Fool's gold, lost treasures, and the randomized clinical trial

BMC Cancer

Volumn 13, Issue , 2013, Pages

  Stewart, David J ^a   Kurzrock, Razelle ^b  

^a UNIVERSITY OF OTTAWA   (Canada)

^b UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

Author keywords

Biomarkers; Drug combinations; Gold standard; Phase II trials; Randomized clinical trials

Indexed keywords

B RAF KINASE; BEVACIZUMAB; CETUXIMAB; CRIZOTINIB; DASATINIB; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; GEFITINIB; GEMCITABINE; IMATINIB; IXABEPILONE; K RAS PROTEIN; LAPATINIB; OXALIPLATIN; PANITUMUMAB; PEMETREXED; PLACEBO; SORAFENIB; TAMOXIFEN; TEMSIROLIMUS; TRASTUZUMAB; TUMOR MARKER; VEMURAFENIB;

ARTICLE; BREAST CANCER; CANCER PATIENT; CHRONIC MYELOID LEUKEMIA; CLINICAL RESEARCH; COLORECTAL CANCER; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DRUG TARGETING; DRUG WITHDRAWAL; ESOPHAGUS CANCER; GASTROINTESTINAL STROMAL TUMOR; HEAD AND NECK CANCER; HEALTH CARE COST; HUMAN; KIDNEY CANCER; KIDNEY METASTASIS; LUNG NON SMALL CELL CANCER; MELANOMA; MESOTHELIOMA; OVARY CANCER; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; STOMACH CANCER; SURVIVAL RATE; TREATMENT OUTCOME; TREATMENT RESPONSE;

ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CLINICAL TRIALS, PHASE II AS TOPIC; DRUG DISCOVERY; HUMANS; NEOPLASMS; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TUMOR MARKERS, BIOLOGICAL;

EID: 84876096711     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-13-193     Document Type: Article

References (179)

1. Masia N, . In: Focus on Intellectual Property Rights. edn The cost of developing a new drug 2008, 82-83. Washington, D.C.: US Department of State Bureau of International Information Programs: Edited by Clack G, Neely MS, In: Focus on Intellectual Property Rights. edn.
2. Silverman E. Clinical Trials Costs are Rising Rapidly (posted 07/26/11): http://www.pharmalive.com/clinical-trial-costs-are-rising-rapidly.
3. Patlak M, Nass S. Improving the quality of cancer clinical trials 2008, National Academies Press: workshop summary.
4. Stewart DJ, Whitney SN, Kurzrock R. Equipoise lost: ethics, costs, and the regulation of cancer clinical research. J Clin Oncol 2010, 28(17):2925-2935.
5. Arrondeau J, Gan HK, Razak AR, Paoletti X, Le Tourneau C. Development of anti-cancer drugs. Discovery Medicine 2010, 10(53):355-362.
6. Dancey JE, Chen HX. Strategies for optimizing combinations of molecularly targeted anticancer agents. Nature Reviews Drug discovery 2006, 5(8):649-659.
7. Eisen T, Ahmad T, Flaherty KT, Gore M, Kaye S, Marais R, Gibbens I, Hackett S, James M, Schuchter LM. Sorafenib in advanced melanoma: a Phase II randomised discontinuation trial analysis. Br J Cancer 2006, 95(5):581-586.
8. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, Dummer R, Garbe C, Testori A, Maio M. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011, 364(26):2507-2516.
9. Frei E. Acute leukemia in children. Model for the development of scientific methodology for clinical therapeutic research in cancer. Cancer 1984, 53(10):2013-2025.
10. Stewart DJ, Kurzrock R. Cancer: the road to Amiens. J Clin Oncol 2009, 27(3):328-333.
11. Fojo AT, Noonan A. Why RECIST Works and Why It Should Stay-Counterpoint. Cancer Research 2012, 72(20):5151-5157.
12. Braiteh F, Kurzrock R. Uncommon tumors and exceptional therapies: paradox or paradigm?. Mol Cancer Ther 2007, 6(4):1175-1179.
13. Lee JJ, Xuemin G, Suyu L. Bayesian adaptive randomization designs for targeted agent development. Clin Trials 2010, 7(5):584-596.
14. Karuri SW, Simon R. A two-stage Bayesian design for co-development of new drugs and companion diagnostics. Statistics in Medicine 2012, 31(10):901-914.
15. Simon R. Clinical trials for predictive medicine. Statistics in Medicine 2012, 31(25):3031-3040.
16. Scher HI, Nasso SF, Rubin EH, Simon R. Adaptive clinical trial designs for simultaneous testing of matched diagnostics and therapeutics. Clin Cancer Res 2011, 17(21):6634-6640.
17. Simon R. Genomic biomarkers in predictive medicine: an interim analysis. EMBO Molecular Medicine 2011, 3(8):429-435.
18. Hoering A, Leblanc M, Crowley JJ. Randomized phase III clinical trial designs for targeted agents. Clin Cancer Res 2008, 14(14):4358-4367.
