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Гефитиниб – терапия выбора 1-й линии немелкоклеточного рака легкого у больных с наличием мутаций в гене EGFR
Гефитиниб – терапия выбора 1-й линии немелкоклеточного рака легкого у больных с наличием мутаций в гене EGFR
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Аннотация
С позиций современных знаний о роли мутаций определенных генов и связанной с этим эффективностью лекарственной терапии необходимо проведение генетических исследований для рационального выбора 1-й линии лечения. Применение ингибиторов тирозинкиназы у больных с наличием мутации EGFR в 1-й линии терапии больных немелкоклеточным раком легкого позволяет добиться достоверного увеличения медианы до прогрессирования заболевания при меньшей токсичности проводимого лечения у грамотно отобранной когорты больных.
Ключевые слова: немелкоклеточный рак легкого, мутации EGFR, ингибиторы тирозинкиназы, гефитиниб.
Key words: non-small cell lung cancer, EGFR mutations, tyrosine kinase inhibitors, gefitinib.
Ключевые слова: немелкоклеточный рак легкого, мутации EGFR, ингибиторы тирозинкиназы, гефитиниб.
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Key words: non-small cell lung cancer, EGFR mutations, tyrosine kinase inhibitors, gefitinib.
Полный текст
Список литературы
1. Давыдов М.И., Аксель Е.М. Статистика злокачественных новообразований в России и странах СНГ 2010 г. 2012.
2. Shiller JH, Harrington D et al. Comparison of four chemotherapy regimen for advanced non-small-cell lung cancer. N Engl J Med 2002; 346: 92–8.
3. Ohe Y, Ohashi Y et al. Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: four-arm cooperative study in Japan. Ann Oncol 2007; 18: 317–23.
4. Salomon DS, Brandt R et al. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995; 9: 183–232.
5. Lynch TJ, Bell DW 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.
6. Paez JG, Janne PA et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004; 304: 1497–500.
7. Toyooka S, Takano T et al. Epidermal growth factor receptor mutation, but not sex and smoking, is independently associated with favorable prognosis of gefitinib-treated patients with lung adenocarcinoma. Cancer Sci 2008; 99: 303–8.
8. Morita S, Okamoto I et al. Combined survival analysis of prospective clinical trials of gefitinib for non-small-cell lung cancer with EGFR mutations. Clin Cancer Res 2009; 15: 4493–8.
9. Mok T, Wu YL et al. Phase III randomized, open-label, first-line study of gefitinib vs carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer (IPASS). Ann Oncol 2008; 19 (Suppl. 8). LB.
10. Fukuoka M, Yano S et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 2003; 21: 2237–46.
11. Kris MG, Natale RB et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small-cell lung cancer: a randomized trial. JAMA 2003; 290: 2149–58.
12. Cohen MN, Williams GA et al. United States Food and Drug Administration drug approval summary: gefitinib (ZD 1839, Iressa) tablets. Clin Cancer Res 2004; 10: 1212–8.
13. Thatcher N, Chang A et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomized, placebo-controlled, multicenter study (ISEL). Lancet 2005; 366: 1527–37.
14. Cufer T, Vrdoljak E et al. Phase II, open-label, randomized study (SIGN) of single-agent gefitinib (Iressa) or docetaxel as second-line therapy in patients with advanced (stage IIIb or IV) non-small-cell lung cancer. Anticancer Drugs 2006; 17: 401–9.
15. Lee D, Kim S et al. A randomized open-label study of gefitinib versus docetaxel in patients with advanced/metastatic non-small-cell lung cancer who have previously received platinum-based chemotherapy. J Clin Oncol 2008; 26 (Suppl.) Аbstr. 8025.
16. Maruyama R, Nishiwaki Y et al. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese of gefitinib versus docetaxel in patients with non-small-cell lung cancer. J Clin Oncol 2008; 26: 4244–52.
17. Kim ES, Hirsh V et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomized phase III trial. Lancet 2008; 372: 1809–18.
18. Shepherd FA, Douillard J et al. Comparison of gefitinib and docetaxel in patients with pretreated advanced non-small-cell lung cancer: meta-analysis from four clinical trials. J Clin Oncol 2009; 27 (Suppl.) Аbstr. 8011.
19. Giaccone G, Herbst RS et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial – INTACT 1. J Clin Oncol 2004; 22: 777–84.
