Cited by 3,336Head and Neck Cancer StudiesCancer Immunotherapy and BiomarkersNonmelanoma Skin Cancer Studies

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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

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Burtness, Barbara, Harrington, Kevin J, Greil, Richard, Soulières, Denis, Tahara, Makoto, de Castro, Gilberto, Psyrri, Amanda, Basté, Neus, Neupane, Prakash, Bratland, Åse, Fuereder, Thorsten, Hughes, Brett G M, Mesía, Ricard, Ngamphaiboon, Nuttapong, Rordorf, Tamara, Wan Ishak, Wan Zamaniah, Hong, Ruey-Long, González Mendoza, René, Roy, Ananya, Zhang, Yayan, Gumuscu, Burak, Cheng, Jonathan D, Jin, Fan, Rischin, Danny, Lerzo, Guillermo, Tatangelo, Marcelo, Varela, Mirta, Zarba, Juan Jose, Boyer, Michael, Gan, Hui, Gao, Bo, Hughes, Brett, Mallesara, Girish, Rischin, Danny, Taylor, Anne, Burian, Martin, Fuereder, Thorsten, Greil, Richard, Barrios, Carlos Henrique, de Castro Junior, Dalvaro Oliveira, Castro, Gilberto, Franke, Fabio Andre, Girotto, Gustavo, Lima, Iane Pinto Figueiredo, Nicolau, Ulisses Ribaldo, Pinto, Gustavo Dix Junqueira, Santos, Lucas, Victorino, Ana-Paula, Chua, Neil, Couture, Felix, Gregg, Richard, Hansen, Aaron, Hilton, John, McCarthy, Joy, Soulieres, Denis, Ascui, Rodrigo, Gonzalez, Pablo, Villanueva, Luis, Torregroza, Marco, Zambrano, Angela, Holeckova, Petra, Kral, Zdenek, Melichar, Bohuslav, Prausova, Jana, Vosmik, Milan, Andersen, Maria, Gyldenkerne, Niels, Jurgens, Hannes, Putnik, Kadri, Reinikainen, Petri, Gruenwald, Viktor, Laban, Simon, Aravantinos, Gerasimos, Boukovinas, Ioannis, Georgoulias, Vassilis, Psyrri, Amanda, Kwong, Dora, Al-Farhat, Yousuf, Csoszi, Tibor, Erfan, Jozsef, Horvai, Geza, Landherr, Laszlo, Remenar, Eva, Ruzsa, Agnes, Szota, Judit, Billan, Salem, Gluck, Iris, Gutfeld, Orit, Popovtzer, Aron, Benasso, Marco, Bui, Simona, Ferrari, Vittorio, Licitra, Lisa, Nole, Franco, Fujii, Takashi, Fujimoto, Yasushi, Hanai, Nobuhiro, Hara, Hiroki, Matsumoto, Koji, Mitsugi, Kenji, Monden, Nobuya, Nakayama, Masahiro, Okami, Kenji, Oridate, Nobuhiko, Shiga, Kiyoto, Shimizu, Yasushi, Sugasawa, Masashi, Tahara, Makoto, Takahashi, Masanobu, Takahashi, Shunji, Tanaka, Kaoru, Ueda, Tsutomu, Yamaguchi, Hironori, Yamazaki, Tomoko, Yasumatsu, Ryuji, Yokota, Tomoya, Yoshizaki, Tomokazu, Kudaba, Iveta, Stara, Zinaida, Wan Ishak, Wan Zamaniah, Cheah, Soon Keat, Aguilar Ponce, Jose, Gonzalez Mendoza, Rene, Hernandez Hernandez, Carlos, Medina Soto, Francisco, Buter, Jan, Hoeben, Ann, Oosting, S., Suijkerbuijk, Karijn, Bratland, Aase, Brydoey, Marianne, Alvarez, Renzo, Mas, Luis, Caguioa, Priscilla, Querol, John, Regala, Eugenio Emmanuel, Tamayo, Maria Belen, Villegas, Ellie May, Kawecki, Andrzej, Karpenko, Andrey, Klochikhin, Arkadiy, Smolin, Alexey, Zarubenkov, Oleg, Goh, Boon Cher, Cohen, Graham, du Toit, Johanna, Jordaan, Christa, Landers, Gregory, Ruff, Paul, Szpak, Waldemar, Tabane, Neonyana, Brana, Irene, Iglesias Docampo, Lara, Lavernia, Javier, Mesia, Ricard, Abel, Edvard, Muratidu, Valentina, Nielsen, Niels, Cristina, Valerie, Rordorf, Tamara, Rothschild, Sacha, Hong, Ruey-Long, Wang, Hung-Ming, Yang, Muh-Hwa, Yeh, Su-Peng, Yen, Chia-Jui, Ngamphaiboon, Nuttapong, Soparattanapaisarn, Nopadol, Sriuranpong, Virote, Aksoy, Sercan, Cicin, Irfan, Ekenel, Meltem, Harputluoglu, Hakan, Ozyilkan, Ozgur, Harrington, Kevin, Agarwala, Sanjiv, Ali, Haythem, Alter, Robert, Anderson, Daniel, Bruce, Justine, Burtness, Barbara, Campbell, Nicholas, Conde, Miguel, Deeken, John, Edenfield, William, Feldman, Lawrence, Gaughan, Elizabeth, Goueli, Basem, Halmos, Balazs, Hegde, Upendra, Hunis, Brian, Jotte, Robert, Karnad, Anand, Khan, Saad, Laudi, Noel, Laux, Douglas, Martincic, Danko, McCune, Steven, McGaughey, Dean, Misiukiewicz, Krzysztof, Mulford, Deborah, Nadler, Eric, Neupane, Prakash, Nunnink, Johannes, Ohr, James, O'Malley, Meaghan, Patson, Brian, Paul, Doru, Popa, Elizabeta, Powell, Steven, Redman, Rebecca, Rella, Vincent, Rocha Lima, Chaio, Sivapiragasam, Abirami, Su, Yungpo, Sukari, Ammar, Wong, Stuart, Yilmaz, Emrullah, Yorio, Jeffrey·2019·The Lancet

