Journal Article
. 2009 Oct;101(21).
doi: 10.1093/jnci/djp335.

Use of archived specimens in evaluation of prognostic and predictive biomarkers

Richard M Simon 1 Soonmyung Paik  Daniel F Hayes  
  • PMID: 19815849
  •     28 References
  •     329 citations


The development of tumor biomarkers ready for clinical use is complex. We propose a refined system for biomarker study design, conduct, analysis, and evaluation that incorporates a hierarchal level of evidence scale for tumor marker studies, including those using archived specimens. Although fully prospective randomized clinical trials to evaluate the medical utility of a prognostic or predictive biomarker are the gold standard, such trials are costly, so we discuss more efficient indirect "prospective-retrospective" designs using archived specimens. In particular, we propose new guidelines that stipulate that 1) adequate amounts of archived tissue must be available from enough patients from a prospective trial (which for predictive factors should generally be a randomized design) for analyses to have adequate statistical power and for the patients included in the evaluation to be clearly representative of the patients in the trial; 2) the test should be analytically and preanalytically validated for use with archived tissue; 3) the plan for biomarker evaluation should be completely specified in writing before the performance of biomarker assays on archived tissue and should be focused on evaluation of a single completely defined classifier; and 4) the results from archived specimens should be validated using specimens from one or more similar, but separate, studies.

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Lisa M McShane, Margaret M Cavenagh, +12 authors, Barbara A Conley.
Nature, 2013 Oct 18; 502(7471). PMID: 24132288    Free PMC article.
Highly Cited.
Statistical and practical considerations for clinical evaluation of predictive biomarkers.
Mei-Yin C Polley, Boris Freidlin, +3 authors, Lisa M McShane.
J Natl Cancer Inst, 2013 Oct 19; 105(22). PMID: 24136891    Free PMC article.
The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2- breast cancer patients.
P Dubsky, J C Brase, +18 authors, Austrian Breast and Colorectal Cancer Study Group (ABCSG).
Br J Cancer, 2013 Oct 26; 109(12). PMID: 24157828    Free PMC article.
Highly Cited.
An international Ki67 reproducibility study.
Mei-Yin C Polley, Samuel C Y Leung, +16 authors, International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group.
J Natl Cancer Inst, 2013 Nov 10; 105(24). PMID: 24203987    Free PMC article.
Highly Cited.
Gene aberrations of RRM1 and RRM2B and outcome of advanced breast cancer after treatment with docetaxel with or without gemcitabine.
Charlotte L T Jørgensen, Bent Ejlertsen, +3 authors, Kirsten V Nielsen.
BMC Cancer, 2013 Nov 13; 13. PMID: 24215511    Free PMC article.
Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration.
Lisa M McShane, Margaret M Cavenagh, +12 authors, Barbara A Conley.
BMC Med, 2013 Nov 16; 11. PMID: 24228635    Free PMC article.
OMICS-based personalized oncology: if it is worth doing, it is worth doing well!
Daniel F Hayes.
BMC Med, 2013 Nov 16; 11. PMID: 24228698    Free PMC article.
Evaluation of serum lysyl oxidase as a blood test for colorectal cancer.
S T Ward, C J Weston, +6 authors, D H Adams.
Eur J Surg Oncol, 2013 Nov 20; 40(6). PMID: 24246612    Free PMC article.
Evaluating many treatments and biomarkers in oncology: a new design.
Richard Kaplan, Timothy Maughan, +4 authors, Mahesh Parmar.
J Clin Oncol, 2013 Nov 20; 31(36). PMID: 24248692    Free PMC article.
Construction and analysis of multiparameter prognostic models for melanoma outcome.
Bonnie E Gould Rothberg, David L Rimm.
Methods Mol Biol, 2013 Nov 22; 1102. PMID: 24258982    Free PMC article.
Systematic Review.
Biomarker enrichment strategies: matching trial design to biomarker credentials.
Boris Freidlin, Edward L Korn.
Nat Rev Clin Oncol, 2013 Nov 28; 11(2). PMID: 24281059
Biomarkers for Basal-like Breast Cancer.
Jennifer R Choo, Torsten O Nielsen.
Cancers (Basel), 2010 Jan 01; 2(2). PMID: 24281106    Free PMC article.
Cost effectiveness of a 21-gene recurrence score assay versus Canadian clinical practice in post-menopausal women with early-stage estrogen or progesterone-receptor-positive, axillary lymph-node positive breast cancer.
Malek B Hannouf, Bin Xie, Muriel Brackstone, Gregory S Zaric.
Pharmacoeconomics, 2013 Nov 30; 32(2). PMID: 24288208
Emerging evidence for CHFR as a cancer biomarker: from tumor biology to precision medicine.
Sarah Derks, Arjen H G Cleven, +7 authors, Manon van Engeland.
Cancer Metastasis Rev, 2014 Jan 01; 33(1). PMID: 24375389    Free PMC article.
Biomarker-guided repurposing of chemotherapeutic drugs for cancer therapy: a novel strategy in drug development.
Jan Stenvang, Iben Kümler, +4 authors, José M A Moreira.
Front Oncol, 2014 Jan 09; 3. PMID: 24400218    Free PMC article.
Identification and validation of an anthracycline/cyclophosphamide-based chemotherapy response assay in breast cancer.
Jude M Mulligan, Laura A Hill, +21 authors, Richard D Kennedy.
J Natl Cancer Inst, 2014 Jan 10; 106(1). PMID: 24402422    Free PMC article.
AGO Recommendations for Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2013.
Anton Scharl, Christoph Thomssen, Nadia Harbeck, Volkmar Müller.
Breast Care (Basel), 2014 Jan 15; 8(3). PMID: 24415966    Free PMC article.
Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers.
Kinga Malottki, Mousumi Biswas, +4 authors, Lucinda Billingham.
BMJ Open, 2014 Jan 29; 4(1). PMID: 24468721    Free PMC article.
Systematic Review.
Accurate data processing improves the reliability of Affymetrix gene expression profiles from FFPE samples.
Maurizio Callari, Antonio Lembo, +5 authors, Paolo Provero.
PLoS One, 2014 Feb 04; 9(1). PMID: 24489733    Free PMC article.
Transcriptome profiling of archived sectioned formalin-fixed paraffin-embedded (AS-FFPE) tissue for disease classification.
Kensuke Kojima, Craig April, +8 authors, Yujin Hoshida.
PLoS One, 2014 Feb 06; 9(1). PMID: 24498002    Free PMC article.
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.
Torsten Nielsen, Brett Wallden, +7 authors, James Storhoff.
BMC Cancer, 2014 Mar 15; 14. PMID: 24625003    Free PMC article.
Highly Cited.
Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial.
Miguel Martin, Jan C Brase, +15 authors, Alvaro Rodriguez-Lescure.
Breast Cancer Res, 2014 Apr 15; 16(2). PMID: 24725534    Free PMC article.
Multigene Assays for Classification, Prognosis, and Prediction in Breast Cancer: a Critical Review on the Background and Clinical Utility.
P Sinn, S Aulmann, +6 authors, A Schneeweiss.
Geburtshilfe Frauenheilkd, 2014 Apr 29; 73(9). PMID: 24771945    Free PMC article.
OPG and PgR show similar cohort specific effects as prognostic factors in ER positive breast cancer.
Nicole Sänger, Eugen Ruckhäberle, +9 authors, Thomas Karn.
Mol Oncol, 2014 May 03; 8(7). PMID: 24785095    Free PMC article.
'Toxgnostics': an unmet need in cancer medicine.
David Church, Rachel Kerr, +5 authors, David Kerr.
Nat Rev Cancer, 2014 May 16; 14(6). PMID: 24827503
The use of Bayesian hierarchical models for adaptive randomization in biomarker-driven phase II studies.
William T Barry, Charles M Perou, +2 authors, Joseph G Ibrahim.
J Biopharm Stat, 2014 May 20; 25(1). PMID: 24836519    Free PMC article.
Predictive and prognostic value of the 21-gene recurrence score in hormone receptor-positive, node-positive breast cancer.
Adam M Brufsky.
Am J Clin Oncol, 2014 May 24; 37(4). PMID: 24853663    Free PMC article.
Systematic Review.
TIMP-1 and responsiveness to gemcitabine in advanced breast cancer; results from a randomized phase III trial from the Danish breast cancer cooperative group.
Charlotte Levin Tykjær Jørgensen, Christina Bjerre, +5 authors, Dorte L Nielsen.
BMC Cancer, 2014 Jun 03; 14. PMID: 24884504    Free PMC article.
Genomic patterns resembling BRCA1- and BRCA2-mutated breast cancers predict benefit of intensified carboplatin-based chemotherapy.
Marieke A Vollebergh, Esther H Lips, +9 authors, Sabine C Linn.
