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Predictive Biomarkers for Anticancer Drugs

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Cancer Biomarkers in Diagnosis and Therapeutics

Abstract

The adverse effects of anticancer drugs, the acquired drug resistance, and tumor heterogeneity among cancer patients limit the effective clinical management of advanced malignancies. To overcome these challenges, predictive biomarkers emerged as an indispensable tool to aid medical oncologists in identifying cancer patients who may respond to several anticancer therapies, hence increasing the risk-to-benefit ratio. This chapter will offer a brief overview of predictive anticancer biomarkers, their characteristics, and brief details about the tools and techniques in practice for their identification. This chapter will also discuss the validated and also commonly researched predictive anticancer biomarkers for anticancer drugs against different cancer types. Finally, the challenges in identification and commercialization of the predictive biomarkers for anticancer drugs will be discussed.

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References

  • Abraham JE, Maranian MJ, Driver KE, Platte R, Kalmyrzaev B, Baynes C, Luccarini C, Shah M, Ingle S, Greenberg D, Earl HM, Dunning AM, Pharoah PD, Caldas C (2010) CYP2D6 gene variants: association with breast cancer specific survival in a cohort of breast cancer patients from the United Kingdom treated with adjuvant tamoxifen. Breast Cancer Res 12(4):R64. https://doi.org/10.1186/bcr2629

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Abramovitz M et al (2019) Personalized cancer treatment and patient stratification using massive parallel sequencing (MPS) and other OMICs data. In: Badve S, Kumar G (eds) Predictive biomarkers in oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-95228-4_10

    Chapter  Google Scholar 

  • Ai B, Liu H, Huang Y, Peng P (2016) Circulating cell-free DNA as a prognostic and predictive biomarker in non-small cell lung cancer. Oncotarget 7(28):44583–44595. https://doi.org/10.18632/oncotarget.10069

    Article  PubMed  PubMed Central  Google Scholar 

  • Al-Khanbashi M, Caramuta S, Alajmi AM, Al-Haddabi I, Al-Riyami M, Lui WO, Mansour SA (2016) Tissue and serum miRNA profile in locally advanced breast cancer (LABC) in response to neo-adjuvant chemotherapy (NAC) treatment. PLoS One 11(4):e0152032

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  • Altman DG, McShane LM, Sauerbrei W, Taube SE (2012) Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration. PLoS Med 9(5):e1001216. https://doi.org/10.1371/journal.pmed.1001216

    Article  PubMed  PubMed Central  Google Scholar 

  • Badgwell BD, Camp ER, Feig B, Wolff RA, Eng C, Ellis LM, Cormier JN (2008) Management of bevacizumab-associated bowel perforation: a case series and review of the literature. Ann Oncol 19(3):577–582. https://doi.org/10.1093/annonc/mdm508

    Article  CAS  PubMed  Google Scholar 

  • Baylin SB (2005) DNA methylation and gene silencing in cancer. Nat Clin Pract Oncol 2(Suppl 1):S4–S11

    Article  CAS  PubMed  Google Scholar 

  • Bean J, Brennan C, Shih JY, Riely G, Viale A, Wang L, Chitale D, Motoi N, Szoke J, Broderick S, Balak M, Chang WC, Yu CJ, Gazdar A, Pass H, Rusch V, Gerald W, Huang SF, Yang PC, Miller V et al (2007) MET amplification occurs with or without T790M mutations in EGFR mutant lung tumors with acquired resistance to gefitinib or erlotinib. Proc Natl Acad Sci U S A 104(52):20932–20937. https://doi.org/10.1073/pnas.0710370104

    Article  PubMed  PubMed Central  Google Scholar 

  • Bras-Gonçalves RA, Rosty C, Laurent-Puig P, Soulié P, Dutrillaux B, Poupon MF (2000) Sensitivity to CPT-11 of xenografted human colorectal cancers as a function of microsatellite instability and p53 status. Br J Cancer 82(4):913–923. https://doi.org/10.1054/bjoc.1999.1019

    Article  PubMed  PubMed Central  Google Scholar 

  • Buonaguro F, Pauza D, Tornesello M, Hainaut P, Franco R, Marincola F (2014) Cancer diagnostic and predictive biomarkers. Biomed Res Int 2014:1–3. https://doi.org/10.1155/2014/980163

    Article  Google Scholar 

  • Cabrini G, Fabbri E, Lo Nigro C, Dechecchi MC, Gambari R (2015) Regulation of expression of O6-methylguanine-DNA methyltransferase and the treatment of glioblastoma (Review). Int J Oncol 47(2):417–428. https://doi.org/10.3892/ijo.2015.3026

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Carpinetti P, Donnard E, Bettoni F, Asprino P, Koyama F, Rozanski A, Sabbaga J, Habr-Gama A, Parmigiani RB, Galante PA, Perez RO, Camargo AA (2015) The use of personalized biomarkers and liquid biopsies to monitor treatment response and disease recurrence in locally advanced rectal cancer after neoadjuvant chemoradiation. Oncotarget 6(35):38360–38371. https://doi.org/10.18632/oncotarget.5256

