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Cited by 303

The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.

Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Open access
Spicer, Jonathan D, Garassino, Marina C, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, Samkari, Ayman, Gao, Shugeng, Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, Zurawski, Bogdan·2024·The Lancet
DOI 10.1016/s0140-6736(24)01756-2
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Abstract

Summary Background: At the first interim analysis of the KEYNOTE-671 trial, adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival in participants with early-stage non-small-cell lung cancer (NSCLC). We report overall survival and health-related quality of life outcomes from the second interim analysis. Methods: KEYNOTE-671 was a global phase 3 trial done at 189 medical centres. Eligible participants with resectable stage II, IIIA, or IIIB (N2) NSCLC were randomised (1:1) to neoadjuvant cisplatin-based chemotherapy plus pembrolizumab (200 mg) or placebo administered intravenously every 3 weeks for 4 cycles and adjuvant pembrolizumab (200 mg) or placebo administered intravenously every 3 weeks for 13 cycles. Randomisation was done centrally using an interactive response technology system and was stratified by disease stage, PD-L1 expression, histology, and geographic region in blocks of four. Participants, investigators, and sponsor personnel were masked to treatment assignments; local pharmacists were unmasked to support treatment preparation. Overall survival evaluated in the intention-to-treat population was a primary endpoint. This study is registered at ClinicalTrials.gov, NCT03425643. Findings: Between April 2018 and December 2021, 1364 patients were screened for eligibility, 797 of whom were randomised to the pembrolizumab group (n=397) or the placebo group (n=400). Median study follow-up at the second interim analysis was 36·6 months (IQR 27·6–47·8). 36-month overall survival estimates were 71% (95% CI 66–76) in the pembrolizumab group and 64% (58–69) in the placebo group (hazard ratio 0·72; [95% CI 0·56–0·93]; one-sided P=0·0052; threshold, one-sided P=0·0054). In the as-treated population, grade 3–5 treatment-related adverse events occurred in 179 (45%) of 396 participants in the pembrolizumab group and in 151 (38%) of 399 participants in the placebo group. Interpretation: The significant overall survival benefit of pembrolizumab plus chemotherapy as neoadjuvant therapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone coupled with a manageable safety profile support the use of perioperative pembrolizumab in patients with resectable, early-stage NSCLC.

