메뉴 건너뛰기




Volumn 9, Issue 10, 2014, Pages 1443-1448

Consensus report of a joint NCI Thoracic Malignancies Steering Committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "Master Protocols" in lung cancer

Author keywords

NCI FDA workshop leading to the inception of "Master Protocols" in lung cancer

Indexed keywords

ANAPLASTIC LYMPHOMA KINASE; BEVACIZUMAB; CISPLATIN; CRIZOTINIB; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; GEMCITABINE; TUMOR MARKER;

EID: 84907972945     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0000000000000314     Document Type: Article
Times cited : (22)

References (33)
  • 1
    • 79958043675 scopus 로고    scopus 로고
    • National Cancer Institute. Bethesda, MD, based on November SEER data submission. Accessed April 2014
    • Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2011, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975-2011/, based on November 2013 SEER data submission. Accessed April 2014.
    • (2013) SEER Cancer Statistics Review, 1975-2011
    • Howlader, N.1    Noone, A.M.2    Krapcho, M.3
  • 2
    • 84857969863 scopus 로고    scopus 로고
    • Chipping away at the lung cancer genome
    • Pao W, Hutchinson KE. Chipping away at the lung cancer genome. Nat Med 2012;18:349-351.
    • (2012) Nat Med , vol.18 , pp. 349-351
    • Pao, W.1    Hutchinson, K.E.2
  • 3
    • 61449134248 scopus 로고    scopus 로고
    • Rapidly rising clinical trial costs worry researchers
    • Collier R. Rapidly rising clinical trial costs worry researchers. CMAJ 2009;180:277-278.
    • (2009) CMAJ , vol.180 , pp. 277-278
    • Collier, R.1
  • 4
    • 27544503230 scopus 로고    scopus 로고
    • Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer)
    • 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 from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005;366:1527-1537.
    • (2005) Lancet , vol.366 , pp. 1527-1537
    • Thatcher, N.1    Chang, A.2    Parikh, P.3
  • 5
    • 84860120032 scopus 로고    scopus 로고
    • Why do phase III clinical trials in oncology fail so often?
    • Laleh A-K, Tito F. Why do phase III clinical trials in oncology fail so often? J Natl Cancer Inst 2012;104:568-569.
    • (2012) J Natl Cancer Inst , vol.104 , pp. 568-569
    • Laleh, A.-K.1    Tito, F.2
  • 6
    • 51649085832 scopus 로고    scopus 로고
    • Randomized, phase III clinical trial designs for targeted agents
    • Hoering A, LeBlanc M, Crowley J. Randomized, phase III clinical trial designs for targeted agents. Clin Cancer Res 2008; 14:4358-4367.
    • (2008) Clin Cancer Res , vol.14 , pp. 4358-4367
    • Hoering, A.1    LeBlanc, M.2    Crowley, J.3
  • 7
    • 14644437012 scopus 로고    scopus 로고
    • Food and Drug Administration regulation of in vitro diagnostic devices
    • Mansfield E, O'Leary TJ, Gutman SI. Food and Drug Administration regulation of in vitro diagnostic devices. J Mol Diagn 2005;7:2-7.
    • (2005) J Mol Diagn , vol.7 , pp. 2-7
    • Mansfield, E.1    O'Leary, T.J.2    Gutman, S.I.3
  • 8
    • 77449127150 scopus 로고    scopus 로고
    • Sources of bias in specimens for research about molecular markers for cancer
    • Ransohoff DF, Gourlay ML. Sources of bias in specimens for research about molecular markers for cancer. J Clin Oncol 2010;28:698-704.
    • (2010) J Clin Oncol , vol.28 , pp. 698-704
    • Ransohoff, D.F.1    Gourlay, M.L.2
  • 9
    • 69849108427 scopus 로고    scopus 로고
    • Clinical trial designs for predictive biomarker validation: Theoretical considerations and practical challenges
    • Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol 2009;27:4027-4034.
    • (2009) J Clin Oncol , vol.27 , pp. 4027-4034
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 10
    • 76349100026 scopus 로고    scopus 로고
    • Randomized clinical trials with biomarkers design issues
    • Freidlin B, McShane LM, Korn EL. Randomized clinical trials with biomarkers design issues. J Natl Cancer Inst 2010;102:152-160.
