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

Journal of Clinical Oncology

Volumn 34, Issue 32, 2016, Pages 3838-3845

  Chow, Laura Q M ^a   Haddad, Robert ^b   Gupta, Shilpa ^c   Mahipal, Amit ^c   Mehra, Ranee ^d   Tahara, Makoto ^j   Berger, Raanan ^l   Eder, Joseph Paul ^e   Burtness, Barbara ^e   Lee, Se Hoon ⁿ   Keam, Bhumsuk ⁿ   Kang, Hyunseok ^f   Muro, Kei ^k   Weiss, Jared ^g   Geva, Ravit ^m   Lin, Chia Chi ^p   Chung, Hyun Cheol ^o   Meister, Amy ^h   Dolled Filhart, Marisa ^h   Pathiraja, Kumudu ^h   Cheng, Jonathan D ^h   Seiwert, Tanguy Y ⁱ   more..

^a UNIVERSITY OF WASHINGTON   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^d FOX CHASE CANCER CENTER   (United States)

^e YALE CANCER CENTER   (United States)

^f JOHNS HOPKINS UNIVERSITY   (United States)

^g UNIVERSITY OF NORTH CAROLINA   (United States)

^h MERCK RESEARCH LABORATORIES   (United States)

ⁱ UNIVERSITY OF CHICAGO   (United States)

^j NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^k AICHI CANCER CENTER HOSPITAL   (Japan)

^l SHEBA MEDICAL CENTER   (Israel)

^m TEL AVIV SOURASKY MEDICAL CENTER   (Israel)

ⁿ Seoul National University Hospital   (South Korea)

^o Yonsei University College of Medicine   (South Korea)

^p NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

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

ABDOMINAL PAIN; ADULT; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER PATIENT; CANCER RECURRENCE; COLITIS; COMPUTER ASSISTED TOMOGRAPHY; DECREASED APPETITE; DECUBITUS; DIABETIC KETOACIDOSIS; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPHAGIA; FACE EDEMA; FATIGUE; FEMALE; HEAD AND NECK SQUAMOUS CELL CARCINOMA; HUMAN; HYPERGLYCEMIA; HYPOTHYROIDISM; IDIOPATHIC THROMBOCYTOPENIC PURPURA; IMMUNOCOMPETENT CELL; INFECTION; INSULIN DEPENDENT DIABETES MELLITUS; INTERSTITIAL LUNG DISEASE; LARYNX EDEMA; LIVER INJURY; MAJOR CLINICAL STUDY; MALE; METASTASIS; NAUSEA; NUCLEAR MAGNETIC RESONANCE IMAGING; OVERALL SURVIVAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RESPIRATORY DISTRESS; STOMATITIS; SURVIVAL RATE; TREATMENT RESPONSE; TUMOR CELL; TUMOR LOCALIZATION; VERY ELDERLY; ANTAGONISTS AND INHIBITORS; BIOSYNTHESIS; CLINICAL TRIAL; COHORT ANALYSIS; HEAD AND NECK TUMOR; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; SQUAMOUS CELL CARCINOMA; TUMOR RECURRENCE;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS, IMMUNOLOGICAL; B7-H1 ANTIGEN; CARCINOMA, SQUAMOUS CELL; COHORT STUDIES; FEMALE; HEAD AND NECK NEOPLASMS; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM RECURRENCE, LOCAL;

EID: 84995489253     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2016.68.1478     Document Type: Article

References (33)

