Literature DB >> 32665297

Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial.

Ravindra Uppaluri1,2, Katie M Campbell3,4, Obi L Griffith3,4,5,6, Douglas R Adkins5,6, Ann Marie Egloff7, Paul Zolkind8, Zachary L Skidmore4, Brian Nussenbaum8,5, Randal C Paniello8,5, Jason T Rich8,5, Ryan Jackson8,5, Patrik Pipkorn8,5, Loren S Michel5,6, Jessica Ley6, Peter Oppelt5,6, Gavin P Dunn5,9, Erica K Barnell3,4, Nicholas C Spies4, Tianxiang Lin8, Tiantian Li10, David T Mulder10, Youstina Hanna10, Iulia Cirlan10, Trevor J Pugh10,11,12, Tenny Mudianto2, Rachel Riley2, Liye Zhou2, Vickie Y Jo7, Matthew D Stachler13, Glenn J Hanna2, Jason Kass7,2, Robert Haddad7,2, Jonathan D Schoenfeld2,14, Evisa Gjini13, Ana Lako13, Wade Thorstad5,15, Hiram A Gay5,15, Mackenzie Daly5,15, Scott J Rodig13,16, Ian S Hagemann17, Dorina Kallogjeri8, Jay F Piccirillo8,5, Rebecca D Chernock17, Malachi Griffith3,4,5,6.   

Abstract

PURPOSE: Pembrolizumab improved survival in patients with recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). The aims of this study were to determine if pembrolizumab would be safe, result in pathologic tumor response (pTR), and lower the relapse rate in patients with resectable human papillomavirus (HPV)-unrelated HNSCC. PATIENTS AND METHODS: Neoadjuvant pembrolizumab (200 mg) was administered and followed 2 to 3 weeks later by surgical tumor ablation. Postoperative (chemo)radiation was planned. Patients with high-risk pathology (positive margins and/or extranodal extension) received adjuvant pembrolizumab. pTR was quantified as the proportion of the resection bed with tumor necrosis, keratinous debris, and giant cells/histiocytes: pTR-0 (<10%), pTR-1 (10%-49%), and pTR-2 (≥50%). Coprimary endpoints were pTR-2 among all patients and 1-year relapse rate in patients with high-risk pathology (historical: 35%). Correlations of baseline PD-L1 and T-cell infiltration with pTR were assessed. Tumor clonal dynamics were evaluated (ClinicalTrials.gov NCT02296684).
RESULTS: Thirty-six patients enrolled. After neoadjuvant pembrolizumab, serious (grades 3-4) adverse events and unexpected surgical delays/complications did not occur. pTR-2 occurred in eight patients (22%), and pTR-1 in eight other patients (22%). One-year relapse rate among 18 patients with high-risk pathology was 16.7% (95% confidence interval, 3.6%-41.4%). pTR ≥10% correlated with baseline tumor PD-L1, immune infiltrate, and IFNγ activity. Matched samples showed upregulation of inhibitory checkpoints in patients with pTR-0 and confirmed clonal loss in some patients.
CONCLUSIONS: Among patients with locally advanced, HPV-unrelated HNSCC, pembrolizumab was safe, and any pathologic response was observed in 44% of patients with 0% pathologic complete responses. The 1-year relapse rate in patients with high-risk pathology was lower than historical. ©2020 American Association for Cancer Research.

Entities:  

Year:  2020        PMID： 32665297      PMCID： PMC7547532          DOI： 10.1158/1078-0432.CCR-20-1695

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  36 in total

1.  Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study.

Authors:  Ezra E W Cohen; Denis Soulières; Christophe Le Tourneau; José Dinis; Lisa Licitra; Myung-Ju Ahn; Ainara Soria; Jean-Pascal Machiels; Nicolas Mach; Ranee Mehra; Barbara Burtness; Pingye Zhang; Jonathan Cheng; Ramona F Swaby; Kevin J Harrington
Journal:  Lancet       Date:  2018-11-30       Impact factor: 79.321

2.  Neoadjuvant PD-1 Blockade in Resectable Lung Cancer.

Authors:  Patrick M Forde; Jamie E Chaft; Kellie N Smith; Valsamo Anagnostou; Tricia R Cottrell; Matthew D Hellmann; Marianna Zahurak; Stephen C Yang; David R Jones; Stephen Broderick; Richard J Battafarano; Moises J Velez; Natasha Rekhtman; Zachary Olah; Jarushka Naidoo; Kristen A Marrone; Franco Verde; Haidan Guo; Jiajia Zhang; Justina X Caushi; Hok Yee Chan; John-William Sidhom; Robert B Scharpf; James White; Edward Gabrielson; Hao Wang; Gary L Rosner; Valerie Rusch; Jedd D Wolchok; Taha Merghoub; Janis M Taube; Victor E Velculescu; Suzanne L Topalian; Julie R Brahmer; Drew M Pardoll
Journal:  N Engl J Med       Date:  2018-04-16       Impact factor: 91.245

3.  Neoadjuvant PD-1 Immune Checkpoint Blockade Reverses Functional Immunodominance among Tumor Antigen-Specific T Cells.