    • (2010) J Natl Cancer Inst , vol.102 , pp. 152-160
    • Freidlin, B.1    McShane, L.M.2    Korn, E.L.3
  • 12
    • 84895905845 scopus 로고    scopus 로고
    • Biomarker enrichment strategies: Matching trial design to biomarker credentials
    • Freidlin B, Korn EL. Biomarker enrichment strategies: matching trial design to biomarker credentials. Nat Rev Clin Oncol 2014;11:81-90.
    • (2014) Nat Rev Clin Oncol , vol.11 , pp. 81-90
    • Freidlin, B.1    Korn, E.L.2
  • 13
    • 84879071011 scopus 로고    scopus 로고
    • Crizotinib versus chemotherapy in advanced ALK-positive lung cancer
    • Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013;368:2385-2394.
    • (2013) N Engl J Med , vol.368 , pp. 2385-2394
    • Shaw, A.T.1    Kim, D.W.2    Nakagawa, K.3
  • 14
    • 22044445517 scopus 로고    scopus 로고
    • Erlotinib in previously treated non-small-cell lung cancer
    • Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al.; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005;353:123-132.
    • (2005) N Engl J Med , vol.353 , pp. 123-132
    • Shepherd, F.A.1    Rodrigues Pereira, J.2    Ciuleanu, T.3
  • 15
    • 34447573875 scopus 로고    scopus 로고
    • Customizing cisplatin based on quantitative excision repair cross-complementing 1 mRNA expression: A phase III trial in non-small-cell lung cancer
    • Cobo M, Isla D, Massuti B, et al. Customizing cisplatin based on quantitative excision repair cross-complementing 1 mRNA expression: a phase III trial in non-small-cell lung cancer. J Clin Oncol 2007;25:2747-2754.
    • (2007) J Clin Oncol , vol.25 , pp. 2747-2754
    • Cobo, M.1    Isla, D.2    Massuti, B.3
  • 16
    • 79959337566 scopus 로고    scopus 로고
    • Rationale for treatment and study design of tailor: A randomized phase III trial of second-line erlotinib versus docetaxel in the treatment of patients affected by advanced non-small-cell lung cancer with the absence of epidermal growth factor receptor mutations
    • Farina G, Longo F, Martelli O, et al. Rationale for treatment and study design of tailor: a randomized phase III trial of second-line erlotinib versus docetaxel in the treatment of patients affected by advanced non-small-cell lung cancer with the absence of epidermal growth factor receptor mutations. Clin Lung Cancer 2011;12:138-141.
    • (2011) Clin Lung Cancer , vol.12 , pp. 138-141
    • Farina, G.1    Longo, F.2    Martelli, O.3
  • 17
    • 74549207384 scopus 로고    scopus 로고
    • The cross-validated adaptive signature design
    • Freidlin B, Jiang W, Simon R. The cross-validated adaptive signature design. Clin Cancer Res 2010;16:691-698.
    • (2010) Clin Cancer Res , vol.16 , pp. 691-698
    • Freidlin, B.1    Jiang, W.2    Simon, R.3
  • 18
    • 79957857433 scopus 로고    scopus 로고
    • The BATTLE trial: Personalizing therapy for lung cancer
    • Kim ES, Herbst RS, Wistuba II, et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov 2011;1:44-53.
    • (2011) Cancer Discov , vol.1 , pp. 44-53
    • Kim, E.S.1    Herbst, R.S.2    Wistuba, I.I.3
  • 19
    • 67650652432 scopus 로고    scopus 로고
    • I-SPY 2: An adaptive breast cancer trial in the setting of neoadjuvant chemotherapy
    • Barker AD, Sigman CC, Kelloff GJ et al. I-SPY 2: an adaptive breast cancer trial in the setting of neoadjuvant chemotherapy. Clin Pharm Therap 2009;86:97-100.
    • (2009) Clin Pharm Therap , vol.86 , pp. 97-100
    • Barker, A.D.1    Sigman, C.C.2    Kelloff, G.J.3
  • 20
    • 78650339993 scopus 로고    scopus 로고
    • Outcome-adaptive randomization: Is it useful?
    • Korn EL, Freidlin B. Outcome-adaptive randomization: Is it useful? J Clin Oncol 2011;29:771-776.
    • (2011) J Clin Oncol , vol.29 , pp. 771-776
    • Korn, E.L.1    Freidlin, B.2
  • 21
    • 79955599186 scopus 로고    scopus 로고
    • On the usefulness of outcome-adaptive randomization
    • Korn EL, Freidlin B. On the usefulness of outcome-adaptive randomization. J Clin Oncol 2011;29: e393.
    • (2011) J Clin Oncol , vol.29 , pp. e393