1. Ferlay J, Soerjomataram I, Dikshit R, et al: Cancer incidence and mortality worldwide: Sources, methods andmajor patterns in GLOBOCAN 2012. Int J Cancer 136: E359-E386, 2015
2. Cohen EE, LaMonte SJ, Erb NL, et al: American Cancer Society head and neck cancer survivorship care guideline. CA Cancer J Clin 66: 203-239, 2016
3. Pelucchi C, Gallus S, Garavello W, et al: Cancer risk associated with alcohol and tobacco use: Focus on upper aero-digestive tract and liver. Alcohol Res Health 29: 193-198, 2006
4. Denaro N, Russi EG, Adamo V, et al: State-ofthe- Art and emerging treatment options in the management of head and neck cancer: News from 2013. Oncology 86: 212-229, 2014
5. Ang KK, Harris J, Wheeler R, et al: Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med 363: 24-35, 2010
6. Vermorken JB, Mesia R, Rivera F, et al: Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 359: 1116-1127, 2008
7. Patel AN, Mehnert JM, Kim S: Treatment of recurrent metastatic head and neck cancer: Focus on cetuximab. Clin Med Insights Ear Nose Throat 5: 1-16, 2012
8. Li Q, Prince ME, Moyer JS: Immunotherapy for head and neck squamous cell carcinoma. Oral Oncol 51: 299-304, 2015
9. Seiwert TY, Zuo Z, Keck MK, et al: Integrative and comparative genomic analysis of HPV-positive and HPV-negative head and neck squamous cell carcinomas. Clin Cancer Res 21: 632-641, 2015
10. Gildener-Leapman N, Ferris RL, Bauman JE: Promising systemic immunotherapies in head and neck squamous cell carcinoma. Oral Oncol 49: 1089-1096, 2013
11. Cancer Genome Atlas Network: Comprehensive genomic characterization of head and neck squamous cell carcinomas. Nature 517: 576-582, 2015
12. Keir ME, Butte MJ, Freeman GJ, et al: PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol 26: 677-704, 2008
13. Pardoll DM: The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 12: 252-264, 2012
14. Latchman Y, Wood CR, Chernova T, et al: PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat Immunol 2: 261-268, 2001
15. Freeman GJ, Long AJ, Iwai Y, et al: Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation. J Exp Med 192: 1027-1034, 2000
16. Iwai Y, Ishida M, Tanaka Y, et al: Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade. Proc Natl Acad Sci USA 99: 12293-12297, 2002
17. Strome SE, Dong H, Tamura H, et al: B7-H1 blockade augments adoptive T-cell immunotherapy for squamous cell carcinoma. Cancer Res 63: 6501-6505, 2003
18. Lyford-Pike S, Peng S, Young GD, et al: Evidence for a role of the PD-1: PD-L1 pathway in immune resistance of HPV-associated head and neck squamous cell carcinoma. Cancer Res 73: 1733-1741, 2013
19. Brown JA, Dorfman DM, Ma FR, et al: Blockade of programmed death-1 ligands on dendritic cells enhances T cell activation and cytokine production. J Immunol 170: 1257-1266, 2003
20. Robert C, Schachter J, Long GV, et al: Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med 372: 2521-2532, 2015
21. 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
22. Hamid O, Robert C, Daud A, et al: Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 369: 134-144, 2013
23. Le DT, Uram JN,Wang H, et al: PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med 372: 2509-2520, 2015
24. 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
25. Robert C, Ribas A, Wolchok JD, et al: Antiprogrammed- death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: A randomised dose-comparison cohort of a phase 1 trial. Lancet 384: 1109-1117, 2014
26. Freshwater T, Stone J, de Greef R, et al: Assessment of pembrolizumab (MK-3475) dosing strategy based on population pharmacokinetics and exposure-response models. J Pharmacomet Pharmacodynam 42: S15, 2015
27. Vermorken JB, Trigo J, Hitt R, et al: Openlabel, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol 25: 2171-2177, 2007
28. Machiels JP, Haddad RI, Fayette J, et al: Afatinib versusmethotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): An open-label, randomised phase 3 trial. LancetOncol 16: 583-594, 2015
29. Yu GT, Bu LL, Huang CF, et al: PD-1 blockade attenuates immunosuppressive myeloid cells due to inhibition of CD47/SIRPa axis in HPV negative head and neck squamous cell carcinoma. Oncotarget 6: 42067-42080, 2015
30. Schlecht NF, Brandwein-Gensler M, Nuovo GJ, et al: A comparison of clinically utilized human papillomavirus detection methods in head and neck cancer. Mod Pathol 24: 1295-1305, 2011
31. Stephen JK, Divine G, Chen KM, et al: Significance of p16 in site-specific HPV positive and HPV negative head and neck squamous cell carcinoma. Cancer Clin Oncol 2: 51-61, 2013
32. Yang CY, Lin MW, Chang YL, et al: Programmed cell death-ligand 1 expression in surgically resected stage I pulmonary adenocarcinoma and its correlation with driver mutations and clinical outcomes. Eur J Cancer 50: 1361-1369, 2014
33. Herbst RS, Soria JC, Kowanetz M, et al: Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 515: 563-567, 2014