메뉴 건너뛰기




Volumn 18, Issue 10, 2012, Pages 2809-2816

Pharmacogenomics in early-phase oncology clinical trials: Is there a sweet spot in phase II?

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CAPECITABINE; IRINOTECAN; OXALIPLATIN; TUMOR MARKER;

EID: 84861123738     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-11-2445     Document Type: Review
Times cited : (10)

References (37)
  • 2
    • 79954562811 scopus 로고    scopus 로고
    • Pharmacogenomic contribution to drug response
    • Watson RG, McLeod HL. Pharmacogenomic contribution to drug response. Cancer J 2011;17:80-8.
    • (2011) Cancer J , vol.17 , pp. 80-88
    • Watson, R.G.1    McLeod, H.L.2
  • 5
    • 84861109953 scopus 로고    scopus 로고
    • Rockville (MD): United States Food and Drug Administration. Updated January 11, 2010 [cited March 29, 2011]; Available from
    • United States Food and Drug Administration. Rockville (MD): United States Food and Drug Administration. Cetuximab (erbitux) and panitumumab (vectibix). 2010 updated January 11, 2010 [cited March 29, 2011]; Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDER/ucm172905.htm.
    • (2010) Cetuximab (Erbitux) and Panitumumab (Vectibix)
  • 6
    • 78349239505 scopus 로고    scopus 로고
    • The challenge of targeting EGFR: Experience with gefitinib in nonsmall cell lung cancer
    • Armour AA, Watkins CL. The challenge of targeting EGFR: experience with gefitinib in nonsmall cell lung cancer. Eur Respir Rev 2010;19: 186-96.
    • (2010) Eur Respir Rev , vol.19 , pp. 186-196
    • Armour, A.A.1    Watkins, C.L.2
  • 7
    • 79960702788 scopus 로고    scopus 로고
    • Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS)
    • Fukuoka M, Wu YL, Thongprasert S, Sunpaweravong P, Leong SS, Sriuranpong V, et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol 2011;29:2866-74.
    • (2011) J Clin Oncol , vol.29 , pp. 2866-2874
    • Fukuoka, M.1    Wu, Y.L.2    Thongprasert, S.3    Sunpaweravong, P.4    Leong, S.S.5    Sriuranpong, V.6
  • 8
    • 0034864020 scopus 로고    scopus 로고
    • Phase I and II clinical trials of trastuzumab
    • Baselga J. Phase I and II clinical trials of trastuzumab. Ann Oncol 2001;12[Suppl 1]:S49-55. (Pubitemid 32750585)
    • (2001) Annals of Oncology , vol.12 , Issue.SUPPL. 1
    • Baselga, J.1
  • 10
    • 6044278144 scopus 로고    scopus 로고
    • Evaluating the efficiency of targeted designs for randomized clinical trials
    • DOI 10.1158/1078-0432.CCR-04-0496
    • Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res 2004;10:6759-63. (Pubitemid 39383023) (Pubitemid 39383023)
    • (2004) Clinical Cancer Research , vol.10 , Issue.20 , pp. 6759-6763
    • Simon, R.1    Maitournam, A.2
  • 11
    • 77949540995 scopus 로고    scopus 로고
    • Oxaliplatin, irinotecan and capecitabine as first-line therapy in metastatic colorectal cancer (mCRC): A dose-finding study and pharmacogenomic analysis
    • Zarate R, Rodríguez J, Bandres E, Patĩno-Garcia A, Ponz-Sarvise M, Viudez A, et al. Oxaliplatin, irinotecan and capecitabine as first-line therapy in metastatic colorectal cancer (mCRC): a dose-finding study and pharmacogenomic analysis. Br J Cancer 2010;102:987-94.
    • (2010) Br J Cancer , vol.102 , pp. 987-994
    • Zarate, R.1    Rodríguez, J.2    Bandres, E.3    Patĩno-Garcia, A.4    Ponz-Sarvise, M.5    Viudez, A.6
  • 12
    • 35648988044 scopus 로고    scopus 로고
    • Interpreting P values in pharmacogenetic studies: A call for process and perspective
    • DOI 10.1200/JCO.2007.12.7803
    • Maitland ML, Ratain MJ, Cox NJ. Interpreting P values in pharmacogenetic studies: a call for process and perspective. J Clin Oncol 2007;25:4513-5. (Pubitemid 350035302)
    • (2007) Journal of Clinical Oncology , vol.25 , Issue.29 , pp. 4513-4515
    • Maitland, M.L.1    Ratain, M.J.2    Cox, N.J.3
  • 14
    • 34249997024 scopus 로고    scopus 로고
    • NCI-NHGRI Working Group on Replication in Association Studies. Replicating genotype-phenotype associations
    • Chanock SJ, Manolio T, Boehnke M, Boerwinkle E, Hunter DJ, Thomas G, et al.NCI-NHGRI Working Group on Replication in Association Studies. Replicating genotype-phenotype associations. Nature 2007;447:655-60.
