Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366:2443–54.
Article
CAS
PubMed
PubMed Central
Google Scholar
Brahmer JR, Drake CG, Wollner I, Powderly JD, Picus J, Sharfman WH, et al. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010;28(19):3167–75. https://doi.org/10.1200/JCO.2009.26.7609 (Epub 2010 Jun 1).
Article
CAS
PubMed
PubMed Central
Google Scholar
Lipson EJ, Sharfman WH, Drake CG, Wollner I, Taube JM, Anders RA, Xu H, Yao S, Pons A, Chen L, Pardoll DM, Brahmer JR, Topalian SL. Durable cancer regression off-treatment and effective reinduction therapy with an anti-PD-1 antibody. Clin Cancer Res. 2013;19(2):462–8. https://doi.org/10.1158/1078-0432.CCR-12-2625 (Epub 2012 Nov 20).
Article
CAS
PubMed
Google Scholar
Le DT, Uram JN, Wang H, Bartlett BR, Kemberling H, Eyring AD, Skora AD, Luber BS, Azad NS, Laheru D, Biedrzycki B, Donehower RC, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Duffy SM, Goldberg RM, de la Chapelle A, Koshiji M, Bhaijee F, Huebner T, Hruban RH, Wood LD, Cuka N, Pardoll DM, Papadopoulos N, Kinzler KW, Zhou S, Cornish TC, Taube JM, Anders RA, Eshleman JR, Vogelstein B, Diaz LA Jr. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med. 2015;372(26):2509–20. https://doi.org/10.1056/NEJMoa1500596 (Epub 2015 May 30).
Article
CAS
PubMed
PubMed Central
Google Scholar
Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017;357(6349):409–13. https://doi.org/10.1126/science.aan6733 (Epub 2017 Jun 8).
Article
CAS
PubMed
PubMed Central
Google Scholar
Pembrolizumab package insert. http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. Accessed 15 Jan 2018.
Opdivo (prescribing information). Princeton: Bristol-Myers Squibb; 2017.
Doebele RC, Davis LE, Vaishnavi A, Le AT, Estrada-Bernal A, Keysar S, Jimeno A, Varella-Garcia M, Aisner DL, Li Y, Stephens PJ, Morosini D, Tuch BB, Fernandes M, Nanda N, Low JA. An oncogenic NTRK fusion in a soft tissue sarcoma patient with response to the tropomyosin-related kinase (TRK) inhibitor LOXO-101. Cancer Discov. 2015;5(10):1049–57.
Article
CAS
PubMed
PubMed Central
Google Scholar
Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of larotrectinib in TRK fusion–positive cancers in adults and children. New Engl J Med. 2018;378:731–9. https://doi.org/10.1056/NEJMoa1714448.
Article
CAS
PubMed
Google Scholar
Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch repair deficiency. 2015 ASCO annual meeting. J Clin Oncol. 2015;33. (suppl; abstr LBA 100). Late Breaking Abstract 100.
Hegde M, Ferber M, Mao R, Working Group of the American College of Medical Genetics and Genomics (ACMG) Laboratory Quality Assurance Committee, et al. ACMG technical standards and guidelines for genetic testing for inherited colorectal cancer (Lynch syndrome, familial adenomatous polyposis, and MYH-associated polyposis. Genet Med. 2014;16(1):101–16. https://doi.org/10.1038/gim.2013.166.
Article
CAS
PubMed
Google Scholar
American Medical Association. National coalition for health professional education in genetics. Colorectal cancer fact sheets: MSI and IHC testing. http://www.nchpeg.org/documents/crc/11-0456%20Fact%20sheets%20(MSI%20and%20IHC%20testing).pdf. Updated February 2012. Accessed 12 July 2017.
Vilar E, Gruber SB. Microsatellite instability in colorectal cancer—the stable evidence. Nat Rev Clin Oncol. 2010;7(3):153–62. https://doi.org/10.1038/nrclinonc.2009.237.
Article
CAS
PubMed
PubMed Central
Google Scholar
Babaei H, Zeinalian M, Emami MH, et al. Simplified microsatellite instability detection protocol provides equivalent sensitivity to robust detection strategies in Lynch syndrome patients. Cancer Biol Med. 2017;14(2):142–50. https://doi.org/10.20892/j.issn.2095-3941.2016.0091.
Article
PubMed
PubMed Central
Google Scholar
Howitt BE, Strickland KC, Sholl LM, et al. Clear cell ovarian cancers with microsatellite instability: a unique subset of ovarian cancers with increased tumor-infiltrating lymphocytes and PD-1/PD-L1 expression. Oncoimmunology. 2017;6(2):e1277308. https://doi.org/10.1080/2162402X.2016.1277308.
Article
PubMed
PubMed Central
Google Scholar
Shia J. Immunohistochemistry versus microsatellite instability testing for screening colorectal cancer patients at risk for hereditary nonpolyposis colorectal cancer syndrome. Part I. The utility of immunohistochemistry. J Mol Diagn. 2008;10(4):293–300. https://doi.org/10.2353/jmoldx.2008.080031.
Article
PubMed
PubMed Central
Google Scholar
Shia J, Stadler Z, Weiser MR, et al. Immunohistochemical staining for DNA mismatch repair proteins in intestinal tract carcinoma: how reliable are biopsy samples? Am J Surg Pathol. 2011;35(3):447–54. https://doi.org/10.1097/PAS.0b013e31820a091d.
Article
PubMed
Google Scholar
Dudley JC, Lin MT, Le DT, Eshleman JR. Microsatellite instability as a biomarker for PD-1 blockade. Clin Cancer Res. 2016;22(4):813–20. https://doi.org/10.1158/1078-0432.CCR-15-1678.
Article
CAS
PubMed
Google Scholar
Hause RJ, Pritchard CC, Shendure J, Salipante SJ. Classification and characterization of microsatellite instability across 18 cancer types. Nat Med. 2016;22(11):1342–50. https://doi.org/10.1038/nm.4191.
Article
CAS
PubMed
Google Scholar
Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations. N Engl J Med. 2015;373(8):726–36. https://doi.org/10.1056/nejmoa1502309.
Article
CAS
PubMed
PubMed Central
Google Scholar
Hyman DM, Piha-Paul SA, Won H, Rodon J, Saura C, Shapiro GI, Juric D, Quinn DI, Moreno V, Doger B, Mayer IA, Boni V, Calvo E, Loi S, Lockhart AC, Erinjeri JP, Scaltriti M, Ulaner GA, Patel J, Tang J, Beer H, Selcuklu SD, Hanrahan AJ, Bouvier N, Melcer M, Murali R, Schram AM, Smyth LM, Jhaveri K, Li BT, Drilon A, Harding JJ, Iyer G, Taylor BS, Berger MF, Cutler Jr RE, Xu F, Butturini A, Eli LD, Mann G, Farrell C, Lalani AS, Bryce RP, Arteaga CL, Meric-Bernstam F, Baselga J, Solit DB. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature. 2018;554:189–94. https://doi.org/10.1038/nature25475.
Article
CAS
PubMed
Google Scholar