Breast Cancer Res, 2014 Jun 03; 16(3). PMID: 24887359    Free PMC article.
Tumor microenvironment of metastasis and risk of distant metastasis of breast cancer.
Thomas E Rohan, Xiaonan Xue, +10 authors, Joan G Jones.
J Natl Cancer Inst, 2014 Jun 05; 106(8). PMID: 24895374    Free PMC article.
Highly Cited.
Cross-study validation for the assessment of prediction algorithms.
Christoph Bernau, Markus Riester, +4 authors, Lorenzo Trippa.
Bioinformatics, 2014 Jun 17; 30(12). PMID: 24931973    Free PMC article.
Stratification and partial ascertainment of biomarker value in biomarker-driven clinical trials.
Richard Simon.
J Biopharm Stat, 2014 Jun 18; 24(5). PMID: 24935478    Free PMC article.
alphaB-crystallin is a marker of aggressive breast cancer behavior but does not independently predict for patient outcome: a combined analysis of two randomized studies.
Triantafyllia Koletsa, Flora Stavridi, +13 authors, George Fountzilas.
BMC Clin Pathol, 2014 Jul 06; 14. PMID: 24987308    Free PMC article.
Prognostic value of tumor-infiltrating lymphocytes in triple-negative breast cancers from two phase III randomized adjuvant breast cancer trials: ECOG 2197 and ECOG 1199.
Sylvia Adams, Robert J Gray, +13 authors, Sunil S Badve.
J Clin Oncol, 2014 Jul 30; 32(27). PMID: 25071121    Free PMC article.
Highly Cited.
Designing biomarker studies for head and neck cancer.
Kelly Y Kim, Lisa M McShane, Barbara A Conley.
Head Neck, 2014 Jul 30; 36(7). PMID: 25072057    Free PMC article.
Pharmacogenomic substudies of randomized controlled trials: consideration of safety outcomes.
Michael J Sorich, Andrew Rowland, Michael D Wiese.
Ther Adv Drug Saf, 2014 Aug 02; 5(2). PMID: 25083262    Free PMC article.
EGFR expression is associated with decreased benefit from trastuzumab in the NCCTG N9831 (Alliance) trial.
H Cheng, K Ballman, +12 authors, E A Perez.
Br J Cancer, 2014 Aug 15; 111(6). PMID: 25117817    Free PMC article.
Acid ceramidase is associated with an improved prognosis in both DCIS and invasive breast cancer.
Nicole Sänger, Eugen Ruckhäberle, +7 authors, Thomas Karn.
Mol Oncol, 2014 Aug 19; 9(1). PMID: 25131496    Free PMC article.
Chemotherapy in early breast cancer: when, how and which one?
Marcus Schmidt.
Breast Care (Basel), 2014 Sep 02; 9(3). PMID: 25177256    Free PMC article.
AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2014.
Cornelia Liedtke, Marc Thill, +2 authors, AGO Breast Committee.
Breast Care (Basel), 2014 Sep 02; 9(3). PMID: 25177261    Free PMC article.
Prognostic significance of FOXP3+ tumor-infiltrating lymphocytes in breast cancer depends on estrogen receptor and human epidermal growth factor receptor-2 expression status and concurrent cytotoxic T-cell infiltration.
Shuzhen Liu, William D Foulkes, +4 authors, Torsten O Nielsen.
Breast Cancer Res, 2014 Sep 07; 16(5). PMID: 25193543    Free PMC article.
The evaluation of tumor-infiltrating lymphocytes (TILs) in breast cancer: recommendations by an International TILs Working Group 2014.
R Salgado, C Denkert, +30 authors, International TILs Working Group 2014.
Ann Oncol, 2014 Sep 13; 26(2). PMID: 25214542    Free PMC article.
Highly Cited.
A systematic review and meta-analysis of somatic and germline DNA sequence biomarkers of esophageal cancer survival, therapy response and stage.
J M Findlay, M R Middleton, I Tomlinson.
Ann Oncol, 2014 Sep 13; 26(4). PMID: 25214541    Free PMC article.
Systematic Review.
Preanalytical variables and performance of diagnostic RNA-based gene expression analysis in breast cancer.
Christopher Poremba, Jennifer Uhlendorff, +10 authors, Carsten Denkert.
Virchows Arch, 2014 Sep 15; 465(4). PMID: 25218890    Free PMC article.
Polymerase ɛ (POLE) mutations in endometrial cancer: clinical outcomes and implications for Lynch syndrome testing.
Caroline C Billingsley, David E Cohn, +3 authors, Paul J Goodfellow.
Cancer, 2014 Sep 17; 121(3). PMID: 25224212    Free PMC article.
Consensus statement with recommendations on active surveillance inclusion criteria and definition of progression in men with localized prostate cancer: the critical role of the pathologist.
Rodolfo Montironi, Elizabeth H Hammond, +24 authors, Association of Directors of Anatomic and Surgical Pathology.
Virchows Arch, 2014 Oct 16; 465(6). PMID: 25316188
Development of circulating tumor cell-endocrine therapy index in patients with hormone receptor-positive breast cancer.
Costanza Paoletti, Maria C Muñiz, +13 authors, Daniel F Hayes.
Clin Cancer Res, 2014 Nov 09; 21(11). PMID: 25381338    Free PMC article.
Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine.
Sumithra J Mandrekar, Daniel J Sargent.
Chin Clin Oncol, 2014 Nov 22; 3(2). PMID: 25414851    Free PMC article.
Survival analysis tools in genomics research.
Xintong Chen, Xiaochen Sun, Yujin Hoshida.
Hum Genomics, 2014 Nov 26; 8. PMID: 25421963    Free PMC article.
Biomarker validation and testing.
Daniel F Hayes.
Mol Oncol, 2014 Dec 03; 9(5). PMID: 25458054    Free PMC article.
Clinical utility of gene-expression profiling in women with early breast cancer: an overview of systematic reviews.
Michael Marrone, Alison Stewart, W David Dotson.
Genet Med, 2014 Dec 05; 17(7). PMID: 25474343    Free PMC article.
Loss of heterozygosity at the CYP2D6 locus in breast cancer: implications for germline pharmacogenetic studies.
Matthew P Goetz, James X Sun, +19 authors, Roman Yelensky.
J Natl Cancer Inst, 2014 Dec 11; 107(2). PMID: 25490892    Free PMC article.
Quantitative measurement of cancer tissue biomarkers in the lab and in the clinic.
Daniel E Carvajal-Hausdorf, Kurt A Schalper, Veronique M Neumeister, David L Rimm.
Lab Invest, 2014 Dec 17; 95(4). PMID: 25502176    Free PMC article.
Prognostic significance of POLE proofreading mutations in endometrial cancer.
David N Church, Ellen Stelloo, +13 authors, Tjalling Bosse.
J Natl Cancer Inst, 2014 Dec 17; 107(1). PMID: 25505230    Free PMC article.
Highly Cited.
Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs.
Alexandre Vivot, Isabelle Boutron, Philippe Ravaud, Raphaël Porcher.
Genet Med, 2014 Dec 19; 17(9). PMID: 25521333
Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer.
Shakun M Malik, Richard Pazdur, +7 authors, Fred R Hirsch.
J Thorac Oncol, 2014 Dec 19; 9(10). PMID: 25521397    Free PMC article.
Molecularly targeted therapies in non-small-cell lung cancer annual update 2014.
Daniel Morgensztern, Meghan J Campo, +21 authors, Ramaswamy Govindan.
J Thorac Oncol, 2014 Dec 24; 10(1 Suppl 1). PMID: 25535693    Free PMC article.
A guide for clinicians in the evaluation of emerging molecular diagnostics for newly diagnosed prostate cancer.
Steven E Canfield, Adam S Kibel, +3 authors, Judd W Moul.
Rev Urol, 2014 Dec 31; 16(4). PMID: 25548544    Free PMC article.
Next-generation clinical trials: Novel strategies to address the challenge of tumor molecular heterogeneity.
Daniel V T Catenacci.
Mol Oncol, 2015 Jan 06; 9(5). PMID: 25557400    Free PMC article.
uPA and PAI-1 as biomarkers in breast cancer: validated for clinical use in level-of-evidence-1 studies.
Michael J Duffy, Patricia M McGowan, +2 authors, Manfred Schmitt.
Breast Cancer Res, 2015 Feb 14; 16(4). PMID: 25677449    Free PMC article.
Highly Cited. Review.
Leveraging biospecimen resources for discovery or validation of markers for early cancer detection.
Sheri D Schully, Danielle M Carrick, +19 authors, David F Ransohoff.
J Natl Cancer Inst, 2015 Feb 18; 107(4). PMID: 25688116    Free PMC article.
An international study to increase concordance in Ki67 scoring.
