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Volumn 21, Issue 20, 2015, Pages 4552-4560

Failures in Phase III: Causes and consequences

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; BEVACIZUMAB; CISPLATIN; DOCETAXEL; FLUOROURACIL; LAPATINIB; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; OXALIPLATIN; RAMUCIRUMAB;

EID: 84945563895     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-15-0124     Document Type: Article
Times cited : (67)

References (62)
  • 1
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003;22:151-85
    • (2003) J Health Econ , vol.22 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 2
    • 84945538442 scopus 로고    scopus 로고
    • Howthe Tufts Center for the Study of Drug Development pegged the cost of a new drug at 2.6 billion [PDF on the Internet]. Boston: Tufts Center for the Study of Drug Development [cited 2015 10 Jul]
    • Howthe Tufts Center for the Study of Drug Development pegged the cost of a new drug at 2.6 billion [PDF on the Internet]. Boston: Tufts Center for the Study of Drug Development; 2014 [cited 2015 10 Jul]. Available from: http://csdd.tufts.edu/files/uploads/cost-study-backgrounder.pdf.
    • (2014)
  • 3
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004;3:711-5
    • (2004) Nat Rev Drug Discov , vol.3 , pp. 711-715
    • Kola, I.1    Landis, J.2
  • 4
    • 77951964372 scopus 로고    scopus 로고
    • Global drug development in cancer: A cross-sectional study of clinical trial registries
    • Seruga B, Hertz PC, Le LW, Tannock IF. Global drug development in cancer: a cross-sectional study of clinical trial registries. Ann Oncol 2010;21: 895-900
    • (2011) Ann Oncol , vol.21 , pp. 895-900
    • Seruga, B.1    Hertz, P.C.2    Le, L.W.3    Tannock, I.F.4
  • 5
    • 79951966897 scopus 로고    scopus 로고
    • Addition of bevacizumab to chemotherapy for treatment of solid tumors: Similar results but different conclusions
    • Ocana A, Amir E, Vera F, Eisenhauer EA, Tannock IF. Addition of bevacizumab to chemotherapy for treatment of solid tumors: similar results but different conclusions. J Clin Oncol 2011;29:254-6
    • (2011) J Clin Oncol , vol.29 , pp. 254-256
    • Ocana A1    Amir E2    Vera F3    Eisenhauer, E.A.4    Tannock, I.F.5
  • 6
    • 84865721505 scopus 로고    scopus 로고
    • Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced non-squamous non-small cell lung cancer
    • Paz-Ares LG, Biesma B, Heigener D, von Pawel J, Eisen T, Bennouna J, et al. Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced non-squamous non-small cell lung cancer. J Clin Oncol 2012; 30:3084-92
    • (2012) J Clin Oncol , vol.30 , pp. 3084-3092
    • Paz-Ares, L.G.1    Biesma, B.2    Heigener, D.3    Von Pawel, J.4    Eisen, T.5    Bennouna, J.6
  • 7
    • 84865095318 scopus 로고    scopus 로고
    • International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small cell lung cancer: MONET1
    • Scagliotti GV, Vynnychenko I, Park K, Ichinose Y, Kubota K, Blackhall F, et al. International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small cell lung cancer: MONET1. J Clin Oncol 2012;30:2829-36
    • (2012) J Clin Oncol , vol.30 , pp. 2829-2836
    • Scagliotti, G.V.1    Vynnychenko, I.2    Park, K.3    Ichinose, Y.4    Kubota, K.5    Blackhall, F.6
  • 8
    • 84888130823 scopus 로고    scopus 로고
    • Docetaxel and dasatinib or placebo in men with metastatic castrationresistant prostate cancer (READY): A randomised, double-blind phase 3 trial
    • Araujo JC, Trudel GC, Saad F, Armstrong AJ, Yu EY, Bellmunt J, et al. Docetaxel and dasatinib or placebo in men with metastatic castrationresistant prostate cancer (READY): a randomised, double-blind phase 3 trial. Lancet Oncol 2013;14:1307-16
    • (2013) Lancet Oncol , vol.14 , pp. 1307-1316
    • Araujo, J.C.1    Trudel, G.C.2    Saad, F.3    Armstrong, A.J.4    Yu, E.Y.5    Bellmunt, J.6
  • 9
    • 80055088241 scopus 로고    scopus 로고
    • Believe it or not: How much can we rely on published data on potential drug targets?