Authors:  Jay Friedman; Ellen C Moore; Paul Zolkind; Yvette Robbins; Paul E Clavijo; Lilian Sun; Sarah Greene; Megan V Morisada; Wojciech K Mydlarz; Nicole Schmitt; James W Hodge; Hans Schreiber; Carter Van Waes; Ravindra Uppaluri; Clint Allen
Journal:  Clin Cancer Res       Date:  2019-10-23       Impact factor: 12.531

4.  Timing of neoadjuvant immunotherapy in relation to surgery is crucial for outcome.

Authors:  Jing Liu; Jake S O'Donnell; Juming Yan; Jason Madore; Stacey Allen; Mark J Smyth; Michele W L Teng
Journal:  Oncoimmunology       Date:  2019-03-01       Impact factor: 8.110

5.  Impact of Neoadjuvant Durvalumab with or without Tremelimumab on CD8+ Tumor Lymphocyte Density, Safety, and Efficacy in Patients with Oropharynx Cancer: CIAO Trial Results.

Authors:  Renata Ferrarotto; Diana Bell; Maria L Rubin; Katherine A Hutcheson; Jason M Johnson; Ryan P Goepfert; Jack Phan; Yasir Y Elamin; Danice K Torman; Carla L Warneke; Amy C Hessel; Adam S Garden; Jeffrey N Myers; Faye M Johnson; J Jack Lee; Andrew G Sikora; Maura L Gillison; Bonnie S Glisson; Neil D Gross
Journal:  Clin Cancer Res       Date:  2020-04-08       Impact factor: 12.531

6.  Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study.

Authors:  Kevin Harrington; Stephane Temam; Hisham Mehanna; Anil D'Cruz; Minish Jain; Ida D'Onofrio; Georgy Manikhas; Zsuzsanna Horvath; Yan Sun; Stefan Dietzsch; Pavol Dubinsky; Petra Holeckova; Iman El-Hariry; Natalie Franklin; Nigel Biswas-Baldwin; Philippe Legenne; Paul Wissel; Thelma Netherway; John Farrell; Catherine Ellis; Jing Wang-Silvanto; Mayur Amonkar; Nazma Ahmed; Sergio Santillana; Jean Bourhis
Journal:  J Clin Oncol       Date:  2015-11-02       Impact factor: 44.544

7.  Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck.

Authors:  Robert L Ferris; George Blumenschein; Jerome Fayette; Joel Guigay; A Dimitrios Colevas; Lisa Licitra; Kevin Harrington; Stefan Kasper; Everett E Vokes; Caroline Even; Francis Worden; Nabil F Saba; Lara C Iglesias Docampo; Robert Haddad; Tamara Rordorf; Naomi Kiyota; Makoto Tahara; Manish Monga; Mark Lynch; William J Geese; Justin Kopit; James W Shaw; Maura L Gillison
Journal:  N Engl J Med       Date:  2016-10-08       Impact factor: 91.245

8.  3D: diversity, dynamics, differential testing - a proposed pipeline for analysis of next-generation sequencing T cell repertoire data.

Authors:  Li Zhang; Jason Cham; Alan Paciorek; James Trager; Nadeem Sheikh; Lawrence Fong
Journal:  BMC Bioinformatics       Date:  2017-02-27       Impact factor: 3.169

9.  Oral Cavity Squamous Cell Carcinoma Xenografts Retain Complex Genotypes and Intertumor Molecular Heterogeneity.

Authors:  Katie M Campbell; Tianxiang Lin; Paul Zolkind; Erica K Barnell; Zachary L Skidmore; Ashley E Winkler; Jonathan H Law; Elaine R Mardis; Lukas D Wartman; Douglas R Adkins; Rebecca D Chernock; Malachi Griffith; Ravindra Uppaluri; Obi L Griffith
Journal:  Cell Rep       Date:  2018-08-21       Impact factor: 9.423

10.  Adaptive resistance to therapeutic PD-1 blockade is associated with upregulation of alternative immune checkpoints.

Authors:  Shohei Koyama; Esra A Akbay; Yvonne Y Li; Grit S Herter-Sprie; Kevin A Buczkowski; William G Richards; Leena Gandhi; Amanda J Redig; Scott J Rodig; Hajime Asahina; Robert E Jones; Meghana M Kulkarni; Mari Kuraguchi; Sangeetha Palakurthi; Peter E Fecci; Bruce E Johnson; Pasi A Janne; Jeffrey A Engelman; Sidharta P Gangadharan; Daniel B Costa; Gordon J Freeman; Raphael Bueno; F Stephen Hodi; Glenn Dranoff; Kwok-Kin Wong; Peter S Hammerman
Journal:  Nat Commun       Date:  2016-02-17       Impact factor: 14.919
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  46 in total

1.  Tadalafil Enhances Immune Signatures in Response to Neoadjuvant Nivolumab in Resectable Head and Neck Squamous Cell Carcinoma.

