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Сравнение влияния афатиниба и осимертиниба на общую выживаемость в 1-й линии лекарственного лечения EGFR-положительного метастатического немелкоклеточного рака легкого: сетевой метаанализ
Сравнение влияния афатиниба и осимертиниба на общую выживаемость в 1-й линии лекарственного лечения EGFR-положительного метастатического немелкоклеточного рака легкого: сетевой метаанализ
Горяйнов С.В. Сравнение влияния афатиниба и осимертиниба на общую выживаемость в 1-й линии лекарственного лечения EGFR-положительного метастатического немелкоклеточного рака легкого: сетевой метаанализ. Современная Онкология. 2021; 23 (3). DOI: 10.26442/18151434.2021.3.201111
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Аннотация
Обоснование. Ингибиторы тирозинкиназы (ИТК) являются стандартом лечения EGFR-положительного метастатического немелкоклеточного рака легкого (мНМРЛ). Разные поколения ИТК отличаются по своим свойствам. Сейчас отсутствуют результаты прямых сравнительных клинических испытаний ИТК II поколения афатиниба и ИТК III поколения осимертиниба. В этой ситуации получить необходимые доказательства можно при помощи сетевого метаанализа.
Цель. Сравнить афатиниб и осимертиниб по влиянию на общую выживаемость (ОВ) в 1-й линии лекарственного лечения EGFR-положительного мНМРЛ.
Материалы и методы. Поиск исследований для построения сети доказательств проводился в базах Medline, CT.gov и EU-CTR. Конечной точкой являлась ОВ, представленная в виде относительного риска (ОР) смерти от всех причин. Исследование состояло из базового анализа и двух анализов чувствительности, выделенных на основании строгости критериев соблюдения допущения транзитивности. Сетевой метаанализ выполнен с использованием модели случайного эффекта. Результаты рассчитывались в общей популяции и подгруппах согласно типу EGFR-мутации, наличию метастазов в центральной нервной системе и баллу по шкале ECOG. Статистический анализ проводился в приложении R с использованием пакета netmeta.
Результаты. Всего для анализа отобрано 14 исследований. В общей популяции не имелось статистически значимой разницы между афатинибом и осимертинибом по влиянию на ОВ ни в основном анализе, ни в 1-м анализе чувствительности: ОР 1,06 [0,79; 1,41], p=0,697 и 1,08 [0,83; 1,41], p=0,561 соответственно. С ними согласовывались результаты сравнения ИТК II поколения в целом с осимертинибом во 2-м анализе чувствительности: ОР 1,03 [0,81; 1,31], p=834. Результаты анализа во всех подгруппах полностью согласовывались друг с другом и с анализом в общей популяции. Ни в одном из анализов в сети не было статистически значимой гетерогенности/рассогласованности.
Заключение. Афатиниб и осимертиниб обладают схожей эффективностью по влиянию на ОВ в 1-й линии лекарственного лечения EGFR-положительного мНМРЛ.
Ключевые слова: рак легкого, ингибиторы тирозинкиназы, выживаемость, афатиниб, осимертиниб
Aim. To compare afatinib and osimertinib effect on overall survival (OS) in first-line drug treatment of EGFR-positive mNSCLC.
Materials and methods. Search of trials to build evidence network was done in Medline, CT.gov, and EU-CTR. Endpoint was OS measured as hazard ratio (HR) of all-cause death. Analysis was split into base case analysis and two sensitivity analyses depending on criteria of transitivity. Random effect model was used for NMA. Results were analyzed in overall population and subgroups according to the type of EGFR-mutation, ECOG score, and presence of CNS metastases. Statistical analysis was done in R with netmeta package.
Results. Fourteen trials were included in the study. There was no statistically significant difference regarding OS between afatinib and osimertinib in overall population neither in base case nor in first sensitivity analysis: HR 1.06 [0.79; 1.41], p=0.697 and 1.08 [0.83; 1.41], p=0.561, respectively. Results of comparison of II generation TKIs against osimertinib in second sensitivity analysis were consistent: HR 1.03 [0.81; 1.31], p=0.834. Results in all subgroups were consistent with each other and overall population. There was no statistically significant heterogeneity/inconsistency in the network in any of the analyses.
Conclusion. Afatinib and osimertinib have similar efficacy regarding OS in first-line drug treatment of EGFR-positive mNSCLC.
