NCCN working group report: Designing clinical trials in the era of multiple biomarkers and targeted therapies

JNCCN Journal of the National Comprehensive Cancer Network

Volumn 12, Issue 11, 2014, Pages 1629-1649

  Venook, Alan P ^a   Arcila, Maria E ^b   Benson, Al B ^c   Berry, Donald A ^d   Camidge, David Ross ^e   Carlson, Robert W ^f,n,p   Choueiri, Toni K ^g   Guild, Valerie ^h   Kalemkerian, Gregory P ⁱ   Kurzrock, Razelle ^j   Lovly, Christine M ^k   McKee, Amy E ^l   Morgan, Robert J ^m   Olszanski, Anthony J ⁿ   Redman, Mary W ^o   Stearns, Vered ^q   McClure, Joan ^r   Birkeland, Marian L ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

^d UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^e University of Colorado Cancer Center   (United States)

^f STANFORD CANCER INSTITUTE   (United States)

^g Dana Farber Brigham and Women's Cancer Center   (United States)

^h AIM at Melanoma Foundation   (United States)

ⁱ UNIVERSITY OF MICHIGAN COMPREHENSIVE CANCER CENTER   (United States)

^j UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^k VANDERBILT INGRAM CANCER CENTER   (United States)

^l FDA CDER OND OHOP DOP1   (United States)

^m CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

ⁿ FOX CHASE CANCER CENTER   (United States)

^o SEATTLE CANCER CARE ALLIANCE   (United States)

^p JOHNS HOPKINS UNIVERSITY   (United States)

^q National Comprehensive Cancer Network   (United States)

^r NONE

more..

Author keywords

[No Author keywords available]

Indexed keywords

B RAF KINASE; BIOLOGICAL MARKER; CARBOPLATIN; CRIZOTINIB; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; NERATINIB; PACLITAXEL; TRASTUZUMAB; VELIPARIB;

ARTICLE; BREAST CANCER; CANCER THERAPY; CHROMOSOMAL INSTABILITY; CLEAR CELL CARCINOMA; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); COLORECTAL CANCER; FOOD AND DRUG ADMINISTRATION; GENE MUTATION; HUMAN; KIDNEY CARCINOMA; LUNG CANCER; MELANOMA; METASTATIC MELANOMA; NON SMALL CELL LUNG CANCER; OVARY CANCER; SIGNAL TRANSDUCTION; SMALL CELL LUNG CANCER; SOLID TUMOR; STUDY DESIGN; TRIPLE NEGATIVE BREAST CANCER; UPREGULATION; METABOLISM; METHODOLOGY; NEOPLASMS; PERSONALIZED MEDICINE; PROCEDURES;

BIOMARKERS; CLINICAL TRIALS AS TOPIC; HUMANS; NEOPLASMS; PRECISION MEDICINE; RESEARCH DESIGN;

EID: 84908530231     PISSN: 15401405     EISSN: 15401413     Source Type: Journal    
DOI: 10.6004/jnccn.2014.0161     Document Type: Article

References (125)

