Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005, 353: 123-132. 10.1056/NEJMoa050753.
Article
CAS
Google Scholar
Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W: Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007, 25: 1960-1966. 10.1200/JCO.2006.07.9525.
Article
CAS
Google Scholar
Thatcher N, Chang A, Parikh P, Rodrigues Pereira J, Ciuleanu T, von Pawel J, Thongprasert S, Tan EH, Pemberton K, Archer V, Carroll K: 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. 10.1016/S0140-6736(05)67625-8.
Article
CAS
Google Scholar
Kelly K, Chansky K, Gaspar LE, Albain KS, Jett J, Ung YC, Lau DH, Crowley JJ, Gandara DR: Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non-small-cell lung cancer: SWOG S0023. J Clin Oncol. 2008, 26: 2450-2456. 10.1200/JCO.2007.14.4824.
Article
CAS
Google Scholar
Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE: Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007, 357: 2666-2676. 10.1056/NEJMoa072113.
Article
CAS
Google Scholar
Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L: Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001, 344: 783-792. 10.1056/NEJM200103153441101.
Article
CAS
Google Scholar
Simon R, Maitournam A: Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res. 2004, 10: 6759-6763. 10.1158/1078-0432.CCR-04-0496.
Article
CAS
Google Scholar
Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD: Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol. 2008, 26: 4672-4678. 10.1200/JCO.2008.16.1612.
Article
CAS
Google Scholar
Morabito A, Di Maio M, De Maio E, Normanno N, Perrone F: Methodology of clinical trials with new molecular-targeted agents: where do we stand?. Ann Oncol. 2006, 17 (Suppl 7): vii128-131. 10.1093/annonc/mdl965.
Google Scholar
Vickers AJ, Ballen V, Scher HI: Setting the bar in phase II trials: the use of historical data for determining "go/no go" decision for definitive phase III testing. Clin Cancer Res. 2007, 13: 972-976. 10.1158/1078-0432.CCR-06-0909.
Article
Google Scholar
Ratain MJ, Karrison TG: Testing the wrong hypothesis in phase II oncology trials: there is a better alternative. Clin Cancer Res. 2007, 13: 781-782. 10.1158/1078-0432.CCR-06-2533.
Article
Google Scholar
Chan JK, Ueda SM, Sugiyama VE, Stave CD, Shin JY, Monk BJ, Sikic BI, Osann K, Kapp DS: Analysis of phase II studies on targeted agents and subsequent phase III trials: what are the predictors for success?. J Clin Oncol. 2008, 26: 1511-1518. 10.1200/JCO.2007.14.8874.
Article
Google Scholar
Karaman MW, Herrgard S, Treiber DK, Gallant P, Atteridge CE, Campbell BT, Chan KW, Ciceri P, Davis MI, Edeen PT, Faraoni R, Floyd M, Hunt JP, Lockhart DJ, Milanov ZV, Morrison MJ, Pallares G, Patel HK, Pritchard S, Wodicka LM, Zarrinkar PP: A quantitative analysis of kinase inhibitor selectivity. Nat Biotechnol. 2008, 26: 127-132. 10.1038/nbt1358.
Article
CAS
Google Scholar
Di Leo A, Moretti E: Anthracyclines: the first generation of cytotoxic targeted agents? A possible dream. J Clin Oncol. 2008, 26: 5011-5013. 10.1200/JCO.2008.18.3137.
Article
Google Scholar
Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J: Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008, 359: 378-390. 10.1056/NEJMoa0708857.
Article
CAS
Google Scholar
Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA: Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007, 356: 115-124. 10.1056/NEJMoa065044.
Article
CAS
Google Scholar
Freidlin B, Simon R: Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clin Cancer Res. 2005, 11: 7872-7878. 10.1158/1078-0432.CCR-05-0605.