    Article  PubMed  PubMed Central  Google Scholar 

  • Castillejo A, Hernández-Illán E, Rodriguez-Soler M, Pérez-Carbonell L, Egoavil C, Barberá VM, Castillejo MI, Guarinos C, Martínez-de-Dueñas E, Juan MJ, Sánchez-Heras AB, García-Casado Z, Ruiz-Ponte C, Brea-Fernández A, Juárez M, Bujanda L, Clofent J, Llor X, Andreu M, Castells A et al (2015) Prevalence of MLH1 constitutional epimutations as a cause of Lynch syndrome in unselected versus selected consecutive series of patients with colorectal cancer. J Med Genet 52(7):498–502. https://doi.org/10.1136/jmedgenet-2015-103076

    Article  CAS  PubMed  Google Scholar 

  • Chakravarti A, Erkkinen MG, Nestler U, Stupp R, Mehta M, Aldape K, Gilbert MR, Black PM, Loeffler JS (2006) Temozolomide-mediated radiation enhancement in glioblastoma: a report on underlying mechanisms. Clin Cancer Res 12(15):4738–4746. https://doi.org/10.1158/1078-0432.CCR-06-0596

    Article  CAS  PubMed  Google Scholar 

  • Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, Begg CB, Agarwala SS, Schuchter LM, Ernstoff MS, Houghton AN, Kirkwood JM (1999) Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol 17(9):2745–2751. https://doi.org/10.1200/JCO.1999.17.9.2745

    Article  CAS  PubMed  Google Scholar 

  • Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, Dummer R, Garbe C, Testori A, Maio M, Hogg D, Lorigan P, Lebbe C, Jouary T, Schadendorf D, Ribas A, O’Day SJ, Sosman JA, Kirkwood JM, Eggermont AM et al (2011) Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 364(26):2507–2516. https://doi.org/10.1056/NEJMoa1103782

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Chen Z, Miao H, Zeng Q, Xu S, Chen Z, Liu K (2020) Circulating cell-free DNA as a diagnostic and prognostic biomarker for non-small-cell lung cancer: a systematic review and meta-analysis. Biomark Med 14(7):587–597. https://doi.org/10.2217/bmm-2018-0093

    Article  CAS  PubMed  Google Scholar 

  • Chonggao YIN, Zhang G, Ruimei SUN, Xinting PAN, Wang X, Hongli LI, Sun Y (2018) miR-185-5p inhibits F-actin polymerization and reverses epithelial mesenchymal transition of human breast cancer cells by modulating RAGE. Mol Med Rep 18(3):2621–2630

    Google Scholar 

  • Cortez MA, Bueso-Ramos C, Ferdin J, Lopez-Berestein G, Sood AK, Calin GA (2011) MicroRNAs in body fluids--the mix of hormones and biomarkers. Nat Rev Clin Oncol 8(8):467–477

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Coulondre C, Miller JH (1977) Genetic studies of the lac repressor. IV. Mutagenic specificity in the lacI gene of Escherichia coli. J Mol Biol 117(3):577–606. https://doi.org/10.1016/0022-2836(77)90059-6

    Article  CAS  PubMed  Google Scholar 

  • Curtin JA, Busam K, Pinkel D, Bastian BC (2006) Somatic activation of KIT in distinct subtypes of melanoma. J Clin Oncol 24(26):4340–4346. https://doi.org/10.1200/JCO.2006.06.2984

    Article  CAS  PubMed  Google Scholar 

  • Curtin K, Slattery ML, Samowitz WS (2011) CpG island methylation in colorectal cancer: past, present and future. Pathol Res Int 2011:902674. https://doi.org/10.4061/2011/902674

    Article  Google Scholar 

  • Davies H, Bignell GR, Cox C, Stephens P, Edkins S, Clegg S, Teague J, Woffendin H, Garnett MJ, Bottomley W, Davis N, Dicks E, Ewing R, Floyd Y, Gray K, Hall S, Hawes R, Hughes J, Kosmidou V, Menzies A et al (2002) Mutations of the BRAF gene in human cancer. Nature 417(6892):949–954. https://doi.org/10.1038/nature00766

    Article  CAS  PubMed  Google Scholar 

  • De Mattos-Arruda L, Caldas C (2016) Cell-free circulating tumor DNA as a liquid biopsy in breast cancer. Mol Oncol 10(3):464–474. https://doi.org/10.1016/j.molonc.2015.12.001

    Article  CAS  PubMed  Google Scholar 

  • Druker BJ, Guilhot F, O’Brien SG, Gathmann I, Kantarjian H, Gattermann N, Deininger MW, Silver RT, Goldman JM, Stone RM, Cervantes F, Hochhaus A, Powell BL, Gabrilove JL, Rousselot P, Reiffers J, Cornelissen JJ, Hughes T, Agis H, Fischer T et al (2006) Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med 355(23):2408–2417. https://doi.org/10.1056/NEJMoa062867