DOI 10.1016/s0140-6736(19)32591-7

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Abstract

Background Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response.Methods KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy). Investigators and participants were aware of treatment assignment. Investigators, participants, and representatives of the sponsor were masked to the PD-L1 combined positive score (CPS) results; PD-L1 positivity was not required for study entry. The primary endpoints were overall survival (time from randomisation to death from any cause) and progression-free survival (time from randomisation to radiographically confirmed disease progression or death from any cause, whichever came first) in the intention-to-treat population (all participants randomly allocated to a treatment group). There were 14 primary hypotheses: superiority of pembrolizumab alone and of pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival and progression-free survival in the PD-L1 CPS of 20 or more, CPS of 1 or more, and total populations and non-inferiority (non-inferiority margin: 1·2) of pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival in the total population. The definitive findings for each hypothesis were obtained when statistical testing was completed for that hypothesis; this occurred at the second interim analysis for 11 hypotheses and at final analysis for three hypotheses. Safety was assessed in the as-treated population (all participants who received at least one dose of allocated treatment). This study is registered at ClinicalTrials.gov, number NCT02358031.Findings Between April 20, 2015, and Jan 17, 2017, 882 participants were allocated to receive pembrolizumab alone (n=301), pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy (n=300); of these, 754 (85%) had CPS of 1 or more and 381 (43%) had CPS of 20 or more. At the second interim analysis, pembrolizumab alone improved overall survival versus cetuximab with chemotherapy in the CPS of 20 or more population (median 14·9 months vs 10·7 months, hazard ratio [HR] 0·61 [95% CI 0·45-0·83], p=0·0007) and CPS of 1 or more population (12·3 vs 10·3, 0·78 [0·64-0·96], p=0·0086) and was non-inferior in the total population (11·6 vs 10·7, 0·85 [0·71-1·03]). Pembrolizumab with chemotherapy improved overall survival versus cetuximab with chemotherapy in the total population (13·0 months vs 10·7 months, HR 0·77 [95% CI 0·63-0·93], p=0·0034) at the second interim analysis and in the CPS of 20 or more population (14·7 vs 11·0, 0·60 [0·45-0·82], p=0·0004) and CPS of 1 or more population (13·6 vs 10·4, 0·65 [0·53-0·80], p<0·0001) at final analysis. Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis. At final analysis, grade 3 or worse all-cause adverse events occurred in 164 (55%) of 300 treated participants in the pembrolizumab alone group, 235 (85%) of 276 in the pembrolizumab with chemotherapy group, and 239 (83%) of 287 in the cetuximab with chemotherapy group. Adverse events led to death in 25 (8%) participants in the pembrolizumab alone group, 32 (12%) in the pembrolizumab with chemotherapy group, and 28 (10%) in the cetuximab with chemotherapy group.Interpretation Based on the observed efficacy and safety, pembrolizumab plus platinum and 5-fluorouracil is an appropriate first-line treatment for recurrent or metastatic HNSCC and pembrolizumab monotherapy is an appropriate first-line treatment for PD-L1-positive recurrent or metastatic HNSCC.Funding Merck Sharp & Dohme.