19. Redman MW, Crowley JJ, Herbst RS, Hirsch FR, Gandara DR. Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819. Clin Cancer Res 2012, 18(15):4004-4012.
20. Brugger W, Triller N, Blasinska-Morawiec M, Curescu S, Sakalauskas R, Manikhas GM, Mazieres J, Whittom R, Ward C, Mayne K. Prospective Molecular Marker Analyses of EGFR and KRAS From a Randomized, Placebo-Controlled Study of Erlotinib Maintenance Therapy in Advanced Non-Small-Cell Lung Cancer. J Clin Oncol 2011, 29(31):4113-4120.
21. Thatcher N, Chang A, Parikh P, Rodrigues Pereira J, Ciuleanu T, von Pawel J, Thongprasert S, Tan EH, Pemberton K, Archer V. 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(9496):1527-1537.
22. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005, 353(2):123-132.
23. Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med 2011, 364(1):11-21.
24. Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med 2010, 362(18):1663-1674.
25. McMurray JJ, Holman RR, Haffner SM, Bethel MA, Holzhauer B, Hua TA, Belenkov Y, Boolell M, Buse JB, Buckley BM. Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med 2010, 362(16):1477-1490.
26. Jamerson K, Weber MA, Bakris GL, Dahlof B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M, Velazquez EJ. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med 2008, 359(23):2417-2428.
27. Ocana A, Tannock IF. When are "positive" clinical trials in oncology truly positive?. J Natl Cancer Inst 2011, 103(1):16-20.
28. Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008, 372(9652):1809-1818.
29. Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol 2010, 28(5):744-752.
30. Stewart DJ. Randomized phase II trials: misleading and unreliable. J Clin Oncol 2010, 28(31):649-650. author reply e651-643.
31. Pao W, Miller V, Zakowski M, Doherty J, Politi K, Sarkaria I, Singh B, Heelan R, Rusch V, Fulton L. EGF receptor gene mutations are common in lung cancers from "never smokers" and are associated with sensitivity of tumors to gefitinib and erlotinib. Proc Natl Acad Sci U S A 2004, 101(36):13306-13311.
32. Koivunen JP, Mermel C, Zejnullahu K, Murphy C, Lifshits E, Holmes AJ, Choi HG, Kim J, Chiang D, Thomas R. EML4-ALK fusion gene and efficacy of an ALK kinase inhibitor in lung cancer. Clin Cancer Res 2008, 14(13):4275-4283.
33. Herbst RS, Prager D, Hermann R, Fehrenbacher L, Johnson BE, Sandler A, Kris MG, Tran HT, Klein P, Li X. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 2005, 23(25):5892-5899.
34. Eberhard DA, Johnson BE, Amler LC, Goddard AD, Heldens SL, Herbst RS, Ince WL, Janne PA, Januario T, Johnson DH. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol 2005, 23(25):5900-5909.
35. Tol J, Koopman M, Cats A, Rodenburg CJ, Creemers GJ, Schrama JG, Erdkamp FL, Vos AH, van Groeningen CJ, Sinnige HA. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med 2009, 360(6):563-572.
36. Bokemeyer C, Bondarenko I, Hartmann JT, de Braud F, Schuch G, Zubel A, Celik I, Schlichting M, Koralewski P. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study. Annals of oncology : official journal of the European Society for Medical Oncology/ESMO 2011, 22(7):1535-1546.
37. Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA. 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(15):1960-1966.
38. Stewart DJ. Before We Throw out Progression-Free Survival As a Valid End Point. J Clin Oncol 2012, 30(27):3426-3427.
39. Broglio KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 2009, 101(23):1642-1649.
40. Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 2010, 363(8):733-742.
41. Wolmark N, Fisher B, Rockette H, Redmond C, Wickerham DL, Fisher ER, Jones J, Glass A, Lerner H, Lawrence W. Postoperative adjuvant chemotherapy or BCG for colon cancer: results from NSABP protocol C-01. J Natl Cancer Inst 1988, 80(1):30-36.
42. Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, Gore M, Desai AA, Patnaik A, Xiong HQ. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 2006, 24(16):2505-2512.
43. Sonpavde G, Hutson TE, Galsky MD, Berry WR. Problems with the randomized discontinuation design. J Clin Oncol 2006, 24(28):4669-4670.
44. Vidaurre T, Wilkerson J, Simon R, Bates SE, Fojo T. Stable disease is not preferentially observed with targeted therapies and as currently defined has limited value in drug development. Cancer J 2009, 15(5):366-373.
45. Stewart DJ. Mechanisms of resistance to cisplatin and carboplatin. Critical Reviews in Oncology/Hematology 2007, 63(1):12-31.
46. Stewart DJ. Tumor and host factors that may limit efficacy of chemotherapy in non-small cell and small cell lung cancer. Critical Reviews in Oncology/Hematology 2010, 75(3):173-234.
47. Simon R. Advances in clinical trial designs for predictive biomarker discovery and validation. Current Breast Cancer Reports 2009, 1:216-221.