    Article  CAS  PubMed  Google Scholar 

  • Eichelser C, Stückrath I, Müller V, Milde-Langosch K, Wikman H, Pantel K, Schwarzenbach H (2014) Increased serum levels of circulating exosomal microRNA-373 in receptor-negative breast cancer patients. Oncotarget 5(20):9650–9663. https://doi.org/10.18632/oncotarget.2520

    Article  PubMed  PubMed Central  Google Scholar 

  • El Bairi K, Atanasov AG, Amrani M, Afqir S (2019) The arrival of predictive biomarkers for monitoring therapy response to natural compounds in cancer drug discovery. Biomed Pharmacother 109:2492–2498. https://doi.org/10.1016/j.biopha.2018.11.097

    Article  CAS  PubMed  Google Scholar 

  • Emery CM, Vijayendran KG, Zipser MC, Sawyer AM, Niu L, Kim JJ, Hatton C, Chopra R, Oberholzer PA, Karpova MB, MacConaill LE, Zhang J, Gray NS, Sellers WR, Dummer R, Garraway LA (2009) MEK1 mutations confer resistance to MEK and B-RAF inhibition. Proc Natl Acad Sci U S A 106(48):20411–20416. https://doi.org/10.1073/pnas.0905833106

    Article  PubMed  PubMed Central  Google Scholar 

  • Esteller M, Hamilton SR, Burger PC, Baylin SB, Herman JG (1999) Inactivation of the DNA repair gene O6-methylguanine-DNA methyltransferase by promoter hypermethylation is a common event in primary human neoplasia. Cancer Res 59(4):793–797

    CAS  PubMed  Google Scholar 

  • Feinberg AP, Vogelstein B (1983) Hypomethylation distinguishes genes of some human cancers from their normal counterparts. Nature 301(5895):89–92. https://doi.org/10.1038/301089a0

    Article  CAS  PubMed  Google Scholar 

  • Filipow S, Laczmanski L (2019) Blood circulating miRNAs as cancer biomarkers for diagnosis and surgical treatment response. Front Genet 10:169

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Giardiello FM, Allen JI, Axilbund JE, Boland CR, Burke CA, Burt RW, Church JM, Dominitz JA, Johnson DA, Kaltenbach T, Levin TR, Lieberman DA, Robertson DJ, Syngal S, Rex DK (2014) Guidelines on genetic evaluation and management of Lynch syndrome: a consensus statement by the US Multi-society Task Force on colorectal cancer. Am J Gastroenterol 109(8):1159–1179. https://doi.org/10.1038/ajg.2014.186

    Article  PubMed  Google Scholar 

  • Gökmen-Polar Y (2019) Overview of PCR-based technologies and multiplexed gene analysis for biomarker studies. In: Badve S, Kumar G (eds) Predictive biomarkers in oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-95228-4_5

    Chapter  Google Scholar 

  • Goodsaid F, Papaluca M (2010) Evolution of biomarker qualification at the health authorities. Nat Biotechnol 28(5):441–443. https://doi.org/10.1038/nbt0510-441

    Article  CAS  PubMed  Google Scholar 

  • Goossens N, Nakagawa S, Sun X, Hoshida Y (2015) Cancer biomarker discovery and validation. Transl Cancer Res 4(3):256–269. https://doi.org/10.3978/j.issn.2218-676X.2015.06.04

    Article  CAS  PubMed  Google Scholar 

  • Greger V, Passarge E, Höpping W, Messmer E, Horsthemke B (1989) Epigenetic changes may contribute to the formation and spontaneous regression of retinoblastoma. Hum Genet 83(2):155–158. https://doi.org/10.1007/BF00286709

    Article  CAS  PubMed  Google Scholar 

  • Gross E, Busse B, Riemenschneider M, Neubauer S, Seck K, Klein HG, Kiechle M, Lordick F, Meindl A (2008) Strong association of a common dihydropyrimidine dehydrogenase gene polymorphism with fluoropyrimidine-related toxicity in cancer patients. PLoS One 3(12):e4003. https://doi.org/10.1371/journal.pone.0004003

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Hamilton P, O’Reilly P, Bankhead P, Abels E, Salto-Tellez M (2019) Digital and computational pathology for biomarker discovery. In: Badve S, Kumar G (eds) Predictive biomarkers in oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-95228-4_7

    Chapter  Google Scholar 

  • Hetta HF, Zahran AM, Shafik EA, El-Mahdy RI, Mohamed NA, Nabil EE, Esmaeel HM, Alkady OA, Elkady A, Mohareb DA, Hosni A, Mostafa MM, Elkady A (2019) Circulating miRNA-21 and miRNA-23a expression signature as potential biomarkers for early detection of non-small-cell lung cancer. MicroRNA 8(3):206–215. https://doi.org/10.2174/1573399815666190115151500