Article
CAS
Google Scholar
Paz-Ares L, Sanchez JM, Garcia-Velasco A, Massuti B, Lopez-Vivanco G, Provencio M, Montes A, Isla D, Amador ML, Rosell R, G Spanish Lung Cancer: A prospective phase II trial of erlotinib in advanced non-small cell lung cancer (NSCLC) patients (p) with mutations in the tyrosine kinase (TK) domain of the epidermal growth factor receptor (EGFR). J Clin Oncol (Meeting Abstracts). 2006, 24: 7020-
Google Scholar
El-Maraghi RH, Eisenhauer EA: Review of phase II trial designs used in studies of molecular targeted agents: outcomes and predictors of success in phase III. J Clin Oncol. 2008, 26: 1346-1354. 10.1200/JCO.2007.13.5913.
Article
Google Scholar
Ratain MJ, Glassman RH: Biomarkers in phase I oncology trials: signal, noise, or expensive distraction?. Clin Cancer Res. 2007, 13: 6545-6548. 10.1158/1078-0432.CCR-07-2133.
Article
CAS
Google Scholar
Stone A, Wheeler C, Barge A: Improving the design of phase II trials of cytostatic anticancer agents. Contemp Clin Trials. 2007, 28: 138-145. 10.1016/j.cct.2006.05.009.
Article
CAS
Google Scholar
Kopec JA, Willison KD: A comparative review of four preference-weighted measures of health-related quality of life. J Clin Epidemiol. 2003, 56: 317-325. 10.1016/S0895-4356(02)00609-1.
Article
Google Scholar
Rosner GL, Stadler W, Ratain MJ: Randomized discontinuation design: application to cytostatic antineoplastic agents. J Clin Oncol. 2002, 20: 4478-4484. 10.1200/JCO.2002.11.126.
Article
CAS
Google Scholar
Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR: K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008, 359: 1757-1765. 10.1056/NEJMoa0804385.
Article
CAS
Google Scholar
Bokemeyer C, Bondarenko I, Hartmann JT, De Braud FG, Volovat C, Nippgen J, Stroh C, Celik I, Koralewski P: KRAS status and efficacy of first-line treatment of patients with metastatic colorectal cancer (mCRC) with FOLFOX with or without cetuximab: The OPUS experience. J Clin Oncol (Meeting Abstracts). 2008, 26: 4000-
Google Scholar
Van Cutsem E, Lang I, D'Haens G, Moiseyenko V, Zaluski J, Folprecht G, Tejpar S, Kisker O, Stroh C, Rougier P: KRAS status and efficacy in the first-line treatment of patients with metastatic colorectal cancer (mCRC) treated with FOLFIRI with or without cetuximab: The CRYSTAL experience. J Clin Oncol (Meeting Abstracts). 2008, 26: 2-
Article
Google Scholar
Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, Juan T, Sikorski R, Suggs S, Radinsky R, Patterson SD, Chang DD: Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008, 26: 1626-1634. 10.1200/JCO.2007.14.7116.
Article
CAS
Google Scholar
Betensky RA, Louis DN, Cairncross JG: Influence of unrecognized molecular heterogeneity on randomized clinical trials. J Clin Oncol. 2002, 20: 2495-2499. 10.1200/JCO.2002.06.140.
Article
Google Scholar
Lagakos SW: The challenge of subgroup analyses – reporting without distorting. N Engl J Med. 2006, 354: 1667-1669. 10.1056/NEJMp068070.
Article
CAS
Google Scholar
Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith G: Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess. 2001, 5: 1-56.
Article
CAS
Google Scholar
Altman DG, Matthews JN: Statistics notes. Interaction 1: Heterogeneity of effects. Bmj. 1996, 313: 486-
Article
CAS
Google Scholar
Hoering A, Leblanc M, Crowley JJ: Randomized phase III clinical trial designs for targeted agents. Clin Cancer Res. 2008, 14: 4358-4367. 10.1158/1078-0432.CCR-08-0288.
Article
CAS
Google Scholar
Carter RE, Woolson RF: Statistical design considerations for pilot studies transitioning therapies from the bench to the bedside. J Transl Med. 2004, 2: 37-10.1186/1479-5876-2-37.
Article
Google Scholar
Bagnato A, Natali PG: Endothelin receptors as novel targets in tumor therapy. J Transl Med. 2004, 2: 16-10.1186/1479-5876-2-16.
Article
Google Scholar