48. Freidlin B, McShane LM, Korn EL. Randomized clinical trials with biomarkers: design issues. J Natl Cancer Inst 2010, 102(3):152-160.
49. Pusztai L, Anderson K, Hess KR. Pharmacogenomic predictor discovery in phase II clinical trials for breast cancer. Clin Cancer Res 2007, 13(20):6080-6086.
50. Simon R. The use of genomics in clinical trial design. Clin Cancer Res 2008, 14(19):5984-5993.
51. Tol J, Punt CJ. Monoclonal antibodies in the treatment of metastatic colorectal cancer: a review. Clin Ther 2010, 32(3):437-453.
52. Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, Juan T, Sikorski R, Suggs S, Radinsky R. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008, 26(10):1626-1634.
53. Lievre A, Bachet JB, Le Corre D, Boige V, Landi B, Emile JF, Cote JF, Tomasic G, Penna C, Ducreux M. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Research 2006, 66(8):3992-3995.
54. De Roock W, Piessevaux H, De Schutter J, Janssens M, De Hertogh G, Personeni N, Biesmans B, Van Laethem JL, Peeters M, Humblet Y. KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Annals of Oncology: official journal of the European Society for Medical Oncology/ESMO 2008, 19(3):508-515.
55. Bokemeyer C, Bondareno I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 2009, 27(5):663-671.
56. Bibeau F, Lopez-Crapez E, Di Fiore F, Thezenas S, Ychou M, Blanchard F, Lamy A, Penault-Llorca F, Frebourg T, Michel P. Impact of Fc{gamma}RIIa-Fc{gamma}RIIIa polymorphisms and KRAS mutations on the clinical outcome of patients with metastatic colorectal cancer treated with cetuximab plus irinotecan. J Clin Oncol 2009, 27(7):1122-1129.
57. Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009, 360(14):1408-1417.
58. Loupakis F, Pollina L, Stasi I, Ruzzo A, Scartozzi M, Santini D, Masi G, Graziano F, Cremolini C, Rulli E. PTEN expression and KRAS mutations on primary tumors and metastases in the prediction of benefit from cetuximab plus irinotecan for patients with metastatic colorectal cancer. J Clin Oncol 2009, 27(16):2622-2629.
59. Tabernero J, Cervantes A, Rivera F, Martinelli E, Rojo F, von Heydebreck A, Macarulla T, Rodriguez-Braun E, Eugenia Vega-Villegas M, Senger S. Pharmacogenomic and pharmacoproteomic studies of cetuximab in metastatic colorectal cancer: biomarker analysis of a phase I dose-escalation study. J Clin Oncol 2010, 28(7):1181-1189.
60. Colucci G, Giuliani F, Garufi C, Mattioli R, Manzione L, Russo A, Lopez M, Parrella P, Tommasi S, Copetti M. Cetuximab plus FOLFOX-4 in untreated patients with advanced colorectal cancer: a Gruppo Oncologico dell'Italia Meridionale Multicenter phase II study. Oncology 2010, 79(5-6):415-422.
61. Van Cutsem E, Kohne CH, Lang I, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Tejpar S. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol 2011, 29(15):2011-2019.
62. Sastre J, Gravalos C, Rivera F, Massuti B, Valladares-Ayerbes M, Marcuello E, Manzano JL, Benavides M, Hidalgo M, Diaz-Rubio E. First-line cetuximab plus capecitabine in elderly patients with advanced colorectal cancer: clinical outcome and subgroup analysis according to KRAS status from a Spanish TTD Group Study. The oncologist 2012, 17(3):339-345.
63. Jackman DM, Miller VA, Cioffredi LA, Yeap BY, Janne PA, Riely GJ, Ruiz MG, Giaccone G, Sequist LV, Johnson BE. Impact of epidermal growth factor receptor and KRAS mutations on clinical outcomes in previously untreated non-small cell lung cancer patients: results of an online tumor registry of clinical trials. Clin Cancer Res 2009, 15(16):5267-5273.
64. Wu YL, Zhong WZ, Li LY, Zhang XT, Zhang L, Zhou CC, Liu W, Jiang B, Mu XL, Lin JY. Epidermal growth factor receptor mutations and their correlation with gefitinib therapy in patients with non-small cell lung cancer: a meta-analysis based on updated individual patient data from six medical centers in mainland China. Journal of Thoracic Oncology: official publication of the International Association for the Study of Lung Cancer 2007, 2(5):430-439.
65. Sutani A, Nagai Y, Udagawa K, Uchida Y, Koyama N, Murayama Y, Tanaka T, Miyazawa H, Nagata M, Kanazawa M. Gefitinib for non-small-cell lung cancer patients with epidermal growth factor receptor gene mutations screened by peptide nucleic acid-locked nucleic acid PCR clamp. Br J Cancer 2006, 95(11):1483-1489.
66. Taron M, Ichinose Y, Rosell R, Mok T, Massuti B, Zamora L, Mate JL, Manegold C, Ono M, Queralt C. Activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor are associated with improved survival in gefitinib-treated chemorefractory lung adenocarcinomas. Clin Cancer Res 2005, 11(16):5878-5885.