    • (2007) Nature , vol.447 , pp. 655-660
    • Chanock, S.J.1    Manolio, T.2    Boehnke, M.3    Boerwinkle, E.4    Hunter, D.J.5    Thomas, G.6
  • 15
    • 0034660559 scopus 로고    scopus 로고
    • Searching for genetic determinants in the new millennium
    • DOI 10.1038/35015718
    • Risch NJ. Searching for genetic determinants in the new millennium. Nature 2000;405:847-56. (Pubitemid 30407863) (Pubitemid 30407863)
    • (2000) Nature , vol.405 , Issue.6788 , pp. 847-856
    • Risch, N.J.1
  • 16
    • 77954420205 scopus 로고    scopus 로고
    • Randomized phase II trials: Time for a new era in clinical trial design
    • Mandrekar SJ, Sargent DJ. Randomized phase II trials: time for a new era in clinical trial design. J Thorac Oncol 2010;5:932-4.
    • (2010) J Thorac Oncol , vol.5 , pp. 932-934
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 17
    • 15744381413 scopus 로고    scopus 로고
    • Randomized phase II trials: What does randomization gain?
    • DOI 10.1200/JCO.2005.10.956
    • Wieand HS. Randomized phase II trials: what does randomization gain? J Clin Oncol 2005;23:1794-5. (Pubitemid 46211355) (Pubitemid 46211355)
    • (2005) Journal of Clinical Oncology , vol.23 , Issue.9 , pp. 1794-1795
    • Wieand, H.S.1
  • 19
    • 34248193851 scopus 로고    scopus 로고
    • The randomized discontinuation trial: A phase II design to assess growth-inhibitory agents
    • DOI 10.1158/1535-7163.MCT-06-0249
    • Stadler WM. The randomized discontinuation trial: a phase II design to assess growth-inhibitory agents. Mol Cancer Ther 2007;6:1180-5. (Pubitemid 46711981)
    • (2007) Molecular Cancer Therapeutics , vol.6 , Issue.4 , pp. 1180-1185
    • Stadler, W.M.1
  • 20
    • 33746789922 scopus 로고    scopus 로고
    • Prospective phase II study of gefitinib for chemotherapy-naive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations
    • DOI 10.1200/JCO.2005.05.4692
    • Inoue A, Suzuki T, Fukuhara T, Maemondo M, Kimura Y, Morikawa N, et al. Prospective phase II study of gefitinib for chemotherapynaive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations. J Clin Oncol 2006; 24:3340-6. (Pubitemid 46638887) (Pubitemid 46638887)
    • (2006) Journal of Clinical Oncology , vol.24 , Issue.21 , pp. 3340-3346
    • Inoue, A.1    Suzuki, T.2    Fukuhara, T.3    Maemondo, M.4    Kimura, Y.5    Morikawa, N.6    Watanabe, H.7    Saijo, Y.8    Nukiwa, T.9
  • 21
    • 79959776574 scopus 로고    scopus 로고
    • BRIM-2: An open-label, multicenter phase II study of vemurafenib in previously treated patients with BRAF V600E mutation-positive metastatic melanoma
    • Ribas A, Kim K, Schuchter L, Gonzalez R, Pavlick A, Weber J, et al. BRIM-2: An open-label, multicenter phase II study of vemurafenib in previously treated patients with BRAF V600E mutation-positive metastatic melanoma. J Clin Oncol 2011;29:8509.
    • (2011) J Clin Oncol , vol.29 , pp. 8509
    • Ribas, A.1    Kim, K.2    Schuchter, L.3    Gonzalez, R.4    Pavlick, A.5    Weber, J.6
  • 22
    • 80051689137 scopus 로고    scopus 로고
    • Australian Ovarian Cancer Study Group. Platinum sensitivity-related germline polymorphism discovered via a cell-based approach and analysis of its associationwith outcome in ovarian cancer patients
    • Huang RS, Johnatty SE, Gamazon ER, Im HK, Ziliak D, Duan S, et al. Australian Ovarian Cancer Study Group. Platinum sensitivity-related germline polymorphism discovered via a cell-based approach and analysis of its associationwith outcome in ovarian cancer patients. Clin Cancer Res 2011;17:5490-500.