Mei-Yin C Polley, Samuel C Y Leung, +28 authors, Torsten O Nielsen.
Mod Pathol, 2015 Feb 24; 28(6). PMID: 25698062
Highly Cited.
Open access to large scale datasets is needed to translate knowledge of cancer heterogeneity into better patient outcomes.
Andrew H Beck.
PLoS Med, 2015 Feb 25; 12(2). PMID: 25710538    Free PMC article.
Antibody response to BK polyomavirus as a prognostic biomarker and potential therapeutic target in prostate cancer.
Xavier Etienne Keller, Piotr Kardas, +8 authors, Maurizio Provenzano.
Oncotarget, 2015 Mar 10; 6(8). PMID: 25749042    Free PMC article.
Improving the quality of biomarker discovery research: the right samples and enough of them.
Margaret S Pepe, Christopher I Li, Ziding Feng.
Cancer Epidemiol Biomarkers Prev, 2015 Apr 04; 24(6). PMID: 25837819    Free PMC article.
Use of formalin-fixed paraffin-embedded samples for gene expression studies in breast cancer patients.
Valeria Musella, Maurizio Callari, +8 authors, Vera Cappelletti.
PLoS One, 2015 Apr 07; 10(4). PMID: 25844937    Free PMC article.
A decision support framework for genomically informed investigational cancer therapy.
Funda Meric-Bernstam, Amber Johnson, +17 authors, Gordon B Mills.
J Natl Cancer Inst, 2015 Apr 12; 107(7). PMID: 25863335    Free PMC article.
Highly Cited. Review.
Developing a new generation of breast cancer clinical gene expression tests.
Zuzana Kos, Torsten O Nielsen.
Breast Cancer Res, 2014 Jan 01; 16(4). PMID: 25928431    Free PMC article.
Tumor homologous recombination deficiency assays: another step closer to clinical application?
Shane R Stecklein, Priyanka Sharma.
Breast Cancer Res, 2014 Jan 01; 16(4). PMID: 25928813    Free PMC article.
Genotype-based clinical trials in cardiovascular disease.
Naveen L Pereira, Daniel J Sargent, Michael E Farkouh, Charanjit S Rihal.
Nat Rev Cardiol, 2015 May 06; 12(8). PMID: 25940926    Free PMC article.
Integrating biomarkers in colorectal cancer trials in the West and China.
Sabine Tejpar, Lin Shen, Xicheng Wang, Richard L Schilsky.
Nat Rev Clin Oncol, 2015 May 13; 12(9). PMID: 25963094
Meta-analysis of BRAF mutation as a predictive biomarker of benefit from anti-EGFR monoclonal antibody therapy for RAS wild-type metastatic colorectal cancer.
A Rowland, M M Dias, +4 authors, M J Sorich.
Br J Cancer, 2015 May 20; 112(12). PMID: 25989278    Free PMC article.
Highly Cited. Systematic Review.
Identification and evaluation of network modules for the prognosis of basal-like breast cancer.
Robin M Hallett, Jessica G Cockburn, +3 authors, Anita Bane.
Oncotarget, 2015 May 21; 6(19). PMID: 25991675    Free PMC article.
Designing a study to evaluate the benefit of a biomarker for selecting patient treatment.
Holly Janes, Marshall D Brown, Margaret S Pepe.
Stat Med, 2015 Jun 27; 34(27). PMID: 26112650    Free PMC article.
Clinical Translation and Validation of a Predictive Biomarker for Patritumab, an Anti-human Epidermal Growth Factor Receptor 3 (HER3) Monoclonal Antibody, in Patients With Advanced Non-small Cell Lung Cancer.
Jeanne Mendell, Daniel J Freeman, +11 authors, Robert A Beckman.
EBioMedicine, 2015 Jul 03; 2(3). PMID: 26137564    Free PMC article.
Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.
Catherine Van Poznak, Mark R Somerfield, +12 authors, Lyndsay N Harris.
J Clin Oncol, 2015 Jul 22; 33(24). PMID: 26195705    Free PMC article.
Highly Cited.
Cancer biomarker discovery and validation.
Nicolas Goossens, Shigeki Nakagawa, Xiaochen Sun, Yujin Hoshida.
Transl Cancer Res, 2015 Jul 28; 4(3). PMID: 26213686    Free PMC article.
Highly Cited.
TLE3 is not a predictive biomarker for taxane sensitivity in the NCIC CTG MA.21 clinical trial.
J M S Bartlett, T O Nielsen, +10 authors, NCIC CTG.
Br J Cancer, 2015 Aug 19; 113(5). PMID: 26284338    Free PMC article.
Development and verification of the PAM50-based Prosigna breast cancer gene signature assay.
Brett Wallden, James Storhoff, +16 authors, Joel S Parker.
BMC Med Genomics, 2015 Aug 25; 8. PMID: 26297356    Free PMC article.
Highly Cited.
Personalized Medicine: Genomics Trials in Oncology.
Daniel F Hayes, Anne F Schott.
Trans Am Clin Climatol Assoc, 2015 Sep 04; 126. PMID: 26330667    Free PMC article.
A four gene signature predicts benefit from anthracyclines: evidence from the BR9601 and MA.5 clinical trials.
Melanie Spears, Fouad Yousif, +7 authors, John M S Bartlett.
Oncotarget, 2015 Sep 16; 6(31). PMID: 26372731    Free PMC article.
Clinical Utility of a Plasma Protein Classifier for Indeterminate Lung Nodules.
Anil Vachani, Zane Hammoud, +9 authors, Paul Kearney.
Lung, 2015 Sep 18; 193(6). PMID: 26376647    Free PMC article.
Enhanced MAF Oncogene Expression and Breast Cancer Bone Metastasis.
Milica Pavlovic, Anna Arnal-Estapé, +16 authors, Roger R Gomis.
J Natl Cancer Inst, 2015 Sep 18; 107(12). PMID: 26376684    Free PMC article.
Methodological issues in current practice may lead to bias in the development of biomarker combinations for predicting acute kidney injury.
Allison Meisner, Kathleen F Kerr, +2 authors, Chirag R Parikh.
Kidney Int, 2015 Sep 24; 89(2). PMID: 26398494    Free PMC article.
Systematic Review.
Prospective Validation of a 21-Gene Expression Assay in Breast Cancer.
Joseph A Sparano, Robert J Gray, +28 authors, George W Sledge.
N Engl J Med, 2015 Sep 29; 373(21). PMID: 26412349    Free PMC article.
Highly Cited.
Molecular prognostic prediction in liver cirrhosis.
Nicolas Goossens, Shigeki Nakagawa, Yujin Hoshida.
World J Gastroenterol, 2015 Oct 01; 21(36). PMID: 26420954    Free PMC article.
Assessing value of innovative molecular diagnostic tests in the concept of predictive, preventive, and personalized medicine.
Ildar Akhmetov, Rostyslav V Bubnov.
EPMA J, 2015 Oct 02; 6. PMID: 26425215    Free PMC article.
Genetic Testing and Tissue Banking for Personalized Oncology: Analytical and Institutional Factors.
George Miles, James Rae, Suresh S Ramalingam, John Pfeifer.
Semin Oncol, 2015 Oct 05; 42(5). PMID: 26433552    Free PMC article.
Genetic Biomarkers of Barrett's Esophagus Susceptibility and Progression to Dysplasia and Cancer: A Systematic Review and Meta-Analysis.
John M Findlay, Mark R Middleton, Ian Tomlinson.
Dig Dis Sci, 2015 Oct 09; 61(1). PMID: 26445852    Free PMC article.
Systematic Review.
Association of Stromal Tumor-Infiltrating Lymphocytes With Recurrence-Free Survival in the N9831 Adjuvant Trial in Patients With Early-Stage HER2-Positive Breast Cancer.
Edith A Perez, Karla V Ballman, +4 authors, Frederick L Baehner.
JAMA Oncol, 2015 Oct 16; 2(1). PMID: 26469139    Free PMC article.
Highly Cited.
SEOM clinical guidelines in early-stage breast cancer 2015.
J A Garcia-Saenz, B Bermejo, +7 authors, E Ciruelos.
Clin Transl Oncol, 2015 Oct 27; 17(12). PMID: 26497356    Free PMC article.
Immune monitoring technology primer.
Kevin K Dobbin.
J Immunother Cancer, 2015 Oct 27; 3. PMID: 26500774    Free PMC article.
Identifying patients at high risk of breast cancer recurrence: strategies to improve patient outcomes.
Yehoda M Martei, Jennifer M Matro.
Breast Cancer (Dove Med Press), 2015 Oct 28; 7. PMID: 26504408    Free PMC article.
Precision medicine for cancer with next-generation functional diagnostics.