1. Arrowsmith J, Miller P. Trial watch: phase II and phase III attrition rates 2011-2012. Nat Rev Drug Discov 2013; 12: 569.
2. Amiri-Kordestani L, Fojo T. Why do phase III clinical trials in oncology fail so often? J Natl Cancer Inst 2012; 104: 568-569.
3. Gan HK, You B, Pond GR, Chen EX. Assumptions of expected benefits in randomized phase III trials evaluating systemic treatments for cancer. J Natl Cancer Inst 2012; 104: 590-598.
4. Munoz J, Swanton C, Kurzrock R. Molecular profiling and the reclassification of cancer: divide and conquer. Am Soc Clin Oncol Educ Book 2013; 2013: 127-134.
5. Gerlinger M, Rowan AJ, Horswell S, et al. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 2012; 366: 883-892.
6. Sequist LV, Waltman BA, Dias-Santagata D, et al. Genotypic and histological evolution of lung cancers acquiring resistance to EGFR inhibitors. Sci Transl Med 2011; 3: 75ra26.
7. Gridelli C, Rossi A. EURTAC first-line phase III randomized study in advanced non-small cell lung cancer: erlotinib works also in European population. J Thorac Dis 2012; 4: 219-220.
8. Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol 2013; 31: 3327-3334.
9. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2+ breast cancer. N Engl J Med 2005; 353: 1673-1684.
10. Slamon D. Herceptin: increasing survival in metastatic breast cancer. Eur J Oncol Nurs 2000; 4: 24-29.
11. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2+ breast cancer. N Engl J Med 2011; 365: 1273-1283.
12. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344: 783-792.
13. Gradishar WJ, Anderson BO, Blair SL, et al. NCCN Guidelines: Breast Cancer. Version 3, 2014. Available at: NCCN.org. Accessed July 16, 2014. To view the most recent and complete version of the NCCN Guidelines, visit NCCN.org.
14. Barker AD, Sigman CC, Kelloff GJ, et al. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharmacol Ther 2009; 86: 97-100.
15. Albain KS, Barlow WE, Ravdin PM, et al. Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with endocrine-responsive, node-positive breast cancer: a phase 3, open-label, randomised controlled trial. Lancet 2009; 374: 2055-2063.
16. Guidance for industry: pathologic complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval. Draft guidance. 2012. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf. Accessed August 8, 2014.
17. Antolin AA, Mestres J. Linking off-target kinase pharmacology to the differential cellular effects observed among PARP inhibitors. Oncotarget 2014; 5: 3023-3028.
18. San Antonio Breast Cancer Symposium Newsletter. I-SPY 2: novel study design. Available at: http://www.sabcs.org/UserPortal/Documents/SABCS-2013-Issue4.pdf. Accessed August 8, 2014.
19. New presurgery combination therapy for triple-negative breast cancer. CenterWatch News Online Web site. Available at: http://www. centerwatch.com/news-online/article/5737/new-presurgery-combination-therapy-for-triple-negative-breast-cancer#sthash.lxxDiwJK.1WpOa3bu. dpbs. Accessed August 8, 2014.
20. Printz C. I-SPY2 trial yields first results on combination therapy for triple-negative breast cancer. Cancer 2014; 120: 773.
21. Bose P, Ozer H. Neratinib: an oral, irreversible dual EGFR/HER2 inhibitor for breast and non-small cell lung cancer. Expert Opin Investig Drugs 2009; 18: 1735-1751.
22. Neratinib graduates to I-SPY 3. Cancer Discov 2014; 4: 624.
23. Puma Biotechnology Announces Positive Top Line Results from Phase III PB272 Trial in Adjuvant Breast Cancer (ExteNET Trial). Available at: http://www.businesswire.com/news/home/20140722005059/en/Puma- Biotechnology-Announces-Positive-Top-Line-Results#.VA3vma90zkh. Accessed September 8, 2014.
24. Jones D. Adaptive trials receive boost. Nat Rev Drug Discov 2010; 9: 345-348.
25. Berry DA. Bayesian clinical trials. Nat Rev Drug Discov 2006; 5: 27-36.
26. Berry DA. Next generation clinical trials. Clin Adv Hematol Oncol 2011; 9: 601-603.