    • Prinz F, Schlange T, Asadullah K. Believe it or not: how much can we rely on published data on potential drug targets? Nat Rev Drug Discov 2011; 10:712
    • (2011) Nat Rev Drug Discov , vol.10 , pp. 712
    • Prinz, F.1    Schlange, T.2    Asadullah, K.3
  • 10
    • 84859169880 scopus 로고    scopus 로고
    • Drug development: Raise standards for preclinical cancer research
    • Begley CG, Ellis LM. Drug development: raise standards for preclinical cancer research. Nature 2012;483:531-3
    • (2012) Nature , vol.483 , pp. 531-533
    • Begley, C.G.1    Ellis, L.M.2
  • 11
    • 84864960860 scopus 로고    scopus 로고
    • How valid are claims for synergy in published clinical studies?
    • Ocana A, Amir E, Yeung C, Seruga B, Tannock IF. How valid are claims for synergy in published clinical studies? Ann Oncol 2012;23:2161-6
    • (2012) Ann Oncol , vol.23 , pp. 2161-2166
    • Ocana, A.1    Amir, E.2    Yeung, C.3    Seruga, B.4    Tannock, I.F.5
  • 12
    • 84908497841 scopus 로고    scopus 로고
    • Translational research in oncology-10 years of progress and future prospects
    • Doroshow JH, Kummar S. Translational research in oncology-10 years of progress and future prospects. Nat Rev Clin Oncol 2014;11: 649-62
    • (2014) Nat Rev Clin Oncol , vol.11 , pp. 649-662
    • Doroshow, J.H.1    Kummar, S.2
  • 14
    • 33645734205 scopus 로고    scopus 로고
    • Contributions of human tumor xenografts to anticancer drug development
    • Sausville EA, Burger AM. Contributions of human tumor xenografts to anticancer drug development. Cancer Res 2006;66:3351-4
    • (2006) Cancer Res , vol.66 , pp. 3351-3354
    • Sausville, E.A.1    Burger, A.M.2
  • 15
    • 84891404742 scopus 로고    scopus 로고
    • Organoid cultures for the analysis of cancer phenotypes
    • Sachs N, Clevers H. Organoid cultures for the analysis of cancer phenotypes. Curr Opin Genet Dev 2014;24:68-73
    • (2014) Curr Opin Genet Dev , vol.24 , pp. 68-73
    • Sachs, N.1    Clevers, H.2
  • 16
    • 84869232766 scopus 로고    scopus 로고
    • Realizing the clinical potential of cancer nanotechnology byminimizing toxicologic and targeted delivery concerns
    • Singh S, Sharma A, Robertson GP. Realizing the clinical potential of cancer nanotechnology byminimizing toxicologic and targeted delivery concerns. Cancer Res 2012;72:5663-8
    • (2012) Cancer Res , vol.72 , pp. 5663-5668
    • Singh, S.1    Sharma, A.2    Robertson, G.P.3
  • 17
    • 84861719757 scopus 로고    scopus 로고
    • Patient-derived tumour xenografts as models for oncology drug development
    • Tentler JJ, Tan AC, Weekes CD. Patient-derived tumour xenografts as models for oncology drug development. Nat Rev Clin Oncol 2012;9:338-50
    • (2012) Nat Rev Clin Oncol , vol.9 , pp. 338-350
    • Tentler, J.J.1    Tan, A.C.2    Weekes, C.D.3
  • 18
    • 84655163904 scopus 로고    scopus 로고
    • Targeted agents how to select the winners in preclinical and early clinical studies?