Keywords: lung cancer, tyrosine kinase inhibitors, survival, afatinib, osimertinib
Цель. Сравнить афатиниб и осимертиниб по влиянию на общую выживаемость (ОВ) в 1-й линии лекарственного лечения EGFR-положительного мНМРЛ.
Материалы и методы. Поиск исследований для построения сети доказательств проводился в базах Medline, CT.gov и EU-CTR. Конечной точкой являлась ОВ, представленная в виде относительного риска (ОР) смерти от всех причин. Исследование состояло из базового анализа и двух анализов чувствительности, выделенных на основании строгости критериев соблюдения допущения транзитивности. Сетевой метаанализ выполнен с использованием модели случайного эффекта. Результаты рассчитывались в общей популяции и подгруппах согласно типу EGFR-мутации, наличию метастазов в центральной нервной системе и баллу по шкале ECOG. Статистический анализ проводился в приложении R с использованием пакета netmeta.
Результаты. Всего для анализа отобрано 14 исследований. В общей популяции не имелось статистически значимой разницы между афатинибом и осимертинибом по влиянию на ОВ ни в основном анализе, ни в 1-м анализе чувствительности: ОР 1,06 [0,79; 1,41], p=0,697 и 1,08 [0,83; 1,41], p=0,561 соответственно. С ними согласовывались результаты сравнения ИТК II поколения в целом с осимертинибом во 2-м анализе чувствительности: ОР 1,03 [0,81; 1,31], p=834. Результаты анализа во всех подгруппах полностью согласовывались друг с другом и с анализом в общей популяции. Ни в одном из анализов в сети не было статистически значимой гетерогенности/рассогласованности.
Заключение. Афатиниб и осимертиниб обладают схожей эффективностью по влиянию на ОВ в 1-й линии лекарственного лечения EGFR-положительного мНМРЛ.
Ключевые слова: рак легкого, ингибиторы тирозинкиназы, выживаемость, афатиниб, осимертиниб
________________________________________________
Aim. To compare afatinib and osimertinib effect on overall survival (OS) in first-line drug treatment of EGFR-positive mNSCLC.
Materials and methods. Search of trials to build evidence network was done in Medline, CT.gov, and EU-CTR. Endpoint was OS measured as hazard ratio (HR) of all-cause death. Analysis was split into base case analysis and two sensitivity analyses depending on criteria of transitivity. Random effect model was used for NMA. Results were analyzed in overall population and subgroups according to the type of EGFR-mutation, ECOG score, and presence of CNS metastases. Statistical analysis was done in R with netmeta package.
Results. Fourteen trials were included in the study. There was no statistically significant difference regarding OS between afatinib and osimertinib in overall population neither in base case nor in first sensitivity analysis: HR 1.06 [0.79; 1.41], p=0.697 and 1.08 [0.83; 1.41], p=0.561, respectively. Results of comparison of II generation TKIs against osimertinib in second sensitivity analysis were consistent: HR 1.03 [0.81; 1.31], p=0.834. Results in all subgroups were consistent with each other and overall population. There was no statistically significant heterogeneity/inconsistency in the network in any of the analyses.
Conclusion. Afatinib and osimertinib have similar efficacy regarding OS in first-line drug treatment of EGFR-positive mNSCLC.
Keywords: lung cancer, tyrosine kinase inhibitors, survival, afatinib, osimertinib
Полный текст
Список литературы
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2. Ripamonti F, Albano L, Rossini A, et al. EGFR Through STAT3 Modulates ΔN63α Expression to Sustain Tumor-Initiating Cell Proliferation in Squamous Cell Carcinomas. J Cell Physiol. 2013;228(4):871-8.
3. Rosell R, Moran T, Queralt C, et al. Screening for epidermal growth factor receptor mutations in Lung Cancer. N Engl J Med. 2009;361(10):958-67.
4. Zhang YL, Yuan JQ, Wan KF, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-93.
5. Park K, Tan EH, O'Byrne K, et al. Afatinib Versus Gefitinib as First-Line Treatment of Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer (LUX-Lung 7): A Phase 2B, Open-Label, Randomised Controlled Trial. Lancet Oncol. 2016;17(5):577-89.
6. Sequist LV, Yang JCH, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327-34.
7. Wu YL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(2):213-22.
8. Yang JCH, Wu YL, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16(2):141-51.
9. Paz-Ares L, Tan EH, O’Byrne K, et al. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017;28(2):270-7.
10. Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018;378(2):113-25.