27. Berry DA. Adaptive clinical trials: the promise and the caution. J Clin Oncol 2011; 29: 606-609.
28. Berry DA. Adaptive clinical trials in oncology. Nat Rev Clin Oncol 2012; 9: 199-207.
29. Lung Cancer Master Protocol Activation Announcement. 2013. Available at: http://www.focr.org/events/2013-friends-brookings-conference-clinical-cancer-research. Accessed August 8, 2014.
30. Trial offers new model for drug development. Cancer Discov 2014; 4: 266-267.
31. Fox JL. Master Protocol for squamous cell lung cancer readies for launch. Nat Biotechnol 2014; 32: 116-118.
32. Abrams J, Conley B, Mooney M, et al. National Cancer Institute's Precision Medicine Initiatives for the new National Clinical Trials Network. Am Soc Clin Oncol Educ Book 2014; 34: 71-76.
33. Tsimberidou AM, Iskander NG, Hong DS, et al. Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative. Clin Cancer Res 2012; 18: 6373-6383.
34. Arcila M, Lau C, Nafa K, Ladanyi M. Detection of KRAS and BRAF mutations in colorectal carcinoma roles for high-sensitivity locked nucleic acid-PCR sequencing and broad-spectrum mass spectrometry genotyping. J Mol Diagn 2011; 13: 64-73.
35. Kabiawu Ajise OE, Feldstein JT, Soslow R, et al. Assessment of BRAF V600E mutation status by immunohistochemistry in lung and ovarian carcinomas [abstract]. Mod Pathol 2013; 26(Suppl 2): Abstract 2060.
36. Liu Y, Casanova J, Nafa K, et al. Detection of BRAF V600E mutation in hairy cell leukemia: comparison of high-sensitivity locked nucleic acid- PCR sequencing and IHC with the VE1 mutation-specific antibody. J Mol Diagn 2013; 15: 871-872.
37. Levy MA, Lovly CM, Horn L, et al. My Cancer Genome: Web-based clinical decision support for genome-directed lung cancer treatment [abstract]. J Clin Oncol 2011; 29(Suppl): Abstract 7576.
38. Van Allen EM, Wagle N, Levy MA. Clinical analysis and interpretation of cancer genome data. J Clin Oncol 2013; 31: 1825-1833.
39. Carney PH. Information technology and precision medicine. Semin Oncol Nurs 2014; 30: 124-129.
40. Levy MA, Lovly CM, Pao W. Translating genomic information into clinical medicine: lung cancer as a paradigm. Genome Res 2012; 22: 2101-2108.
41. SEER Stat Fact Sheets: melanoma of the skin. SEER Web site. Available at: http://seer.cancer.gov/statfacts/html/melan.html. Accessed August 8, 2014.
42. Davies H, Bignell GR, Cox C, et al. Mutations of the BRAF gene in human cancer. Nature 2002; 417: 949-954.
43. Hall RD, Kudchadkar RR. BRAF mutations: signaling, epidemiology, and clinical experience in multiple malignancies. Cancer Control 2014; 21: 221-230.
44. Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011; 364: 2507-2516.
45. Flaherty KT, Infante JR, Daud A, et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med 2012; 367: 1694-1703.
46. Turajlic S, Furney SJ, Stamp G, et al. Whole-genome sequencing reveals complex mechanisms of intrinsic resistance to BRAF inhibition. Ann Oncol 2014; 25: 959-967.
47. Falchook GS, Lewis KD, Infante JR, et al. Activity of the oral MEK inhibitor trametinib in patients with advanced melanoma: a phase 1 dose-escalation trial. Lancet Oncol 2012; 13: 782-789.
48. Falchook GS, Long GV, Kurzrock R, et al. Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trial. Lancet 2012; 379: 1893-1901.
49. Sosman JA, Daud A, Weber JS, et al. BRAF inhibitor (BRAFi) dabrafenib in combination with the MEK1/2 inhibitor (MEKi) trametinib in BRAFi-naive and BRAFi-resistant patients (pts) with BRAF mutation-positive metastatic melanoma (MM) [abstract]. J Clin Oncol 2013; 31(Suppl): Abstract 9005.
50. Haarberg HE, Smalley KS. Resistance to Raf inhibition in cancer. Drug Discov Today Technol 2014; 11: 27-32.
51. Huang V, Hepper D, Anadkat M, Cornelius L. Cutaneous toxic effects associated with vemurafenib and inhibition of the BRAF pathway. Arch Dermatol 2012; 148: 628-633.
