New drugs in advanced non-small-cell lung cancer: searching for the correct clinical development

Bibliography

• Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108
   PubMed Web of Science ®Google Scholar
• Non – Small Cell Lung Cancer (NSCLC): Drug Pipeline Analysis and Market Forecasts to 2015. Global Data, 2009. Available from: http://www.fastmr.com/prod/56455_nonsmallcell_ lung_cancer_nsclc_drug_pipeline_ analysis_and_market_forecasts_to_2015.aspx [Last accessed 5 July 2010]
   Google Scholar
• Non-Small Cell Lung Cancer Drug Discoveries: what the future holds 2009. Espicom Business Intelligence, 2009. Available from: https://www.espicom.com/prodcat.nsf/Product_ID_Lookup/00000204?OpenDocument [Last accessed 5 July 2010]
   Google Scholar
• Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol 2009;27:4027-34
   PubMed Web of Science ®Google Scholar
• Mok TS, Wu YL, Thongprasert S, Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009;361:947-57
   PubMed Web of Science ®Google Scholar
• Mitsudomi T, Morita S, Yatabe Y, ; West Japan Oncology Group. 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;11:121-8
   PubMed Web of Science ®Google Scholar
• Maemondo M, Inoue A, Kobayashi K, ; North-East Japan Study Group. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010;362:2380-8
   PubMed Web of Science ®Google Scholar
• Gridelli C, Ciardiello F, Feld R, ; on behalf of the TORCH Investigators. International multicenter randomized phase III study of first-line erlotinib (E) followed by second-line cisplatin plus gemcitabine (CG) versus first-line CG followed by second-line E in advanced non-small cell lung cancer (aNSCLC): the TORCH trial. J Clin Oncol 2010;28(15S): abstract 7508
   Google Scholar
• Soda M, Choi YL, Enomoto M, Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 2007;448:561-6
   PubMed Web of Science ®Google Scholar
• Sasaki T, Rodig SJ, Chirieac LR, Janne PA. The biology and treatment of EML4-ALK non-small cell lung cancer. Eur J Cancer 2010;46:1773-80
   PubMed Web of Science ®Google Scholar
• Shaw AT, Yeap BY, Mino-Kenudson M, Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J Clin Oncol 2009;27:4247-53
   PubMed Web of Science ®Google Scholar
• Varella-Garcia M, Cho Y, Lu X, ALK gene rearrangements in unselected caucasians with non-small cell lung carcinoma (NSCLC). J Clin Oncol 2010;28(15S): abstract 10533
   PubMed Web of Science ®Google Scholar
• Bang Y, Kwak EL, Shaw AT, Clinical activity of the oral ALK inhibitor PF-02341066 in ALK-positive patients with non-small cell lung cancer (NSCLC). J Clin Oncol 2010;28(18s): abstract 3
   Google Scholar
• Regales L, Gong Y, Shen R, Dual targeting of EGFR can overcome a major drug resistance mutation in mouse models of EGFR mutant lung cancer. J Clin Invest 2009;119:3000-10
   PubMed Web of Science ®Google Scholar
• Yang C, Shih J, Su W, A phase II study of BIBW 2992 in patients with adenocarcinoma of the lung and activating EGFR mutations (LUX-Lung 2). J Clin Oncol 2010;28(15s): abstract 7521
   Google Scholar
• Gonzales AJ, Hook KE, Althaus IW, Antitumor activity and pharmacokinetic properties of PF-00299804, a second-generation irreversible pan-erbB receptor tyrosine kinase inhibitor. Mol Cancer Ther 2008;7:1880-9
   PubMed Web of Science ®Google Scholar
• Engelman JA, Zejnullahu K, Gale CM, PF00299804, an irreversible pan-ERBB inhibitor, is effective in lung cancer models with EGFR and ERBB2 mutations that are resistant to gefitinib. Cancer Res 2007;67:11924-32
   PubMed Web of Science ®Google Scholar
• Janne PA, Reckamp K, Koczywas M, Efficacy and safety of PF-00299804 (PF299) in patients (pt) with advanced NSCLC after failure of at least one prior chemotherapy regimen and prior treatment with erlotinib (E): a two-arm, phase II trial. J Clin Oncol 2009;27(15S): abstract 8063
   Google Scholar
