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Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study
Barbara Burtness, Kevin J. Harrington, Richard Greil, Denis Soulières, Makoto Tahara, Gilberto de Castro, Amanda Psyrri, Neus Basté, Prakash Neupane, Åse Bratland, Thorsten Fuereder, Brett Hughes, Ricard Mesı́a, Nuttapong Ngamphaiboon, Tamara Rordorf, Wan Zamaniah Wan Ishak, Ruey‐Long Hong, René González Mendoza, Ananya Roy, Yayan Zhang, Burak Gümüşçü, Jonathan D. Cheng, Fan Jin, Danny Rischin, Guillermo Lerzo, Marcelo Tatangelo, Mirta Varela, Juan José Zarbá, Michael Boyer, Hui Gan, Bo Gao, Girish Mallesara, Anne L. Taylor, Martin Burian, Carlos H. Barrios, Fábio Franke, Gustavo Girotto, Iane Pinto Figueiredo Lima, Ulisses Ribaldo Nicolau, Gustavo Dix Junqueira Pinto, Lucas Vieira dos Santos, Ana-Paula Victorino, Neil Chua, Félix Couture, Richard Gregg, Aaron R. Hansen, John Hilton, Joy McCarthy, Rodrigo Ascuí, Pablo Gonzalez, Luis J. Villanueva-Rivera, Marco Torregroza, Ángela R. Zambrano, Petra Holečková, Zdeněk Král, Bohuslav Melichar, Prausova Jana, Milan Vošmik, Maria Andersen, Niels Gyldenkerne, Hannes Jürgens, Kadri Putnik, Petri Reinikainen, Viktor Gruenwald, Simon Laban, Gerasimos Aravantinos, Ioannis Boukovinas, Vassilis Georgoulias, D.L.W. Kwong, Yousuf Al-Farhat, Tibor Csőszi, József Erfán, Geza Horvai, László Landherr, Éva Remenár, Ágnes Ruzsa, Judit Szota, Salem Billan, Iris Gluck, Orit Gutfeld, Aron Popovtzer, Marco Benasso, Simona Bui, Vittorio Ferrari, Lisa Licitra, Franco Nolè, Takashi Fujii, Yasushi Fujimoto, Nobuhiro Hanai, Hiroki Hara, Koji Matsumoto, Kenji Mitsugi, Nobuya Monden, Masahiro Nakayama, Kenji Okami, Nobuhiko Oridate, Kiyoto Shiga, Yasushi Shimizu, Masashi Sugasawa, Masanobu Takahashi, Shunji Takahashi, Kaoru Tanaka, Tsutomu Ueda, Hironori Yamaguchi, Tomoko Yamazaki, Ryuji Yasumatsu, Tomoya Yokota, Tomokazu Yoshizaki, Iveta Kudaba, Zinaida Stara, Soon Keat Cheah, Jose Aguilar Ponce, Carlos Hernández Hernández, Francisco Soto, Jan Buter, Ann Hoeben, Sjoukje F. Oosting, Karijn P.M. Suijkerbuijk, Å. Bratland, Marianne Brydoey, Renzo Alvarez, Luís Más, Priscilla B. Caguioa, J. Marruecos Querol, Eugenio Emmanuel Regala, Maria Belen Tamayo, Ellie May Villegas, Andrzej Kawecki, А. А. Карпенко, A L Klochikhin, Alexey Smolin, Oleg Zarubenkov, Boon Cher Goh, Graham Cohen, Johanna du Toit, Christa Jordaan, Gregory Landers, Paul Ruff, Waldemar Szpak, Neonyana Keorapetse Rebecca Tabane, Irene Braña, Lara Iglesias Docampo, Javier Lavernia, Edvard Abel, Valentina Muratidu, Niels Hilmer Nielsen, Valérie Cristina, Sacha I. Rothschild, Hung‐Ming Wang, Muh‐Hwa Yang, Su‐Peng Yeh, Chia‐Jui Yen, Nopadol Soparattanapaisarn, Virote Sriuranpong, Sercan Aksoy, İrfan Çiçin, Meltem Ekenel, Hakan Harputluoğlu, Özgür Özyılkan, Sanjiv S. Agarwala, Haythem Ali, Robert Alter, Daniel M. Anderson, Justine Y. Bruce, Nicholas Campbell, Miguel Á. Conde, John F. Deeken, W. Jeff Edenfield, Lawrence Feldman, Elizabeth Gaughan, Basem Goueli, Balázs Halmos, Upendra P. Hegde, Brian Hunis, Robert M. Jotte, Anand B. Karnad, Saad A. Khan, Noel Laudi, Douglas Laux, Danko Martincic, Steven McCune, Dean McGaughey, Krzysztof Misiukiewicz, Deborah Mulford, Eric Nadler, Johannes C. Nunnink, James Ohr, Meaghan O’Malley, Brian J. Patson, Doru Paul, E Popa, Steven Powell, Rebecca Redman, Vincent Rella, Chaio Rocha Lima, Abirami Sivapiragasam, Yungpo Bernard Su, Ammar Sukari, Stuart J. Wong, Emrullah Yilmaz, Jeffrey T. Yorio
Bibliographic record
VenueThe Lancet · 2019
Typearticle
Languageen
FieldMedicine
TopicHead and Neck Cancer Studies
Canadian institutionsCentre Hospitalier de l’Université de Montréal
FundersNational Institute for Health and Care ResearchRegeneron PharmaceuticalsEisaiSanofiAmgenPfizerAstraZenecaEli Lilly and CompanyGlaxoSmithKline
KeywordsCetuximabPembrolizumabMedicineChemotherapyHead and neckOncologyOpen labelInternal medicineHead and neck squamous-cell carcinomaHead and neck cancerBasal cellRadiation therapyRandomized controlled trialSurgeryCancerImmunotherapyColorectal cancer
Abstract
No abstract in any covered source. Its absence is recorded, not treated as a negative.
No abstract. This is not a gap in this database; OpenAlex has none either. 23.3% of the frame is in this state, and the screen finds HALF as much metaresearch here, so the absence is a measured bias rather than a missing field.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
metaresearch head score (Codex)0.003
metaresearch head score (Gemma)0.002
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.010
Threshold uncertainty score0.034
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.005 |
| Insufficient payload (model declined to judge) | 0.010 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
Opus teacher head0.073
GPT teacher head0.362
Teacher spread0.289 · how far apart the two teachers sit on this one work
Validation status
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".
Quick stats
Citations3,211
Published2019
Admission routes1
Has abstractno