52. Sloot S, Fedorenko IV, Smalley KS, Gibney GT. Long-term effects of BRAF inhibitors in melanoma treatment: friend or foe? Expert Opin Pharmacother 2014; 15: 589-592.
53. Perez-Lorenzo R, Zheng B. Targeted inhibition of BRAF kinase: opportunities and challenges for therapeutics in melanoma. Biosci Rep 2012; 32: 25-33.
54. Holderfield M, Deuker MM, McCormick F, McMahon M. Targeting RAF kinases for cancer therapy: BRAF-mutated melanoma and beyond. Nat Rev Cancer 2014; 14: 455-467.
55. Planchard D, Mazieres J, Riely GJ, et al. Interim results of phase II study BRF113928 of dabrafenib in BRAF V600E mutation-positive non-small cell lung cancer (NSCLC) patients [abstract]. J Clin Oncol 2013; 31(Suppl): Abstract 8009.
56. Kopetz S, Desai J, Chan E, et al. PLX4032 in metastatic colorectal cancer patients with mutant BRAF tumors [abstract]. J Clin Oncol 2010; 28(Suppl): Abstract 3534.
57. Prahallad A, Sun C, Huang S, et al. Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR. Nature 2012; 483: 100-103.
58. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA 2014; 311: 1998-2006.
59. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947-957.
60. Rosell R, Moran T, Queralt C, et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009; 361: 958-967.
61. Yang JC, Shih JY, Su WC, et al. Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial. Lancet Oncol 2012; 13: 539-548.
62. Shaw AT, Engelman JA. ALK in lung cancer: past, present, and future. J Clin Oncol 2013; 31: 1105-1111.
63. Camidge DR, Pao W, Sequist LV. Acquired resistance to TKIs in solid tumours: learning from lung cancer. Nat Rev Clin Oncol 2014; 11: 473-481.
64. Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010; 363: 1693-1703.
65. Camidge DR, Bang YJ, Kwak EL, 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: 1011-1019.
66. Kwak EL, Camidge DR, Clark J, et al. Clinical activity observed in a phase I dose escalation trial of an oral c-met and ALK inhibitor, PF-02341066 [abstract]. J Clin Oncol 2009; 27(Suppl): Abstract 3509.
67. Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004; 22: 1589-1597.
68. Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013; 368: 2385-2394.
69. Weickhardt AJ, Scheier B, Burke JM, et al. Local ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene-addicted non-small-cell lung cancer. J Thorac Oncol 2012; 7: 1807-1814.
70. Costa DB, Kobayashi S, Pandya SS, et al. CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib. J Clin Oncol 2011; 29: e443-445.
71. Lin NU, Lee EQ, Aoyama H, et al. Challenges relating to solid tumour brain metastases in clinical trials, part 1: patient population, response, and progression. A report from the RANO group. Lancet Oncol 2013; 14: e396-406.
72. Riely GJ, Kris MG, Zhao B, et al. Prospective assessment of discontinuation and reinitiation of erlotinib or gefitinib in patients with acquired resistance to erlotinib or gefitinib followed by the addition of everolimus. Clin Cancer Res 2007; 13: 5150-5155.
73. Weickhardt A, Doebele R, Oton A, et al. A phase I/II study of erlotinib in combination with the anti-insulin-like growth factor-1 receptor monoclonal antibody IMC-A12 (cixutumumab) in patients with advanced non-small cell lung cancer. J Thorac Oncol 2012; 7: 419-426.
74. Hutchins G, Southward K, Handley K, et al. Value of mismatch repair, KRAS, and BRAF mutations in predicting recurrence and benefits from chemotherapy in colorectal cancer. J Clin Oncol 2011; 29: 1261-1270.
75. Marshall JL. Risk assessment in Stage II colorectal cancer. Oncology (Williston Park) 2010; 24: 9-13.
76. Sanz-Pamplona R, Berenguer A, Cordero D, et al. Clinical value of prognosis gene expression signatures in colorectal cancer: a systematic review. PLoS One 2012; 7: e48877.