    • Goodwin R, Giaccone G, Calvert H, Lobbezoo M, Eisenhauer EA. Targeted agents: how to select the winners in preclinical and early clinical studies? Eur J Cancer 2012;48:170-8
    • (2012) Eur J Cancer , vol.48 , pp. 170-178
    • Goodwin, R.1    Giaccone, G.2    Calvert, H.3    Lobbezoo, M.4    Eisenhauer, E.A.5
  • 19
    • 84879469745 scopus 로고    scopus 로고
    • Phase III trials with docetaxel-based combinations for metastatic castration-resistant prostate cancer: Time to learn from past experiences
    • Antonarakis ES, Eisenberger MA. Phase III trials with docetaxel-based combinations for metastatic castration-resistant prostate cancer: time to learn from past experiences. J Clin Oncol 2013;31:1709-12
    • (2013) J Clin Oncol , vol.31 , pp. 1709-1712
    • Antonarakis, E.S.1    Eisenberger, M.A.2
  • 21
    • 79960746726 scopus 로고    scopus 로고
    • Randomized phase II trials: A longterm investment with promising returns
    • Sharma MR, Stadler WM, Ratain MJ. Randomized phase II trials: a longterm investment with promising returns. J Natl Cancer Inst 2011;103: 1093-100
    • (2011) J Natl Cancer Inst , vol.103 , pp. 1093-1100
    • Sharma, M.R.1    Stadler, W.M.2    Ratain, M.J.3
  • 22
    • 41649118967 scopus 로고    scopus 로고
    • Review of phase II trial designs used in studies of molecular targeted agents: Outcomes and predictors of success in phase III
    • 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;26:1346-54
    • (2008) J Clin Oncol , vol.26 , pp. 1346-1354
    • El-Maraghi, R.H.1    Eisenhauer, E.A.2
  • 23
    • 27244440177 scopus 로고    scopus 로고
    • Comparison of outcomes of phase II studies and subsequent randomized control studies using identical chemotherapeutic regimens
    • Zia MI, Siu LL, Pond GR, Chen EX. Comparison of outcomes of phase II studies and subsequent randomized control studies using identical chemotherapeutic regimens. J Clin Oncol 2005;23:6982-91
    • (2005) J Clin Oncol , vol.23 , pp. 6982-6991
    • Zia, M.I.1    Siu, L.L.2    Pond, G.R.3    Chen, E.X.4
  • 24
    • 84866934606 scopus 로고    scopus 로고
    • Activity and safety of crizotinib in patients with ALK-positive non-small cell lung cancer: Updated results from a phase 1 study
    • Camidge DR, Bang YJ, Kwak EL, Iafrate AJ, Varella-Garcia M, Fox SB, et al. Activity and safety of crizotinib in patients with ALK-positive non-small cell lung cancer: updated results from a phase 1 study. Lancet Oncol 2012;13:1011-9
    • (2012) Lancet Oncol , vol.13 , pp. 1011-1019
    • Camidge, D.R.1    Bang, Y.J.2    Kwak, E.L.3    Iafrate, A.J.4    Varella-Garcia, M.5    Fox, S.B.6
  • 27
    • 84892996802 scopus 로고    scopus 로고
    • Oncology clinical trials-secrets of success
    • Feb 24 [cited 2015 Mar 31]
    • Thomas D. Oncology clinical trials-secrets of success. BIOtech Now 2014 Feb 24 [cited 2015 Mar 31]. Available from: http://www.biotech-now. org/business-And-investments/2012/02/oncology-clinical-trials-secrets-ofsuccess.
