Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Ингибиторы тирозинкиназы EGFR в терапии 1-й линии немелкоклеточного рака легкого: переход от эмпирического подхода к персонализации лечения
Ингибиторы тирозинкиназы EGFR в терапии 1-й линии немелкоклеточного рака легкого: переход от эмпирического подхода к персонализации лечения
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
В статье рассматриваются вопросы применения ингибиторов тирозинкиназы (ИТК) EGFR в 1-й линии лечения больных немелкоклеточным раком легкого. При наличии активирующих мутаций в гене EGFR эрлотиниб и гефитиниб достоверно превосходят стандартные платиносодержащие режимы в отношении выживаемости без прогрессирования болезни и частоты объективного ответа. Монотерапия ИТК характеризуется более благоприятным профилем безопасности при сравнимых показателях общей выживаемости. Эрлотиниб доказал свою эффективность в европейской популяции больных. Для назначения ИТК в 1-й линии лечения обязательно определение мутационного статуса EGFR.
Ключевые слова: немелкоклеточный рак, рецептор эпидермального фактора роста, мутации, эрлотиниб, гефитиниб, 1-я линия терапии.
Key words: non-small-cell lung cancer, epidermal growth factor receptor, mutations, erlotinib, gefitinib, first line therapy.
Ключевые слова: немелкоклеточный рак, рецептор эпидермального фактора роста, мутации, эрлотиниб, гефитиниб, 1-я линия терапии.
________________________________________________
Key words: non-small-cell lung cancer, epidermal growth factor receptor, mutations, erlotinib, gefitinib, first line therapy.
Полный текст
Список литературы
1. Section of Cancer Information (6/3/2011); p. 13. Int J Cancer 2010; 127 (I 12): 2893–917. http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-027766.pd...
2. Alatar ML, Gold KA, Kim ES. Evolving treatment paradigms in non-small-cell lung cancer. Clin Oncol 2009; 12 (2): 29–43.
3. Злокачественные новообразования в России в 2010 г. (заболеваемость и смертность). Под ред. В.И.Чиссова, В.В.Старинского, Г.В.Петровой. М., 2012.
4. Kelly K, Crowley J, Bunn PA et al. Randomized phase III trial of paclitaxel plus carboplatin vs vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial. JCO 2001; 19 (13): 3210–8.
5. Schiller JH, Harrington D, Belani CP et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002; 346 (2): 92–8.
6. Scagliotti GV, De Marinis F, Rinaldi M et al. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. JCO 2002; 20 (21): 4285–91.
7. Belani CP; TAX 326 study group. Docetaxel in combination with platinums (cisplatin or carboplatin) in advanced and metastatic non-small-cell lung cancer. Semin Oncol 2002; 29 (3 Suppl. 12): 4–9.
8. Gandara DR, Lara PN Jr, Mack P, Scagliotti GV. Individualizing therapy for non-small-cell lung cancer: a paradigm shift from empiric to integrated decision-making. Clin Lung Cancer 2009; 10 (3): 148–50.
9. Wells A. EGF receptor. Int J Biochem Cell Biol 1999; 31 (6): 637–43.
10. Downward J, Yarden Y, Mayes E et al. Close similarity of epidermal growth factor receptor and v-erb-B oncogene protein sequences. Nature 1984; 307: 521–7.
11. Pavelic K, Banjac Z, Рavelic J et al. Evidence for a role of EGF receptor in the progression of human lung carcinoma. Anticancer Res 1993; 13: 1133–7.
12. Arteaga CL. Overview of epidermal growth factor receptor biology and its role as a therapeutic target in human neoplasia. Semin Oncol 2002; 29: 3–9.
13. Salomon DS, Brandt R, Ciardiello F et al. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995; 19: 183–232.
14. Yarden Y. The EGFR family and its ligands in human cancer. Signalling mechanisms and therapeutic opportunities. Eur J Cancer 2001; 37: s3–8.
15. Lynch TJ, Bell DW, Sordella R et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350: 2129–39.
16. Paez JG, Janne PA, Lee JC et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004; 304: 1497–500.
17. Mok TS. A target or demi-target. Clinical lung cancer 2010; 11 (3): 147–8.
18. Murray S, Dahabreh IJ, Linardou H et al. Somatic mutations of the tyrosine kinase domain of epidermal growth factor receptor and tyrosine kinase inhibitor response to TKIs in non-small-cell lung cancer: an analytical database. J Thorac Oncol 2008; 3: 832–9.