    Article  CAS  PubMed  Google Scholar 

  • Hewitt S, Takikita M, Braunschweig T, Chung J (2007) Promises and challenges of predictive tissue biomarkers. Biomark Med 1(2):313–318. https://doi.org/10.2217/17520363.1.2.313

    Article  CAS  PubMed  Google Scholar 

  • Huang Q, Gumireddy K, Schrier M, leSage C, Nagel R, Nair S, Egan DA, Li A, Huang G, Klein-Szanto AJ, Gimotty PA, Katsaros D, Coukos G, Zhang L, Puré E, Agami R (2008) The microRNAs miR-373 and miR-520c promote tumor invasion and metastasis. Nat Cell Biol 10(2):202–210

    Article  CAS  PubMed  Google Scholar 

  • Institute of Medicine (2012) Evolution of translational omics, lessons learned and the path forward. The National Academies Press, Washington, DC

    Google Scholar 

  • Jiang WQ, Fu FF, Li YX, Wang WB, Wang HH, Jiang HP, Teng LS (2012) Molecular biomarkers of colorectal cancer: prognostic and predictive tools for clinical practice. J Zhejiang Univ Sci B 13(9):663–675

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Jiang T, Ren S, Zhou C (2015) Role of circulating-tumor DNA analysis in non-small cell lung cancer. Lung Cancer 90:128–134

    Article  PubMed  Google Scholar 

  • Kamińska K, Nalejska E, Kubiak M, Wojtysiak J, Żołna Ł, Kowalewski J, Lewandowska MA (2019) Prognostic and predictive epigenetic biomarkers in oncology. Mol Diagno Ther 23(1):83–95. https://doi.org/10.1007/s40291-018-0371-7

    Article  CAS  Google Scholar 

  • Kashyap D, Tuli HS, Garg VK, Goel N, Bishayee A (2018) Oncogenic and tumor-suppressive roles of microRNAs with special reference to apoptosis: molecular mechanisms and therapeutic potential. Mol Diagno Ther 22(2):179–201. https://doi.org/10.1007/s40291-018-0316

    Article  CAS  Google Scholar 

  • Kenny LM, Al-Nahhas A, Aboagye EO (2011) Novel PET biomarkers for breast cancer imaging. Nucl Med Commun 32:333–335

    Article  PubMed  Google Scholar 

  • Kodahl AR, Zeuthen P, Binder H, Knoop AS, Ditzel HJ (2014) Alterations in circulating miRNA levels following early-stage estrogen receptor-positive breast cancer resection in post-menopausal women. PLoS One 9(7):e101950. https://doi.org/10.1371/journal.pone.0101950

    Article  PubMed  PubMed Central  Google Scholar 

  • Kosaka N, Iguchi H, Ochiya T (2010) Circulating microRNA in body fluid: a new potential biomarker for cancer diagnosis and prognosis. Cancer Sci 101(10):2087–2092

    Article  CAS  PubMed  Google Scholar 

  • Krawczyk P, Ramlau R, Powrózek T, Wojas-Krawczyk K, Sura S, Jarosz B, Walczyna B, Pankowski J, Szumiło J, Dyszkiewicz W, Woźniak A, Milanowski J (2012) Wykrywalność mutacji w genie EGFR u chorych na niedrobnokomórkowego raka płuca w wybranych ośrodkach w Polsce zaangażowanych w diagnostykę molekularną. J Cardio Thorac Surg 9(4):431–438

    Google Scholar 

  • La Thangue NB, Kerr DJ (2011) Predictive biomarkers: a paradigm shift towards personalized cancer medicine. Nat Rev Clin Oncol 8(10):587–596. https://doi.org/10.1038/nrclinonc.2011.121

    Article  CAS  PubMed  Google Scholar 

  • Lassere MN (2008) The biomarker-surrogacy evaluation schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints. Stat Methods Med Res 17(3):303–340. https://doi.org/10.1177/0962280207082719

    Article  PubMed  Google Scholar 

  • Lei Y, Li X, Huang Q, Zheng X, Liu M (2021) Progress and challenges of predictive biomarkers for immune checkpoint blockade. Front Oncol 11:617335. https://doi.org/10.3389/fonc.2021.617335

    Article  PubMed  PubMed Central  Google Scholar 

  • Lewandowska MA, Jóźwicki W, Starzynski J, Kowalewski J (2012) Analysis of EGFR mutation frequency and coexistence of KRAS and EGFR mutations using RT-PCR in lung adenocarcinoma: may a clinical and pathological model of a patient’s qualification for targeted therapy have an impact on time to obtain genetic results? Pol J Cardio Thorac Surg 9(4):443–451

    Article  Google Scholar 

  • Lewandowska MA, Żurawski B, Jozwicki W (2013) KRAS and BRAF mutation analysis in colorectal adenocarcinoma specimens with a low-age of tumor cells. Mol Diagn Ther 17(3):193–203