67. Takano T, Ohe Y, Sakamoto H, Tsuta K, Matsuno Y, Tateishi U, Yamamoto S, Nokihara H, Yamamoto N, Sekine I. Epidermal growth factor receptor gene mutations and increased copy numbers predict gefitinib sensitivity in patients with recurrent non-small-cell lung cancer. J Clin Oncol 2005, 23(28):6829-6837.
68. Cortes-Funes H, Gomez C, Rosell R, Valero P, Garcia-Giron C, Velasco A, Izquierdo A, Diz P, Camps C, Castellanos D. Epidermal growth factor receptor activating mutations in Spanish gefitinib-treated non-small-cell lung cancer patients. Annals of Oncology: official journal of the European Society for Medical Oncology/ESMO 2005, 16(7):1081-1086.
69. Pallis AG, Voutsina A, Kentepozidis N, Giassas S, Papakotoulas P, Agelaki S, Tryfonidis K, Kotsakis A, Vamvakas L, Vardakis N. A phase II trial of erlotinib as front-line treatment in clinically selected patients with non-small-cell lung cancer. Clinical Lung Cancer 2012, 13(2):129-135.
70. Zhu CQ, da Cunha SG, Ding K, Sakurada A, Cutz JC, Liu N, Zhang T, Marrano P, Whitehead M, Squire JA. Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 2008, 26(26):4268-4275.
71. Lee CK, Lord SJ, Coates AS, Simes RJ. Molecular biomarkers to individualise treatment: assessing the evidence. The Medical Journal of Australia 2009, 190(11):631-636.
72. Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, Harris PL, Haserlat SM, Supko JG, Haluska FG. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004, 350(21):2129-2139.
73. Paez JG, Janne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004, 304(5676):1497-1500.
74. Kwak EL, Bang YJ, Camidge DR, Shaw AT, Solomon B, Maki RG, Ou SH, Dezube BJ, Janne PA, Costa DB. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010, 363(18):1693-1703.
75. Hammerman PS, Sos ML, Ramos AH, Xu C, Dutt A, Zhou W, Brace LE, Woods BA, Lin W, Zhang J. Mutations in the DDR2 kinase gene identify a novel therapeutic target in squamous cell lung cancer. Cancer Discovery 2011, 1(1):78-89.
76. Sen B, Peng S, Tang X, Erickson HS, Galindo H, Mazumdar T, Stewart DJ, Wistuba I, Johnson FM. Kinase-impaired BRAF mutations in lung cancer confer sensitivity to dasatinib. Science Translational Medicine 2012, 4(136):136-170.
77. Rose C, Thorpe SM, Lober J, Daenfeldt JL, Palshof T, Mouridsen HT. Therapeutic effect of tamoxifen related to estrogen receptor level. Recent Results Cancer Res 1980, 71:134-141.
78. Vogel CL, Cobleigh MA, Tripathy D, Gutheil JC, Harris LN, Fehrenbacher L, Slamon DJ, Murphy M, Novotny WF, Burchmore M. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002, 20(3):719-726.
79. Druker BJ, Talpaz M, Resta DJ, Peng B, Buchdunger E, Ford JM, Lydon NB, Kantarjian H, Capdeville R, Ohno-Jones S. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 2001, 344(14):1031-1037.
80. Bumming P, Andersson J, Meis-Kindblom JM, Klingenstierna H, Engstrom K, Stierner U, Wangberg B, Jansson S, Ahlman H, Kindblom LG. Neoadjuvant, adjuvant and palliative treatment of gastrointestinal stromal tumours (GIST) with imatinib: a centre-based study of 17 patients. Br J Cancer 2003, 89(3):460-464.
81. Flaherty KT, Puzanov I, Kim KB, Ribas A, McArthur GA, Sosman JA, O'Dwyer PJ, Lee RJ, Grippo JF, Nolop K. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med 2010, 363(9):809-819.
82. Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012, 366(26):2443-2454.
83. Tsimberidou AM, Iskander NG, Hong DS, Wheler JJ, Falchook GS, Fu S, Piha-Paul S, Naing A, Janku F, Luthra R. Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative. Clin Cancer Res 2012, 18(22):6373-6383.
84. Johnson BE. EGFR in lung cancer: http://www.iom.edu/~/media/Files/Activity%20Files/Disease/NCPF/EGFRinLungCancer.pdf.
85. Lara-Guerra H, Waddell TK, Salvarrey MA, Joshua AM, Chung CT, Paul N, Boerner S, Sakurada A, Ludkovski O, Ma C. Phase II study of preoperative gefitinib in clinical stage I non-small-cell lung cancer. J Clin Oncol 2009, 27(36):6229-6236.
86. Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. The Lancet Oncology 2012, 13(3):239-246.
87. Paik PK, Varghese AM, Sima CS, Moreira AL, Ladanyi M, Kris MG, Rekhtman N. Response to Erlotinib in Patients with EGFR Mutant Advanced Non-Small Cell Lung Cancers with a Squamous or Squamous-like Component. Mol Cancer Ther 2012, 11(11):2535-2540.