19. Paz-Ares L. Gefitinib – the resurrection. ESMO 2010. Ann Oncol 2010; 21 (8): 24.
20. D’Angelo S, Pietanza MC, Johnson ML et al. Incidence of EGFR exon 19 deletions and L858R in tumor specimens from men and cigarette smokers with lung adenocarcinomas. JCO 2011; 29 (15): 2066–70.
21. Моисеенко Ф.В. Частота активирующих мутаций в гене EGFR в аденокарциномах легкого, полученных от больных Северо-Западной части РФ. Автореф. дис. … канд. мед. наук. СПб., 2009.
22. Moiseyenko VM, Procenko SA, Levchenko EV et al. High efficacy of first-line gefitinib in non-asian patients with EGFR-mutated lung adenocarcinoma. Oncol 2010; 33: 231–8.
23. Zhu CQ, da Cunha Santos G, Ding K et al. Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 2008; 26: 4268–75.
24. Hirsch FR, Varella-Garcia M, Bunn PA Jr et al. Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer. J Clin Oncol 2006; 24: 5034–42.
25. Douillard J, Hirsh V, Mok TS et al. Molecular and clinical subgroup analyses from a phase III trial comparing gefitinib with docetaxel in previously treated non-small-cell lung cancer (INTEREST). J Clin Oncol 2008; 26: 424s.
26. Brugger W, Triller N, Blasinska-Morawiec M et al. Biomarker analyses from the phase III placebo-controlled SATURN study of maintenance erlotinib following first-line chemotherapy for advanced NSCLC. J Clin Oncol 2009; 27: 411s.
27. Rosell R, Moran T, Queralt C et al. Screening for epidermal growth factor receptor mutations in lung cancer. NEJM 2009; 361 (10): 958–67.
28. De Grève J. First-line erlotinib in advanced non-small-cell lung cancer (NSCLC) carrying an activating EGFR mutation: a multicenter academic phase II study in Caucasian patients (pts) (NCT 00339586) – FIELT study group. ASCO 2011. JCO 2011; 29 (15): 499. Abstr. 7597.
29. Rosell R, Carcereny E, Gervais R et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol 2012; 13: 239–46.
30. Janne PA et al. Outcome of advanced NSCLC patients with EGFR exon 19 and 21 mutations treated with erlotinib alone or in combination with carboplatin/paclitaxel (CP) in CALGB 30406. 2011; WCLC. Abstr. O39.01.
31. Mok TS, Wu YL, Thongprasert S et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947–57.
32. Zhou C, Wu Y, Chen G et al. Erlotinib vs chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 2011; 12: 735–42.
33. Han JY, Park K, Kim SW et al. First-SIGNAL: first-line single-agent iressa vs gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. Clin Oncol 2012; 30 (10): 1122–8.
34. Mitsudomi T, Morita S, Yatabe Y et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harboring mutations of the epidermal growth factor receptor (WJTOG 3405): an open label, randomised phase 3 trial. Lancet Oncol 2010; 11 (2): 121–8.
35. Maemondo M, Inoue A, Kobayashi K et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010; 362 (25): 2380–8.
36. Pérez-Soler R, Delord JP, Halpern A et al. HER1/EGFR inhibitor-associated rash: future directions for management and investigation outcomes from the HER1/EGFR inhibitor rash management forum. Oncolog 2005; 10: 345–56.
37. Elez E, Macarulla T, Tabernero J. Handling side-effects of targeted therapies: safety of targeted therapies in solid tumours. Ann Oncol 2008; 7: 146–52.
38. Costa EC, Taron M, Queralt C et al. Differential progression-free survival (PFS) to erlotinib according to EGFR exon 19 deletion type in non-small-cell lung cancer (NSCLC) patients (p) in the EURTAC study. ASCO 2012. Abstr. 7540.
39. Zhou C et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced ERFR mutation-positive NSCLC (OPTIMAL). Lancet Oncol 2011; 12: 735–42.
