Safety and antitumor activity of the anti–PD-1 antibody pembrolizumab in patients with advanced colorectal carcinoma

PLoS ONE

Volumn 12, Issue 12, 2017, Pages

  O’Neil, Bert H ^a   Wallmark, John M ^b   Lorente, David ^c   Elez, Elena ^d   Raimbourg, Judith ^e   Gomez Roca, Carlos ^f   Ejadi, Samuel ^g   Piha Paul, Sarina A ^h   Stein, Mark N ⁱ   Abdul Razak, Albiruni R ^j   Dotti, Katia ^k   Santoro, Armando ^l   Cohen, Roger B ^m   Gould, Marlena ⁿ   Saraf, Sanatan ⁿ   Stein, Karen ⁿ   Han, Sae Won ^o  

^a INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Maryland Hematology Oncology ^*  (United States)

^c Prostate Cancer Targeted Therapy Group   (United Kingdom)

^d HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^e UMR INSERM U892 CNRS 6299   (France)

^f INSTITUT CLAUDIUS REGAUD   (France)

^g HonorHealth and the Scottsdale Lincoln Health Network   (United States)

^h UNIVERSITY OF TEXAS   (United States)

ⁱ RUTGERS CANCER INSTITUTE OF NEW JERSEY   (United States)

^j PRINCESS MARGARET HOSPITAL   (Canada)

^k NATIONAL CANCER INSTITUTE   (Italy)

^l HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

^m UNIVERSITY OF PENNSYLVANIA   (United States)

ⁿ MERCK RESEARCH LABORATORIES   (United States)

^o Seoul National University Hospital   (South Korea)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BILIRUBIN; PEMBROLIZUMAB; PROGRAMMED DEATH 1 LIGAND 1; CD274 PROTEIN, HUMAN; IMMUNOLOGICAL ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; ASTHENIA; BILIRUBIN BLOOD LEVEL; CANADA; CANCER PROGNOSIS; CANCER RADIOTHERAPY; CLINICAL ARTICLE; COHORT ANALYSIS; COLORECTAL CARCINOMA; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ERYTHEMA; FATIGUE; FEMALE; FLATULENCE; FRANCE; HUMAN; ITALY; KOREA; MALE; MICROSATELLITE INSTABILITY; MULTICENTER STUDY; MYALGIA; NAUSEA; NUCLEAR MAGNETIC RESONANCE IMAGING; PHASE 1 CLINICAL TRIAL; PROGNOSIS; PROTEIN EXPRESSION; PRURITUS; RETROSPECTIVE STUDY; SOLID MALIGNANT NEOPLASM; SPAIN; STOMATITIS; TREATMENT RESPONSE; UNITED KINGDOM; UNITED STATES; VOMITING; X-RAY COMPUTED TOMOGRAPHY; CLINICAL TRIAL; COLORECTAL TUMOR; IMMUNOLOGY; MIDDLE AGED;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS, IMMUNOLOGICAL; B7-H1 ANTIGEN; COHORT STUDIES; COLORECTAL NEOPLASMS; FEMALE; HUMANS; MALE; MIDDLE AGED;

EID: 85039844510     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0189848     Document Type: Article

References (29)