    • (2014) BIOtech Now
    • Thomas, D.1
  • 28
    • 84886377249 scopus 로고    scopus 로고
    • First-inhuman, pharmacokinetic and pharmacodynamic phase i study of Resminostat, an oral histone deacetylase inhibitor, in patients with advanced solid tumors
    • Brunetto AT, Ang JE, Lal R, Olmos D, Molife LR, Kristeleit R, et al. First-inhuman, pharmacokinetic and pharmacodynamic phase I study of Resminostat, an oral histone deacetylase inhibitor, in patients with advanced solid tumors. Clin Cancer Res 2013;19:5494-504
    • (2013) Clin Cancer Res , vol.19 , pp. 5494-5504
    • Brunetto, A.T.1    Ang, J.E.2    Lal, R.3    Olmos, D.4    Molife, L.R.5    Kristeleit, R.6
  • 29
    • 33750614686 scopus 로고    scopus 로고
    • Impact and perceptions of mandatory tumor biopsies for correlative studies in clinical trials of novel anticancer agents
    • Agulnik M, Oza AM, Pond GR, Siu LL. Impact and perceptions of mandatory tumor biopsies for correlative studies in clinical trials of novel anticancer agents. J Clin Oncol 2006;24:4801-7
    • (2006) J Clin Oncol , vol.24 , pp. 4801-4807
    • Agulnik, M.1    Oza, A.M.2    Pond, G.R.3    Siu, L.L.4
  • 31
    • 84883074556 scopus 로고    scopus 로고
    • Phase III randomized, placebo-controlled study of cetuximab plus brivanib alaninate versus cetuximab plus placebo in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal carcinoma: The NCIC Clinical Trials Group and AGITG CO.20 Trial
    • Siu LL, Shapiro JD, JonkerDJ, Karapetis CS, Zalcberg JR, Simes J, et al. Phase III randomized, placebo-controlled study of cetuximab plus brivanib alaninate versus cetuximab plus placebo in patients with metastatic, chemotherapy-refractory, wild-type K-RAS colorectal carcinoma: the NCIC Clinical Trials Group and AGITG CO.20 Trial. J Clin Oncol 2013;31: 2477-84
    • (2013) J Clin Oncol , vol.31 , pp. 2477-2484
    • Siu, L.L.1    Shapiro, J.D.2    Jonker, D.J.3    Karapetis, C.S.4    Zalcberg, J.R.5    Simes, J.6
  • 32
    • 84871999001 scopus 로고    scopus 로고
    • Impact of biomarker usage on oncology drug development
    • Hayashi K, Masuda S, Kimura H. Impact of biomarker usage on oncology drug development. J Clin Pharm Ther 2013;38:62-7
    • (2013) J Clin Pharm Ther , vol.38 , pp. 62-67
    • Hayashi, K.1    Masuda, S.2    Kimura, H.3
  • 35
    • 77951639655 scopus 로고    scopus 로고
    • Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small cell lung cancer
    • Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, et al. 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
    • (2011) J Clin Oncol , vol.28 , pp. 1835-1842
    • Scagliotti, G.1    Novello, S.2    Von Pawel, J.3    Reck, M.4    Pereira, J.R.5    Thomas, M.6
  • 36
    • 84867602821 scopus 로고    scopus 로고
    • Aflibercept and docetaxel versus docetaxel alone after platinum failure in patients with advanced or metastatic non-small cell lung cancer: A randomized, controlled phase III trial
    • Ramlau R, Gorbunova V, Ciuleanu TE, Novello S, Ozguroglu M, Goksel T, et al. Aflibercept and docetaxel versus docetaxel alone after platinum failure in patients with advanced or metastatic non-small cell lung cancer: a randomized, controlled phase III trial. J Clin Oncol 2012;30:3640-7
    • (2012) J Clin Oncol , vol.30 , pp. 3640-3647
    • Ramlau, R.1    Gorbunova, V.2    Ciuleanu, T.E.3    Novello, S.4    Ozguroglu, M.5    Goksel, T.6
  • 37
    • 84860625265 scopus 로고    scopus 로고