88. Rizvi NA, Rusch V, Pao W, Chaft JE, Ladanyi M, Miller VA, Krug LM, Azzoli CG, Bains M, Downey R. Molecular characteristics predict clinical outcomes: prospective trial correlating response to the EGFR tyrosine kinase inhibitor gefitinib with the presence of sensitizing mutations in the tyrosine binding domain of the EGFR gene. Clin Cancer Res 2011, 17(10):3500-3506.
89. Takahashi R, Hirata H, Tachibana I, Shimosegawa E, Inoue A, Nagatomo I, Takeda Y, Kida H, Goya S, Kijima T. Early [18F]fluorodeoxyglucose positron emission tomography at two days of gefitinib treatment predicts clinical outcome in patients with adenocarcinoma of the lung. Clin Cancer Res 2012, 18(1):220-228.
90. Camidge DR, Bang YJ, Kwak EL, Iafrate AJ, Varella-Garcia M, Fox SB, Riely GJ, Solomon B, Ou SH, Kim DW. Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. The Lancet Oncology 2012, 13(10):1011-1019.
91. Lee JS, Hirsh V, Park K, Qin S, Blajman CR, Perng RP, Chen YM, Emerson L, Langmuir P, Manegold C. Vandetanib versus placebo in patients with advanced non-small-cell lung cancer after prior therapy with an epidermal growth factor receptor tyrosine kinase inhibitor: a randomized, double-blind phase III trial (ZEPHYR). J Clin Oncol 2012, 30(10):1114-1121.
92. Goss G, Ferry D, Wierzbicki R, Laurie SA, Thompson J, Biesma B, Hirsch FR, Varella-Garcia M, Duffield E, Ataman OU. Randomized phase II study of gefitinib compared with placebo in chemotherapy-naive patients with advanced non-small-cell lung cancer and poor performance status. J Clin Oncol 2009, 27(13):2253-2260.
93. Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008, 359(17):1757-1765.
94. Rao S, Cunningham D, de Gramont A, Scheithauer W, Smakal M, Humblet Y, Kourteva G, Iveson T, Andre T, Dostalova J. Phase III double-blind placebo-controlled study of farnesyl transferase inhibitor R115777 in patients with refractory advanced colorectal cancer. J Clin Oncol 2004, 22(19):3950-3957.
95. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007, 356(2):125-134.
96. Demetri GD, Garrett CR, Schoffski P, Shah MH, Verweij J, Leyvraz S, Hurwitz HI, Pousa AL, Le Cesne A, Goldstein D. Complete longitudinal analyses of the randomized, placebo-controlled, phase III trial of sunitinib in patients with gastrointestinal stromal tumor following imatinib failure. Clin Cancer Res 2012, 18(11):3170-3179.
97. Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010, 28(6):1061-1068.
98. Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grunwald V, Thompson JA, Figlin RA, Hollaender N. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008, 372(9637):449-456.
99. Mulders P, Hawkins R, Nathan P, de Jong I, Osanto S, Porfiri E, Protheroe A, van Herpen CM, Mookerjee B, Pike L. Cediranib monotherapy in patients with advanced renal cell carcinoma: results of a randomised phase II study. Eur J Cancer 2012, 48(4):527-537.
100. Hsu C, Yang TS, Huo TI, Hsieh RK, Yu CW, Hwang WS, Hsieh TY, Huang WT, Chao Y, Meng R. Vandetanib in patients with inoperable hepatocellular carcinoma: a phase II, randomized, double-blind, placebo-controlled study. Journal of Hepatology 2012, 56(5):1097-1103.
101. Barbare JC, Bouche O, Bonnetain F, Dahan L, Lombard-Bohas C, Faroux R, Raoul JL, Cattan S, Lemoine A, Blanc JF. Treatment of advanced hepatocellular carcinoma with long-acting octreotide: a phase III multicentre, randomised, double blind placebo-controlled study. Eur J Cancer 2009, 45(10):1788-1797.
102. Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. The Lancet Oncology 2009, 10(1):25-34.
103. Del Campo JM, Hitt R, Sebastian P, Carracedo C, Lokanatha D, Bourhis J, Temam S, Cupissol D, De Raucourt D, Maroudias N. Effects of lapatinib monotherapy: results of a randomised phase II study in therapy-naive patients with locally advanced squamous cell carcinoma of the head and neck. Br J Cancer 2011, 105(5):618-627.
104. Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sorensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. The Lancet Oncology 2011, 12(4):333-343.
105. Werner JA, Kehrl W, Pluzanska A, Arndt O, Lavery KM, Glaholm J, Dietz A, Dyckhoff G, Maune S, Stewart ME. A phase III placebo-controlled study in advanced head and neck cancer using intratumoural cisplatin/epinephrine gel. Br J Cancer 2002, 87(9):938-944.
106. Bellmunt J, Theodore C, Demkov T, Komyakov B, Sengelov L, Daugaard G, Caty A, Carles J, Jagiello-Gruszfeld A, Karyakin O. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol 2009, 27(27):4454-4461.
107. Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med 2011, 364(6):501-513.
108. Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012, 367(13):1187-1197.
109. van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schoffski P, Aglietta M, Staddon AP, Beppu Y. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2012, 379(9829):1879-1886.
110. Wells SA, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol 2012, 30(2):134-141.
111. Jassem J, Ramlau R, Santoro A, Schuette W, Chemaissani A, Hong S, Blatter J, Adachi S, Hanauske A, Manegold C. Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma. J Clin Oncol 2008, 26(10):1698-1704.
112. Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011, 364(6):514-523.
113. Oxnard GR, Zhao B, Sima CS, Ginsberg MS, James LP, Lefkowitz RA, Guo P, Kris MG, Schwartz LH, Riely GJ. Variability of lung tumor measurements on repeat computed tomography scans taken within 15 minutes. J Clin Oncol 2011, 29(23):3114-3119.
114. Clark GM, Zborowski DM, Santabarbara P, Ding K, Whitehead M, Seymour L, Shepherd FA. Smoking history and epidermal growth factor receptor expression as predictors of survival benefit from erlotinib for patients with non-small-cell lung cancer in the National Cancer Institute of Canada Clinical Trials Group study BR.21. Clinical Lung Cancer 2006, 7(6):389-394.
115. Di Nicolantonio F, Martini M, Molinari F, Sartore-Bianchi A, Arena S, Saletti P, De Dosso S, Mazzucchelli L, Frattini M, Siena S. Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer. J Clin Oncol 2008, 26(35):5705-5712.
116. Sartore-Bianchi A, Martini M, Molinari F, Veronese S, Nichelatti M, Artale S, Di Nicolantonio F, Saletti P, De Dosso S, Mazzucchelli L. PIK3CA mutations in colorectal cancer are associated with clinical resistance to EGFR-targeted monoclonal antibodies. Cancer Research 2009, 69(5):1851-1857.
117. Rizvi NA, Rusch V, Zhao B, Senturk E, Schwartz L, Fury M, Downey R, Rizk N, Krug L, Kris MG. Single agent bevacizumab and bevacizumab in combination with docetaxel and cisplatin as induction therapy for resectable IB-IIIA non-small cell lung cancer. J Clin Oncol 2007, 25(18S):18045.
118. Nagane M, Nishikawa R, Narita Y, Kobayashi H, Takano S, Shinoura N, Aoki T, Sugiyama K, Kuratsu J, Muragaki Y. Phase II study of single-agent bevacizumab in Japanese patients with recurrent malignant glioma. Japanese journal of clinical oncology 2012, 42(10):887-895.
119. Aghajanian C, Sill MW, Darcy KM, Greer B, McMeekin DS, Rose PG, Rotmensch J, Barnes MN, Hanjani P, Leslie KK. Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. J Clin Oncol 2011, 29(16):2259-2265.
120. Stopeck AT, Unger JM, Rimsza LM, Bellamy WT, Iannone M, Persky DO, Leblanc M, Fisher RI, Miller TP. A phase II trial of single agent bevacizumab in patients with relapsed, aggressive non-Hodgkin lymphoma: Southwest oncology group study S0108. Leukemia & Lymphoma 2009, 50(5):728-735.
121. Cannistra SA, Matulonis UA, Penson RT, Hambleton J, Dupont J, Mackey H, Douglas J, Burger RA, Armstrong D, Wenham R. Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. J Clin Oncol 2007, 25(33):5180-5186.
122. Bukowski RM, Kabbinavar FF, Figlin RA, Flaherty K, Srinivas S, Vaishampayan U, Drabkin HA, Dutcher J, Ryba S, Xia Q. Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. J Clin Oncol 2007, 25(29):4536-4541.
123. Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med 2012, 366(26):2455-2465.
124. Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer 2009, 115(16):3670-3679.
125. Allred DC, Brown P, Medina D. The origins of estrogen receptor alpha-positive and estrogen receptor alpha-negative human breast cancer. Breast Cancer Research: BCR 2004, 6(6):240-245.
126. Pirker R, Pereira JR, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt WE, Paz-Ares L, Storkel S. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. The Lancet Oncology 2012, 13(1):33-42.
127. Hofmann M, Stoss O, Gaiser T, Kneitz H, Heinmoller P, Gutjahr T, Kaufmann M, Henkel T, Ruschoff J. Central HER2 IHC and FISH analysis in a trastuzumab (Herceptin) phase II monotherapy study: assessment of test sensitivity and impact of chromosome 17 polysomy. Journal of Clinical Pathology 2008, 61(1):89-94.
128. Cobleigh MA, Vogel CL, Tripathy D, Robert NJ, Scholl S, Fehrenbacher L, Wolter JM, Paton V, Shak S, Lieberman G. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999, 17(9):2639-2648.
129. Sauter G, Lee J, Bartlett JM, Slamon DJ, Press MF. Guidelines for human epidermal growth factor receptor 2 testing: biologic and methodologic considerations. J Clin Oncol 2009, 27(8):1323-1333.