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Authors
Spicer, J. D., Garassino, M. C., Wakelee, H., Liberman, M., Kato, T., Tsuboi, M., Lee, S.-H., Chen, K.-N., Dooms, C., Majem, M., Eigendorff, E., Martinengo, G. L., Bylicki, O., Rodríguez-Abreu, D., Chaft, J. E., Novello, S., Yang, J., Arunachalam, A., Keller, S. M., Samkari, A., Gao, S., Afanasyev, S., Ahmed, S., Alekshun, T., Alves, G., Anderson, I., Araujo, L. H., Arkhipov, A., Arora, A., Bai, J., Begin, P., Belonogov, A., Berard, H., Berceanu-Ion, R., Bernabe Caro, R., Bondarenko, I., Bonnet, R., Bosch Barrera, J., Brocca, C., Bryl, M., Bulotta, A., Bylicki, O., Calles Blanco, A., Carcereny, E., Carvalho, L., Cebotaru, C., Chaft, J., Charu, V., Chaves, F., Chen, J., Chen, K.-N., Chen, H., Chen, Q., Chen, K., Chiang, C.-L., Chiu, C.-H., Cicenas, S., Ciubotaru, E., Ciuleanu, T., Ciurescu, I., Cobb, P., Coetzee, C., Collins, D., Cortinovis, D., Costas, K., Costin, D., Cronemberger, E. H., Cuevo, R., Cuffe, S., De Marchi, P. R. M., de Paiva Junior, T., Delmonte, A., Demedts, I., Deschepper, K., Dias, J., Dooms, C., Duchemann, B., Dutra, C., Duvivier, H., Eigendorff, E., Ernani, V., Faehling, M., Faria, L., Fedenko, A., Fernando, H., Ferrara, R., Ferrari, V., Finley, G., Fix, P., Flores, M., Fourie, S., Franke, F., Frohling, K.-P., Furqan, M., Gal, C., Galamaga, R., Ganea, D., Ganti, A. K., Gao, S., Garassino, M., Gentzler, R., Gianni, L., Gilli, M., Girard, N., Goranov, B., Gregorc, V., Greystoke, A., Grisanti, S., Grohe, C., Guarino, M., Guimaraes, J. L., Guisier, F., Halmos, B., Hammoud, Z. T., Han, J.-Y., Hegmane, A., Heng, F. Y., Horinouchi, H., Horio, Y., Hu, J., Huang, H.-C., Hui, R., Ikeda, N., Intagliata, S., Iordan, I., Jacobs, C., Jain, K., Jain, S., Jiang, T., Karaseva, N., Kato, T., Kaywin, P., Kazmi, S., Keresztes, R., Khan, S., Kim, J., Kolesnik, O., Kolesnik, O., Kollmeier, J., Komiya, T., Koontz, M., Krasnohrud, Y., Kristedja, T., Kryzhanivska, A., Kuroda, H., Laktionov, K., Lambrechts, M., Lang, S., Langleben, A., Lee, S.-H., Lehmann, M., Levchenko, E., Levenko, O., Li, S., Liao, B.-C., Liberman, M., Lima, I., Liu, G., Liu-Dumlao, T., Lo Russo, G., Lou, Y. Y., Lowczak, A., Luft, A., Ma, S., Majem Tarruella, M., Makles, K., Martinengo, G., Martinez Marti, A., Matias, D., Mazieres, J., Mazilu, L., Mennecier, B., Migliorino, M. R., Misleh, J., Molina, J., Morbeck, I., Mueller, A., Muto, S., Nadal Alforja, E., Nesterova, A., Nishio, W., Niu, J., Novello, S., O'Brien, M., O'Day, S., Ogliari, F., Okada, M., Pang, Y. K., Paramonov, V., Pastor, A., Pawlak, I., Piantedosi, F., Pollock, T., Pope, T., Puig, J., Radhi, S., Rao, S., Rathnasabapathy, C., Reck, M., Reinacher-Schick, A., Rich, P., Ritgen, M., Rittmeyer, A., Roca, E., Rodriguez-Abreu, D., Ruff, P., Rybkin, I., Saji, H., Sakao, Y., Sangal, A., Santoro, A., Sardenberg, R., Savvides, P., Scheusan, R., Schiller, J., Schumacher, L., Serke, M., Shim, B. Y., Shimizu, J., Shio, Y., Sibille, A., Siegel, R., Signorelli, D., Smagina, M., Sokur, I., Spicer, J., Srkalovic, G., Stampleman, L., Starodub, A., Stencel, K., Sugio, K., Surmont, V., Suzuki, H., Tabacof, J., Takamochi, K., Tan, L., Tanaka, F., Tatangelo, M., Täuscher, D., Teixeira, C., Thiberville, L., Trukhin, D., Tsai, C.-L., Tsuboi, M., Ungureanu, A., Ursol, G., Vanakesa, T., Vansteenkiste, J., Varela, M., Villalona-Calero, M., Villaruz, L., Vogel, G., Voitko, N., Wakelee, H., Wang, Q., Wang, W., Wang, C.-C., Wang, S., Wehler, T., Weksler, B., Wermke, M., Wesseler, C., Wirtz, H., Wong, M., Yan, X., Yang, Y., Yu, K. L., Zasadny, X., Zemaitis, M., Zhang, L., Zhao, G., Zhao, Q., Zhu, Y., & Zurawski, B.
Venue
The Lancet
Publisher
Elsevier BV
Published
2024-09
Volume
404
Issue
10459
Pages
1240-1252
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(24)01756-2
OpenAlex
W4402543961
Cited by
303
References
21
FWCI
77.31
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. https://app.cochat.ai/papers/10.1016/s0140-6736(24)01756-2
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Spicer, J. D., Garassino, M. C., Wakelee, H., Liberman, M., Kato, T., Tsuboi, M., Lee, S.-H., Chen, K.-N., Dooms, C., Majem, M., Eigendorff, E., Martinengo, G. L., Bylicki, O., Rodríguez-Abreu, D., Chaft, J. E., Novello, S., Yang, J., Arunachalam, A., Keller, S. M., . . . Zurawski, B. (2024). Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. https://doi.org/10.1016/s0140-6736(24)01756-2

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