    • Korn, E.L.1    Freidlin, B.2
  • 22
    • 79959280313 scopus 로고    scopus 로고
    • Overall survival as the outcome for randomized clinical trials with effective subsequent therapies
    • Korn EL, Freidlin B, Abrams JS. Overall survival as the outcome for randomized clinical trials with effective subsequent therapies. J Clin Oncol 2011;29:2439-2442.
    • (2011) J Clin Oncol , vol.29 , pp. 2439-2442
    • Korn, E.L.1    Freidlin, B.2    Abrams, J.S.3
  • 24
    • 70449420123 scopus 로고    scopus 로고
    • Use of archived specimens in evaluation of prognostic and predictive biomarkers
    • Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst 2009;101:1446-1452.
    • (2009) J Natl Cancer Inst , vol.101 , pp. 1446-1452
    • Simon, R.M.1    Paik, S.2    Hayes, D.F.3
  • 25
    • 84896537994 scopus 로고    scopus 로고
    • FDA perspective on companion diagnostics: An evolving paradigm
    • Mansfield EA. FDA perspective on companion diagnostics: an evolving paradigm. Clin Cancer Res 2014;20:1453-1457.
    • (2014) Clin Cancer Res , vol.20 , pp. 1453-1457
    • Mansfield, E.A.1
  • 27
    • 33845490014 scopus 로고    scopus 로고
    • Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer
    • Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006;355:2542-2550.
    • (2006) N Engl J Med , vol.355 , pp. 2542-2550
    • Sandler, A.1    Gray, R.2    Perry, M.C.3
  • 28
    • 0142055937 scopus 로고    scopus 로고
    • Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer
    • Kris M G, Natale R B, Herbst R S et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer JAMA 2003;290:2149-2158.
    • (2003) JAMA , vol.290 , pp. 2149-2158
    • Kris, M.G.1    Natale, R.B.2    Herbst, R.S.3
  • 29
    • 22044445517 scopus 로고    scopus 로고
    • Erlotinib in previously treated non-small-cell lung cancer
    • Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al.; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005;353:123-132.
    • (2005) N Engl J Med , vol.353 , pp. 123-132
    • Shepherd, F.A.1    Rodrigues Pereira, J.2    Ciuleanu, T.3
  • 30
    • 24744450387 scopus 로고    scopus 로고
    • Epidermal growth factor receptor mutations in patients with non-small cell lung cancer
    • Johnson BE, Jänne PA. Epidermal growth factor receptor mutations in patients with non-small cell lung cancer. Cancer Res 2005;65:7525-7529.
    • (2005) Cancer Res , vol.65 , pp. 7525-7529
    • Johnson, B.E.1    Jänne, P.A.2
  • 31
    • 33746034167 scopus 로고    scopus 로고
    • Exon 19 deletion mutations of epidermal growth factor receptor are associated with prolonged survival in non-small cell lung cancer patients treated with gefitinib and erlotinib
    • Jackman DM, Yeap BY, Sequist LV, Lindeman N, Holmes AJ, Joshi VA et al. Exon 19 deletion mutations of epidermal growth factor receptor are associated with prolonged survival in non-small cell lung cancer patients treated with gefitinib and erlotinib. Clin Cancer Res 2006;12:3908-3914.
    • (2006) Clin Cancer Res , vol.12 , pp. 3908-3914
    • Jackman, D.M.1    Yeap, B.Y.2    Sequist, L.V.3    Lindeman, N.4    Holmes, A.J.5    Joshi, V.A.6
  • 32
    • 69949162760 scopus 로고    scopus 로고
    • Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
    • Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009;361:947-957.
    • (2009) N Engl J Med , vol.361 , pp. 947-957
    • Mok, T.S.1    Wu, Y.L.2    Thongprasert, S.3
  • 33
    • 79960889662 scopus 로고    scopus 로고
    • Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): A multicenter, open-label, randomized, phase 3 study
    • Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, 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 multicenter, open-label, randomized, phase 3 study. Lancet Oncol 2011;12:735-742.
    • (2011) Lancet Oncol , vol.12 , pp. 735-742
    • Zhou, C.1    Wu, Y.L.2    Chen, G.3    Feng, J.4    Liu, X.Q.5    Wang, C.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.