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Li C, Gao Y, Zhang K, Chen J, Han S, Feng B, Wang R, Chen L (2015) Multiple roles of microRNA-100 in human cancer and its therapeutic potential. Cell Physiol Biochem 37(6):2143–2159. https://doi.org/10.1159/000438572

    Article  CAS  PubMed  Google Scholar 

  • Li X, Gao P, Wang Y, Wang X (2018) Blood-derived microRNAs for pancreatic cancer diagnosis: a narrative review and meta-analysis. Front Physiol 9:685

    Article  PubMed  PubMed Central  Google Scholar 

  • Lim HS, Ju Lee H, Seok Lee K, Sook Lee E, Jang IJ, Ro J (2007) Clinical implications of CYP2D6 genotypes predictive of tamoxifen pharmacokinetics in metastatic breast cancer. J Clin Oncol 25(25):3837–3845

    Article  CAS  PubMed  Google Scholar 

  • Lim JS, Chen XA, Singh O, Yap YS, Ng RC, Wong NS, Wong M, Lee EJ, Chowbay B (2011) Impact of CYP2D6, CYP3A5, CYP2C9 and CYP2C19 polymorphisms on tamoxifen pharmacokinetics in Asian breast cancer patients. Br J Clin Pharmacol 71(5):737–750

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Linden HM, Dehdashti F (2013) Novel methods and tracers for breast cancer imaging. Semin Nucl Med 43:324–329

    Article  PubMed  Google Scholar 

  • Livide G, Epistolato MC, Amenduni M, Disciglio V, Marozza A, Mencarelli MA et al (2012) Epigenetic and copy number variation analysis in retinoblastoma by MS-MLPA. Pathol Oncol Res 18(3):703–712

    Article  CAS  PubMed  Google Scholar 

  • Loupakis F, Ruzzo A, Cremolini C, Vincenzi B, Salvatore L, Santini D, Masi G, Stasi I, Canestrari E, Rulli E, Floriani I, Bencardino K, Galluccio N, Catalano V, Tonini G, Magnani M, Fontanini G, Basolo F, Falcone A, Graziano F (2009) KRAS codon 61, 146 and BRAF mutations predict resistance to cetuximab plus irinotecan in KRAS codon 12 and 13 wild-type metastatic colorectal cancer. Br J Cancer 101(4):715–721

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Mandrekar SJ, Sargent DJ (2014) Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine. Chin Clin Oncol 3(2):14

    PubMed  PubMed Central  Google Scholar 

  • Mankoff DA, Pryma DA, Clark AS (2014) J Nucl Med 55(4):525–528. https://doi.org/10.2967/jnumed.113.126128

    Article  CAS  PubMed  Google Scholar 

  • Max KEA, Bertram K, Akat KM, Bogardus KA, Li J, Morozov P, Ben-Dov IZ, Li X, Weiss ZR, Azizian A, Sopeyin A, Diacovo TG, Adamidi C, Williams Z, T. (2018) Tuschl Human plasma and serum extracellular small RNA reference profiles and their clinical utility. Proc Natl Acad Sci U S A 115(23):E5334–E5343

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Meric-Bernstam F, Brusco L, Shaw K, Horombe C, Kopetz S, Davies MA, Routbort M, Piha-Paul SA, Janku F, Ueno N, Hong D, De Groot J, Ravi V, Li Y, Luthra R, Patel K, Broaddus R, Mendelsohn J, Mills GB (2015) Feasibility of large-scale genomic testing to facilitate enrollment onto genomically matched clinical trials. J Clin Oncol 33(25):2753–2762

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  • Mitra D, Brumlik MJ, Okamgba SU, Zhu Y, Duplessis TT, Parvani JG, Lesko SM, Brogi E, Jones FE (2009) An oncogenic isoform of HER2 associated with locally disseminated breast cancer and trastuzumab resistance. Mol Cancer Ther 8(8):2152–2162

    Article  CAS  PubMed  Google Scholar 

  • Moldovan L, Batte KE, Trgovcich J, Wisler J, Marsh CB, M. (2014) Piper methodological challenges in utilizing miRNAs as circulating biomarkers. J Cell Mol Med 18(3):371–390

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Montagut C, Sharma SV, Shioda T, McDermott U, Ulman M, Ulkus LE, Dias-Santagata D, Stubbs H, Lee DY, Singh A, Drew L, Haber DA, Settleman J (2008) Elevated CRAF as a potential mechanism of acquired resistance to BRAF inhibition in melanoma. Cancer Res 68(12):4853–4861

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Nalejska E, Mączyńska E, Lewandowska MA (2014) Prognostic and predictive biomarkers: tools in personalized oncology. Mol Diagn Ther 18:273–284. https://doi.org/10.1007/s40291-013-0077-9