11. Ramalingam SS, Vansteenkiste J, Planchard D, et al. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020;382(1):41-50.
12. Cheng Y, He Y, Li W, et al. Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. Target Oncol. 2021;16(2):165-76.
13. Han JY, Park K, Kim SW, et al. First-SIGNAL: first-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. J Clin Oncol. 2012;30(10):1122-8.
14. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361(10):947-57.
15. Satouchi M, Ichinose Y, Nishiwaki Y, et al. Final Analysis of Overall Survival (OS) in the IPASS, an International Multicenter Phase III Study on Gefitinib and Carboplatin Paclitaxel for Treatment-naïve NSCLC Patients. JJLC. 2012;52:153-60.
16. Yang J, Wu YL, Saijo N, et al. Efficacy Outcomes in First-line Treatment of Advanced NSCLC With Gefitinib (G) vs Carboplatin/paclitaxel (C/P) by Epidermal Growth Factor Receptor (EGFR) Gene-copy Number Score and by Most Common EGFR Mutation Subtypes − Exploratory Data From IPASS. Eur J Cancer. 2011;47(Suppl. 1):S633.
17. 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.
18. Inoue A, Kobayashi K, Maemondo M, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013;24(1):54-9.
19. Mitsudomi T, Morita S, Yatabe Y, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol. 2010;11(2):121-8.
20. Yoshioka H, Shimokawa M, Seto T, et al. Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell Lung Cancer. Ann Oncol. 2019;30(12):1978-84.
21. Wu YL, Zhou C, Liam CK, et al. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015;26(9):1883-9.
22. 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(3):239-46.
23. Khozin S, Blumenthal GM, Jiang X, et al. U.S. Food and Drug Administration Approval Summary: Erlotinib for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations. Oncologist. 2014;19(7):774-9.
24. Zhou С, Wu YL, Chen G, et al. Erlotinib versus 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(8):735-42.
25. Zhou C, Wu YL, Chen G, et al. Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced nonsmall-cell lung cancer (OPTIMAL, CTONG-0802). Ann Oncol. 2015;26:1877-83.
26. Shi YK, Wang L, Han BH, et al. First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study. Ann Oncol. 2017;28(10):2443-50.
27. Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454-66.
28. Mok TS, Cheng Y, Zhou X, et al. Updated Overall Survival in a Randomized Study Comparing Dacomitinib with Gefitinib as First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. Drugs. 2021;81(2):257-66.
29. Yang JJ, Zhou Q, Yan HH, et al. A phase III randomised controlled trial of erlotinib vs gefitinib in advanced non-small cell lung cancer with EGFR mutations. Br J Cancer. 2017;116(5):568-74.
30. Griesinger F, Korol EE, Kayaniyil S, et al. Efficacy and safety of first-line carboplatin-versus cisplatin-based chemotherapy for non-small cell lung cancer: A meta-analysis. Lung Cancer. 2019;135:196-204.
31. Vasconcellos VF, Marta GN, Mk da Silva E, et al. Cisplatin Versus Carboplatin in Combination With Third-Generation Drugs for Advanced Non-Small Cell Lung Cancer. Cochrane Database Syst Rev. 2020;1(1):CD009256.
32. Higgins JPT, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions. 2nd Edition. Chichester (UK): John Wiley & Sons, 2019; p. 285-320.
33. Steindl A, Yadavalli S, Gruber KA, et al. Neurological symptom burden impacts survival prognosis in patients with newly diagnosed non-small cell lung cancer brain metastases. Cancer. 2020;126(19):4341-52.
34. Holleman MS, Tinteren HV, Groen HJ, et al. First-line tyrosine kinase inhibitors in EGFR mutation-positive non-small-cell lung cancer: a network meta-analysis. Onco Targets Ther. 2019;12:1413-21.
35. Zhao Y, Liu J, Cai X, et al. Efficacy and safety of first line treatments for patients with advanced epidermal growth factor receptor mutated, non-small cell lung cancer: systematic review and network meta-analysis. BMJ. 2019;367:l5460.
36. Alanazi A, Yunusa I, Elenizi K, et al. Efficacy and safety of tyrosine kinase inhibitors in advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutation: a network meta-analysis. Lung Cancer Manag. 2020;10(1):LMT43.