Adam A Friedman, Anthony Letai, David E Fisher, Keith T Flaherty.
Nat Rev Cancer, 2015 Nov 06; 15(12). PMID: 26536825    Free PMC article.
Highly Cited. Review.
Loss of antigenicity with tissue age in breast cancer.
Susan E Combs, Gang Han, +3 authors, David L Rimm.
Lab Invest, 2015 Nov 17; 96(3). PMID: 26568292
Clinico-pathological nomogram for predicting BRAF mutational status of metastatic colorectal cancer.
Fotios Loupakis, Roberto Moretto, +18 authors, Emilio Bria.
Br J Cancer, 2015 Nov 18; 114(1). PMID: 26575603    Free PMC article.
Radiomics: Images Are More than Pictures, They Are Data.
Robert J Gillies, Paul E Kinahan, Hedvig Hricak.
Radiology, 2015 Nov 19; 278(2). PMID: 26579733    Free PMC article.
Highly Cited.
Introducing Cytology-Based Theranostics in Oral Squamous Cell Carcinoma: A Pilot Program.
Anna Patrikidou, Rosalia Maria Valeri, +2 authors, Konstantinos Vahtsevanos.
Pathol Oncol Res, 2015 Nov 20; 22(2). PMID: 26581612
Biomarkers in Breast Cancer - An Update.
M Schmidt, P A Fasching, M W Beckmann, H Kölbl.
Geburtshilfe Frauenheilkd, 2012 Sep 01; 72(9). PMID: 26640290    Free PMC article.
Clinical relevance of host immunity in breast cancer: from TILs to the clinic.
Peter Savas, Roberto Salgado, +4 authors, Sherene Loi.
Nat Rev Clin Oncol, 2015 Dec 17; 13(4). PMID: 26667975
Highly Cited. Review.
Recommendations from the EGAPP Working Group: does the use of Oncotype DX tumor gene expression profiling to guide treatment decisions improve outcomes in patients with breast cancer?
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group*.
Genet Med, 2015 Dec 19; 18(8). PMID: 26681310
Downregulation of histone H2A and H2B pathways is associated with anthracycline sensitivity in breast cancer.
Marsela Braunstein, Linda Liao, +11 authors, Melanie Spears.
Breast Cancer Res, 2016 Feb 08; 18(1). PMID: 26852132    Free PMC article.
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.
Lyndsay N Harris, Nofisat Ismaila, +11 authors, American Society of Clinical Oncology.
J Clin Oncol, 2016 Feb 10; 34(10). PMID: 26858339    Free PMC article.
Highly Cited. Review.
Statistical aspect of translational and correlative studies in clinical trials.
Herbert Pang, Xiaofei Wang.
Chin Clin Oncol, 2016 Mar 05; 5(1). PMID: 26932435    Free PMC article.
The complexity of microRNAs in human cancer.
Jennifer Y Y Kwan, Pamela Psarianos, +2 authors, Fei-Fei Liu.
J Radiat Res, 2016 Mar 18; 57 Suppl 1. PMID: 26983984    Free PMC article.
Analysis of RET promoter CpG island methylation using methylation-specific PCR (MSP), pyrosequencing, and methylation-sensitive high-resolution melting (MS-HRM): impact on stage II colon cancer patient outcome.
Muriel X G Draht, Kim M Smits, +7 authors, Veerle Melotte.
Clin Epigenetics, 2016 Apr 28; 8. PMID: 27118999    Free PMC article.
WRN Promoter CpG Island Hypermethylation Does Not Predict More Favorable Outcomes for Patients with Metastatic Colorectal Cancer Treated with Irinotecan-Based Therapy.
Linda J W Bosch, Yanxin Luo, +15 authors, William M Grady.
Clin Cancer Res, 2016 Apr 29; 22(18). PMID: 27121793    Free PMC article.
Cell Line Derived 5-FU and Irinotecan Drug-Sensitivity Profiles Evaluated in Adjuvant Colon Cancer Trial Data.
Ida Kappel Buhl, Sarah Gerster, +8 authors, Steen Knudsen.
PLoS One, 2016 May 14; 11(5). PMID: 27171152    Free PMC article.
Intratumor Heterogeneity Affects Gene Expression Profile Test Prognostic Risk Stratification in Early Breast Cancer.
Rekha Gyanchandani, Yan Lin, +10 authors, Adrian V Lee.
Clin Cancer Res, 2016 Nov 03; 22(21). PMID: 27185370    Free PMC article.
Tumor-Infiltrating Lymphocytes: A Promising Biomarker in Breast Cancer.
Barbara Ingold Heppner, Sibylle Loibl, Carsten Denkert.
Breast Care (Basel), 2016 May 31; 11(2). PMID: 27239170    Free PMC article.
Clinical Outcome From Oxaliplatin Treatment in Stage II/III Colon Cancer According to Intrinsic Subtypes: Secondary Analysis of NSABP C-07/NRG Oncology Randomized Clinical Trial.
Nan Song, Katherine L Pogue-Geile, +9 authors, Soonmyung Paik.
JAMA Oncol, 2016 Jun 09; 2(9). PMID: 27270348    Free PMC article.
Predicting Clinical Outcomes Using Molecular Biomarkers.
Harry B Burke.
Biomark Cancer, 2016 Jun 10; 8. PMID: 27279751    Free PMC article.
TwoPhaseInd: an R package for estimating gene-treatment interactions and discovering predictive markers in randomized clinical trials.
Xiaoyu Wang, James Y Dai.
Bioinformatics, 2016 Oct 30; 32(21). PMID: 27378290    Free PMC article.
Technical validation of an RT-qPCR in vitro diagnostic test system for the determination of breast cancer molecular subtypes by quantification of ERBB2, ESR1, PGR and MKI67 mRNA levels from formalin-fixed paraffin-embedded breast tumor specimens.
Mark Laible, Kornelia Schlombs, +8 authors, Ugur Sahin.
BMC Cancer, 2016 Jul 09; 16. PMID: 27389414    Free PMC article.
L1CAM as a prognostic marker in stage I endometrial cancer: a validation study.
Elisabeth Smogeli, Ben Davidson, +5 authors, Kristina Lindemann.
BMC Cancer, 2016 Aug 05; 16. PMID: 27488577    Free PMC article.
Prospective Evaluation of a 12-Gene Assay on Patient Treatment Decisions and Physician Confidence in Mismatch Repair Proficient Stage IIA Colon Cancer.
Lindsay A Renfro, Nan Zhang, +2 authors, Steven R Alberts.
Clin Colorectal Cancer, 2016 Sep 08; 16(1). PMID: 27600983    Free PMC article.
From High-Throughput Microarray-Based Screening to Clinical Application: The Development of a Second Generation Multigene Test for Breast Cancer Prognosis.
Jan C Brase, Ralf Kronenwett, +2 authors, Marcus Schmidt.
Microarrays (Basel), 2013 Jan 01; 2(3). PMID: 27605191    Free PMC article.
Statistical controversies in clinical research: prognostic gene signatures are not (yet) useful in clinical practice.
S Michiels, N Ternès, F Rotolo.
Ann Oncol, 2016 Sep 17; 27(12). PMID: 27634691    Free PMC article.
Biomarker analysis of the MITO2 phase III trial of first-line treatment in ovarian cancer: predictive value of DNA-PK and phosphorylated ACC.
Francesco Perrone, Gustavo Baldassarre, +27 authors, Sandro Pignata.
Oncotarget, 2016 Sep 23; 7(45). PMID: 27655643    Free PMC article.
Best Practices for Genomic Assay Testing in Early-Stage Breast Cancer: Clinical and Medicolegal Perspectives.
Andrew D Seidman, Darius K Amjadi, Tammy De La Melena, Darren Wheeler.
Popul Health Manag, 2016 Sep 30; 20(4). PMID: 27684734    Free PMC article.
Profiling cancer testis antigens in non-small-cell lung cancer.
Dijana Djureinovic, Björn M Hallström, +19 authors, Patrick Micke.
JCI Insight, 2016 Oct 05; 1(10). PMID: 27699219    Free PMC article.
Neutrophil-to-lymphocyte ratio as a bladder cancer biomarker: Assessing prognostic and predictive value in SWOG 8710.
Eric Ojerholm, Andrew Smith, +6 authors, John P Christodouleas.
Cancer, 2016 Oct 28; 123(5). PMID: 27787873    Free PMC article.
Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial.
Harriet Johansson, Kathryn P Gray, +17 authors, the TEXT principal investigators.
Breast Cancer Res, 2016 Nov 09; 18(1). PMID: 27825388    Free PMC article.
"A rising tide lifts all boats": establishing a multidisciplinary genomic tumor board for breast cancer patients with advanced disease.
Michelle L McGowan, Roselle S Ponsaran, +2 authors, Patricia A Marshall.