Authors:  Adam J Luginbuhl; Young J Kim; Andrew P South; Athanassios Argiris; Jennifer M Johnson; Larry A Harshyne; Alban J Linnenbach; Sanket K Shukla; Angela Alnemri; Gaurav Kumar; David M Cognetti; Joseph M Curry; Nikita Kotlov; Zoya Antysheva; Sandrine Degryse; Kyle Mannion; Michael K Gibson; James Netterville; Brandee Brown; Rita Axelrod; Ralph Zinner; Madalina Tuluc; Stacey Gargano; Benjamin E Leiby; Ayako Shimada; My G Mahoney; Ubaldo Martinez-Outschoorn; Ulrich Rodeck
Journal:  Clin Cancer Res       Date:  2022-03-01       Impact factor: 12.531

Review 2.  Induction Chemotherapy for Advanced Oral Cavity Cancer.

Authors:  Thiago Bueno de Oliveira; Gustavo Nader Marta; Gilberto de Castro Junior; Luiz Paulo Kowalski
Journal:  Curr Oncol Rep       Date:  2021-08-27       Impact factor: 5.075

3.  New Developments in the Treatment of Hepatocellular Carcinoma: The Concept of Adjuvant and Neoadjuvant Chemotherapy.

Authors:  Anil C Anand; Subrat K Acharya
Journal:  J Clin Exp Hepatol       Date:  2021-04-27

Review 4.  Immunotherapy in Head and Neck Cancer-Ready for Prime Time or More Research Needed?

Authors:  Sana D Karam; Carryn M Anderson; Daniel Ma; Melvin L K Chua; Randall J Kimple
Journal:  Int J Radiat Oncol Biol Phys       Date:  2021-03-01       Impact factor: 7.038

5.  Neoadjuvant nivolumab for patients with resectable HPV-positive and HPV-negative squamous cell carcinomas of the head and neck in the CheckMate 358 trial.

Authors:  Robert L Ferris; William C Spanos; Rom Leidner; Anthony Gonçalves; Uwe M Martens; Chrisann Kyi; William Sharfman; Christine H Chung; Lot A Devriese; Helene Gauthier; Simon I Chiosea; Lazar Vujanovic; Janis M Taube; Julie E Stein; Jun Li; Bin Li; Tian Chen; Adam Barrows; Suzanne L Topalian
Journal:  J Immunother Cancer       Date:  2021-06       Impact factor: 12.469

Review 6.  Shooting at Moving and Hidden Targets-Tumour Cell Plasticity and the Notch Signalling Pathway in Head and Neck Squamous Cell Carcinomas.

Authors:  Joanna Kałafut; Arkadiusz Czerwonka; Alinda Anameriç; Alicja Przybyszewska-Podstawka; Julia O Misiorek; Adolfo Rivero-Müller; Matthias Nees
Journal:  Cancers (Basel)       Date:  2021-12-10       Impact factor: 6.639

7.  Influence of Tumor Immune Infiltration on Immune Checkpoint Inhibitor Therapeutic Efficacy: A Computational Retrospective Study.

Authors:  Rong Liu; Fang Yang; Ji-Ye Yin; Ying-Zi Liu; Wei Zhang; Hong-Hao Zhou
Journal:  Front Immunol       Date:  2021-06-17       Impact factor: 7.561

Review 8.  Preoperative Immunotherapy in the Multidisciplinary Management of Oral Cavity Cancer.

Authors:  Ramez Philips; Chihun Han; Brian Swendseid; Joseph Curry; Athanassios Argiris; Adam Luginbuhl; Jennifer Johnson
Journal:  Front Oncol       Date:  2021-07-01       Impact factor: 6.244

9.  NRG-HN003: Phase I and Expansion Cohort Study of Adjuvant Pembrolizumab, Cisplatin and Radiation Therapy in Pathologically High-Risk Head and Neck Cancer.

Authors:  Julie E Bauman; Jonathan Harris; Ravindra Uppaluri; Min Yao; Robert L Ferris; Josephine Chen; Richard C Jordan; Nikhil P Joshi; Srinivas Jujjuvaparu; Dukagjin M Blakaj; Christina Henson; Jawad Sheqwara; Loren K Mell; Neilayan Sen; David A Clump; Madhur K Garg; Emrullah Yilmaz; Pedro Torres-Saavedra; Quynh-Thu Le
Journal:  Cancers (Basel)       Date:  2021-06-09       Impact factor: 6.639

10.  Neoadjuvant Immunotherapy of Oral Squamous Cell Carcinoma: Case Report and Assessment of Histological Response.

Authors:  Manuel Olmos; Jacek Glajzer; Tjark-Ole Büntemeyer; Gesche Frohwitter; Jutta Ries; Markus Eckstein; Markus Hecht; Rainer Lutz; Marco Rainer Kesting; Manuel Weber
Journal:  Front Oncol       Date:  2021-07-21       Impact factor: 6.244
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