37. Kuan FC, Kuo LT, Che MC, et al. Overall survival benefits of first-line EGFR tyrosine kinase inhibitors in EGFR-mutated non-small-cell lung cancers: a systematic review and meta-analysis. Br J Cancer. 2015;113(10):1519-28.
38. Shinno Y, Goto Y, Watanabe S, et al. Evaluation of time to failure of strategy as an alternative surrogate endpoint in patients with lung cancer with EGFR mutations. ESMO Open. 2018;3(7):e000399.
39. Lee CK, Davies L, Wu YL, et al. Gefitinib or Erlotinib vs Chemotherapy for EGFR Mutation-Positive Lung Cancer: Individual Patient Data Meta-Analysis of Overall Survival. J Natl Cancer Inst. 2017;109(6).
40. Hotta K, Suzuki E, Maio MD, et al. Progression-free survival and overall survival in phase III trials of molecular-targeted agents in advanced non-small-cell Lung Cancer. Lung Cancer. 2013;79(1):20-6.
41. Soria JC, Massard C, Le Chevalier T. Should progression-free survival be the primary measure of efficacy for advanced NSCLC therapy? Ann Oncol. 2010;21(12):2324-32.
42. Belin L, Tan A, De Rycke Y, et al. Progression-free survival as a surrogate for overall survival in oncology trials: a methodological systematic review. Br J Cancer. 2020;122(11):1707-14.
43. Hotte SJ, Bjarnason GA, Heng DYC, et al. Progression-free survival as a clinical trial endpoint in advanced renal cell carcinoma. Curr Oncol. 2011;18(Suppl. 2): S11-S19.
44. Johnson KR, Liauw W, Lassere MND. Evaluating surrogacy metrics and investigating approval decisions of progression-free survival (PFS) in metastatic renal cell cancer: a systematic review. Ann Oncol. 2015;26(3):485-96.
45. Yoon HY, Ryu JS, Sim YS, et al. Clinical significance of EGFR mutation types in lung adenocarcinoma: A multi-centre Korean study. PLoS One. 2020;15(2):e0228925.
2. Ripamonti F, Albano L, Rossini A, et al. EGFR Through STAT3 Modulates ΔN63α Expression to Sustain Tumor-Initiating Cell Proliferation in Squamous Cell Carcinomas. J Cell Physiol. 2013;228(4):871-8.
3. Rosell R, Moran T, Queralt C, et al. Screening for epidermal growth factor receptor mutations in Lung Cancer. N Engl J Med. 2009;361(10):958-67.
4. Zhang YL, Yuan JQ, Wan KF, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-93.
5. Park K, Tan EH, O'Byrne K, et al. Afatinib Versus Gefitinib as First-Line Treatment of Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer (LUX-Lung 7): A Phase 2B, Open-Label, Randomised Controlled Trial. Lancet Oncol. 2016;17(5):577-89.
6. Sequist LV, Yang JCH, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327-34.
7. Wu YL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(2):213-22.
8. Yang JCH, Wu YL, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16(2):141-51.
9. Paz-Ares L, Tan EH, O’Byrne K, et al. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017;28(2):270-7.
10. Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018;378(2):113-25.
11. Ramalingam SS, Vansteenkiste J, Planchard D, et al. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020;382(1):41-50.
12. Cheng Y, He Y, Li W, et al. Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. Target Oncol. 2021;16(2):165-76.
13. Han JY, Park K, Kim SW, et al. First-SIGNAL: first-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. J Clin Oncol. 2012;30(10):1122-8.
14. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361(10):947-57.
15. Satouchi M, Ichinose Y, Nishiwaki Y, et al. Final Analysis of Overall Survival (OS) in the IPASS, an International Multicenter Phase III Study on Gefitinib and Carboplatin Paclitaxel for Treatment-naïve NSCLC Patients. JJLC. 2012;52:153-60.
16. Yang J, Wu YL, Saijo N, et al. Efficacy Outcomes in First-line Treatment of Advanced NSCLC With Gefitinib (G) vs Carboplatin/paclitaxel (C/P) by Epidermal Growth Factor Receptor (EGFR) Gene-copy Number Score and by Most Common EGFR Mutation Subtypes − Exploratory Data From IPASS. Eur J Cancer. 2011;47(Suppl. 1):S633.
17. 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.