BMC Med Genomics, 2016 Nov 23; 9(1). PMID: 27871291    Free PMC article.
Quantification and expert evaluation of evidence for chemopredictive biomarkers to personalize cancer treatment.
Shruti Rao, Robert A Beckman, +6 authors, Subha Madhavan.
Oncotarget, 2016 Nov 27; 8(23). PMID: 27888622    Free PMC article.
Tumour-infiltrating lymphocytes in advanced HER2-positive breast cancer treated with pertuzumab or placebo in addition to trastuzumab and docetaxel: a retrospective analysis of the CLEOPATRA study.
Stephen J Luen, Roberto Salgado, +8 authors, Sherene Loi.
Lancet Oncol, 2016 Dec 15; 18(1). PMID: 27964843    Free PMC article.
Highly Cited.
The Challenges of Validating in Precision Medicine: The Case of Excision Repair Cross-Complement Group 1 Diagnostic Testing.
Brianna Barsanti-Innes, Spencer Phillips Hey, Jonathan Kimmelman.
Oncologist, 2017 Jan 28; 22(1). PMID: 28126916    Free PMC article.
Association of osteopontin with specific prognostic factors and survival in adjuvant breast cancer trials of the Hellenic Cooperative Oncology Group.
Amanda Psyrri, Konstantine T Kalogeras, +21 authors, George Fountzilas.
J Transl Med, 2017 Feb 15; 15(1). PMID: 28193231    Free PMC article.
Selecting postoperative adjuvant systemic therapy for early stage breast cancer: A critical assessment of commercially available gene expression assays.
David M Hyams, Eric Schuur, +7 authors, Aníbal Nuñez De Pierro.
J Surg Oncol, 2017 Feb 18; 115(6). PMID: 28211064    Free PMC article.
The Routine Clinical use of Pharmacogenetic Tests: What it Will Require?
Mafalda M Dias, Michael J Sorich, +2 authors, Ross A McKinnon.
Pharm Res, 2017 Feb 27; 34(8). PMID: 28236061
A Prospective, Multi-institutional, Pathologist-Based Assessment of 4 Immunohistochemistry Assays for PD-L1 Expression in Non-Small Cell Lung Cancer.
David L Rimm, Gang Han, +17 authors, Ignacio I Wistuba.
JAMA Oncol, 2017 Mar 10; 3(8). PMID: 28278348    Free PMC article.
Highly Cited.
Adaptive Clinical Trials: Advantages and Disadvantages of Various Adaptive Design Elements.
Edward L Korn, Boris Freidlin.
J Natl Cancer Inst, 2017 Apr 05; 109(6). PMID: 28376148    Free PMC article.
Limitations in predicting PAM50 intrinsic subtype and risk of relapse score with Ki67 in estrogen receptor-positive HER2-negative breast cancer.
Aranzazu Fernandez-Martinez, Tomás Pascual, +30 authors, Miguel Martin.
Oncotarget, 2017 Apr 21; 8(13). PMID: 28423537    Free PMC article.
Beyond Correlations, Sensitivities, and Specificities: A Roadmap for Demonstrating Utility of Advanced Imaging in Oncology Treatment and Clinical Trial Design.
Erich P Huang, Frank I Lin, Lalitha K Shankar.
Acad Radiol, 2017 May 01; 24(8). PMID: 28456570    Free PMC article.
Data-Based Radiation Oncology: Design of Clinical Trials in the Toxicity Biomarkers Era.
David Azria, Ariane Lapierre, +16 authors, Barry S Rosenstein.
Front Oncol, 2017 May 13; 7. PMID: 28497027    Free PMC article.
A critical analysis of cancer biobank practices in relation to biospecimen quality.
Amanda Rush, Kevin Spring, Jennifer A Byrne.
Biophys Rev, 2015 Dec 01; 7(4). PMID: 28510101    Free PMC article.
A meta-analysis of CXCL12 expression for cancer prognosis.
Harsh Samarendra, Keaton Jones, +4 authors, Alex Gordon-Weeks.
Br J Cancer, 2017 May 24; 117(1). PMID: 28535157    Free PMC article.
Systematic Review.
Did the reporting of prognostic studies of tumour markers improve since the introduction of REMARK guideline? A comparison of reporting in published articles.
Peggy Sekula, Susan Mallett, Douglas G Altman, Willi Sauerbrei.
PLoS One, 2017 Jun 15; 12(6). PMID: 28614415    Free PMC article.
Overcoming intratumoural heterogeneity for reproducible molecular risk stratification: a case study in advanced kidney cancer.
Alexander L R Lubbock, Grant D Stewart, +6 authors, Ian M Overton.
BMC Med, 2017 Jun 27; 15(1). PMID: 28648142    Free PMC article.
Making Meaningful Clinical Use of Biomarkers.
Matthew J Selleck, Maheswari Senthil, Nathan R Wall.
Biomark Insights, 2017 Jul 01; 12. PMID: 28659713    Free PMC article.
Evaluation of the Prognostic Value of RANK, OPG, and RANKL mRNA Expression in Early Breast Cancer Patients Treated with Anthracycline-Based Adjuvant Chemotherapy.
Eleni Timotheadou, Konstantine T Kalogeras, +16 authors, George Fountzilas.
Transl Oncol, 2017 Jul 01; 10(4). PMID: 28666187    Free PMC article.
Role of Cytotoxic Tumor-Infiltrating Lymphocytes in Predicting Outcomes in Metastatic HER2-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial.
Shuzhen Liu, Bingshu Chen, +8 authors, Torsten O Nielsen.
JAMA Oncol, 2017 Jul 28; 3(11). PMID: 28750133    Free PMC article.
Evidence for Treatment-by-Biomarker interaction for FDA-approved Oncology Drugs with Required Pharmacogenomic Biomarker Testing.
Alexandre Vivot, Isabelle Boutron, +3 authors, Raphaël Porcher.
Sci Rep, 2017 Aug 02; 7(1). PMID: 28761069    Free PMC article.
Assessing Tumor-infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method From the International Immunooncology Biomarkers Working Group: Part 1: Assessing the Host Immune Response, TILs in Invasive Breast Carcinoma and Ductal Carcinoma In Situ, Metastatic Tumor Deposits and Areas for Further Research.
Shona Hendry, Roberto Salgado, +97 authors, Stephen B Fox.
Adv Anat Pathol, 2017 Aug 05; 24(5). PMID: 28777142    Free PMC article.
Highly Cited. Review.
Gene expression profiling in uveal melanoma: technical reliability and correlation of molecular class with pathologic characteristics.
Kristen M Plasseraud, Jeff K Wilkinson, +4 authors, Federico A Monzon.
Diagn Pathol, 2017 Aug 06; 12(1). PMID: 28778171    Free PMC article.
Identifying Biomarkers to Select Patients with Early Breast Cancer Suitable for Extended Adjuvant Endocrine Therapy.
Ivana Sestak.
Breast Care (Basel), 2017 Aug 09; 12(3). PMID: 28785181    Free PMC article.
Adjusting for covariates in evaluating markers for selecting treatment, with application to guiding chemotherapy for treating estrogen-receptor-positive, node-positive breast cancer.
Holly Janes, Marshall D Brown, +2 authors, William E Barlow.
Contemp Clin Trials, 2017 Aug 19; 63. PMID: 28818434    Free PMC article.
Decision impact and feasibility of different ASCO-recommended biomarkers in early breast cancer: Prospective comparison of molecular marker EndoPredict and protein marker uPA/PAI-1.
Johannes Ettl, Evelyn Klein, +7 authors, Marion Kiechle.
PLoS One, 2017 Sep 07; 12(9). PMID: 28877230    Free PMC article.
Implications of ABCG2 Expression on Irinotecan Treatment of Colorectal Cancer Patients: A Review.
Dorte Lisbet Nielsen, Jesper Andreas Palshof, +2 authors, Birgitte Martine Viuff.
Int J Mol Sci, 2017 Sep 08; 18(9). PMID: 28880238    Free PMC article.
OncoKB: A Precision Oncology Knowledge Base.
Debyani Chakravarty, Jianjiong Gao, +45 authors, Nikolaus Schultz.
JCO Precis Oncol, 2017 Sep 12; 2017. PMID: 28890946    Free PMC article.
Highly Cited.
Predictive and prognostic impact of tumour-infiltrating lymphocytes in triple-negative breast cancer treated with neoadjuvant chemotherapy.
Carmen Herrero-Vicent, Angel Guerrero, +7 authors, Amparo Ruiz-Simón.
Ecancermedicalscience, 2017 Sep 14; 11. PMID: 28900472    Free PMC article.
Evaluating Molecular Biomarkers for the Early Detection of Lung Cancer: When Is a Biomarker Ready for Clinical Use? An Official American Thoracic Society Policy Statement.
