| Autor: |
Burtness, Barbara, Haddad, Robert, Dinis, Jose, Trigo, Jose, Yokota, Tomoya, de Viana, Luciano Souza, Romanov, Ilya, Vermorken, Jan Baptist, Bourhis, Jean, Tahara, Makoto, Martins Segalla, Jose Getulio, Psyrri, Amanda, Vasilevskaya, Irina, Nangia, Chaitali Singh, Chaves-Conde, Manuel, Kiyota, Naomi, Homma, Akihiro, Holeckova, Petra, Del Campo, Josep Maria, Asarawala, Nirav, Nicolau, Ulisses Ribaldo, Rauch, Daniel, Even, Caroline, Wang, Bushi, Gibson, Neil, Ehrnrooth, Eva, Harrington, Kevin, Cohen, Ezra E. W., Eduardo Giglio, Raul, Raul Blajman, Cesar, Mario Freue, Jose, Graciela Pilnik, Norma, Salvador Palazzo, Felipe, McGrath, Margaret, Fureder, Thorsten, Kornek, Gabriela, Pichler, Angelika, Bauernhofer, Thomas, Tinchon, Christoph, Greil, Richard, Burian, Martin, Kienzer, Heinz, Specenier, Pol, Sautois, Brieuc, Debruyne, Philip, Graas, Marie-Pascale, Maes, Annelies, Lonchay, Christophe, Daisne, Jean-Francois, Fontaine, Christel, Castro Junior, Gilberto, de Oliveira, Frias, Pereira, Rodrigo Perez, Martins De Marchi, Pedro Rafael, Lazaretti, Nicolas Silva, Kulkarni, Swati, Alam, Yasmin, Ho, Cheryl, Shenouda, George, Soulieres, Denis, Sultanem, Khalil, Singh, Simron, Gonzalez Mella, Pablo, Solis Campos, Jose Antonio, Prausova, Jana, Obermannova, Radka, Friborg, Jeppe, Specht, Lena, Elsaid, Amr Abdelaziz, Minn, Heikki, Martin, Laurent, Rolland, Frederic, Ceruse, Philippe, Calais, Gilles, Guigay, Joe, Ferte, Charles, Peyrade, Frederic, Duffaud, Florence, Champeaux-Orange, Elise, Coutte, Alexandre, Clatot, Florian, Fournel, Pierre, Le Moal, Laurence Bozec, Dietz, Andreas, Gruenwald, Viktor, Gauler, Thomas, Guntinas-Lichius, Orlando, Hildebrandt, Guido, Kuhnt, Thomas, Schmidt, Horst-Juergen, Henke, Michael, Rueckert, Anja, Brugger, Wolfram, Rotter, Nicole, Mahlberg, Rolf, Karavasilis, Vasilios, Fountzilas, Georgios, Psyrri, Diamanto, Lang, Istvan, Boer, Andras, Kocsis, Judit, Pajkos, Gabor, Tamas, Laszlo, Anand, A. L., Sharma, Ajay, Sharma, Voona, Murali, Pandy, Ananda Selvakumar, Kumar, Kirushna, Nathan, Raj Kumar Poovna, Srinivasan, Venkatesan, Zade, Bhooshan, Jain, Minish, Srinivasa, B. J., Naik, Radheshyam, Mohanty, B. K., Charas, Tomer, Billan, Salem, Popovtzer, Aron, Licitra, Lisa, Ferrari, Daris, Fao, Paolo, Merlano, Marco, Rocca, Maria Cossu, Fujii, Hirofumi, Minami, Syujiro, Fujii, Masato, Kadowaki, Shigenori, Muro, Kei, Okami, Kenji, Yagi, Toshinari, Yoshino, Kunitoshi, Matsumoto, Koji, Takahashi, Shunji, Matsuura, Kazuto, Alvarez Avitia, Miguel Angel, Gonzalez Riestra, Hector Jorge, van Meerten, E., Buter, J., Gelderblom, A. J., Kawecki, Andrzej, Golusinski, Wojciech, Dinis, Rui, Ribeiro, Leonor, Silva, Regina, Mansinho, Helder, Selezneva, Irina, Biakhov, Mikhail, Galiulin, Rinat, Izmailov, Adel, Vladimirov, Vladimir, Vinogradov, Valery, Mufazalov, Fagim, Baste, Neus, Ma del Campo, Josep, Mesia Nin, Ricard, Lopez Pousa, Antonio, Jose Grau de Castro, Juan, Reig, Oscar, Vera, Ruth, Trigo, JoseManuel, Iglesias, Lara, Martinez Trufero, Javier, Vazquez, Sergio, Rubio, Belen, Enrique Ales, Jose, Villar, Esther, Rubio, Jordi, Escobar, Yolanda, Soria, Ainara, Chaves, Mauel, Johansson, Gun Wickart, Friesland, Signe, Tell, Roger, Nyman, Jan, Rothschild, Sacha, Zippelius, Alfred, Usluoglu, Nurguel, Gogunska, Inna, Zabolotniy, Dmytro, Vinnyk, Yuriy, Burian, Oleksandr, Sykes, Andrew, Peel, David, Lester, James, Robinson, Martin, Srinivasan, Devraj, Fragkandrea-Nixon, Ioanna, Junor, Elizabeth, Gollins, Simon, Evans, Mererid, Newbold, Kate, Hwang, David, Schipani, Stefano, Rizwanullah, Mohammed, Atiq, Omar, Arnaoutakis, Konstantinos, Bauman, Jessica, Mehra, Ranee, Kang, Hyunseok, Chung, Christine, Davis, Thomas, Jimeno, Antonio, Keresztes, Roger, Nangia, Chaitali, Ignatius, Sai-Hong, Su, Yungpo Bernard, Overton, Lindsay Carol, Garrison, Mitchell A., Jeong, Woondong, Wehbe, Ahmad, Argiris, Athanassios, Chiang, Anne, Morgensztern, Daniel, Haigentz, Missak, Jr., Martincic, Danko, Porosnicu, Mercedes |
| Přispěvatelé: |
LUX-HEAD & Neck 2 Investigators, Medical Oncology, Boehringer Ingelheim Fonds |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Předmět: |
|
| Zdroj: |
JAMA ONCOLOGY
JAMA Oncology, 5(8), 1170-1180. AMER MEDICAL ASSOC
JAMA Oncology, 5(8), 1170-1180. American Medical Association
JAMA Oncol
Digital.CSIC. Repositorio Institucional del CSIC
instname
JAMA Oncology |
| ISSN: |
2374-2437 |
| Popis: |
LUX-Head & Neck 2 investigators.
[Importance] Locoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC.
[Objective] To assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC.
[Design, Setting, and Participants] This multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population.
[Interventions] Patients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal.
[Main Outcomes and Measures] The primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life.
[Results] A total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group).
[Conclusions and Relevance] This study’s findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended.
[Trial Registration] ClinicalTrials.gov identifier: NCT01345669.
The study was funded by Boehringer Ingelheim. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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