20. Herbst RS, Giaccone G et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial – INTACT 2. J Clin Oncol 2004; 22: 785–94.
21. Reck M, Buchholz E et al. Gefitinib monotherapy in chemotherapy-naïve patients with inoperable stage III/IV non-small-cell lung cancer. Clin Lung Cancer 2006; 7: 406–11.
22. Niho S, Kubota K et al. First-line single agent treatment with gefitinib in patients with advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 2006; 24: 64–9.
23. Crino L, Cappuzo F et al. Gefitinib versus vinorelbine in chemotherapy-naïve elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized phase II study. J Clin Oncol 2008; 26: 4253–60.
24. Asahina H, Yamazaki K et al. A phase II trial of gefitinib as first-line therapy for advanced non-small-cell lung cancer with epidermal growth factor receptor mutations. Br J Cancer 2006; 95: 998–1004.
25. Inoue A, Suzuki T et al. Prospective phase II study of gefitinib for in chemotherapy-naïve patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations. J Clin Oncol 2006; 24: 3340–6.
26. Sutani A, Nagai Y et al. Gefitinib for non-small-cell lung cancer patients with epidermal growth factor receptor gene mutations screened by peptide nucleic acid-locked nucleic acid PCR clamp. Br J Cancer 2006; 95: 1483–9.
27. Namura K, Okamoto I. Multicenter prospective phase II trial of gefitinib for advanced non-small-cell lung cancer with epidermal growth factor receptor mutations: results of the West Japan Thoracic Oncology Group trial (WJTOG0403). Br J Cancer 2008; 98: 907–14.
28. Sequist LV, Martins RG et al. First-line gefitinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations. J Clin Oncol 2008; 26: 2442–9. J Clin Oncol 2008; 26: 3472.
29. Mok T, Wu YL et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947–57.
30. Lee JS, Park K et al. Presented at World Conference on Lung Cancer. A randomized phase III study of gefitinib (IRESSA) versus standard chemotherapy (gemcitabine plus cisplatin) as a first-line treatment for never-smokers with advanced or metastatic adenocarcinoma of the lung. 2009. Abstr. PRS.4.
31. Mitsudomi T, Morita S et al. Gefitinib versus cisplatin plus docetaxel in patients with advanced non-small-cell lung cancer harboring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomized phase III trial. Lancet Oncol 2010; 11: 121–8.
32. Maemondo M, Inoue A et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010; 362: 2380–8.
33. Rosell R, Moran T et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009; 361: 958–67.
34. Ku GY, Haaland BA et al. Gefitinib vs. chemotherapy as first-line therapy in advanced non-small cell lung cancer: Meta-analysis of phase III trials. Lung Cancer 2011; 74: 469–73.
35. Shepherd FA, Rodrigues Pereira J et al. Erlotinib in previously treated non-small cell lung cancer. N Engl J Med 2005; 353: 123–32.
36. Yoshida T, Yamada K et al. Comparison of adverse events and efficacy between gefitinib and erlotinib in patients with non-small cell lung cancer. Med Oncol 2013; 30: 349.
37. Takeda M, Okamoto I et al. Successful treatment with erlotinib after gefitinib-related severe hepatotoxicity. J Clin Oncol 2010; 28: e273–4.
38. Kijima T, Shimizu T et al. Safe and successful treatment with erlotinib after gefitinib-induced hepatotoxicity. J Clin Oncol 2011; 29: e588–90.
39. Katayava T, Matsuo K et al. Effect of gefitinib on the survival of patients with recurrence of lung adenocarcinoma after surgery: A retrospective case-matching cohort study. Surgical Oncology 2010; 19: e144–9.
40. Goss GD, Lorimer I et al. A phase III randomized, double-blind, placebo controlled trial of the epidermal growth factor receptor inhibitor gefitinib in completely resected stage IB-IIIA non-small cell lung cancer (NSCLC): NCIC CTG BR.19. J Clin Oncol 2010; 28 (Suppl. 18). Abstr. no. LBA7005.
41. Kelly K, Chansky K et al. Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel concolidation in inoperable stage III non-small cell lung cancer: SWOG S0023. J Clin Oncol 2008; 26 (15): 2450–6.