Peter J Mazzone, Catherine Rufatto Sears, +9 authors, ATS Assembly on Thoracic Oncology.
Am J Respir Crit Care Med, 2017 Sep 30; 196(7). PMID: 28960111    Free PMC article.
Case-only approach to identifying markers predicting treatment effects on the relative risk scale.
James Y Dai, C Jason Liang, +2 authors, Holly Janes.
Biometrics, 2017 Sep 30; 74(2). PMID: 28960244    Free PMC article.
Decoy receptor 1 (DCR1) promoter hypermethylation and response to irinotecan in metastatic colorectal cancer.
Linda J W Bosch, Geert Trooskens, +21 authors, Gerrit A Meijer.
Oncotarget, 2017 Oct 04; 8(38). PMID: 28968978    Free PMC article.
Risk factors and prevention of hepatocellular carcinoma in the era of precision medicine.
Naoto Fujiwara, Scott L Friedman, Nicolas Goossens, Yujin Hoshida.
J Hepatol, 2017 Oct 11; 68(3). PMID: 28989095    Free PMC article.
Highly Cited. Review.
The status of transarterial chemoembolization treatment in the era of precision oncology.
Valerie Fako, Xin Wei Wang.
Hepat Oncol, 2017 Oct 11; 4(2). PMID: 28989699    Free PMC article.
Clinical utility of multigene profiling assays in early-stage breast cancer.
M C Chang, L H Souter, +6 authors, Molecular Oncology Advisory Committee.
Curr Oncol, 2017 Nov 02; 24(5). PMID: 29089811    Free PMC article.
Tumor-adjacent tissue co-expression profile analysis reveals pro-oncogenic ribosomal gene signature for prognosis of resectable hepatocellular carcinoma.
Oleg V Grinchuk, Surya P Yenamandra, +5 authors, Vladamir A Kuznetsov.
Mol Oncol, 2017 Nov 09; 12(1). PMID: 29117471    Free PMC article.
A metastasis biomarker (MetaSite Breast™ Score) is associated with distant recurrence in hormone receptor-positive, HER2-negative early-stage breast cancer.
Joseph A Sparano, Robert Gray, +13 authors, Joan Jones.
NPJ Breast Cancer, 2017 Nov 16; 3. PMID: 29138761    Free PMC article.
Clinical significance of CD73 in triple-negative breast cancer: multiplex analysis of a phase III clinical trial.
L Buisseret, S Pommey, +13 authors, J Stagg.
Ann Oncol, 2017 Nov 18; 29(4). PMID: 29145561    Free PMC article.
Biomarkers in breast cancer: A consensus statement by the Spanish Society of Medical Oncology and the Spanish Society of Pathology.
R Colomer, I Aranda-López, +7 authors, J Palacios-Calvo.
Clin Transl Oncol, 2017 Dec 24; 20(7). PMID: 29273958    Free PMC article.
Impact of homologous recombination deficiency biomarkers on outcomes in patients with triple-negative breast cancer treated with adjuvant doxorubicin and cyclophosphamide (SWOG S9313).
P Sharma, W E Barlow, +10 authors, D F Hayes.
Ann Oncol, 2018 Jan 03; 29(3). PMID: 29293876    Free PMC article.
Performance of a prognostic 31-gene expression profile in an independent cohort of 523 cutaneous melanoma patients.
Jonathan S Zager, Brian R Gastman, +20 authors, Pedram Gerami.
BMC Cancer, 2018 Feb 07; 18(1). PMID: 29402264    Free PMC article.
Oncoprotein HBXIP enhances HOXB13 acetylation and co-activates HOXB13 to confer tamoxifen resistance in breast cancer.
Bowen Liu, Tianjiao Wang, +8 authors, Lihong Ye.
J Hematol Oncol, 2018 Feb 24; 11(1). PMID: 29471853    Free PMC article.
Prognostic impact of CD4-positive T cell subsets in early breast cancer: a study based on the FinHer trial patient population.
Marcus Schmidt, Veronika Weyer-Elberich, +12 authors, Heikki Joensuu.
Breast Cancer Res, 2018 Feb 28; 20(1). PMID: 29482642    Free PMC article.
Expression of dihydropyrimidine dehydrogenase (DPD) and hENT1 predicts survival in pancreatic cancer.
N O Elander, K Aughton, +25 authors, European Study Group for Pancreatic Cancer.
Br J Cancer, 2018 Mar 09; 118(7). PMID: 29515256    Free PMC article.
ABC Transporters and Their Role in the Neoadjuvant Treatment of Esophageal Cancer.
David Vrana, Viktor Hlavac, +7 authors, Pavel Soucek.
Int J Mol Sci, 2018 Mar 16; 19(3). PMID: 29543757    Free PMC article.
Novel biomarker-based model for the prediction of sorafenib response and overall survival in advanced hepatocellular carcinoma: a prospective cohort study.
Hwi Young Kim, Dong Hyeon Lee, +5 authors, Jung-Hwan Yoon.
BMC Cancer, 2018 Mar 22; 18(1). PMID: 29558905    Free PMC article.
Personalizing Breast Cancer Irradiation Using Biology: From Bench to the Accelerator.
David Azria, Muriel Brengues, Sophie Gourgou, Celine Bourgier.
Front Oncol, 2018 Apr 21; 8. PMID: 29675397    Free PMC article.
Prognostic factors and prognostic models for renal cell carcinoma: a literature review.
Tobias Klatte, Sabrina H Rossi, Grant D Stewart.
World J Urol, 2018 May 02; 36(12). PMID: 29713755
Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer.
Joseph A Sparano, Robert J Gray, +27 authors, George W Sledge.
N Engl J Med, 2018 Jun 05; 379(2). PMID: 29860917    Free PMC article.
Highly Cited.
Association of Somatic Driver Alterations With Prognosis in Postmenopausal, Hormone Receptor-Positive, HER2-Negative Early Breast Cancer: A Secondary Analysis of the BIG 1-98 Randomized Clinical Trial.
Stephen J Luen, Rebecca Asher, +13 authors, Sherene Loi.
JAMA Oncol, 2018 Jun 15; 4(10). PMID: 29902286    Free PMC article.
Biomarkers in early-phase trials: fundamental issues.
Laura M Yee, Tracy G Lively, Lisa M McShane.
Bioanalysis, 2018 Jun 21; 10(12). PMID: 29923753    Free PMC article.
Development of a Novel Proteomic Risk-Classifier for Prognostication of Patients With Early-Stage Hormone Receptor-Positive Breast Cancer.
Charusheila Ramkumar, Ljubomir Buturovic, +7 authors, Manjiri M Bakre.
Biomark Insights, 2018 Aug 08; 13. PMID: 30083053    Free PMC article.
Clinical relevance of the 21-gene Recurrence Score® assay in treatment decisions for patients with node-positive breast cancer in the genomic era.
Eleftherios P Mamounas, Christy A Russell, +2 authors, Kathy S Albain.
NPJ Breast Cancer, 2018 Aug 30; 4. PMID: 30155517    Free PMC article.
Evaluation of the prognostic value of CD3, CD8, and FOXP3 mRNA expression in early-stage breast cancer patients treated with anthracycline-based adjuvant chemotherapy.
Marinos Tsiatas, Konstantine T Kalogeras, +17 authors, George Fountzilas.
Cancer Med, 2018 Sep 22; 7(10). PMID: 30240146    Free PMC article.
A prognostic mRNA expression signature of four 16q24.3 genes in radio(chemo)therapy-treated head and neck squamous cell carcinoma (HNSCC).
Ludmila Wintergerst, Martin Selmansberger, +12 authors, Julia Hess.
Mol Oncol, 2018 Sep 28; 12(12). PMID: 30259648    Free PMC article.
Predicting the response to neoadjuvant therapy for early-stage breast cancer: tumor-, blood-, and imaging-related biomarkers.
Wenyong Tan, Ming Yang, +2 authors, Weixi Shen.
Cancer Manag Res, 2018 Oct 24; 10. PMID: 30349367    Free PMC article.
21-Gene assay as predictor of chemotherapy benefit in HER2-negative breast cancer.
Charles E Geyer, Gong Tang, +8 authors, Norman Wolmark.
NPJ Breast Cancer, 2018 Nov 21; 4. PMID: 30456299    Free PMC article.
Level of Evidence Review for a Gene Expression Profile Test for Cutaneous Melanoma.
Danielle P Dubin, Scott M Dinehart, Aaron S Farberg.
Am J Clin Dermatol, 2019 Jul 31; 20(6). PMID: 31359351    Free PMC article.
Artificial intelligence in digital pathology - new tools for diagnosis and precision oncology.
Kaustav Bera, Kurt A Schalper, +2 authors, Anant Madabhushi.