    • First-line treatment of advanced breast cancer with sunitinib in combination with docetaxel versus docetaxel alone: Results of a prospective, randomized phase III study
    • Bergh J, Bondarenko IM, Lichinitser MR, Liljegren A, Greil R, Voytko NL, et al. First-line treatment of advanced breast cancer with sunitinib in combination with docetaxel versus docetaxel alone: results of a prospective, randomized phase III study. J Clin Oncol 2012;30:921-9
    • (2012) J Clin Oncol , vol.30 , pp. 921-929
    • Bergh, J.1    Bondarenko, I.M.2    Lichinitser, M.R.3    Liljegren, A.4    Greil, R.5    Voytko, N.L.6
  • 38
    • 84884126500 scopus 로고    scopus 로고
    • Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer
    • Crown JP, Dieras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, et al. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol 2013;31:2870-8
    • (2013) J Clin Oncol , vol.31 , pp. 2870-2878
    • Crown, J.P.1    Dieras, V.2    Staroslawska, E.3    Yardley, D.A.4    Bachelot, T.5    Davidson, N.6
  • 39
    • 84920919864 scopus 로고    scopus 로고
    • Primary results of ROSE/TRIO-12, a randomized placebo-controlled phase III trial evaluating the addition of ramucirumab to first-line docetaxel chemotherapy in metastatic breast cancer
    • Mackey JR, Ramos-Vazquez M, Lipatov O, McCarthy N, Krasnozhon D, Semiglazov V, et al. Primary results of ROSE/TRIO-12, a randomized placebo-controlled phase III trial evaluating the addition of ramucirumab to first-line docetaxel chemotherapy in metastatic breast cancer. J Clin Oncol 2015;33:141-8
    • (2015) J Clin Oncol , vol.33 , pp. 141-148
    • Mackey, J.R.1    Ramos-Vazquez, M.2    Lipatov, O.3    McCarthy, N.4    Krasnozhon, D.5    Semiglazov, V.6
  • 40
    • 79956334386 scopus 로고    scopus 로고
    • Randomized, placebo-controlled, phase III study of first-line oxaliplatinbased chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma
    • Hecht JR, Trarbach T, Hainsworth JD, Major P, Jager E, Wolff RA, et al. Randomized, placebo-controlled, phase III study of first-line oxaliplatinbased chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol 2011;29:1997-2003
    • (2011) J Clin Oncol , vol.29 , pp. 1997-2003
    • Hecht, J.R.1    Trarbach, T.2    Hainsworth, J.D.3    Major, P.4    Jager, E.5    Wolff, R.A.6
  • 41
    • 79956297102 scopus 로고    scopus 로고
    • Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma
    • Van Cutsem E, Bajetta E, Valle J, Kohne CH, Hecht JR, Moore M, et al. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma. J Clin Oncol 2011;29:2004-10
    • (2011) J Clin Oncol , vol.29 , pp. 2004-2010
    • Van Cutsem, E.1    Bajetta, E.2    Valle, J.3    Kohne, C.H.4    Hecht, J.R.5    Moore, M.6
  • 42
    • 84863936062 scopus 로고    scopus 로고
    • Sunitinib plus erlotinib versus placebo plus erlotinib in patients with previously treated advanced non-small cell lung cancer: A phase III trial
    • Scagliotti GV, Krzakowski M, Szczesna A, Strausz J, Makhson A, Reck M, et al. Sunitinib plus erlotinib versus placebo plus erlotinib in patients with previously treated advanced non-small cell lung cancer: a phase III trial. J Clin Oncol 2012;30:2070-8
    • (2012) J Clin Oncol , vol.30 , pp. 2070-2078
    • Scagliotti, G.V.1    Krzakowski, M.2    Szczesna, A.3    Strausz, J.4    Makhson, A.5    Reck, M.6
  • 43
    • 84883360843 scopus 로고    scopus 로고