77. Gavin PG, Colangelo LH, Fumagalli D, et al. Mutation profiling and microsatellite instability in stage II and III colon cancer: an assessment of their prognostic and oxaliplatin predictive value. Clin Cancer Res 2012; 18: 6531-6541.
78. Douillard JY, Rong A, Sidhu R. RAS mutations in colorectal cancer. N Engl J Med 2013; 369: 2159-2160.
79. Douillard JY, Oliner KS, Siena S, et al. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med 2013; 369: 1023-1034.
80. COSMIC: Catalogue of Somatic Mutations in Cancer. Available at: http://cancer.sanger.ac.uk/cancergenome/projects/cosmic/. Accessed August 8, 2014.
81. Lochhead P, Kuchiba A, Imamura Y, et al. Microsatellite instability and BRAF mutation testing in colorectal cancer prognostication. J Natl Cancer Inst 2013; 105: 1151-1156.
82. Hann CL, Rudin CM. Fast, hungry and unstable: finding the Achilles' heel of small-cell lung cancer. Trends Mol Med 2007; 13: 150-157.
83. Kalemkerian GP, Jiroutek M, Ettinger DS, et al. A phase II study of all-trans-retinoic acid plus cisplatin and etoposide in patients with extensive stage small cell lung carcinoma: an Eastern Cooperative Oncology Group Study. Cancer 1998; 83: 1102-1108.
84. Peifer M, Fernandez-Cuesta L, Sos ML, et al. Integrative genome analyses identify key somatic driver mutations of small-cell lung cancer. Nat Genet 2012; 44: 1104-1110.
85. Rudin CM, Durinck S, Stawiski EW, et al. Comprehensive genomic analysis identifies SOX2 as a frequently amplified gene in small-cell lung cancer. Nat Genet 2012; 44: 1111-1116.
86. Sos ML, Dietlein F, Peifer M, et al. A framework for identification of actionable cancer genome dependencies in small cell lung cancer. Proc Natl Acad Sci U S A 2012; 109: 17034-17039.
87. Boldrini L, Ursino S, Gisfredi S, et al. Expression and mutational status of c-kit in small-cell lung cancer: prognostic relevance. Clin Cancer Res 2004; 10: 4101-4108.
88. LaPoint RJ, Bourne PA, Wang HL, Xu H. Coexpression of c-kit and bcl-2 in small cell carcinoma and large cell neuroendocrine carcinoma of the lung. Appl Immunohistochem Mol Morphol 2007; 15: 401-406.
89. Lopez-Martin A, Ballestin C, Garcia-Carbonero R, et al. Prognostic value of KIT expression in small cell lung cancer. Lung Cancer 2007; 56: 405-413.
90. Naeem M, Dahiya M, Clark JI, et al. Analysis of c-kit protein expression in small-cell lung carcinoma and its implication for prognosis. Hum Pathol 2002; 33: 1182-1187.
91. Rossi G, Cavazza A, Marchioni A, et al. Kit expression in small cell carcinomas of the lung: effects of chemotherapy. Mod Pathol 2003; 16: 1041-1047.
92. Sihto H, Sarlomo-Rikala M, Tynninen O, et al. KIT and platelet-derived growth factor receptor alpha tyrosine kinase gene mutations and KIT amplifications in human solid tumors. J Clin Oncol 2005; 23: 49-57.
93. Dy GK, Miller AA, Mandrekar SJ, et al. A phase II trial of imatinib (ST1571) in patients with c-kit expressing relapsed small-cell lung cancer: a CALGB and NCCTG study. Ann Oncol 2005; 16: 1811-1816.
94. Krug LM, Crapanzano JP, Azzoli CG, et al. Imatinib mesylate lacks activity in small cell lung carcinoma expressing c-kit protein: a phase II clinical trial. Cancer 2005; 103: 2128-2131.
95. Schneider BJ, Kalemkerian GP, Ramnath N, et al. Phase II trial of imatinib maintenance therapy after irinotecan and cisplatin in patients with c-Kit-positive, extensive-stage small-cell lung cancer. Clin Lung Cancer 2010; 11: 223-227.
96. SEER Stat Fact Sheets: kidney and renal pelvis cancer. SEER Web site. Available at: http://seer.cancer.gov/statfacts/html/kidrp.html. Accessed August 8, 2014.
97. Di Napoli A, Signoretti S. Tissue biomarkers in renal cell carcinoma: issues and solutions. Cancer 2009; 115: 2290-2297.
98. Choueiri TK. Clinical treatment decisions for advanced renal cell cancer. J Natl Compr Canc Netw 2013; 11: 694-697.
99. Hudes GR, Carducci MA, Choueiri TK, et al. NCCN Task Force report: optimizing treatment of advanced renal cell carcinoma with molecular targeted therapy. J Natl Compr Canc Netw 2011; 9(Suppl 1): S1-29.