    • (2011) Clin Cancer Res , vol.17 , pp. 5490-5500
    • Huang, R.S.1    Johnatty, S.E.2    Gamazon, E.R.3    Im, H.K.4    Ziliak, D.5    Duan, S.6
  • 23
    • 59249100224 scopus 로고    scopus 로고
    • Genome-wide interrogation of germline genetic variation associated with treatment response in childhood acute lymphoblastic leukemia
    • Yang JJ, Cheng C, Yang W, Pei D, Cao X, Fan Y, et al. Genome-wide interrogation of germline genetic variation associated with treatment response in childhood acute lymphoblastic leukemia. JAMA 2009;301: 393-403.
    • (2009) JAMA , vol.301 , pp. 393-403
    • Yang, J.J.1    Cheng, C.2    Yang, W.3    Pei, D.4    Cao, X.5    Fan, Y.6
  • 24
    • 79952149366 scopus 로고    scopus 로고
    • The host genetic background ofDNArepair mechanisms is an independent predictor of survival in diffuse large B-cell lymphoma
    • Rossi D, Rasi S, Di Rocco A, Fabbri A, Forconi F, Gloghini A, et al. The host genetic background ofDNArepair mechanisms is an independent predictor of survival in diffuse large B-cell lymphoma. Blood 2011;117: 2405-13.
    • (2011) Blood , vol.117 , pp. 2405-2413
    • Rossi, D.1    Rasi, S.2    Di Rocco, A.3    Fabbri, A.4    Forconi, F.5    Gloghini, A.6
  • 25
    • 33845893608 scopus 로고    scopus 로고
    • Pharmacogenetics of irinotecan: Clinical perspectives on the utility of genotyping
    • DOI 10.2217/14622416.7.8.1211
    • Innocenti F, Ratain MJ. Pharmacogenetics of irinotecan: clinical perspectives on the utility of genotyping. Pharmacogenomics 2006;7: 1211-21. (Pubitemid 46024184)
    • (2006) Pharmacogenomics , vol.7 , Issue.8 , pp. 1211-1221
    • Innocenti, F.1    Ratain, M.J.2
  • 26
    • 4344579337 scopus 로고    scopus 로고
    • Pharmacogenetics of Thiopurine S-Methyltransferase and Thiopurine Therapy
    • DOI 10.1097/00007691-200404000-00018
    • Evans WE. Pharmacogenetics of thiopurine S-methyltransferase and thiopurine therapy. Ther Drug Monit 2004;26:186-91. (Pubitemid 38501216)
    • (2004) Therapeutic Drug Monitoring , vol.26 , Issue.2 , pp. 186-191
    • Evans, W.E.1
  • 27
    • 68049140789 scopus 로고    scopus 로고
    • Cancer pharmacoethnicity: Ethnic differences in susceptibility to the effects of chemotherapy
    • O'Donnell PH, Dolan ME. Cancer pharmacoethnicity: ethnic differences in susceptibility to the effects of chemotherapy. Clin Cancer Res 2009;15:4806-14.
    • (2009) Clin Cancer Res , vol.15 , pp. 4806-4814
    • O'Donnell, P.H.1    Dolan, M.E.2
  • 28
    • 70249137644 scopus 로고    scopus 로고
    • Japanese-US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: A model for assessing population-related pharmacogenomics
    • Gandara DR, Kawaguchi T, Crowley J, Moon J, Furuse K, Kawahara M, et al. Japanese-US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. J Clin Oncol 2009;27:3540-6.
    • (2009) J Clin Oncol , vol.27 , pp. 3540-3546
    • Gandara, D.R.1    Kawaguchi, T.2    Crowley, J.3    Moon, J.4    Furuse, K.5    Kawahara, M.6
  • 29
    • 70449513464 scopus 로고    scopus 로고
    • Back to the future: Why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine
    • Frueh FW. Back to the future: why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine. Pharmacogenomics 2009;10:1077-81.
    • (2009) Pharmacogenomics , vol.10 , pp. 1077-1081
    • Frueh, F.W.1
  • 30
    • 78951495386 scopus 로고    scopus 로고
    • Why, when, and how should pharmacogenetics be applied in clinical studies?: Current and future approaches to study designs
    • Stingl Kirchheiner JC, Brockmöller J. Why, when, and how should pharmacogenetics be applied in clinical studies?: current and future approaches to study designs. Clin Pharmacol Ther 2011;89:198-209.