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Newman AM, Bratman SV, To J et al (2014) An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med 20(5):548–554

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Newton K, Jorgensen NM, Wallace AJ, Buchanan DD, Lalloo F, McMahon RF et al (2014) Tumor MLH1 promoter region methylation testing is an effective prescreen for Lynch Syndrome (HNPCC). J Med Genet 51(12):789–796

    Article  CAS  PubMed  Google Scholar 

  • Ohtani-Fujita N, Dryja TP, Rapaport JM, Fujita T, Matsumura S, Ozasa K et al (1997) Hypermethylation in the retinoblastoma gene is associated with unilateral, sporadic retinoblastoma. Cancer Genet Cytogenet 98(1):43–49

    Article  CAS  PubMed  Google Scholar 

  • Palanisamy N (2019) Introduction to microarray technology. In: Badve S, Kumar G (eds) Predictive biomarkers in oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-95228-4_6

    Chapter  Google Scholar 

  • Pao W, Miller VA, Politi KA, Riely GJ, Somwar R, Zakowski MF, Kris MG, Varmus H (2005) Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain. PLoS Med 2(3):e73

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  • Pardini B, De Maria D, Francavilla A, Di Gaetano C, Ronco G, Naccarati A (2018) MicroRNAs as markers of progression in cervical cancer: a systematic review. BMC Cancer 18(1):696. https://doi.org/10.1186/s12885-018-4590-4

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Perera-Bel J, Leha A, Beißbarth T (2019) Bioinformatic methods and resources for biomarker discovery, validation, development, and integration. In: Badve S, Kumar G (eds) Predictive biomarkers in oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-95228-4_11

    Chapter  Google Scholar 

  • Pérez-Carbonell L, Alenda C, Payá A, Castillejo A, Barberá VM, Guillén C et al (2010) Methylation analysis of MLH1 improves the selection of patients for genetic testing in Lynch syndrome. J Mol Diagn 12(4):498–504

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  • Peterson LM, Kurland BF, Schubert EK et al (2014) A Phase 2 study of 16α-[18F]-fluoro-17β-estradiol positron emission tomography (FES-PET) as a marker of hormone sensitivity in metastatic breast cancer (MBC). Mol Imaging Biol 16:431

    Article  CAS  PubMed  Google Scholar 

  • Raida M, Schwabe W, Hausler P, Van Kuilenburg AB, Van Gennip AH, Behnke D, Hoffken K (2001) Prevalence of a common point mutation in the dihydropyrimidine dehydrogenase (DPD) gene within the 5’-splice donor site of intron 14 in patients with severe 5-fluorouracil (5-FU)-related toxicity compared with controls. Clin Cancer Res 7(9):2832–2839

    CAS  PubMed  Google Scholar 

  • Renfro LA, Mallick H, An MW, Sargent DJ, Mandrekar SJ (2016) Clinical trial designs incorporating predictive biomarkers. Cancer Treat Rev 43:74–82. https://doi.org/10.1016/j.ctrv.2015.12.008

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Ribic CM, Sargent DJ, Moore MJ, Thibodeau SN, French AJ, Goldberg RM, Hamilton SR, Laurent-Puig P, Gryfe R, Shepherd LE, Tu D, Redston M, Gallinger S (2003) Tumor microsatellite-instability status as a predictor of benefit from fluorouracil-based adjuvant chemotherapy for colon cancer. N Engl J Med 349(3):247–257

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Riely GJ, Pao W, Pham D, Li AR, Rizvi N, Venkatraman ES, Zakowski MF, Kris MG, Ladanyi M, Miller VA (2006) Clinical course of patients with non-small cell lung cancer and epidermal growth factor receptor exon 19 and exon 21 mutations treated with gefitinib or erlotinib. Clin Cancer Res 12(3 Pt 1):839–844

    Article  CAS  PubMed  Google Scholar 

  • Roszkowski K, Furtak J, Zurawski B, Szylberg T, Lewandowska MA (2016) Potential role of methylation marker in glioma supporting clinical decisions. Int J Mol Sci 17(11):1876

    Article  PubMed Central  CAS  Google Scholar 

  • Rustgi AK (2007) The genetics of hereditary colon cancer. Genes Dev 21(20):2525–2538

    Article  CAS  PubMed  Google Scholar 

  • Sartore-Bianchi A, Martini M, Molinari F, Veronese S, Nichelatti M, Artale S, Di Nicolantonio F, Saletti P, De Dosso S, Mazzucchelli L, Frattini M, Siena S, Bardelli A (2009) PIK3CA mutations in colorectal cancer are associated with clinical resistance to EGFR-targeted monoclonal antibodies. Cancer Res 69(5):1851–1857

    Article  CAS  PubMed  Google Scholar 

  • Sauerbrei W, Taube SE, McShane LM et al (2018) Reporting recommendations for tumor marker prognostic studies (REMARK): an abridged explanation and elaboration. J Natl Cancer Inst 110(8):803–811. https://doi.org/10.1093/jnci/djy088