• Campbell A, Reckamp KL, Camidge DR, PF-00299804 (PF299) patient (pt)-reported outcomes (PROs) and efficacy in adenocarcinoma (adeno) and nonadeno non-small cell lung cancer (NSCLC): a phase (P) II trial in advanced NSCLC after failure of chemotherapy (CT) and erlotinib (E). J Clin Oncol 2010;28(15S): abstract 7596
   Google Scholar
• Schiller JH, Akerley WL, Brugger W, Results from ARQ 197-209: a global randomized placebo-controlled phase II clinical trial of erlotinib plus ARQ 197 versus erlotinib plus placebo in previously treated EGFR inhibitor-naive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). J Clin Oncol 2010;28(18S): abstract LBA7502
   Google Scholar
• Scagliotti G, Novello S, von Pawel J, Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced-non-small cell lung cancer. J Clin Oncol 2010;28:1835-42
   PubMed Web of Science ®Google Scholar
• Press release, Wayne, NJ and Emeryville, CA – 14 June 2010 – Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc
   Google Scholar
• Schiller JH, Lee JW, Hanna NH, A randomized discontinuation phase II study of sorafenib versus placebo in patients with non-small cell lung cancer who have failed at least two prior chemotherapy regimens: E2501. J Clin Oncol 2008;26(20 Suppl): abstract 8014
   Google Scholar
• Socinski MA, Novello S, Brahmer JR, Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. J Clin Oncol 2008;26:650-6
   PubMed Web of Science ®Google Scholar
• Novello S, Scagliotti GV, Rosell R, Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. Br J Cancer 2009;101:1543-8
   PubMed Web of Science ®Google Scholar
• Wedge SR, Kendrew J, Hennequin LF, AZD2171: a highly potent, orally bioavailable, vascular endothelial growth factor receptor-2 tyrosine kinase inhibitor for the treatment of cancer. Cancer Res 2005;65:4389-400
   PubMed Web of Science ®Google Scholar
• Drevs J, Siegert P, Medinger M, Phase I clinical study of AZD2171, an oral vascular endothelial growth factor signaling inhibitor, in patients with advanced solid tumors. J Clin Oncol 2007;25:3045-54
   PubMed Web of Science ®Google Scholar
• van Cruijsen H, Voest EE, Punt CJ, Phase I evaluation of cediranib, a selective VEGFR signalling inhibitor, in combination with gefitinib in patients with advanced tumours. Eur J Cancer 2010;46:901-11
   PubMed Web of Science ®Google Scholar
• Laurie SA, Gauthier I, Arnold A, Phase I and pharmacokinetic study of daily oral AZD2171, an inhibitor of vascular endothelial growth factor tyrosine kinases, in combination with carboplatin and paclitaxel in patients with advanced non-small-cell lung cancer: the National Cancer Institute of Canada clinical trials group. J Clin Oncol 2008;26:1871-8
   PubMed Web of Science ®Google Scholar
• Goss G, Shepherd FA, Laurie S, A phase I and pharmacokinetic study of daily oral cediranib, an inhibitor of vascular endothelial growth factor tyrosine kinases, in combination with cisplatin and gemcitabine in patients with advanced non-small cell lung cancer: a study of the National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer 2009;45:782-8
   PubMed Web of Science ®Google Scholar
• Goss GD, Arnold A, Shepherd FA, Randomized, double-blind trial of carboplatin and paclitaxel with either daily oral cediranib or placebo in advanced non-small-cell lung cancer: NCIC clinical trials group BR24 study. J Clin Oncol 2010;28:49-55
   PubMed Web of Science ®Google Scholar
• Dy GK, Mandrekar SJ, Nelson GD, A randomized phase II study of gemcitabine (G) and carboplatin (C) with or without cediranib (AZD2171 [CED]) as first-line therapy in advanced non-small cell lung cancer (NSCLC). J Clin Oncol 2010;28(15S): abstract 7603
   PubMed Web of Science ®Google Scholar
• Blumenschein GR Jr, Reckamp K, Stephenson GJ, Phase 1b study of motesanib, an oral angiogenesis inhibitor, in combination with carboplatin/paclitaxel and/or panitumumab for the treatment of advanced non-small cell lung cancer. Clin Cancer Res 2010;16:279-90
