Safety and antitumor activity of pembrolizumab in patients with programmed death-ligand 1-positive nasopharyngeal carcinoma: Results of the KEYNOTE-028 study

Journal of Clinical Oncology

Volumn 35, Issue 36, 2017, Pages 4050-4056

  Hsu, Chiun ^a   Lee, Se Hoon ^b   Ejadi, Samuel ^c   Even, Caroline ^h   Cohen, Roger B ^d   Le Tourneau, Christophe ^i,j   Mehnert, Janice M ^e   Algazi, Alain ^f   Van Brummelen, Emilie M J ^k   Saraf, Sanatan ^g   Thanigaimani, Pradeep ^g   Cheng, Jonathan D ^g   Hansen, Aaron R ^l  

^a NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^b Seoul National University Hospital   (South Korea)

^c Virginia G Piper Cancer Center   (United States)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

^e RUTGERS CANCER INSTITUTE OF NEW JERSEY   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g MERCK RESEARCH LABORATORIES   (United States)

^h INSTITUT GUSTAVE ROUSSY   (France)

ⁱ INSTITUT CURIE   (France)

^j INSERM   (France)

^k NETHERLANDS CANCER INSTITUTE   (Netherlands)

^l PRINCESS MARGARET HOSPITAL   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; CARBOPLATIN; CISPLATIN; CREATINE KINASE; CYCLOPHOSPHAMIDE; DOCETAXEL; FLUOROURACIL; GEMCITABINE; PACLITAXEL; PEMBROLIZUMAB; PROGRAMMED DEATH 1 LIGAND 1; CD274 PROTEIN, HUMAN; IMMUNOLOGICAL ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTHRITIS; AUTOIMMUNE HEPATITIS; CANCER GROWTH; CANCER PATIENT; CLINICAL ARTICLE; COHORT ANALYSIS; CONFERENCE PAPER; COUGHING; CREATINE KINASE BLOOD LEVEL; DIARRHEA; DIPLOPIA; DRUG SAFETY; DRUG TREATMENT FAILURE; FACE PAIN; FATIGUE; FEMALE; FOLLOW UP; HEPATITIS; HERPES ZOSTER; HUMAN; HYPOTHYROIDISM; INOPERABLE CANCER; MALE; METASTASIS; MYALGIA; NASOPHARYNX CARCINOMA; PAIN; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROTEINURIA; PRURITUS; RASH; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; SEPSIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT CONGESTION; ADOLESCENT; ANTAGONISTS AND INHIBITORS; BIOSYNTHESIS; CARCINOMA; CLINICAL TRIAL; IMMUNOLOGY; MIDDLE AGED; MULTICENTER STUDY; NASOPHARYNX TUMOR; TUMOR RECURRENCE; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS, IMMUNOLOGICAL; B7-H1 ANTIGEN; CARCINOMA; COHORT STUDIES; FEMALE; HUMANS; MALE; MIDDLE AGED; NASOPHARYNGEAL NEOPLASMS; NEOPLASM RECURRENCE, LOCAL; YOUNG ADULT;

EID: 85038381568     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2017.73.3675     Document Type: Conference Paper

References (42)

