Pulse Brain · Growing Health Evidence Index
Tier 2 — RCT / large cohortPeer-reviewed

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, Brett Hughes, Girish Mallesara, Danny Rischin, Anne L. Taylor, Martin Burian, Thorsten Fuereder, Richard Greil, Carlos H. Barrios, Dalvaro Oliveira de Castro Junior, Gilberto de Castro, 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, Denis Soulières, Rodrigo Ascuí, Pablo Gonzalez, Luis J. Villanueva-Rivera, Marco Torregroza, Ángela R. Zambrano, Petra Holeckova, 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, Amanda Psyrri, 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

The Lancet · 2019

Read source ↗ All evidence

Summary

KEYNOTE-048 was a phase 3 randomised controlled trial evaluating pembrolizumab as monotherapy or in combination with chemotherapy against the standard cetuximab-chemotherapy regimen for recurrent or metastatic head and neck squamous cell carcinoma. As suggested by the trial design and journal prominence, the study appears to have demonstrated clinically meaningful efficacy differences between immunotherapy and targeted chemotherapy approaches in this patient population. This work contributes to understanding first-line treatment options in advanced head and neck cancer.

UK applicability

The findings are directly applicable to UK oncology practice, as pembrolizumab and treatment algorithms for recurrent/metastatic head and neck cancer are relevant to NHS cancer services. Results would inform standard-of-care recommendations within UK clinical guidelines for head and neck malignancies.

Key measures

Overall survival, progression-free survival, objective response rate, duration of response, safety and adverse events

Outcomes reported

The study compared efficacy and safety of pembrolizumab monotherapy or combined with chemotherapy versus cetuximab with chemotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Primary outcomes likely included overall survival, progression-free survival, and objective response rates.

Theme
Nutrition & health
Subject
Other / interdisciplinary
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s0140-6736(19)32591-7
Catalogue ID
SNmoh0ds1j-lh5l0b

Topic tags

Pulse AI · ask about this record

Dig deeper with Pulse AI.

Pulse AI has read the whole catalogue. Ask about this record, its theme, or how the findings apply to UK farming and policy — every answer cites the underlying studies.