18. Inoue A, Kobayashi K, Maemondo M, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013;24(1):54-9.
19. Mitsudomi T, Morita S, Yatabe Y, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol. 2010;11(2):121-8.
20. Yoshioka H, Shimokawa M, Seto T, et al. Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell Lung Cancer. Ann Oncol. 2019;30(12):1978-84.
21. Wu YL, Zhou C, Liam CK, et al. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015;26(9):1883-9.
22. 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(3):239-46.
23. Khozin S, Blumenthal GM, Jiang X, et al. U.S. Food and Drug Administration Approval Summary: Erlotinib for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations. Oncologist. 2014;19(7):774-9.
24. Zhou С, Wu YL, Chen G, et al. Erlotinib versus 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(8):735-42.
25. Zhou C, Wu YL, Chen G, et al. Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced nonsmall-cell lung cancer (OPTIMAL, CTONG-0802). Ann Oncol. 2015;26:1877-83.
26. Shi YK, Wang L, Han BH, et al. First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study. Ann Oncol. 2017;28(10):2443-50.
27. Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454-66.
28. Mok TS, Cheng Y, Zhou X, et al. Updated Overall Survival in a Randomized Study Comparing Dacomitinib with Gefitinib as First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. Drugs. 2021;81(2):257-66.
29. Yang JJ, Zhou Q, Yan HH, et al. A phase III randomised controlled trial of erlotinib vs gefitinib in advanced non-small cell lung cancer with EGFR mutations. Br J Cancer. 2017;116(5):568-74.
30. Griesinger F, Korol EE, Kayaniyil S, et al. Efficacy and safety of first-line carboplatin-versus cisplatin-based chemotherapy for non-small cell lung cancer: A meta-analysis. Lung Cancer. 2019;135:196-204.
31. Vasconcellos VF, Marta GN, Mk da Silva E, et al. Cisplatin Versus Carboplatin in Combination With Third-Generation Drugs for Advanced Non-Small Cell Lung Cancer. Cochrane Database Syst Rev. 2020;1(1):CD009256.
32. Higgins JPT, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions. 2nd Edition. Chichester (UK): John Wiley & Sons, 2019; p. 285-320.
33. Steindl A, Yadavalli S, Gruber KA, et al. Neurological symptom burden impacts survival prognosis in patients with newly diagnosed non-small cell lung cancer brain metastases. Cancer. 2020;126(19):4341-52.
34. Holleman MS, Tinteren HV, Groen HJ, et al. First-line tyrosine kinase inhibitors in EGFR mutation-positive non-small-cell lung cancer: a network meta-analysis. Onco Targets Ther. 2019;12:1413-21.
35. Zhao Y, Liu J, Cai X, et al. Efficacy and safety of first line treatments for patients with advanced epidermal growth factor receptor mutated, non-small cell lung cancer: systematic review and network meta-analysis. BMJ. 2019;367:l5460.
36. Alanazi A, Yunusa I, Elenizi K, et al. Efficacy and safety of tyrosine kinase inhibitors in advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutation: a network meta-analysis. Lung Cancer Manag. 2020;10(1):LMT43.
37. Kuan FC, Kuo LT, Che MC, et al. Overall survival benefits of first-line EGFR tyrosine kinase inhibitors in EGFR-mutated non-small-cell lung cancers: a systematic review and meta-analysis. Br J Cancer. 2015;113(10):1519-28.
38. Shinno Y, Goto Y, Watanabe S, et al. Evaluation of time to failure of strategy as an alternative surrogate endpoint in patients with lung cancer with EGFR mutations. ESMO Open. 2018;3(7):e000399.
39. Lee CK, Davies L, Wu YL, et al. Gefitinib or Erlotinib vs Chemotherapy for EGFR Mutation-Positive Lung Cancer: Individual Patient Data Meta-Analysis of Overall Survival. J Natl Cancer Inst. 2017;109(6).
40. Hotta K, Suzuki E, Maio MD, et al. Progression-free survival and overall survival in phase III trials of molecular-targeted agents in advanced non-small-cell Lung Cancer. Lung Cancer. 2013;79(1):20-6.
41. Soria JC, Massard C, Le Chevalier T. Should progression-free survival be the primary measure of efficacy for advanced NSCLC therapy? Ann Oncol. 2010;21(12):2324-32.
42. Belin L, Tan A, De Rycke Y, et al. Progression-free survival as a surrogate for overall survival in oncology trials: a methodological systematic review. Br J Cancer. 2020;122(11):1707-14.