1. American Cancer Society: Colorectal Cancer Facts and Figures 2014–2016. http://www.cancer.org/acs/groups/content/documents/document/acspc-042280.pdf. Accessed March 7, 2017.
2. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016; 66:7–30. https://doi.org/10.3322/caac.21332 PMID: 26742998
3. Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. et al. Global cancer statistics, 2012. CA Cancer J Clin 2015; 65:87–108. https://doi.org/10.3322/caac.21262 PMID: 25651787
4. National Cancer Institute: SEER Stat Fact Sheets: Colon and Rectum Cancer 2016. http://seer.cancer.gov/statfacts/html/colorect.html. Accessed June 13, 2016
5. Kocarnik JM, Shiovitz S, Phipps AI. Molecular phenotypes of colorectal cancer and potential clinical applications. Gastroenterol Rep (Oxford) 2015; 3:269–276.
6. Keir ME, Butte MJ, Freeman GJ, Sharpe AH. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol 2008; 26:677–704. https://doi.org/10.1146/annurev.immunol.26.021607.090331 PMID: 18173375
7. Francisco LM, Sage PT, Sharpe AH. The PD-1 pathway in tolerance and autoimmunity. Immunol Rev 2010; 236:219–242. https://doi.org/10.1111/j.1600-065X.2010.00923.x PMID: 20636820
8. Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 2012; 12:252–264. https://doi.org/10.1038/nrc3239 PMID: 22437870
9. Disis ML. Immune regulation of cancer. J Clin Oncol 2010; 28:4531–4538. https://doi.org/10.1200/JCO.2009.27.2146 PMID: 20516428
10. Llosa NJ, Cruise M, Tam A, Wicks EC, Hechenbleikner EM, Taube JM et al. The vigorous immune microenvironment of microsatellite instable colon cancer is balanced by multiple counter-inhibitory checkpoints. Cancer Discov 2015; 5:43–51. https://doi.org/10.1158/2159-8290.CD-14-0863 PMID: 25358689
11. Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 2014; 515:563–567. https://doi.org/10.1038/nature14011 PMID: 25428504
12. Kerr KM, Tsao MS, Nicholson AG, Yatabe Y, Wistuba II, Hirsch FR et al. Programmed death-ligand 1 immunohistochemistry in lung cancer: in what state is this art? J Thoracic Oncol 2015; 10:985–989.
13. Dolled-Filhart M, Locke D, Murphy T, Lynch F, Yearley JH, Frisman D et al. Development of a prototype immunohistochemistry assay to measure programmed death ligand-1 expression in tumor tissue. Arch Pathol Lab Med 2016; 140:1259–1266. https://doi.org/10.5858/arpa.2015-0544-OA PMID: 27788043
14. Sehdev A, Cramer HM, Ibrahim AA, Younger AE, O’Neil BH. Pathological complete response with anti-PD-1 therapy in a patient with microsatellite instable high, BRAF mutant metastatic colon cancer: a case report and review of literature. Discov Med 2016; 21:341–347. PMID: 27355330
15. Deeks ED. Pembrolizumab: a review in advanced melanoma. Drugs 2016; 76:375–386. https://doi.org/10.1007/s40265-016-0543-x PMID: 26846323
16. Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med 2012; 366:2455–2465. https://doi.org/10.1056/NEJMoa1200694 PMID: 22658128
17. 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; 366:2443–2454. https://doi.org/10.1056/NEJMoa1200690 PMID: 22658127
18. Lipson EJ, Sharfman WH, Drake CG, Wollner I, Taube JM, Anders RA et al. Durable cancer regression off-treatment and effective reinduction therapy with an anti-PD-1 antibody. Clin Cancer Res 2013; 19:462–468. https://doi.org/10.1158/1078-0432.CCR-12-2625 PMID: 23169436
19. Norton SE, Ward-Hartstonge KA, Taylor ES, Kemp RA. Immune cell interplay in colorectal cancer prognosis. World J Gastrointestinal Oncol 2015; 7:221–232.
20. Roth AD, Tejpar S, Delorenzi M, Yan P, Fiocca R, Klingbiel D et al. Prognostic role of KRAS and BRAF in stage II and III resected colon cancer: results of the translational study on the PETACC-3, EORTC 40993, SAKK 60–00 trial. J Clin Oncol 2010; 28:466–474. https://doi.org/10.1200/JCO.2009.23.3452PMID: 20008640
21. Therkildsen C, Bergmann TK, Henrichsen-Schnack T, Ladelund S, Nilbert M. The predictive value of KRAS, NRAS, BRAF, PIK3CA and PTEN for anti-EGFR treatment in metastatic colorectal cancer: a systematic review and meta-analysis. Acta Oncol 2014; 53:852–864. https://doi.org/10.3109/0284186X.2014.895036 PMID: 24666267
22. Lochhead P, Kuchiba A, Imamura Y, Liao X, Yamauchi M, Nishihara R et al. Microsatellite instability and BRAF mutation testing in colorectal cancer prognostication. J National Cancer Inst 2013; 105:1151–1156.
23. Le DT, Uram JN, Wang H, Bartlett B, Kemberling H, Eyring A et al. Programmed death-1 blockade in mismatch repair deficient colorectal cancer. J Clin Oncol 2016; 34(suppl):abstr 103.
24. Diaz LA, Uram JN, Wang H, Bartlett B, Kemberling H, Eyring A et al. Programmed death-1 blockade in mismatch repair deficient cancer independent of tumor histology. J Clin Oncol 2016; 34(suppl): abstr 3003.
25. Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol 2016; 17:1497–1508. https://doi.org/10.1016/S1470-2045(16)30498-3 PMID: 27745820
26. Chow LQ, Haddad R, Gupta S, Mahipal A, Mehra R, Tahara M et al. Antitumor activity of pembrolizumab in biomarker-unselected patients with recurrent and/or metastatic head and neck squamous cell carcinoma: results from the phase Ib KEYNOTE-012 expansion cohort. J Clin Oncol. 2016; 34: 3838–3845. https://doi.org/10.1200/JCO.2016.68.1478 PMID: 27646946
27. Keytruda [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; 2017
28. Patnaik A, Kang SP, Rasco D, Papadopoulos KP, Elassaiss-Schaap J, Beeram M et al. Phase I study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in patients with advanced solid tumors. Clin Cancer Res 2015; 21:4286–4293. https://doi.org/10.1158/1078-0432.CCR-14-2607 PMID: 25977344
29. Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 2015; 372:2018–2028. https://doi.org/10.1056/ NEJMoa1501824 PMID: 25891174