Nat Rev Clin Oncol, 2019 Aug 11; 16(11). PMID: 31399699    Free PMC article.
Highly Cited. Review.
Multigene expression signatures in early hormone receptor positive HER 2 negative breast cancer.
Tanja Ovcaricek, Iztok Takac, Erika Matos.
Radiol Oncol, 2019 Sep 26; 53(3). PMID: 31553709    Free PMC article.
MPIC: Molecular Prognostic Indicators in Cirrhosis Database for Clinical Context-Specific in Silico Prognostic Biomarker Validation.
Shun H Yip, Naoto Fujiwara, +6 authors, Yujin Hoshida.
Front Genet, 2019 Oct 18; 10. PMID: 31620162    Free PMC article.
The trans-DATA study: aims and design of a translational breast cancer prognostic marker identification study.
Tim C de Ruijter, Kim M Smits, +7 authors, Vivianne C G Tjan-Heijnen.
Diagn Progn Res, 2019 Oct 24; 3. PMID: 31641693    Free PMC article.
Prognostic Value of Ki-67 in Patients With Resected Triple-Negative Breast Cancer: A Meta-Analysis.
Qiang Wu, Guangzhi Ma, +4 authors, Qinghua Zhou.
Front Oncol, 2019 Nov 05; 9. PMID: 31681601    Free PMC article.
Systematic Review.
Decision of Adjuvant Systemic Treatment in HR+ HER2- Early Invasive Breast Cancer: Which Biomarkers Could Help?
Marie Alexandre, Aurélie Maran-Gonzalez, +6 authors, Séverine Guiu.
Cancer Manag Res, 2019 Dec 19; 11. PMID: 31849525    Free PMC article.
Breast Cancer Index and prediction of benefit from extended endocrine therapy in breast cancer patients treated in the Adjuvant Tamoxifen-To Offer More? (aTTom) trial.
J M S Bartlett, D C Sgroi, +8 authors, D W Rea.
Ann Oncol, 2019 Sep 11; 30(11). PMID: 31504126    Free PMC article.
Antisense transcription at the TRPM2 locus as a novel prognostic marker and therapeutic target in prostate cancer.
U Orfanelli, E Jachetti, +11 authors, G Lavorgna.
Oncogene, 2014 Jun 17; 34(16). PMID: 24931166
Prostate cancer androgen receptor splice variant 7 biomarker study - a multicentre randomised feasibility trial of biomarker-guided personalised treatment in patients with advanced prostate cancer (the VARIANT trial) study protocol.
Emma Clark, Miranda Morton, +14 authors, Rakesh Heer.
BMJ Open, 2019 Dec 21; 9(12). PMID: 31857319    Free PMC article.
Qualifying antibodies for image-based immune profiling and multiplexed tissue imaging.
Ziming Du, Jia-Ren Lin, +6 authors, Sandro Santagata.
Nat Protoc, 2019 Sep 20; 14(10). PMID: 31534232    Free PMC article.
Prognostic DNA methylation markers for hormone receptor breast cancer: a systematic review.
Tim C de Ruijter, Frank van der Heide, +3 authors, Vivianne C G Heijnen.
Breast Cancer Res, 2020 Feb 02; 22(1). PMID: 32005275    Free PMC article.
Systematic Review.
Evaluation of heart failure biomarker tests: a survey of statistical considerations.
Arkendra De, Kristen Meier, +4 authors, Gene Pennello.
J Cardiovasc Transl Res, 2013 May 15; 6(4). PMID: 23670231
Considerations for the successful co-development of targeted cancer therapies and companion diagnostics.
Jane Fridlyand, Richard M Simon, +7 authors, Howard I Scher.
Nat Rev Drug Discov, 2013 Sep 07; 12(10). PMID: 24008432
Indications for prognostic gene expression profiling in early breast cancer.
Erin F Cobain, Daniel F Hayes.
Curr Treat Options Oncol, 2015 May 02; 16(5). PMID: 25929335
Generating and evaluating evidence of the clinical utility of molecular diagnostic tests in oncology.
Patricia Deverka, Donna A Messner, +10 authors, Sean R Tunis.
Genet Med, 2015 Dec 04; 18(8). PMID: 26633547
The Prosigna 50-gene profile and responsiveness to adjuvant anthracycline-based chemotherapy in high-risk breast cancer patients.
Maj-Britt Jensen, Anne-Vibeke Lænkholm, +9 authors, Bent Ejlertsen.
NPJ Breast Cancer, 2020 Mar 07; 6. PMID: 32140564    Free PMC article.
Association of Circulating Tumor Cells With Late Recurrence of Estrogen Receptor-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial.
Joseph Sparano, Anne O'Neill, +5 authors, Kathy D Miller.
JAMA Oncol, 2018 Jul 29; 4(12). PMID: 30054636    Free PMC article.
Highly Cited.
Case-only Methods Identified Genetic Loci Predicting a Subgroup of Men with Reduced Risk of High-grade Prostate Cancer by Finasteride.
James Y Dai, Michael LeBlanc, +3 authors, Catherine M Tangen.
Cancer Prev Res (Phila), 2018 Dec 13; 12(2). PMID: 30538099    Free PMC article.
A systematic review of the prevalence of DNA damage response gene mutations in prostate cancer.
Shona H Lang, Stephanie L Swift, +3 authors, Ruben G W Quek.
Int J Oncol, 2019 Jul 20; 55(3). PMID: 31322208    Free PMC article.
Systematic Review.
Management of Ductal Carcinoma In Situ (DCIS) of the Breast: Present Approaches and Future Directions.
Lawrence J Solin.
Curr Oncol Rep, 2019 Mar 06; 21(4). PMID: 30834994
A framework for the development of effective anti-metastatic agents.
Robin L Anderson, Theo Balasas, +16 authors, Cancer Research UK and Cancer Therapeutics CRC Australia Metastasis Working Group.
Nat Rev Clin Oncol, 2018 Dec 06; 16(3). PMID: 30514977    Free PMC article.
Highly Cited.
The Predictive Value of Estrogen Receptor 1 on Adjuvant Chemotherapy in Locally Advanced Colorectal Cancer: A Retrospective Analysis With Independent Validation and Its Potential Mechanism.
Shu-Biao Ye, Yi-Kan Cheng, +4 authors, Ping Lan.
Front Oncol, 2020 Apr 09; 10. PMID: 32266127    Free PMC article.
Identification of risk in cutaneous melanoma patients: Prognostic and predictive markers.
David M Hyams, Robert W Cook, Antonio C Buzaid.
J Surg Oncol, 2018 Dec 15; 119(2). PMID: 30548543    Free PMC article.
Independent Validation of EarlyR Gene Signature in BIG 1-98: A Randomized, Double-Blind, Phase III Trial Comparing Letrozole and Tamoxifen as Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone Receptor-Positive, Early Breast Cancer.
Steven A Buechler, Kathryn P Gray, +7 authors, Meredith M Regan.
JNCI Cancer Spectr, 2020 Apr 28; 3(4). PMID: 32337480    Free PMC article.
Toronto Workshop on Late Recurrence in Estrogen Receptor-Positive Breast Cancer: Part 1: Late Recurrence: Current Understanding, Clinical Considerations.
Ryan J O Dowling, Kevin Kalinsky, +29 authors, Pamela J Goodwin.
JNCI Cancer Spectr, 2020 Apr 28; 3(4). PMID: 32337479    Free PMC article.
Applying the New Guidelines of HER2 Testing in Breast Cancer.
Huina Zhang, Ioana Moisini, +2 authors, David G Hicks.
Curr Oncol Rep, 2020 Apr 30; 22(5). PMID: 32346807
Tumour-infiltrating CD8+ lymphocytes and colorectal cancer recurrence by tumour and nodal stage.
Mark A Glaire, Enric Domingo, +13 authors, David N Church.
Br J Cancer, 2019 Aug 08; 121(6). PMID: 31388185    Free PMC article.
Pitfalls in assessing stromal tumor infiltrating lymphocytes (sTILs) in breast cancer.
Zuzana Kos, Elvire Roblin, +91 authors, International Immuno-Oncology Biomarker Working Group.
NPJ Breast Cancer, 2020 May 16; 6. PMID: 32411819    Free PMC article.
An Explorative Analysis of ABCG2/TOP-1 mRNA Expression as a Biomarker Test for FOLFIRI Treatment in Stage III Colon Cancer Patients: Results from Retrospective Analyses of the PETACC-3 Trial.
Jan Stenvang, Eva Budinská, +3 authors, Nils Brünner.
Cancers (Basel), 2020 Apr 25; 12(4). PMID: 32326511    Free PMC article.
17-Gene Genomic Prostate Score Test Results in the Canary Prostate Active Surveillance Study (PASS) Cohort.