40. Zhou C, Wu Y, Chen G et al. Erlotinib vs chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG 0802): a multicentre, open-label, randomised, study. Lancet Oncol 2011; 12: 735–42.
41. Gridelli C, Ciardiello F, Feld R et al. International multicenter randomized phase III study of first-line erlotinib (E) followed by second-line cisplatin plus gemcitabine (CG) vs first-line CG followed second-line E in advanced non-small-cell lung cancer (aNSCLC): the TORCH trial. Proc ASCO 2010; JCO 2010; 28 (18): 540. Abstr. 7508.
42. Paz-Ares L, Soulieres D, Melezinec I et al. Clinical outcomes in non-small-cell lung cancer patients with EGFR mutations: pooled analysis. J Cell Mol Med 2010; 14 (1–2): 51–69.
2. Alatar ML, Gold KA, Kim ES. Evolving treatment paradigms in non-small-cell lung cancer. Clin Oncol 2009; 12 (2): 29–43.
3. Злокачественные новообразования в России в 2010 г. (заболеваемость и смертность). Под ред. В.И.Чиссова, В.В.Старинского, Г.В.Петровой. М., 2012.
4. Kelly K, Crowley J, Bunn PA et al. Randomized phase III trial of paclitaxel plus carboplatin vs vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial. JCO 2001; 19 (13): 3210–8.
5. Schiller JH, Harrington D, Belani CP et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002; 346 (2): 92–8.
6. Scagliotti GV, De Marinis F, Rinaldi M et al. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. JCO 2002; 20 (21): 4285–91.
7. Belani CP; TAX 326 study group. Docetaxel in combination with platinums (cisplatin or carboplatin) in advanced and metastatic non-small-cell lung cancer. Semin Oncol 2002; 29 (3 Suppl. 12): 4–9.
8. Gandara DR, Lara PN Jr, Mack P, Scagliotti GV. Individualizing therapy for non-small-cell lung cancer: a paradigm shift from empiric to integrated decision-making. Clin Lung Cancer 2009; 10 (3): 148–50.
9. Wells A. EGF receptor. Int J Biochem Cell Biol 1999; 31 (6): 637–43.
10. Downward J, Yarden Y, Mayes E et al. Close similarity of epidermal growth factor receptor and v-erb-B oncogene protein sequences. Nature 1984; 307: 521–7.
11. Pavelic K, Banjac Z, Рavelic J et al. Evidence for a role of EGF receptor in the progression of human lung carcinoma. Anticancer Res 1993; 13: 1133–7.
12. Arteaga CL. Overview of epidermal growth factor receptor biology and its role as a therapeutic target in human neoplasia. Semin Oncol 2002; 29: 3–9.
13. Salomon DS, Brandt R, Ciardiello F et al. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995; 19: 183–232.
14. Yarden Y. The EGFR family and its ligands in human cancer. Signalling mechanisms and therapeutic opportunities. Eur J Cancer 2001; 37: s3–8.
15. Lynch TJ, Bell DW, Sordella R et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350: 2129–39.
16. Paez JG, Janne PA, Lee JC et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004; 304: 1497–500.
17. Mok TS. A target or demi-target. Clinical lung cancer 2010; 11 (3): 147–8.
18. Murray S, Dahabreh IJ, Linardou H et al. Somatic mutations of the tyrosine kinase domain of epidermal growth factor receptor and tyrosine kinase inhibitor response to TKIs in non-small-cell lung cancer: an analytical database. J Thorac Oncol 2008; 3: 832–9.
19. Paz-Ares L. Gefitinib – the resurrection. ESMO 2010. Ann Oncol 2010; 21 (8): 24.
20. D’Angelo S, Pietanza MC, Johnson ML et al. Incidence of EGFR exon 19 deletions and L858R in tumor specimens from men and cigarette smokers with lung adenocarcinomas. JCO 2011; 29 (15): 2066–70.
21. Моисеенко Ф.В. Частота активирующих мутаций в гене EGFR в аденокарциномах легкого, полученных от больных Северо-Западной части РФ. Автореф. дис. … канд. мед. наук. СПб., 2009.
22. Moiseyenko VM, Procenko SA, Levchenko EV et al. High efficacy of first-line gefitinib in non-asian patients with EGFR-mutated lung adenocarcinoma. Oncol 2010; 33: 231–8.