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Cannabinoid Cancer Biology and Prevention
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Authors: Burtness, B., Harrington, K. J., Greil, R., Soulières, D., Tahara, M., de Castro, G., Psyrri, A., Basté, N., Neupane, P., Bratland, Å., Fuereder, T., Hughes, B. G. M., Mesía, R., Ngamphaiboon, N., Rordorf, T., Wan Ishak, W. Z., Hong, R.-L., González Mendoza, R., Roy, A., Zhang, Y., Gumuscu, B., Cheng, J. D., Jin, F., Rischin, D., Lerzo, G., Tatangelo, M., Varela, M., Zarba, J. J., Boyer, M., Gan, H., Gao, B., Hughes, B., Mallesara, G., Rischin, D., Taylor, A., Burian, M., Fuereder, T., Greil, R., Barrios, C. H., de Castro Junior, D. O., Castro, G., Franke, F. A., Girotto, G., Lima, I. P. F., Nicolau, U. R., Pinto, G. D. J., Santos, L., Victorino, A.-P., Chua, N., Couture, F., Gregg, R., Hansen, A., Hilton, J., McCarthy, J., Soulieres, D., Ascui, R., Gonzalez, P., Villanueva, L., Torregroza, M., Zambrano, A., Holeckova, P., Kral, Z., Melichar, B., Prausova, J., Vosmik, M., Andersen, M., Gyldenkerne, N., Jurgens, H., Putnik, K., Reinikainen, P., Gruenwald, V., Laban, S., Aravantinos, G., Boukovinas, I., Georgoulias, V., Psyrri, A., Kwong, D., Al-Farhat, Y., Csoszi, T., Erfan, J., Horvai, G., Landherr, L., Remenar, E., Ruzsa, A., Szota, J., Billan, S., Gluck, I., Gutfeld, O., Popovtzer, A., Benasso, M., Bui, S., Ferrari, V., Licitra, L., Nole, F., Fujii, T., Fujimoto, Y., Hanai, N., Hara, H., Matsumoto, K., Mitsugi, K., Monden, N., Nakayama, M., Okami, K., Oridate, N., Shiga, K., Shimizu, Y., Sugasawa, M., Tahara, M., Takahashi, M., Takahashi, S., Tanaka, K., Ueda, T., Yamaguchi, H., Yamazaki, T., Yasumatsu, R., Yokota, T., Yoshizaki, T., Kudaba, I., Stara, Z., Wan Ishak, W. Z., Cheah, S. K., Aguilar Ponce, J., Gonzalez Mendoza, R., Hernandez Hernandez, C., Medina Soto, F., Buter, J., Hoeben, A., Oosting, S., Suijkerbuijk, K., Bratland, A., Brydoey, M., Alvarez, R., Mas, L., Caguioa, P., Querol, J., Regala, E. E., Tamayo, M. B., Villegas, E. M., Kawecki, A., Karpenko, A., Klochikhin, A., Smolin, A., Zarubenkov, O., Goh, B. C., Cohen, G., du Toit, J., Jordaan, C., Landers, G., Ruff, P., Szpak, W., Tabane, N., Brana, I., Iglesias Docampo, L., Lavernia, J., Mesia, R., Abel, E., Muratidu, V., Nielsen, N., Cristina, V., Rordorf, T., Rothschild, S., Hong, R.-L., Wang, H.-M., Yang, M.-H., Yeh, S.-P., Yen, C.-J., Ngamphaiboon, N., Soparattanapaisarn, N., Sriuranpong, V., Aksoy, S., Cicin, I., Ekenel, M., Harputluoglu, H., Ozyilkan, O., Harrington, K., Agarwala, S., Ali, H., Alter, R., Anderson, D., Bruce, J., Burtness, B., Campbell, N., Conde, M., Deeken, J., Edenfield, W., Feldman, L., Gaughan, E., Goueli, B., Halmos, B., Hegde, U., Hunis, B., Jotte, R., Karnad, A., Khan, S., Laudi, N., Laux, D., Martincic, D., McCune, S., McGaughey, D., Misiukiewicz, K., Mulford, D., Nadler, E., Neupane, P., Nunnink, J., Ohr, J., O'Malley, M., Patson, B., Paul, D., Popa, E., Powell, S., Redman, R., Rella, V., Rocha Lima, C., Sivapiragasam, A., Su, Y., Sukari, A., Wong, S., Yilmaz, E., & Yorio, J.
Affiliations: Vall d'Hebron Hospital Universitari (ES)
Oslo University Hospital (NO)
Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
Mahidol University (TH)
Paracelsus Medical University (AT)
National Cancer Center Hospital East (JP)
The University of Melbourne (AU)
Autonomous University of Chihuahua (MX)
ORCID: Basté, Neus
Bratland, Åse
