USA.
16. Peeters M, Siena S, Tabernero J. Survival outcomes in the PRIME study for patients (pts) with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC), by baseline Eastern Cooperative Oncology Group (ECOG) performance status (PS). J Clin Oncol 2014; 32 (Suppl.): 5, Abstract 3557.
17. Rivera F. Extended RAS analysis and subsequent anti-EGFR and anti-VEGF treatment (tx) in PEAK: A first-line phase 2 study of FOLFOX6 + panitumumab (pmab) or bevacizumab (bev) in metastatic colorectal cancer (mCRC). ASCO Annual 2014; Abstract 3629.
18. Ning Y. Genetic variants of TCF7L2 and AXIN2 predict gender and tumor location-dependent clinical outcome in FIRE-3 trial: A validation study. ASCO Annual Meeting 2014; Abstract 3602.
19. Martin P, Jung S-H, Johnson J. CALGB 50803 (Alliance): A phase II trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma. J Clin Oncol 2014; 32 (Suppl.): 5, Abstract 8521.
20. Gray R, Bhattacharya S, Bowden C et al. Independent Review of E2100: A Phase III Trial of Bevacizumab Plus Paclitaxel Versus Paclitaxel in Women With Metastatic Breast Cancer. J Clin Oncol 2009; 27 (30): 4966–72.
21. Miles D, Chan A, Romieu G et al. Randomized, double-blind, placebo-controlled, phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. J Clin Oncol 2008; 26 (Suppl.): 43.
22. Robert NJ, Die´ras V, Glaspy J. RIBBON-1: Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Chemotherapy With or Without Bevacizumab for First-Line Treatment of Human Epidermal Growth Factor Receptor 2-Negative, Locally Recurrent or Metastatic Breast Cancer. J Clin Oncol 2011; 29 (10): 1252–60.
23. O’Shaughnessy J, Dieras V, Glaspy J et al. Comparison of subgroup analyses of PFS from three phase III studies of bevacizumab in combination with chemotherapy in patients with HER2-negative metastatic breast cancer (MBC). Cancer Res 2009; 69: 512, Abstract 207.
24. Miles DW, Diéras V, Cortés J et al. First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup analyses of data from 2447 patients. Ann Oncol 2014; 24 (11): 1–8.
25. Sandler A, Yi J, Dahlberg S et al. Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. J Thorac Oncol 2010; 5: 1416–23.
26. Dansin E et al. ESMO 2010.
27. Nadler E, Yu E, Ravelo A. Bevacizumab Treatment to Progression After Chemotherapy: Outcomes from a U.S. Community Practice Network. The Oncologist 2011; 16 (4): 486–96.
28. Burger RA, Brady MF, Bookman MA et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med 2011; 365: 2473–83.
29. Perren T, Swart A-M, Pfisterer J et al. A Phase 3 Trial of Bevacizumab in Ovarian Cancer N Engl J Med 2011; 365: 2484–96.
30. Aghajanian C, Blank SV, Goff BA et al: OCEANS: A randomized, double-blind, placebocontrolled phase III trial of chemotherapy with or without bevacizumab in patients with platinumsensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 2012; 30: 2039–45.
31. Pujade-Lauraine E, Hilpert F, Weber B et al. Bevacizumab Combined With Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer: The AURELIA Open-Label Randomized Phase III Trial. J Clin Oncol 2013; 54.
32. Stupp R, Hegi ME, Gilbert MR, Chakravarti A. Chemoradiotherapy in malignant glioma: standard of care and future directions. J Clin Oncol 2007; 25: 4127–36.
33. Nghiemphu PL, Liu W, Lee Y et al. Bevacizumab and chemotherapy for recurrent glioblastoma: a single-institution experience. Neurology 2009; 72: 1217–22.
34. Norden AD, Young GS, Setayesh K et al. Bevacizumab for recurrent malignant gliomas: efficacy, toxicity, and patterns of recurrence. Neurology 2008; 70: 779–87.
35. Pope WB, Lai A, Nghiemphu P et al. MRI in patients with high-grade gliomas treated with bevacizumab and chemotherapy. Neurology 2006; 66: 1258–60.
36. Stark VV. Bevacizumab (Avastin) and CPT-11 (Camptosar) in the treatment of relapsed malignant glioma (abstract). Neurooncology 2005;7: 369.
37. Yung WK, Albright RE, Olson J et al. A phase II study of temozolomide vs procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer 2000; 83: 588–93.
38. Wagner SA, Desjardins A, Reardon DA, et al. Update on survival from the original phase II trial of bevacizumab and irinotecan in recurrent malignant gliomas (abstract). J Clin Oncol 2008; 26: 2021.
39. Vredenburgh JJ, Desjardins A, Herndon 2nd JE et al. Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. Clin Cancer Res 2007; 13: 1253–9.
40. Vredenburgh JJ, Desjardins A, Herndon 2nd JE et al. Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. J Clin Oncol 2007; 25: 4722–9.
41. Cloughesy TF, Prados MD, Mikkelsen T et al. A phase II, randomized, non-comparative clinical trial of the effect of bevacizumab (BV) alone or in combination with irinotecan (CPT) on 6-month progression free survival (PFS6) in recurrent, treatment-refractory glioblastoma (GBM) (abstract). J Clin Oncol 2008; 26: 2010b.
42. Kreisl TN, Kim L, Moore K et al. Phase II trial of single-agent bevacizumab followed by bevacizumab and irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol 2009; 27: 740–5.
Авторы
В.А.Горбунова
ФГБУ Российский онкологический научный центр им. Н.Н.Блохина РАМН, Москва
ФГБУ Российский онкологический научный центр им. Н.Н.Блохина РАМН, Москва
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