130. Cobleigh MA, Tabesh B, Bitterman P, Baker J, Cronin M, Liu ML, Borchik R, Mosquera JM, Walker MG, Shak S. Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes. Clin Cancer Res 2005, 11(24 Pt 1):8623-8631.
131. Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR, Tsao A, Stewart DJ, Hicks ME, Erasmus J, Gupta S. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discovery 2011, 1(1):44-53.
132. Bai H, Wang Z, Chen K, Zhao J, Lee JJ, Wang S, Zhou Q, Zhuo M, Mao L, An T. Influence of chemotherapy on EGFR mutation status among patients with non-small-cell lung cancer. J Clin Oncol 2012, 30(25):3077-3083.
133. Inukai M, Toyooka S, Ito S, Asano H, Ichihara S, Soh J, Suehisa H, Ouchida M, Aoe K, Aoe M. Presence of epidermal growth factor receptor gene T790M mutation as a minor clone in non-small cell lung cancer. Cancer Research 2006, 66(16):7854-7858.
134. Pusztai L, Ayers M, Stec J, Clark E, Hess K, Stivers D, Damokosh A, Sneige N, Buchholz TA, Esteva FJ. Gene expression profiles obtained from fine-needle aspirations of breast cancer reliably identify routine prognostic markers and reveal large-scale molecular differences between estrogen-negative and estrogen-positive tumors. Clin Cancer Res 2003, 9(7):2406-2415.
135. Maitournam A, Simon R. On the efficiency of targeted clinical trials. Statistics in Medicine 2005, 24(3):329-339.
136. Simon R. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 1989, 10(1):1-10.
137. Barton S, Starling N, Swanton C. Predictive molecular markers of response to epidermal growth factor receptor (EGFR) family-targeted therapies. Current Cancer Drug Targets 2010, 10(8):799-812.
138. Ou SH, Kwak EL, Siwak-Tapp C, Dy J, Bergethon K, Clark JW, Camidge DR, Solomon BJ, Maki RG, Bang YJ. Activity of crizotinib (PF02341066), a dual mesenchymal-epithelial transition (MET) and anaplastic lymphoma kinase (ALK) inhibitor, in a non-small cell lung cancer patient with de novo MET amplification. Journal of Thoracic Oncology: official publication of the International Association for the Study of Lung Cancer 2011, 6(5):942-946.
139. Ou SH, Bartlett CH, Mino-Kenudson M, Cui J, Iafrate AJ. Crizotinib for the Treatment of ALK-Rearranged Non-Small Cell Lung Cancer: A Success Story to Usher in the Second Decade of Molecular Targeted Therapy in Oncology. The Oncologist 2012, 17(11):1351-1375.
140. Ahmed SM, Salgia R. Epidermal growth factor receptor mutations and susceptibility to targeted therapy in lung cancer. Respirology 2006, 11(6):687-692.
141. Martinez-Rivera M, Siddik ZH. Resistance and gain-of-resistance phenotypes in cancers harboring wild-type p53. Biochemical Pharmacology 2012, 83(8):1049-1062.
142. Ihle NT, Byers LA, Kim ES, Saintigny P, Lee JJ, Blumenschein GR, Tsao A, Liu S, Larsen JE, Wang J. Effect of KRAS oncogene substitutions on protein behavior: implications for signaling and clinical outcome. J Natl Cancer Inst 2012, 104(3):228-239.
143. 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(8):1346-1354.
144. Bruzzi P, Del Mastro L, Sormani MP, Bastholt L, Danova M, Focan C, Fountzilas G, Paul J, Rosso R, Venturini M. Objective response to chemotherapy as a potential surrogate end point of survival in metastatic breast cancer patients. J Clin Oncol 2005, 23(22):5117-5125.
145. Tsimberidou AM, Braiteh F, Stewart DJ, Kurzrock R. Ultimate fate of oncology drugs approved by the US Food and Drug Administration without a randomized Trial. J Clin Oncol 2009, 27(36):6243-6250.
146. Seymour L, Ivy SP, Sargent D, Spriggs D, Baker L, Rubinstein L, Ratain MJ, Le Blanc M, Stewart D, Crowley J. The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the National Cancer Institute Investigational Drug Steering Committee. Clin Cancer Res 2010, 16(6):1764-1769.
147. Cannistra SA. Phase II trials in Journal of Clinical Oncology. J Clin Oncol 2009, 27(19):3073-3076.
148. Stewart DJ, Chiritescu G, Dahrouge S, Banerjee S, Tomiak EM. Chemotherapy dose-response relationships in non-small cell lung cancer and implied resistance mechanisms. Cancer Treatment Reviews 2007, 33(2):101-137.
149. Chlebowski RT, Smalley RV, Weiner JM, Irwin LE, Bartolucci AA, Bateman JR. Combination versus sequential single agent chemotherapy in advanced breast cancer: associations with metastatic sites and long-term survival. The Western Cancer Study Group and The Southeastern Cancer Study Group. Br J Cancer 1989, 59(2):227-230.