Daniel W Lin, Yingye Zheng, +18 authors, Lisa F Newcomb.
J Clin Oncol, 2020 Mar 05; 38(14). PMID: 32130059    Free PMC article.
MST1R (RON) expression is a novel prognostic biomarker for metastatic progression in breast cancer patients.
Brian G Hunt, Christina A Wicker, +3 authors, Susan E Waltz.
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EndoPredict® in early hormone receptor-positive, HER2-negative breast cancer.
K Almstedt, S Mendoza, +9 authors, M Schmidt.
Breast Cancer Res Treat, 2020 May 22; 182(1). PMID: 32436145    Free PMC article.
Distribution of the 21-Gene Breast Recurrence Score in Patients with Primary Breast Cancer in Germany.
Vincent P Walter, Florin-Andrei Taran, +6 authors, Andreas Daniel Hartkopf.
Geburtshilfe Frauenheilkd, 2020 Jun 23; 80(6). PMID: 32565552    Free PMC article.
Prognostic significance of branched-chain amino acid transferase 1 and CD133 in triple-negative breast cancer.
Yu Song, Bin Zhao, +4 authors, Qiang Sun.
BMC Cancer, 2020 Jun 24; 20(1). PMID: 32571264    Free PMC article.
De-Escalation of Locoregional Therapy in Low-Risk Disease for DCIS and Early-Stage Invasive Cancer.
E Shelley Hwang, Lawrence Solin.
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Targeted next-generation sequencing identifies genomic abnormalities potentially driving the prognosis of early-stage invasive lobular breast carcinoma patients stratified according to a validated clinico-pathological model.
Luisa Carbognin, Michele Simbolo, +19 authors, Emilio Bria.
Breast, 2020 Feb 07; 50. PMID: 32028173    Free PMC article.
ABCG2 Protein Levels and Association to Response to First-Line Irinotecan-Based Therapy for Patients with Metastatic Colorectal Cancer.
Jesper Andreas Palshof, Camilla Natasha Cederbye, +11 authors, Dorte Lisbet Nielsen.
Int J Mol Sci, 2020 Jul 28; 21(14). PMID: 32708825    Free PMC article.
Clinical Utility of the Nuclear-localized AR-V7 Biomarker in Circulating Tumor Cells in Improving Physician Treatment Choice in Castration-resistant Prostate Cancer.
Ryon P Graf, Melanie Hullings, +3 authors, Howard I Scher.
Eur Urol, 2019 Oct 28; 77(2). PMID: 31648903    Free PMC article.
Downstream neighbor of SON (DONSON) is associated with unfavorable survival across diverse cancers with oncogenic properties in clear cell renal cell carcinoma.
Niklas Klümper, Iulia Blajan, +5 authors, Jörg Ellinger.
Transl Oncol, 2020 Aug 18; 13(11). PMID: 32805676    Free PMC article.
Clinical Validation of PITX2 DNA Methylation to Predict Outcome in High-Risk Breast Cancer Patients Treated with Anthracycline-Based Chemotherapy.
Manfred Schmitt, Olaf G Wilhelm, +11 authors, Marion Kiechle.
Breast Care (Basel), 2019 Feb 26; 13(6). PMID: 30800037    Free PMC article.
Gene Expression Assays for Early-Stage Hormone Receptor-Positive Breast Cancer: Understanding the Differences.
Ana Tablante Nunes, Deborah E Collyar, Lyndsay N Harris.
JNCI Cancer Spectr, 2017 Dec 11; 1(1). PMID: 31360834    Free PMC article.
A Prognostic Gene Signature Expressed in Primary Cutaneous Melanoma: Synergism With Conventional Staging.
Georg Brunner, Achim Heinecke, +6 authors, Carola Berking.
JNCI Cancer Spectr, 2019 Jul 31; 2(3). PMID: 31360859    Free PMC article.
Assessment of tumour proliferation by use of the mitotic activity index, and Ki67 and phosphohistone H3 expression, in early-stage luminal breast cancer.
Julia E C van Steenhoven, Anne Kuijer, +4 authors, Paul J van Diest.
Histopathology, 2020 Jun 20; 77(4). PMID: 32557844    Free PMC article.
Non-Coding RNAs, a Novel Paradigm for the Management of Gastrointestinal Stromal Tumors.
Azadeh Amirnasr, Stefan Sleijfer, Erik A C Wiemer.
Int J Mol Sci, 2020 Sep 26; 21(18). PMID: 32972022    Free PMC article.
The Role of Prognostic and Predictive Biomarkers for Assessing Cardiovascular Risk in Chronic Kidney Disease Patients.
Michele Provenzano, Michele Andreucci, +11 authors, Raffaele Serra.
Biomed Res Int, 2020 Oct 27; 2020. PMID: 33102575    Free PMC article.
Challenges and Opportunities in Clinical Applications of Blood-Based Proteomics in Cancer.
Ruchika Bhawal, Ann L Oberg, Sheng Zhang, Manish Kohli.
Cancers (Basel), 2020 Sep 02; 12(9). PMID: 32867043    Free PMC article.
Integrated Multiparametric Radiomics and Informatics System for Characterizing Breast Tumor Characteristics with the OncotypeDX Gene Assay.
Michael A Jacobs, Christopher B Umbricht, +5 authors, Antonio C Wolff.
Cancers (Basel), 2020 Oct 01; 12(10). PMID: 32992569    Free PMC article.
Biobanking for Cancer Biomarker Research: Issues and Solutions.
Lise A Matzke, Peter H Watson.
Biomark Insights, 2020 Nov 17; 15. PMID: 33192050    Free PMC article.
Immunogenic cell death pathway polymorphisms for predicting oxaliplatin efficacy in metastatic colorectal cancer.
Hiroyuki Arai, Yi Xiao, +14 authors, Heinz-Josef Lenz.
J Immunother Cancer, 2020 Nov 12; 8(2). PMID: 33172883    Free PMC article.
Molecular predictors of prevention of recurrence in HCC with sorafenib as adjuvant treatment and prognostic factors in the phase 3 STORM trial.
Roser Pinyol, Robert Montal, +27 authors, Josep M Llovet.
Gut, 2018 Aug 16; 68(6). PMID: 30108162    Free PMC article.
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The prognostic significance of estrogen and progesterone receptors in grade I and II endometrioid endometrial adenocarcinoma: hormone receptors in risk stratification.
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J Gynecol Oncol, 2018 Nov 28; 30(1). PMID: 30479097    Free PMC article.
Target molecule expression profiles in metastatic renal cell carcinoma: Development of individual targeted therapy.
Jun Nyung Lee, So Young Chun, +7 authors, Tae Gyun Kwon.
Tissue Eng Regen Med, 2016 Aug 05; 13(4). PMID: 30603423    Free PMC article.
Opposite Prognostic Impact of Single PTEN-loss and PIK3CA Mutations in Early High-risk Breast Cancer.
Georgios Lazaridis, Vassiliki Kotoula, +17 authors, George Fountzilas.
Cancer Genomics Proteomics, 2019 Apr 26; 16(3). PMID: 31018950    Free PMC article.
Clinical and Molecular Prediction of Hepatocellular Carcinoma Risk.
Naoto Kubota, Naoto Fujiwara, Yujin Hoshida.
J Clin Med, 2020 Dec 02; 9(12). PMID: 33256232    Free PMC article.
Epigenetics in Breast Cancer Therapy-New Strategies and Future Nanomedicine Perspectives.
Verona Buocikova, Ivan Rios-Mondragon, +15 authors, Bozena Smolkova.
Cancers (Basel), 2020 Dec 09; 12(12). PMID: 33287297    Free PMC article.
The Exceptional Responders Initiative: Feasibility of a National Cancer Institute Pilot Study.
Barbara A Conley, Lou Staudt, +36 authors, S Percy Ivy.
J Natl Cancer Inst, 2020 Apr 28; 113(1). PMID: 32339229    Free PMC article.
Transcriptomic biomarkers for predicting response to neoadjuvant treatment in oesophageal cancer.
Anita Lavery, Richard C Turkington.
Gastroenterol Rep (Oxf), 2021 Jan 15; 8(6). PMID: 33442473    Free PMC article.
The ganglioside GD2 as a circulating tumor biomarker for neuroblastoma.
Frank Milton Balis, Christine Maria Busch, +5 authors, Elizabeth Fox.
Pediatr Blood Cancer, 2019 Oct 16; 67(1). PMID: 31612589    Free PMC article.
The impact of different sources of heterogeneity on loss of accuracy from genomic prediction models.
Yuqing Zhang, Christoph Bernau, Giovanni Parmigiani, Levi Waldron.
Biostatistics, 2018 Sep 12; 21(2). PMID: 30202918    Free PMC article.

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