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Терапия гефитинибом в сравнении с доцетакселом у пациентов с НМКРЛ, ранее получавших терапию: рандомизированное исследование III фазы (INTEREST) новые данные о лечении немелкоклеточного рака легкого
Терапия гефитинибом в сравнении с доцетакселом у пациентов с НМКРЛ, ранее получавших терапию: рандомизированное исследование III фазы (INTEREST) новые данные о лечении немелкоклеточного рака легкого
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Аннотация
Расширенный реферат
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Список литературы
1. Parkin M, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005; 55: 74–108.
2. Jemal A, Siegel R, Ward E et al. Cancer statistics, 2007. CA Cancer J Clin 2007; 57: 43–66.
3. Shepherd FA, Dancey J, Ramlau R et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000; 18: 2095–103.
4. Fossella FV, Devore R, Kerr RN et al. Randomized phase III trial of docetaxel versus vinorelbine or infosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol 2000; 18: 2354–62.
5. Hanna N, Shepherd FA, Fossella FV et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004; 22: 1589–97.
6. Cufer T, Vrdoljak E, Caafar R 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.
7. Herbst RS, Fukuoka M, Baselga J. Gefitinib – a novel targeted approach to treating cancer. Nat Rev Cancer 2004; 4: 956–65.
8. Shepherd FA, Rodrigues PJ, Ciuleanu T et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005; 353: 123–32.
9. Fukuoka M, Yano S, Giaccone G 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.
10. Kris MG, Natale RB, Herbst RS 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.
11. Maruyama R, Nishiwaki Y, Tamura T et al. Phase III study, V-15–32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol 2008; 26: 4244–52.
12. Thatcher N, Chang A, Parikh P et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results form a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005; 366: 1527–37.
13. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205–16.
14. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31: 103–15.
15. Cella DF, Tulsky DS, Gray G et al. The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol 1993; 11: 570–9.
16. Cella DF, Bonomi AE, Lloyd SR et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer 1995; 12: 199–220.
17. Cella D, Eton DT, Fairclough DL et al. What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results form Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol 2002; 55:285–95.
18. Cancer Therapy Evaluation Program. Common Toxicity Criteria, 1999. http://ctep.cancer.gov/forms/CTCv20_4–30–992.pdf (accessed Dec 10, 2007).
19. Cappuzzo F, Varella-Garcia M, Shigematsu H et al. Increased HER2 gene copy number is asociated with response to gefitinib therapy in epidermal growth factor receptor-positive non-small-sell lung cancer patients. J Clin Oncol 2005; 23: 5007–18.
20. 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.,
21. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988; 75: 800–2.
22. Rothmann M, Li N, Chen G et al. Design and analysis of non-inferiority mortality trials in oncology. Stat Med 2003; 22: 239–64.
23. The International Conference on Harmonisation (ICH) guidelines. Statistical principles for clinical trials. The Internation.pdf (accessed Nov al Conference on Harmonisation (ICH), 1998. http://www.ich.org/LOB/media/MEDIA485.pdf (accessed Nov 29, 2007.
24. Lynch TJ, Bell DW, Sordell R et al. Activating mutations in the epidermal growht factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350: 2129–39.
25. Tsao M-S, Sakurada A, Cutz J-C et al. Erlotinib in lung cancer – molecular and clinical predictors of outcome. N Engl J Med 2005; 353: 133–44.
26. Pao W, Wang TY, Riely GJ et al. KRAS mutations and primary resistance of lung adenocarcinomas to gefitinib or erlotinib. PLoS Med 2005; e17.
27. Eberhard DA, Johnson BE, Amler LC et al. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell jung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol 2005; 23: 5856–8.
28. Hirsch FR, Varella-Garcia M, Bunn PA et al. Epidermal growth factor receptor in non-small-cell lung carcinomas: correlation between gene copy number and protein expression and impact on prognosis. J Clin Oncol 2003; 21: 3798–807.
2. Jemal A, Siegel R, Ward E et al. Cancer statistics, 2007. CA Cancer J Clin 2007; 57: 43–66.
3. Shepherd FA, Dancey J, Ramlau R et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000; 18: 2095–103.
4. Fossella FV, Devore R, Kerr RN et al. Randomized phase III trial of docetaxel versus vinorelbine or infosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol 2000; 18: 2354–62.
5. Hanna N, Shepherd FA, Fossella FV et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004; 22: 1589–97.
6. Cufer T, Vrdoljak E, Caafar R 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.
7. Herbst RS, Fukuoka M, Baselga J. Gefitinib – a novel targeted approach to treating cancer. Nat Rev Cancer 2004; 4: 956–65.
8. Shepherd FA, Rodrigues PJ, Ciuleanu T et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005; 353: 123–32.
9. Fukuoka M, Yano S, Giaccone G 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.
10. Kris MG, Natale RB, Herbst RS 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.
11. Maruyama R, Nishiwaki Y, Tamura T et al. Phase III study, V-15–32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol 2008; 26: 4244–52.
12. Thatcher N, Chang A, Parikh P et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results form a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005; 366: 1527–37.
13. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205–16.
14. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975; 31: 103–15.
15. Cella DF, Tulsky DS, Gray G et al. The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol 1993; 11: 570–9.
16. Cella DF, Bonomi AE, Lloyd SR et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer 1995; 12: 199–220.
17. Cella D, Eton DT, Fairclough DL et al. What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results form Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol 2002; 55:285–95.
18. Cancer Therapy Evaluation Program. Common Toxicity Criteria, 1999. http://ctep.cancer.gov/forms/CTCv20_4–30–992.pdf (accessed Dec 10, 2007).
19. Cappuzzo F, Varella-Garcia M, Shigematsu H et al. Increased HER2 gene copy number is asociated with response to gefitinib therapy in epidermal growth factor receptor-positive non-small-sell lung cancer patients. J Clin Oncol 2005; 23: 5007–18.
20. 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.,
21. Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988; 75: 800–2.
22. Rothmann M, Li N, Chen G et al. Design and analysis of non-inferiority mortality trials in oncology. Stat Med 2003; 22: 239–64.
23. The International Conference on Harmonisation (ICH) guidelines. Statistical principles for clinical trials. The Internation.pdf (accessed Nov al Conference on Harmonisation (ICH), 1998. http://www.ich.org/LOB/media/MEDIA485.pdf (accessed Nov 29, 2007.
24. Lynch TJ, Bell DW, Sordell R et al. Activating mutations in the epidermal growht factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350: 2129–39.
25. Tsao M-S, Sakurada A, Cutz J-C et al. Erlotinib in lung cancer – molecular and clinical predictors of outcome. N Engl J Med 2005; 353: 133–44.
26. Pao W, Wang TY, Riely GJ et al. KRAS mutations and primary resistance of lung adenocarcinomas to gefitinib or erlotinib. PLoS Med 2005; e17.
27. Eberhard DA, Johnson BE, Amler LC et al. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell jung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol 2005; 23: 5856–8.
28. Hirsch FR, Varella-Garcia M, Bunn PA et al. Epidermal growth factor receptor in non-small-cell lung carcinomas: correlation between gene copy number and protein expression and impact on prognosis. J Clin Oncol 2003; 21: 3798–807.
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