   PubMed Web of Science ®Google Scholar
• Blumenschein GR, Kabbinavar FF, Menon H, Randomized, open-label phase II study of motesanib or bevacizumab in combination with paclitaxel and carboplatin (P/C) for advanced nonsquamous non-small cell lung cancer (NSCLC). J Clin Oncol 2010;28(15S): abstract 7528
   PubMed Web of Science ®Google Scholar
• Gridelli C, Rossi A, Bareschino MA, The potential role of insulin-like growth factor receptor inhibitors in the treatment of advanced non-small cell lung cancer. Expert Opin Investig Drugs 2010;19:631-9
   PubMed Web of Science ®Google Scholar
• Jassem J, Langer CJ, Karp DD, Randomized, open label, phase III trial of figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC). J Clin Oncol 2010;28(15S): abstract 7500
   Google Scholar
• Karp DD, Pollak MN, Cohen RB, Safety, pharmacokinetics, and pharmacodynamics of the insulin-like growth factor type 1 receptor inhibitor figitumumab (CP-751,871) in combination with paclitaxel and carboplatin. J Thorac Oncol 2009;4:1397-403
   PubMed Web of Science ®Google Scholar
• Karp DD, Paz-Ares LG, Novello S, Phase II study of the anti-insulin-like growth factor type 1 receptor antibody CP-751,871 in combination with paclitaxel and carboplatin in previously untreated, locally advanced, or metastatic non-small-cell lung cancer. J Clin Oncol 2009;27:2516-22
   PubMed Web of Science ®Google Scholar
• Von Pawel J, Harvey JH, Spigel DR, A randomized phase II trial of mapatumumab, a TRAIL-R1 agonist monoclonal antibody, in combination with carboplatin and paclitaxel in patients with advanced NSCLC. J Clin Oncol 2010;28(18S): abstract LBA7501
   Google Scholar
• Stegehuis JH, de Wilt LH, de Vries EG, TRAIL receptor targeting therapies for non-small cell lung cancer: current status and perspectives. Drug Resist Updat 2010;13:2-15
   PubMed Web of Science ®Google Scholar
• Traynor AM, Dubey S, Eickhoff JC, Vorinostat (NSC# 701852) in patients with relapsed non-small cell lung cancer: a Wisconsin Oncology Network phase II study. J Thorac Oncol 2009;4:522-6
   PubMed Web of Science ®Google Scholar
• Owonikoko TK, Ramalingam SS, Kanterewicz B, Vorinostat increases carboplatin and paclitaxel activity in non-small-cell lung cancer cells. Int J Cancer 2010;126:743-55
   PubMed Web of Science ®Google Scholar
• Ramalingam SS, Parise RA, Ramanathan RK, Phase I and pharmacokinetic study of vorinostat, a histone deacetylase inhibitor, in combination with carboplatin and paclitaxel for advanced solid malignancies. Clin Cancer Res 2007;13:3605-10
   PubMed Web of Science ®Google Scholar
• Ramalingam SS, Maitland ML, Frankel P, Carboplatin and Paclitaxel in combination with either vorinostat or placebo for first-line therapy of advanced non-small-cell lung cancer. J Clin Oncol 2010;28:56-62
   PubMed Web of Science ®Google Scholar
• Misset J, Tredaniel J, Descourt R. Vorinostat in combination with gemcitabine plus platinum in patients with advanced non-small-cell lung cancer: a phase I, dose-escalation study. J Clin Oncol 2008;26(20 Suppl): abstract 14601
   Google Scholar
• Fong PC, Boss DS, Yap TA, Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med 2009;361:123-34
   PubMed Web of Science ®Google Scholar
• Verweij J. Changes in clinical trial design for molecular targeted agents. In: American Society of Clinical Oncology 2001 Grand Rounds: Molecular Oncology Symposium. Available from: http://www.asco.org
   Google Scholar
• Di Maio M, Gallo C, De Maio E, Methodological aspects of lung cancer clinical trials in the era of targeted agents. Lung Cancer 2010;67:127-35
   PubMed Web of Science ®Google Scholar
• Duda DG, Ancukiewicz M, Jain RK. Biomarkers of antiangiogenic therapy: how do we move from candidate biomarkers to valid biomarkers? J Clin Oncol 2010;28:183-5
   PubMed Web of Science ®Google Scholar