Roy, Ananya
Jin, Fan
Boyer, Michael
Gan, Hui
Gao, Bo
Mallesara, Girish
Burian, Martin
Barrios, Carlos Henrique
Franke, Fabio Andre
Girotto, Gustavo
Nicolau, Ulisses Ribaldo
Pinto, Gustavo Dix Junqueira
Santos, Lucas
Victorino, Ana-Paula
Chua, Neil
Gregg, Richard
Hansen, Aaron
Hilton, John
Zambrano, Angela
Melichar, Bohuslav
Andersen, Maria
Reinikainen, Petri
Laban, Simon
Aravantinos, Gerasimos
Boukovinas, Ioannis
Billan, Salem
Popovtzer, Aron
Bui, Simona
Licitra, Lisa
Fujii, Takashi
Fujimoto, Yasushi
Hanai, Nobuhiro
Hara, Hiroki
Matsumoto, Koji
Monden, Nobuya
Nakayama, Masahiro
Okami, Kenji
Oridate, Nobuhiko
Shiga, Kiyoto
Shimizu, Yasushi
Sugasawa, Masashi
Takahashi, Masanobu
Takahashi, Shunji
Tanaka, Kaoru
Ueda, Tsutomu
Yamaguchi, Hironori
Yamazaki, Tomoko
Yasumatsu, Ryuji
Yokota, Tomoya
Yoshizaki, Tomokazu
Buter, Jan
Hoeben, Ann
Oosting, S.
Suijkerbuijk, Karijn
Mas, Luis
Caguioa, Priscilla
Kawecki, Andrzej
Klochikhin, Arkadiy
Smolin, Alexey
Goh, Boon Cher
Cohen, Graham
Ruff, Paul
Szpak, Waldemar
Lavernia, Javier
Abel, Edvard
Rothschild, Sacha
Wang, Hung-Ming
Yang, Muh-Hwa
Yeh, Su-Peng
Yen, Chia-Jui
Sriuranpong, Virote
Aksoy, Sercan
Ekenel, Meltem
Agarwala, Sanjiv
Ali, Haythem
Alter, Robert
Anderson, Daniel
Bruce, Justine
Campbell, Nicholas
Conde, Miguel
Deeken, John
Feldman, Lawrence
Gaughan, Elizabeth
Hegde, Upendra
Jotte, Robert
Karnad, Anand
Khan, Saad
Laudi, Noel
Laux, Douglas
McCune, Steven
Misiukiewicz, Krzysztof
Nadler, Eric
Ohr, James
Paul, Doru
Powell, Steven
Sivapiragasam, Abirami
Sukari, Ammar
Wong, Stuart
Yilmaz, Emrullah
Yorio, Jeffrey
Venue: The Lancet
Publisher: Elsevier BV
Published: 2019-11
Volume: 394
Issue: 10212
Pages: 1915-1928
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(19)32591-7
OpenAlex: W2986633517
Cited by: 3,336
References: 25
Citations by year: 2026: 434 · 2025: 551 · 2024: 549 · 2023: 522 · 2022: 535 · 2021: 465 · 2020: 270 · 2019: 5
FWCI: 268.52
Type: journal article
Language: en
Update notices: erratum (2020-02-22)
erratum (2020-01-25)
erratum (2021-06-12)
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet (publishedVersion)
PubMed (publishedVersion)
University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
IRIS (submittedVersion)
SERVAL (Université de Lausanne) (submittedVersion)
Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
Funders: Amgen
Eli Lilly and Company
Pfizer
AstraZeneca
GlaxoSmithKline
Sanofi
Regeneron Pharmaceuticals
National Institute for Health and Care Research (NF-SI-0515-10101)
Eisai
Japan Society for the Promotion of Science (17H01590, 17K19718)
Topics: Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Dermatology › Nonmelanoma Skin Cancer Studies
Keywords: cetuximab, head and neck squamous cell carcinoma, recurrent or metastatic cancer, PD-L1 expression, PD-L1 combined positive score, immune checkpoint inhibitors, overall survival, progression-free survival, non-inferiority, p16 status, treatment safety
MeSH terms: Cetuximab, Antineoplastic Agents, Immunological, Squamous Cell Carcinoma of Head and Neck, Progression-Free Survival, Aged, Antimetabolites, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Female, Fluorouracil, Head and Neck Neoplasms, Humans, Male, Middle Aged, Antibodies, Monoclonal, Humanized

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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

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