    • A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small cell lung cancer (NSCLC
    • Groen HJ, Socinski MA, Grossi F, Juhasz E, Gridelli C, Baas P, et al. A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small cell lung cancer (NSCLC). Ann Oncol 2013;24:2382-9
    • (2013) Ann Oncol , vol.24 , pp. 2382-2389
    • Groen, H.J.1    Socinski, M.A.2    Grossi, F.3    Juhasz, E.4    Gridelli, C.5    Baas, P.6
  • 44
    • 33845490014 scopus 로고    scopus 로고
    • Paclitaxel-carboplatin alone or with bevacizumab for non-small cell lung cancer
    • Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small cell lung cancer. N Engl J Med 2006;355:2542-50
    • (2006) N Engl J Med , vol.355 , pp. 2542-2550
    • Sandler, A.1    Gray, R.2    Perry, M.C.3    Brahmer, J.4    Schiller, J.H.5    Dowlati, A.6
  • 45
    • 79957953692 scopus 로고    scopus 로고
    • Randomized, open-label phase III trial of docetaxel plus high-dose calcitriol versus docetaxel plus prednisone for patients with castration-resistant prostate cancer
    • Scher HI, Jia X, Chi K, de Wit R, Berry WR, Albers P, et al. Randomized, open-label phase III trial of docetaxel plus high-dose calcitriol versus docetaxel plus prednisone for patients with castration-resistant prostate cancer. J Clin Oncol 2011;29:2191-8
    • (2011) J Clin Oncol , vol.29 , pp. 2191-2198
    • Scher, H.I.1    Jia, X.2    Chi, K.3    De Wit, R.4    Berry, W.R.5    Albers, P.6
  • 46
    • 84905867935 scopus 로고    scopus 로고
    • Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small cell lung cancer
    • Langer CJ, Novello S, Park K, Krzakowski M, Karp DD, Mok T, et al. Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small cell lung cancer. J Clin Oncol 2014;32:2059-66
    • (2014) J Clin Oncol , vol.32 , pp. 2059-2066
    • Langer, C.J.1    Novello, S.2    Park, K.3    Krzakowski, M.4    Karp, D.D.5    Mok, T.6
  • 47
    • 84876992498 scopus 로고    scopus 로고
    • Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oesophagogastric cancer (REAL3): A randomised, open-label phase 3 trial
    • Waddell T, Chau I, Cunningham D, Gonzalez D, Okines AF, Okines C, et al. Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oesophagogastric cancer (REAL3): a randomised, open-label phase 3 trial. Lancet Oncol 2013;14: 481-9
    • (2013) Lancet Oncol , vol.14 , pp. 481-489
    • Waddell, T.1    Chau, I.2    Cunningham, D.3    Gonzalez, D.4    Okines, A.F.5    Okines, C.6
  • 48
    • 65549153613 scopus 로고    scopus 로고
    • Efficacy does not necessarily translate to cost effectiveness: A case study in the challenges associated with 21st-century cancer drug pricing
    • Hillner BE, Smith TJ. Efficacy does not necessarily translate to cost effectiveness: a case study in the challenges associated with 21st-century cancer drug pricing. J Clin Oncol 2009;27:2111-3
    • (2009) J Clin Oncol , vol.27 , pp. 2111-2113
    • Hillner, B.E.1    Smith, T.J.2
  • 50
    • 33846995628 scopus 로고    scopus 로고
    • Economics of new oncology drug development
    • DiMasi JA, Grabowski HG. Economics of new oncology drug development. J Clin Oncol 2007;25:209-16
    • (2007) J Clin Oncol , vol.25 , pp. 209-216
    • DiMasi, J.A.1    Grabowski, H.G.2
  • 52
    • 84945544300 scopus 로고    scopus 로고
    • The urgent need for clinical research reform to permit faster, less expensive access to new therapies for lethal diseases