43. Hotte SJ, Bjarnason GA, Heng DYC, et al. Progression-free survival as a clinical trial endpoint in advanced renal cell carcinoma. Curr Oncol. 2011;18(Suppl. 2): S11-S19.
44. Johnson KR, Liauw W, Lassere MND. Evaluating surrogacy metrics and investigating approval decisions of progression-free survival (PFS) in metastatic renal cell cancer: a systematic review. Ann Oncol. 2015;26(3):485-96.
45. Yoon HY, Ryu JS, Sim YS, et al. Clinical significance of EGFR mutation types in lung adenocarcinoma: A multi-centre Korean study. PLoS One. 2020;15(2):e0228925.
________________________________________________
2. Ripamonti F, Albano L, Rossini A, et al. EGFR Through STAT3 Modulates ΔN63α Expression to Sustain Tumor-Initiating Cell Proliferation in Squamous Cell Carcinomas. J Cell Physiol. 2013;228(4):871-8.
3. Rosell R, Moran T, Queralt C, et al. Screening for epidermal growth factor receptor mutations in Lung Cancer. N Engl J Med. 2009;361(10):958-67.
4. Zhang YL, Yuan JQ, Wan KF, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-93.
5. Park K, Tan EH, O'Byrne K, et al. Afatinib Versus Gefitinib as First-Line Treatment of Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer (LUX-Lung 7): A Phase 2B, Open-Label, Randomised Controlled Trial. Lancet Oncol. 2016;17(5):577-89.
6. Sequist LV, Yang JCH, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327-34.
7. Wu YL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(2):213-22.
8. Yang JCH, Wu YL, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16(2):141-51.
9. Paz-Ares L, Tan EH, O’Byrne K, et al. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017;28(2):270-7.
10. Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018;378(2):113-25.
11. Ramalingam SS, Vansteenkiste J, Planchard D, et al. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020;382(1):41-50.
12. Cheng Y, He Y, Li W, et al. Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. Target Oncol. 2021;16(2):165-76.
13. Han JY, Park K, Kim SW, et al. First-SIGNAL: first-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. J Clin Oncol. 2012;30(10):1122-8.
14. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361(10):947-57.
15. Satouchi M, Ichinose Y, Nishiwaki Y, et al. Final Analysis of Overall Survival (OS) in the IPASS, an International Multicenter Phase III Study on Gefitinib and Carboplatin Paclitaxel for Treatment-naïve NSCLC Patients. JJLC. 2012;52:153-60.
16. Yang J, Wu YL, Saijo N, et al. Efficacy Outcomes in First-line Treatment of Advanced NSCLC With Gefitinib (G) vs Carboplatin/paclitaxel (C/P) by Epidermal Growth Factor Receptor (EGFR) Gene-copy Number Score and by Most Common EGFR Mutation Subtypes − Exploratory Data From IPASS. Eur J Cancer. 2011;47(Suppl. 1):S633.
17. 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.
18. Inoue A, Kobayashi K, Maemondo M, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013;24(1):54-9.
19. Mitsudomi T, Morita S, Yatabe Y, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol. 2010;11(2):121-8.
20. Yoshioka H, Shimokawa M, Seto T, et al. Final overall survival results of WJTOG3405, a randomized phase III trial comparing gefitinib versus cisplatin with docetaxel as the first-line treatment for patients with stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell Lung Cancer. Ann Oncol. 2019;30(12):1978-84.
21. Wu YL, Zhou C, Liam CK, et al. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015;26(9):1883-9.
22. 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(3):239-46.
23. Khozin S, Blumenthal GM, Jiang X, et al. U.S. Food and Drug Administration Approval Summary: Erlotinib for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations. Oncologist. 2014;19(7):774-9.
24. Zhou С, Wu YL, Chen G, et al. Erlotinib versus 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(8):735-42.
25. Zhou C, Wu YL, Chen G, et al. Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced nonsmall-cell lung cancer (OPTIMAL, CTONG-0802). Ann Oncol. 2015;26:1877-83.
26. Shi YK, Wang L, Han BH, et al. First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study. Ann Oncol. 2017;28(10):2443-50.
27. Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454-66.
28. Mok TS, Cheng Y, Zhou X, et al. Updated Overall Survival in a Randomized Study Comparing Dacomitinib with Gefitinib as First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. Drugs. 2021;81(2):257-66.
