English   español  
Please use this identifier to cite or link to this item: http://hdl.handle.net/10261/213867
Share/Impact:
Statistics
logo share SHARE logo core CORE   Add this article to your Mendeley library MendeleyBASE

Visualizar otros formatos: MARC | Dublin Core | RDF | ORE | MODS | METS | DIDL
Exportar a otros formatos:

Title

Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck. A Randomized Clinical Trial

AuthorsBurtness, Bárbara; Haddad, Robert; Dinis, José; Trigo, José Manuel; Yokota, Tomoya; de Souza Viana, Luciano; Romanov, Ilya; Vermorken, Jan; Bourhis, Jean; Tahara, Makoto; Martins Segalla, José Getulio; Psyrri, Amanda; Vasilevskaya, Irina; Singh Nangia, Chaitali; Chaves-Conde, Manuel; Kiyota, Naomi; Homma, Akihiro; Holeckova, Petra; Campo, Josep Maria del; Asarawala, Nirav; Nicolau, Ulisses Ribaldo; Rauch, Daniel; Even, Caroline; Wang, Bushi; Gibson, Neil; Ehrnrooth, Eva; Harrington, Kevin; Cohe, Ezra E. W.
Issue Date13-Jun-2019
PublisherAmerican Medical Association
CitationJAMA Oncology 5(8): 1170-1180 (2019)
Abstract[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.
DescriptionLUX-Head & Neck 2 investigators.
Publisher version (URL)http://dx.doi.org/10.1001/jamaoncol.2019.1146
URIhttp://hdl.handle.net/10261/213867
Identifiersdoi: 10.1001/jamaoncol.2019.1146
issn: 2374-2437
e-issn: 2374-2445
Appears in Collections:(IBIS) Artículos
Files in This Item:
File Description SizeFormat 
accesoRestringido.pdf15,38 kBAdobe PDFThumbnail
View/Open
Show full item record
Review this work
 

Related articles:


WARNING: Items in Digital.CSIC are protected by copyright, with all rights reserved, unless otherwise indicated.