    Article  PubMed  PubMed Central  Google Scholar 

  • Sawyers C (2004) Targeted cancer therapy. Nature 432:294–297

    Article  CAS  PubMed  Google Scholar 

  • Schildhaus HU (2019) Significance of immunohistochemistry and in situ hybridization techniques for predictive biomarker studies. In: Badve S, Kumar G (eds) Predictive biomarkers in oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-95228-4_4

    Chapter  Google Scholar 

  • Schilsky RL (2010) Personalized medicine in oncology: the future is now. Nat Rev Drug Discov 9:363–366

    Article  CAS  PubMed  Google Scholar 

  • Segal NH, Saltz LB (2009) Evolving treatment of advanced colon cancer. Annu Rev Med 60:207–219

    Article  CAS  PubMed  Google Scholar 

  • Soda M, Choi YL, Enomoto M, Takada S, Yamashita Y, Ishikawa S, Fujiwara S, Watanabe H, Kurashina K, Hatanaka H, Bando M, Ohno S, Ishikawa Y, Aburatani H, Niki T, Sohara Y, Sugiyama Y, Mano H (2007) Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 448(7153):561–566

    Article  CAS  PubMed  Google Scholar 

  • Soda M, Takada S, Takeuchi K, Choi YL, Enomoto M, Ueno T, Haruta H, Hamada T, Yamashita Y, Ishikawa Y, Sugiyama Y, Mano H (2008) A mouse model for EML4-ALK-positive lung cancer. Proc Natl Acad Sci U S A 105(50):19893–19897

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Soda M, Isobe K, Inoue A, Maemondo M, Oizumi S, Fujita Y, Gemma A, Yamashita Y, Ueno T, Takeuchi K, Choi YL, Miyazawa H, Tanaka T, Hagiwara K, Mano H (2012) A prospective PCR-based screening for the EML4-ALK oncogene in non-small cell lung cancer. Clin Cancer Res 18(20):5682–5689

    Article  CAS  PubMed  Google Scholar 

  • Søes S, Daugaard IL, Sørensen BS, Carus A, Mattheisen M, Alsner J et al (2014) Hypomethylation and increased expression of the putative oncogene ELMO3 are associated with lung cancer development and metastases formation. Oncoscience 1(5):367–374

    Article  PubMed  PubMed Central  Google Scholar 

  • Sohel MH (2016) Extracellular/circulating microRNAs: release mechanisms, functions and challenges Ach. Life Sci 10(2):175–186

    Google Scholar 

  • Spittle C, Ward MR, Nathanson KL, Gimotty PA, Rappaport E, Brose MS, Medina A, Letrero R, Herlyn M, Edwards RH (2007) Application of a BRAF pyrosequencing assay for mutation detection and copy number analysis in malignant melanoma. J Mol Diagn 9(4):464–471

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Stewart GD, Van Neste L, Delvenne P, Delrée P, Delga A, McNeill SA et al (2013) Clinical utility of an epigenetic assay to detect occult prostate cancer in histopathologically negative biopsies: results of the MATLOC study. J Urol 189(3):1110–1116

    Article  PubMed  Google Scholar 

  • Teixeira AL, Ferreira M, Silva J, Gomes M, Dias F, Santos JI, Maurício J, Lobo F, Medeiros R (2014) Higher circulating expression levels of miR-221 associated with poor overall survival in renal cell carcinoma patients. Tumourbiology 35(5):4057–4066. https://doi.org/10.1007/s13277-013-1531-3

    Article  CAS  Google Scholar 

  • Tembhare PR, Gujral S, Krishnamurthy H (2019) Measurement of predictive cancer biomarkers by flow cytometry. In: Badve S, Kumar G (eds) Predictive biomarkers in oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-95228-4_9

    Chapter  Google Scholar 

  • Toyama T, Yamashita H, Sugiura H, Kondo N, Iwase H, Fujii Y (2009) No association between CYP2D6*10 genotype and survival of node-negative Japanese breast cancer patients receiving adjuvant tamoxifen treatment. Jpn J Clin Oncol 39(10):651–656

    Article  PubMed  Google Scholar 

  • Toyota M, Ahuja N, Ohe-Toyota M, Herman JG, Baylin SB, Issa JP (1999) CpG island methylator phenotype in colorectal cancer. Proc Natl Acad Sci U S A 96(15):8681–8686

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Tsujikawa T, Yoshida Y, Kudo T et al (2009) Functional images reflect aggressiveness of endometrial carcinoma: estrogen receptor expression combined with 18F-FDG PET. J Nucl Med 50:1598–1604

    Article  CAS  PubMed  Google Scholar 

  • Turchinovich TR, Samatov AG, Tonevitsky B (2013) Burwinkel circulating miRNAs: cell-cell communication function? Front Genet 4:119