42. Crino L, Capuzzo F et al. Gefitinib versus vinorelbine in chemotherapy-naïve elderly patients with advanced non-small cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol 2008; 26 (26): 4253–60.
43. Goss D, Ferry D et al. Randomized phase II study of gefitinib compared with placebo in chemotherapy-naïve elderly patients with advanced non-small cell lung cancer and poor performance status. J Clin Oncol 2009; 27 (13): 2253–60.
44. Leidner RS, Fu P et al. Genetic abnormalities of the EGFR pathway in African American Patients with non-small cell lung cancer J Clin Oncol 2009; 27: 5620–6.
2. Shiller JH, Harrington D et al. Comparison of four chemotherapy regimen for advanced non-small-cell lung cancer. N Engl J Med 2002; 346: 92–8.
3. Ohe Y, Ohashi Y et al. Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: four-arm cooperative study in Japan. Ann Oncol 2007; 18: 317–23.
4. Salomon DS, Brandt R et al. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995; 9: 183–232.
5. Lynch TJ, Bell DW 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.
6. Paez JG, Janne PA et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004; 304: 1497–500.
7. Toyooka S, Takano T et al. Epidermal growth factor receptor mutation, but not sex and smoking, is independently associated with favorable prognosis of gefitinib-treated patients with lung adenocarcinoma. Cancer Sci 2008; 99: 303–8.
8. Morita S, Okamoto I et al. Combined survival analysis of prospective clinical trials of gefitinib for non-small-cell lung cancer with EGFR mutations. Clin Cancer Res 2009; 15: 4493–8.
9. Mok T, Wu YL et al. Phase III randomized, open-label, first-line study of gefitinib vs carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer (IPASS). Ann Oncol 2008; 19 (Suppl. 8). LB.
10. Fukuoka M, Yano S et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 2003; 21: 2237–46.
11. Kris MG, Natale RB et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small-cell lung cancer: a randomized trial. JAMA 2003; 290: 2149–58.
12. Cohen MN, Williams GA et al. United States Food and Drug Administration drug approval summary: gefitinib (ZD 1839, Iressa) tablets. Clin Cancer Res 2004; 10: 1212–8.
13. Thatcher N, Chang A et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomized, placebo-controlled, multicenter study (ISEL). Lancet 2005; 366: 1527–37.
14. Cufer T, Vrdoljak E et al. Phase II, open-label, randomized study (SIGN) of single-agent gefitinib (Iressa) or docetaxel as second-line therapy in patients with advanced (stage IIIb or IV) non-small-cell lung cancer. Anticancer Drugs 2006; 17: 401–9.
15. Lee D, Kim S et al. A randomized open-label study of gefitinib versus docetaxel in patients with advanced/metastatic non-small-cell lung cancer who have previously received platinum-based chemotherapy. J Clin Oncol 2008; 26 (Suppl.) Аbstr. 8025.
16. Maruyama R, Nishiwaki Y et al. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese of gefitinib versus docetaxel in patients with non-small-cell lung cancer. J Clin Oncol 2008; 26: 4244–52.
17. Kim ES, Hirsh V et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomized phase III trial. Lancet 2008; 372: 1809–18.
18. Shepherd FA, Douillard J et al. Comparison of gefitinib and docetaxel in patients with pretreated advanced non-small-cell lung cancer: meta-analysis from four clinical trials. J Clin Oncol 2009; 27 (Suppl.) Аbstr. 8011.
19. Giaccone G, Herbst RS et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial – INTACT 1. J Clin Oncol 2004; 22: 777–84.
20. Herbst RS, Giaccone G et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial – INTACT 2. J Clin Oncol 2004; 22: 785–94.
21. Reck M, Buchholz E et al. Gefitinib monotherapy in chemotherapy-naïve patients with inoperable stage III/IV non-small-cell lung cancer. Clin Lung Cancer 2006; 7: 406–11.
22. Niho S, Kubota K et al. First-line single agent treatment with gefitinib in patients with advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 2006; 24: 64–9.
23. Crino L, Cappuzo F et al. Gefitinib versus vinorelbine in chemotherapy-naïve elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized phase II study. J Clin Oncol 2008; 26: 4253–60.
24. Asahina H, Yamazaki K et al. A phase II trial of gefitinib as first-line therapy for advanced non-small-cell lung cancer with epidermal growth factor receptor mutations. Br J Cancer 2006; 95: 998–1004.