150. Li T, Ling YH, Goldman ID, Perez-Soler R. Schedule-dependent cytotoxic synergism of pemetrexed and erlotinib in human non-small cell lung cancer cells. Clin Cancer Res 2007, 13(11):3413-3422.
151. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006, 355(24):2542-2550.
152. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004, 350(23):2335-2342.
153. Giantonio BJ, Catalano PJ, Meropol NJ, O'Dwyer PJ, Mitchell EP, Alberts SR, Schwartz MA, Benson AB. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007, 25(12):1539-1544.
154. Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007, 370(9605):2103-2111.
155. Escudier B, Bellmunt J, Negrier S, Bajetta E, Melichar B, Bracarda S, Ravaud A, Golding S, Jethwa S, Sneller V. Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival. J Clin Oncol 2010, 28(13):2144-2150.
156. Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol 2008, 26(35):5721-5727.
157. Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 2003, 21(14):2636-2644.
158. Albain KS, Nag SM, Calderillo-Ruiz G, Jordaan JP, Llombart AC, Pluzanska A, Rolski J, Melemed AS, Reyes-Vidal JM, Sekhon JS. Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol 2008, 26(24):3950-3957.
159. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 2006, 24(31):4991-4997.
160. Long HJ, Bundy BN, Grendys EC, Benda JA, McMeekin DS, Sorosky J, Miller DS, Eaton LA, Fiorica JV. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol 2005, 23(21):4626-4633.
161. Pfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, Wagner U, Stahle A, Stuart G, Kimmig R. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol 2006, 24(29):4699-4707.
162. Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med 2007, 357(17):1695-1704.
163. Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, Jagiello-Gruszfeld A, Crown J, Chan A, Kaufman B. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006, 355(26):2733-2743.
164. Cameron D, Casey M, Press M, Lindquist D, Pienkowski T, Romieu CG, Chan S, Jagiello-Gruszfeld A, Kaufman B, Crown J. A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Research and Ttreatment 2008, 112(3):533-543.
165. Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007, 356(22):2271-2281.
166. Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 2007, 25(33):5210-5217.
167. Hortobagyi GN, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Lerzo GL, Pivot XB, de Mendoza H. Analysis of overall survival from a phase III study of ixabepilone plus capecitabine versus capecitabine in patients with MBC resistant to anthracyclines and taxanes. Breast Cancer Research and Treatment 2010, 122(2):409-418.
168. Johnston S, Pippen J, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol 2009, 27(33):5538-5546.
169. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet 2010, 376(9742):687-697.
170. Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 2008, 359(11):1116-1127.
171. Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts S. Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: a North American Intergroup Trial. J Clin Oncol 2006, 24(21):3347-3353.
172. Raaphorst G, Wang G, Ng C. Radiosensitization by cisplatin treatment in Cisplatin-resistant and sensitive human ovarian-carcinoma cell-lines. International Journal of Oncology 1995, 7(2):325-330.
173. Engelman JA, Zejnullahu K, Mitsudomi T, Song Y, Hyland C, Park JO, Lindeman N, Gale CM, Zhao X, Christensen J. MET amplification leads to gefitinib resistance in lung cancer by activating ERBB3 signaling. Science 2007, 316(5827):1039-1043.
174. Stewart DJ, Evans WK, Logan D. Addition of pentoxifylline plus nifedipine to chemotherapy in patients with cisplatin-resistant cancers of the lung and other sites. American Journal of Clinical Oncology 1994, 17(4):313-316.
175. Wilson WH, Bates SE, Fojo A, Bryant G, Zhan Z, Regis J, Wittes RE, Jaffe ES, Steinberg SM, Herdt J. Controlled trial of dexverapamil, a modulator of multidrug resistance, in lymphomas refractory to EPOCH chemotherapy. J Clin Oncol 1995, 13(8):1995-2004.
176. Dalton WS, Crowley JJ, Salmon SS, Grogan TM, Laufman LR, Weiss GR, Bonnet JD. A phase III randomized study of oral verapamil as a chemosensitizer to reverse drug resistance in patients with refractory myeloma. A Southwest Oncology Group study. Cancer 1995, 75(3):815-820.
177. Thurlimann B, Kroger N, Greiner J, Mross K, Schuller J, Schernhammer E, Schumacher K, Gastl G, Hartlapp J, Kupper H. Dexverapamil to overcome epirubicin resistance in advanced breast cancer. Journal of Cancer Research and Clinical Oncology 1995, 121(Suppl 3):R3-6.
178. Salmon SE, Dalton WS, Grogan TM, Plezia P, Lehnert M, Roe DJ, Miller TP. Multidrug-resistant myeloma: laboratory and clinical effects of verapamil as a chemosensitizer. Blood 1991, 78(1):44-50.
179. Chaft JE, Oxnard GR, Sima CS, Kris MG, Miller VA, Riely GJ. Disease flare after tyrosine kinase inhibitor discontinuation in patients with EGFR-mutant lung cancer and acquired resistance to erlotinib or gefitinib: implications for clinical trial design. Clin Cancer Res 2011, 17(19):6298-6303.