100. Topalian SL, Drake CG, Pardoll DM. Targeting the PD-1/B7-H1(PD-L1) pathway to activate anti-tumor immunity. Curr Opin Immunol 2012; 24: 207-212.
101. Thompson RH, Dong H, Kwon ED. Implications of B7-H1 expression in clear cell carcinoma of the kidney for prognostication and therapy. Clin Cancer Res 2007; 13: 709s-715s.
102. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012; 366: 2443-2454.
103. Cho DC, Sosman JA, Sznol M, et al. Clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with metastatic renal cell carcinoma (mRCC) [abstract]. J Clin Oncol 2013; 31(Suppl): Abstract 4505.
104. Choueiri TK, Fishman MN, Escudier BJ, et al. Immunomodulatory activity of nivolumab in previously treated and untreated metastatic renal cell carcinoma (mRCC): Biomarker-based results from a randomized clinical trial [abstract]. J Clin Oncol 2014; 32(Suppl): Abstract 5012.
105. Armstrong DK, Bundy B, Wenzel L, et al. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med 2006; 354: 34-43.
106. McCluggage WG. Morphological subtypes of ovarian carcinoma: a review with emphasis on new developments and pathogenesis. Pathology 2011; 43: 420-432.
107. Bookman MA. Molecular wanderings through the DNA damage response and risk for ovarian cancer. J Natl Cancer Inst 2014; 106: djt350.
108. Bast RC Jr, Hennessy B, Mills GB. The biology of ovarian cancer: new opportunities for translation. Nat Rev Cancer 2009; 9: 415-428.
109. Bast RC Jr. CA 125 and the detection of recurrent ovarian cancer: a reasonably accurate biomarker for a difficult disease. Cancer 2010; 116: 2850-2853.
110. Bast RC Jr, Feeney M, Lazarus H, et al. Reactivity of a monoclonal antibody with human ovarian carcinoma. J Clin Invest 1981; 68: 1331-1337.
111. Kaneko O, Gong L, Zhang J, et al. A binding domain on mesothelin for CA125/MUC16. J Biol Chem 2009; 284: 3739-3749.
112. Rustin GJ, van der Burg ME, Griffin CL, et al. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet 2010; 376: 1155-1163.
113. Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004; 351: 2817-2826.
114. Sorlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A 2001; 98: 10869-10874.
115. Goldhirsch A, Winer EP, Coates AS, et al. Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol 2013; 24: 2206-2223.
116. Nielsen T, Wallden B, Schaper C, et al. Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens. BMC Cancer 2014; 14: 177.
117. Martin M, Brase JC, Calvo L, et al. Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial. Breast Cancer Res 2014; 16: R38.
118. Connolly RM, Stearns V. Current approaches for neoadjuvant chemotherapy in breast cancer. Eur J Pharmacol 2013; 717: 58-66.
119. Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet 2014; 384: 164-172.
120. Goncalves R, Ma C, Luo J, et al. Use of neoadjuvant data to design adjuvant endocrine therapy trials for breast cancer. Nat Rev Clin Oncol 2012; 9: 223-229.
121. Paik S, Kim C, Wolmark N. HER2 status and benefit from adjuvant trastuzumab in breast cancer. N Engl J Med 2008; 358: 1409-1411.
122. Carey LA, Dees EC, Sawyer L, et al. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res 2007; 13: 2329-2334.
123. Lehmann BD, Bauer JA, Chen X, et al. Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies. J Clin Invest 2011; 121: 2750-2767.
124. Department of Health and Human Services. Limited competition: biospecimen banks to support NCI-Clinical Trials Network (NCTN) (U24). Available at: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-14-501.html#-Part-2.-Full. Accessed August 8, 2014.
125. Department of Health and Human Services. NCI to provide $12M for biobanks to support Clinical Trials Network. Available at: http://www. genomeweb.com/nci-provide-12m-biobanks-support-clinical-trials-network. Accessed August 6, 2014.