25. Inoue A, Suzuki T et al. Prospective phase II study of gefitinib for in chemotherapy-naïve patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations. J Clin Oncol 2006; 24: 3340–6.
26. Sutani A, Nagai Y et al. Gefitinib for non-small-cell lung cancer patients with epidermal growth factor receptor gene mutations screened by peptide nucleic acid-locked nucleic acid PCR clamp. Br J Cancer 2006; 95: 1483–9.
27. Namura K, Okamoto I. Multicenter prospective phase II trial of gefitinib for advanced non-small-cell lung cancer with epidermal growth factor receptor mutations: results of the West Japan Thoracic Oncology Group trial (WJTOG0403). Br J Cancer 2008; 98: 907–14.
28. Sequist LV, Martins RG et al. First-line gefitinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations. J Clin Oncol 2008; 26: 2442–9. J Clin Oncol 2008; 26: 3472.
29. Mok T, Wu YL et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947–57.
30. Lee JS, Park K et al. Presented at World Conference on Lung Cancer. A randomized phase III study of gefitinib (IRESSA) versus standard chemotherapy (gemcitabine plus cisplatin) as a first-line treatment for never-smokers with advanced or metastatic adenocarcinoma of the lung. 2009. Abstr. PRS.4.
31. Mitsudomi T, Morita S et al. Gefitinib versus cisplatin plus docetaxel in patients with advanced non-small-cell lung cancer harboring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomized phase III trial. Lancet Oncol 2010; 11: 121–8.
32. Maemondo M, Inoue A et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010; 362: 2380–8.
33. Rosell R, Moran T et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009; 361: 958–67.
34. Ku GY, Haaland BA et al. Gefitinib vs. chemotherapy as first-line therapy in advanced non-small cell lung cancer: Meta-analysis of phase III trials. Lung Cancer 2011; 74: 469–73.
35. Shepherd FA, Rodrigues Pereira J et al. Erlotinib in previously treated non-small cell lung cancer. N Engl J Med 2005; 353: 123–32.
36. Yoshida T, Yamada K et al. Comparison of adverse events and efficacy between gefitinib and erlotinib in patients with non-small cell lung cancer. Med Oncol 2013; 30: 349.
37. Takeda M, Okamoto I et al. Successful treatment with erlotinib after gefitinib-related severe hepatotoxicity. J Clin Oncol 2010; 28: e273–4.
38. Kijima T, Shimizu T et al. Safe and successful treatment with erlotinib after gefitinib-induced hepatotoxicity. J Clin Oncol 2011; 29: e588–90.
39. Katayava T, Matsuo K et al. Effect of gefitinib on the survival of patients with recurrence of lung adenocarcinoma after surgery: A retrospective case-matching cohort study. Surgical Oncology 2010; 19: e144–9.
40. Goss GD, Lorimer I et al. A phase III randomized, double-blind, placebo controlled trial of the epidermal growth factor receptor inhibitor gefitinib in completely resected stage IB-IIIA non-small cell lung cancer (NSCLC): NCIC CTG BR.19. J Clin Oncol 2010; 28 (Suppl. 18). Abstr. no. LBA7005.
41. Kelly K, Chansky K et al. Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel concolidation in inoperable stage III non-small cell lung cancer: SWOG S0023. J Clin Oncol 2008; 26 (15): 2450–6.
42. Crino L, Capuzzo F et al. Gefitinib versus vinorelbine in chemotherapy-naïve elderly patients with advanced non-small cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol 2008; 26 (26): 4253–60.
43. Goss D, Ferry D et al. Randomized phase II study of gefitinib compared with placebo in chemotherapy-naïve elderly patients with advanced non-small cell lung cancer and poor performance status. J Clin Oncol 2009; 27 (13): 2253–60.
44. Leidner RS, Fu P et al. Genetic abnormalities of the EGFR pathway in African American Patients with non-small cell lung cancer J Clin Oncol 2009; 27: 5620–6.
Авторы
Л.В.Болотина
ФГБУ Московский научно-исследовательский онкологический институт им. П.А.Герцена Минздрава РФ
ФГБУ Московский научно-исследовательский онкологический институт им. П.А.Герцена Минздрава РФ
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