1. American Cancer Society: Cancer facts and figures 2016. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annualcancer-facts-and-figures/2016/cancer-facts-and-figures-2016.pdf
2. Chang ET, Adami HO: The enigmatic epidemiology of nasopharyngeal carcinoma. Cancer Epidemiol Biomarkers Prev 15:1765-1777, 2006
3. World Health Organization: GLOBOCAN 2012: Estimated cancer incidence, mortality and prevalence worldwide in 2012. http://globocan.iarc.fr/Pages/fact-sheets-population.aspx
4. Lau HY, Leung CM, Chan YH, et al: Secular trends of salted fish consumption and nasopharyngeal carcinoma: A multi-jurisdiction ecological study in 8 regions from 3 continents. BMC Cancer 13:298, 2013
5. Hsu C, Shen YC, Cheng CC, et al: Difference in the incidence trend of nasopharyngeal and oropharyngeal carcinomas in Taiwan: Implication from age-period-cohort analysis. Cancer Epidemiol Biomarkers Prev 15:856-861, 2006
6. Tang LL, Chen WQ, Xue WQ, et al: Global trends in incidence and mortality of nasopharyngeal carcinoma. Cancer Lett 374:22-30, 2016
7. National Comprehensive Cancer Network: NCCN Guidelines: Head and neck cancer version 2. https://www.nccn.org/professionals/physician-gls/pdf/head-and-neck.pdf
8. Ngan RK, Yiu HH, Lau WH, et al: Combination gemcitabine and cisplatin chemotherapy for metastatic or recurrent nasopharyngeal carcinoma: Report of a phase II study. Ann Oncol 13:1252-1258, 2002
9. Chua DT, Yiu HH, Seetalarom K, et al: Phase II trial of capecitabine plus cisplatin as first-line therapy in patients with metastatic nasopharyngeal cancer. Head Neck 34:1225-1230, 2012
10. Zhang L, Huang Y, Hong S, et al: Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: A multicentre, randomised, open-label, phase 3 trial. Lancet 388:1883-1892, 2016
11. Bei JX, Su WH, Ng CC, et al: A GWAS metaanalysis and replication study identifies a novel locus within CLPTM1L/TERT associated with nasopharyngeal carcinoma in individuals of Chinese ancestry. Cancer Epidemiol Biomarkers Prev 25:188-192, 2016
12. Lo KW, Chung GT, To KF: Deciphering the molecular genetic basis of NPC through molecular, cytogenetic, and epigenetic approaches. Semin Cancer Biol 22:79-86, 2012
13. Lin DC, Meng X, Hazawa M, et al: The genomic landscape of nasopharyngeal carcinoma. Nat Genet 46:866-871, 2014
14. Tsao SW, Yip YL, Tsang CM, et al: Etiological factors of nasopharyngeal carcinoma. Oral Oncol 50:330-338, 2014
15. Raghupathy R, Hui EP, Chan AT: Epstein-Barr virus as a paradigm in nasopharyngeal cancer: From lab to clinic. Am Soc Clin Oncol Educ Book 2014:149-153, 2014
16. Fang W, Zhang J, Hong S, et al: EBV-driven LMP1 and IFN-γ up-regulate PD-L1 in nasopharyngeal carcinoma: Implications for oncotargeted therapy. Oncotarget 5:12189-12202, 2014
17. Zhang J, Fang W, Qin T, et al: Coexpression of PD-1 and PD-L1 predicts poor outcome in nasopharyngeal carcinoma. Med Oncol 32:86, 2015
18. Chen BJ, Chapuy B, Ouyang J, et al: PD-L1 expression is characteristic of a subset of aggressive B-cell lymphomas and virus-associated malignancies. Clin Cancer Res 19:3462-3473, 2013
19. Kim HS, Lee JY, Lim SH, et al: Association between PD-L1 and HPV status and the prognostic value of PD-L1 in oropharyngeal squamous cell carcinoma. Cancer Res Treat 48:527-536, 2016
20. Merck Sharp and Dohme: Keytruda. Package insert. Whitehouse Station, NJ, 2017
21. Merck Sharp and Dohme: Keytruda. Summary of product characteristics. Hoddesdon, United Kingdom, 2017
22. Dolled-Filhart M, Roach C, Toland G, et al: Development of a companion diagnostic for pembrolizumab in non-small cell lung cancer using immunohistochemistry for programmed death ligand-1. Arch Pathol Lab Med 140:1243-1249, 2016
23. Romeu JL; Science Reliability Center: Selected topics in assurance related technologies: Understanding binomial sequential testing. https://src.alionscience.com/pdf/BINSEQ.pdf
24. Zhang L, Chen QY, Liu H, et al: Emerging treatment options for nasopharyngeal carcinoma. Drug Des Devel Ther 7:37-52, 2013
25. Chan AT, Felip E: Nasopharyngeal cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 20:123-125, 2009 (suppl 4)
26. Ma BB, Goh BC, Lim WT, et al: Multicenter phase II study of nivolumab in previously treated patients with recurrent and metastatic non-keratinizing nasopharyngeal carcinoma-Mayo Clinic Phase 2 Consortium P2C-MN026, NCI9742, NCT02339558. Cancer Res 77, 2017 (abstr CT076)
27. Seiwert TY, Burtness B, Mehra R, et al: Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): An open-label, multicentre, phase 1b trial. Lancet Oncol 17:956-965, 2016
28. Chow LQ, Haddad R, Gupta S, 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 34:3838-3847, 2016
29. Nghiem PT, Bhatia S, Lipson EJ, et al: PD-1 blockade with pembrolizumab in advanced Merkelcell carcinoma. N Engl J Med 374:2542-2552, 2016
30. Lin JC, Wang WY, Chen KY, et al: Quantification of plasma Epstein-Barr virus DNA in patients with advanced nasopharyngeal carcinoma. N Engl J Med 350:2461-2470, 2004
31. An X, Wang FH, Ding PR, et al: Plasma Epstein-Barr virus DNA level strongly predicts survival in metastatic/recurrent nasopharyngeal carcinoma treated with palliative chemotherapy. Cancer 117:3750-3757, 2011
32. Wang WY, Twu CW, Chen HH, et al: Plasma EBV DNA clearance rate as a novel prognostic marker for metastatic/recurrent nasopharyngeal carcinoma. Clin Cancer Res 16:1016-1024, 2010
33. Kao HF, Hsu C, Huang HC, et al: Correlation between plasma Epstein-Barr virus DNA and clinical response to pembrolizumab in patients with advanced or metastatic nasopharyngeal carcinoma. Eur J Cancer 51:S576, 2016 (abstr 2860)
34. Patel SP, Kurzrock R: PD-L1 expression as a predictive biomarker in cancer immunotherapy. Mol Cancer Ther 14:847-856, 2015
35. Daud AI, Wolchok JD, Robert C, et al: Programmed death-ligand 1 expression and response to the anti-programmed death 1 antibody pembrolizumab in melanoma. J Clin Oncol 34:4102-4109, 2016
36. Garon EB, Rizvi NA, Hui R, et al: Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 372:2018-2028, 2015
37. Muro K, Chung HC, Shankaran V, et al: Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): A multicentre, open-label, phase 1b trial. Lancet Oncol 17:717-726, 2016
38. Rosenberg JE, Hoffman-Censits J, Powles T, et al: Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: A single-arm, multicentre, phase 2 trial. Lancet 387:1909-1920, 2016
39. Fehrenbacher L, Spira A, Ballinger M, et al: Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POP-LAR): A multicentre, open-label, phase 2 randomised controlled trial. Lancet 387:1837-1846, 2016
40. Langer CJ, Gadgeel SM, Borghaei H, et al: Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-smallcell lung cancer: A randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol 17:1497-1508, 2016
41. Khoja L, Butler MO, Kang SP, et al: Pembrolizumab. J Immunother Cancer 3:36, 2015
42. Ribas A, Hamid O, Daud A, et al: Association of pembrolizumab with tumor response and survival among patients with advanced melanoma. JAMA 315:1600-1609, 2016