    • Stewart DJ, Batist G, Kantarjian HM, Bradford J-P, Schiller JH, Kurzrock R. The urgent need for clinical research reform to permit faster, less expensive access to new therapies for lethal diseases. Clin Cancer Res 2015;21:4561-8
    • (2015) Clin Cancer Res , vol.21 , pp. 4561-4568
    • Stewart, D.J.1    Batist, G.2    Kantarjian, H.M.3    Bradford, J.-P.4    Schiller, J.H.5    Kurzrock, R.6
  • 53
    • 56749154421 scopus 로고    scopus 로고
    • KrzyzanowskaMK. Evolution of the randomized controlled trial in oncology over three decades
    • Booth CM, Cescon DW, Wang L, Tannock IF, KrzyzanowskaMK. Evolution of the randomized controlled trial in oncology over three decades. J Clin Oncol 2008;26:5458-64
    • (2008) J Clin Oncol , vol.26 , pp. 5458-5464
    • Booth, C.M.1    Cescon, D.W.2    Wang, L.3    Tannock, I.F.4
  • 55
    • 84923052492 scopus 로고    scopus 로고
    • Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer
    • Swain SM, Baselga J, Kim SB, Ro J, Semiglazov V, Campone M, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 2015;372:724-34
    • (2015) N Engl J Med , vol.372 , pp. 724-734
    • Swain, S.M.1    Baselga, J.2    Kim, S.B.3    Ro, J.4    Semiglazov, V.5    Campone, M.6
  • 56
    • 34447551610 scopus 로고    scopus 로고
    • Industry, clinical trials, and the cost of cancer drugs: An investor's perspective
    • Fiorino T. Industry, clinical trials, and the cost of cancer drugs: an investor's perspective. J Clin Oncol 2007;25:e21-3
    • (2007) J Clin Oncol , vol.25 , pp. e21-e23
    • Fiorino, T.1
  • 57
    • 84861690508 scopus 로고    scopus 로고
    • Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401
    • Kelly WK, Halabi S, Carducci M, George D, Mahoney JF, Stadler WM, et al. Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401. J Clin Oncol 2012;30:1534-40
    • (2012) J Clin Oncol , vol.30 , pp. 1534-1540
    • Kelly, W.K.1    Halabi, S.2    Carducci, M.3    George, D.4    Mahoney, J.F.5    Stadler, W.M.6
  • 58
    • 84879785532 scopus 로고    scopus 로고
    • Cisplatin and fluorouracil with or without panitumumab in patients with recurrent ormetastatic squamous-cell carcinoma of the head and neck (SPECTRUM): An open-label phase 3 randomised trial
    • Vermorken JB, Stohlmacher-Williams J, Licitra L, Winquist E, Villanueva C, et al. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent ormetastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol 2013;14:697-710
    • (2013) Lancet Oncol , vol.14 , pp. 697-710
    • Vermorken, J.B.1    Stohlmacher-Williams, J.2    Licitra, L.3    Winquist, E.4    Villanueva, C.5
  • 60
    • 84884736973 scopus 로고    scopus 로고
    • Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations
    • Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol 2013;3:3327-34.
    • (2013) J Clin Oncol , vol.3 , pp. 3327-3334
    • Sequist, L.V.1    Yang, J.C.2    Yamamoto, N.3    O'Byrne, K.4    Hirsh, V.5    Mok, T.6
  • 61
    • 84864285704 scopus 로고    scopus 로고
    • Dabrafenib in BRAF-mutated metastatic melanoma: A multicentre, openlabel, phase 3 randomised controlled trial
    • Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, openlabel, phase 3 randomised controlled trial. Lancet 2012;380:358-65
    • (2012) Lancet , vol.380 , pp. 358-365
    • Hauschild, A.1    Grob, J.J.2    Demidov, L.V.3    Jouary, T.4    Gutzmer, R.5    Millward, M.6


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