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Van Kuilenburg AB, Meinsma R, Zoetekouw L, Van Gennip AH (2002) Increased risk of grade IV neutropenia after administration of 5-fluorouracil due to a dihydropyrimidine dehydrogenase deficiency: high prevalence of the IVS14+1g>a mutation. Int J Cancer 101(3):253–258

    Article  PubMed  CAS  Google Scholar 

  • Vogelstein B, Fearon ER, Hamilton SR, Kern SE, Preisinger AC, Leppert M, Nakamura Y, White R, Smits AM, Bos JL (1988) Genetic alterations during colorectal-tumor development. N Engl J Med 319(9):525–532

    Article  CAS  PubMed  Google Scholar 

  • Wang S, Han X, Hu X et al (2014) Clinical significance of pretreatment plasma biomarkers in advanced non-small cell lung cancer patients. Clin Chim Acta 430:63–70

    Article  CAS  PubMed  Google Scholar 

  • Weisenberger DJ, Siegmund KD, Campan M, Young J, Long TI, Faasse MA et al (2006) CpG island methylator phenotype underlies sporadic microsatellite instability and is tightly associated with BRAF mutation in colorectal cancer. Nat Genet 38(7):787–793

    Article  CAS  PubMed  Google Scholar 

  • Weiss G, Schlegel A, Kottwitz D, König T, Tetzner R (2017) Validation of the SHOX2/PTGER4 DNA methylation marker panel for plasma-based discrimination between patients with malignant and nonmalignant lung disease. J Thorac Oncol 12(1):77–84

    Article  PubMed  PubMed Central  Google Scholar 

  • Wick W, Platten M, Meisner C, Felsberg J, Tabatabai G, Simon M et al (2012) Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: the NOA-08 randomised, phase 3 trial. Lancet Oncol 13(7):707–715

    Article  CAS  PubMed  Google Scholar 

  • Williams Z, Ben-Dov IZ, Elias R, Mihailovic A, Brown M, Rosenwaks Z, Tuschl T (2013) Comprehensive profiling of circulating microRNA via small RNA sequencing of cDNA libraries reveals biomarker potential and limitations. Proc Natl Acad Sci U S A 110(11):4255–4260. https://doi.org/10.1073/pnas.1214046110

    Article  PubMed  PubMed Central  Google Scholar 

  • Wong DW, Leung EL, So KK, Tam IY, Sihoe AD, Cheng LC, Ho KK, Au JS, Chung LP, Pik WM (2009) The EML4-ALK fusion gene is involved in various histologic types of lung cancers from nonsmokers with wild-type EGFR and KRAS. Cancer 115(8):1723–1733

    Article  CAS  PubMed  Google Scholar 

  • World Health Organization (2001) Biomarkers in risk assessment: validity and validation. WHO, Geneva

    Google Scholar 

  • Xia S, Kohli M, Du M et al (2015) Plasma genetic and genomic abnormalities predict treatment response and clinical outcome in advanced prostate cancer. Oncotarget 6:16411–16421

    Article  PubMed  PubMed Central  Google Scholar 

  • Xu Y, Sun Y, Yao L, Shi L, Wu Y, Ouyang T, Li J, Wang T, Fan Z, Fan T, Lin B, He L, Li P, Xie Y (2008) Association between CYP2D6 *10 genotype and survival of breast cancer patients receiving tamoxifen treatment. Ann Oncol 19(8):1423–1429

    Article  CAS  PubMed  Google Scholar 

  • Yu XM, Wu YC, Liu X, Huang XC, Hou XX, Wang JL, Cheng XL, Mao WM, Ling ZQ (2016) Cell-free RNA content in peripheral blood as potential biomarkers for detecting circulating tumor cells in non-small cell lung carcinoma. Int J Mol Sci 17(11):1845

    Article  PubMed Central  CAS  Google Scholar 

  • Yun CH, Mengwasser KE, Toms AV, Woo MS, Greulich H, Wong KK, Meyerson M, Eck MJ (2008) The T790M mutation in EGFR kinase causes drug resistance by increasing the affinity for ATP. Proc Natl Acad Sci U S A 105(6):2070–2075

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Zhang H, Liu D, Li S et al (2013) Comparison of EGFR signaling pathway somatic DNA mutations derived from peripheral blood and corresponding tumor tissue of patients with advanced non-small-cell lung cancer using liquidchip technology. J Mol Diagn 15(6):819–826

    Article  CAS  PubMed  Google Scholar 

  • Zhou J, Shi YH, Fan J (2012) Circulating cell-free nucleic acids: promising biomarkers of hepatocellular carcinoma. Semin Oncol 39(4):440–448

    Article  CAS  PubMed  Google Scholar 

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Rana, N.F., Tanweer, T. (2022). Predictive Biomarkers for Anticancer Drugs. In: Shehzad, A. (eds) Cancer Biomarkers in Diagnosis and Therapeutics. Springer, Singapore. https://doi.org/10.1007/978-981-16-5759-7_6

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