23. Zhu CQ, da Cunha Santos G, Ding K et al. Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 2008; 26: 4268–75.
24. Hirsch FR, Varella-Garcia M, Bunn PA Jr et al. Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer. J Clin Oncol 2006; 24: 5034–42.
25. Douillard J, Hirsh V, Mok TS et al. Molecular and clinical subgroup analyses from a phase III trial comparing gefitinib with docetaxel in previously treated non-small-cell lung cancer (INTEREST). J Clin Oncol 2008; 26: 424s.
26. Brugger W, Triller N, Blasinska-Morawiec M et al. Biomarker analyses from the phase III placebo-controlled SATURN study of maintenance erlotinib following first-line chemotherapy for advanced NSCLC. J Clin Oncol 2009; 27: 411s.
27. Rosell R, Moran T, Queralt C et al. Screening for epidermal growth factor receptor mutations in lung cancer. NEJM 2009; 361 (10): 958–67.
28. De Grève J. First-line erlotinib in advanced non-small-cell lung cancer (NSCLC) carrying an activating EGFR mutation: a multicenter academic phase II study in Caucasian patients (pts) (NCT 00339586) – FIELT study group. ASCO 2011. JCO 2011; 29 (15): 499. Abstr. 7597.
29. Rosell R, Carcereny E, Gervais R et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol 2012; 13: 239–46.
30. Janne PA et al. Outcome of advanced NSCLC patients with EGFR exon 19 and 21 mutations treated with erlotinib alone or in combination with carboplatin/paclitaxel (CP) in CALGB 30406. 2011; WCLC. Abstr. O39.01.
31. Mok TS, Wu YL, Thongprasert S et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947–57.
32. Zhou C, Wu Y, Chen G et al. Erlotinib vs chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 2011; 12: 735–42.
33. Han JY, Park K, Kim SW et al. First-SIGNAL: first-line single-agent iressa vs gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. Clin Oncol 2012; 30 (10): 1122–8.
34. Mitsudomi T, Morita S, Yatabe Y et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harboring mutations of the epidermal growth factor receptor (WJTOG 3405): an open label, randomised phase 3 trial. Lancet Oncol 2010; 11 (2): 121–8.
35. Maemondo M, Inoue A, Kobayashi K et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010; 362 (25): 2380–8.
36. Pérez-Soler R, Delord JP, Halpern A et al. HER1/EGFR inhibitor-associated rash: future directions for management and investigation outcomes from the HER1/EGFR inhibitor rash management forum. Oncolog 2005; 10: 345–56.
37. Elez E, Macarulla T, Tabernero J. Handling side-effects of targeted therapies: safety of targeted therapies in solid tumours. Ann Oncol 2008; 7: 146–52.
38. Costa EC, Taron M, Queralt C et al. Differential progression-free survival (PFS) to erlotinib according to EGFR exon 19 deletion type in non-small-cell lung cancer (NSCLC) patients (p) in the EURTAC study. ASCO 2012. Abstr. 7540.
39. Zhou C et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced ERFR mutation-positive NSCLC (OPTIMAL). Lancet Oncol 2011; 12: 735–42.
40. Zhou C, Wu Y, Chen G et al. Erlotinib vs chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG 0802): a multicentre, open-label, randomised, study. Lancet Oncol 2011; 12: 735–42.
41. Gridelli C, Ciardiello F, Feld R et al. International multicenter randomized phase III study of first-line erlotinib (E) followed by second-line cisplatin plus gemcitabine (CG) vs first-line CG followed second-line E in advanced non-small-cell lung cancer (aNSCLC): the TORCH trial. Proc ASCO 2010; JCO 2010; 28 (18): 540. Abstr. 7508.
42. Paz-Ares L, Soulieres D, Melezinec I et al. Clinical outcomes in non-small-cell lung cancer patients with EGFR mutations: pooled analysis. J Cell Mol Med 2010; 14 (1–2): 51–69.
Авторы
Е.В.Артамонова
ФГБУ РОНЦ им. Н.Н.Блохина РАМН
ФГБУ РОНЦ им. Н.Н.Блохина РАМН
________________________________________________
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.