    • (2011) Clin Pharmacol Ther , vol.89 , pp. 198-209
    • Stingl Kirchheiner, J.C.1    Brockmöller, J.2
  • 31
    • 36448979900 scopus 로고    scopus 로고
    • Limitations of pharmacogenomic predictor discovery in Phase II clinical trials
    • DOI 10.2217/14622416.8.10.1443
    • Pusztai L. Limitations of pharmacogenomic predictor discovery in Phase II clinical trials. Pharmacogenomics 2007;8:1443-8. (Pubitemid 350162856) (Pubitemid 350162856)
    • (2007) Pharmacogenomics , vol.8 , Issue.10 , pp. 1443-1448
    • Pusztai, L.1
  • 32
    • 35948959022 scopus 로고    scopus 로고
    • Pharmacogenomic predictor discovery in phase II clinical trials for breast cancer
    • DOI 10.1158/1078-0432.CCR-07-0809
    • Pusztai L, Anderson K, Hess KR. Pharmacogenomic predictor discovery in phase II clinical trials for breast cancer. Clin Cancer Res 2007;13:6080-6. (Pubitemid 350075065) (Pubitemid 350075065)
    • (2007) Clinical Cancer Research , vol.13 , Issue.20 , pp. 6080-6086
    • Pusztai, L.1    Anderson, K.2    Hess, K.R.3
  • 33
    • 24644466557 scopus 로고    scopus 로고
    • Enrichment designs: Efficiency in development of cancer treatments
    • DOI 10.1200/JCO.2005.02.913
    • Temple RJ. Enrichment designs: efficiency in development of cancer treatments. J Clin Oncol 2005;23:4838-9. (Pubitemid 46223984)
    • (2005) Journal of Clinical Oncology , vol.23 , Issue.22 , pp. 4838-4839
    • Temple, R.J.1
  • 34
    • 77956225836 scopus 로고    scopus 로고
    • The maximum tolerated dose and biologic effects of 3-aminopyridine-2- carboxaldehyde thiosemicarbazone (3-AP) in combination with irinotecan for patients with refractory solid tumors
    • Choi BS, Alberti DB, Schelman WR, Kolesar JM, Thomas JP, Marnocha R, et al. The maximum tolerated dose and biologic effects of 3-aminopyridine-2- carboxaldehyde thiosemicarbazone (3-AP) in combination with irinotecan for patients with refractory solid tumors. Cancer Chemother Pharmacol 2010;66:973-80.
    • (2010) Cancer Chemother Pharmacol , vol.66 , pp. 973-980
    • Choi, B.S.1    Alberti, D.B.2    Schelman, W.R.3    Kolesar, J.M.4    Thomas, J.P.5    Marnocha, R.6
  • 35
    • 52049103354 scopus 로고    scopus 로고
    • Cisplatin plus weekly CPT-11/docetaxel in advanced esophagogastric cancer: A phase I study with pharmacogenetic assessment of XPD, XRCC3 and UGT1A1 polymorphisms
    • Font A, Salazar R, Maurel J, Taron M, Ramirez JL, Tabernero J, et al. Cisplatin plus weekly CPT-11/docetaxel in advanced esophagogastric cancer: a phase I study with pharmacogenetic assessment of XPD, XRCC3 and UGT1A1 polymorphisms. Cancer Chemother Pharmacol 2008;62:1075-83.
    • (2008) Cancer Chemother Pharmacol , vol.62 , pp. 1075-1083
    • Font, A.1    Salazar, R.2    Maurel, J.3    Taron, M.4    Ramirez, J.L.5    Tabernero, J.6
  • 36
    • 45849101581 scopus 로고    scopus 로고
    • A phase 2 consortium (P2C) trial of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) for advanced adenocarcinoma of the pancreas
    • Attia S, Kolesar J, Mahoney MR, Pitot HC, Laheru D, Heun J, et al. A phase 2 consortium (P2C) trial of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) for advanced adenocarcinoma of the pancreas. Invest New Drugs 2008;26:369-79.
    • (2008) Invest New Drugs , vol.26 , pp. 369-379
    • Attia, S.1    Kolesar, J.2    Mahoney, M.R.3    Pitot, H.C.4    Laheru, D.5    Heun, J.6
  • 37
    • 65549094094 scopus 로고    scopus 로고
    • Phase II studies of gemcitabine and cisplatin in heavily and minimally pretreated metastatic breast cancer
    • Chew HK, Doroshow JH, Frankel P, Margolin KA, Somlo G, Lenz HJ, et al. Phase II studies of gemcitabine and cisplatin in heavily and minimally pretreated metastatic breast cancer. J Clin Oncol 2009; 27:2163-9.
    • (2009) J Clin Oncol , vol.27 , pp. 2163-2169
    • Chew, H.K.1    Doroshow, J.H.2    Frankel, P.3    Margolin, K.A.4    Somlo, G.5    Lenz, H.J.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.