29. Yang JJ, Zhou Q, Yan HH, et al. A phase III randomised controlled trial of erlotinib vs gefitinib in advanced non-small cell lung cancer with EGFR mutations. Br J Cancer. 2017;116(5):568-74.
30. Griesinger F, Korol EE, Kayaniyil S, et al. Efficacy and safety of first-line carboplatin-versus cisplatin-based chemotherapy for non-small cell lung cancer: A meta-analysis. Lung Cancer. 2019;135:196-204.
31. Vasconcellos VF, Marta GN, Mk da Silva E, et al. Cisplatin Versus Carboplatin in Combination With Third-Generation Drugs for Advanced Non-Small Cell Lung Cancer. Cochrane Database Syst Rev. 2020;1(1):CD009256.
32. Higgins JPT, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions. 2nd Edition. Chichester (UK): John Wiley & Sons, 2019; p. 285-320.
33. Steindl A, Yadavalli S, Gruber KA, et al. Neurological symptom burden impacts survival prognosis in patients with newly diagnosed non-small cell lung cancer brain metastases. Cancer. 2020;126(19):4341-52.
34. Holleman MS, Tinteren HV, Groen HJ, et al. First-line tyrosine kinase inhibitors in EGFR mutation-positive non-small-cell lung cancer: a network meta-analysis. Onco Targets Ther. 2019;12:1413-21.
35. Zhao Y, Liu J, Cai X, et al. Efficacy and safety of first line treatments for patients with advanced epidermal growth factor receptor mutated, non-small cell lung cancer: systematic review and network meta-analysis. BMJ. 2019;367:l5460.
36. Alanazi A, Yunusa I, Elenizi K, et al. Efficacy and safety of tyrosine kinase inhibitors in advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutation: a network meta-analysis. Lung Cancer Manag. 2020;10(1):LMT43.
37. Kuan FC, Kuo LT, Che MC, et al. Overall survival benefits of first-line EGFR tyrosine kinase inhibitors in EGFR-mutated non-small-cell lung cancers: a systematic review and meta-analysis. Br J Cancer. 2015;113(10):1519-28.
38. Shinno Y, Goto Y, Watanabe S, et al. Evaluation of time to failure of strategy as an alternative surrogate endpoint in patients with lung cancer with EGFR mutations. ESMO Open. 2018;3(7):e000399.
39. Lee CK, Davies L, Wu YL, et al. Gefitinib or Erlotinib vs Chemotherapy for EGFR Mutation-Positive Lung Cancer: Individual Patient Data Meta-Analysis of Overall Survival. J Natl Cancer Inst. 2017;109(6).
40. Hotta K, Suzuki E, Maio MD, et al. Progression-free survival and overall survival in phase III trials of molecular-targeted agents in advanced non-small-cell Lung Cancer. Lung Cancer. 2013;79(1):20-6.
41. Soria JC, Massard C, Le Chevalier T. Should progression-free survival be the primary measure of efficacy for advanced NSCLC therapy? Ann Oncol. 2010;21(12):2324-32.
42. Belin L, Tan A, De Rycke Y, et al. Progression-free survival as a surrogate for overall survival in oncology trials: a methodological systematic review. Br J Cancer. 2020;122(11):1707-14.
43. Hotte SJ, Bjarnason GA, Heng DYC, et al. Progression-free survival as a clinical trial endpoint in advanced renal cell carcinoma. Curr Oncol. 2011;18(Suppl. 2): S11-S19.
44. Johnson KR, Liauw W, Lassere MND. Evaluating surrogacy metrics and investigating approval decisions of progression-free survival (PFS) in metastatic renal cell cancer: a systematic review. Ann Oncol. 2015;26(3):485-96.
45. Yoon HY, Ryu JS, Sim YS, et al. Clinical significance of EGFR mutation types in lung adenocarcinoma: A multi-centre Korean study. PLoS One. 2020;15(2):e0228925.
Авторы
С.В. Горяйнов*
ООО «Берингер Ингельхайм», Москва, Россия
*sergey.goryaynov@gmail.com
Boehringer Ingelheim LLC, Russia, Moscow
*sergey.goryaynov@gmail.com
ООО «Берингер Ингельхайм», Москва, Россия
*sergey.goryaynov@gmail.com
________________________________________________
Boehringer Ingelheim LLC, Russia, Moscow
*sergey.goryaynov@gmail.com
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.