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Afatinib as second-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: Subgroup analyses of treatment adherence, safety and mode of afatinib administration in the LUX-Head and Neck 1 trial
R. Haddad, J. Guigay, U. Keilholz, PM. Clement, J. Fayette, L. de Souza Viana, F. Rolland, D. Cupissol, L. Geoffrois, G. Kornek, L. Licitra, B. Melichar, U. Ribaldo Nicolau, D. Rauch, S. Zanetta-Devauges, EEW. Cohen, JP. Machiels, M. Tahara, J....
Jazyk angličtina Země Velká Británie
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
- MeSH
- adherence a compliance při léčbě MeSH
- afatinib terapeutické užití MeSH
- chinazoliny aplikace a dávkování MeSH
- dlaždicobuněčné karcinomy hlavy a krku farmakoterapie metabolismus MeSH
- erbB receptory metabolismus MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie metabolismus MeSH
- methotrexát aplikace a dávkování MeSH
- nádory hlavy a krku farmakoterapie metabolismus MeSH
- přežití bez známek nemoci MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
OBJECTIVES: Patients with head and neck squamous cell carcinoma (HNSCC) can experience severe symptom burden and/or difficulty swallowing, leading to problems with treatment adherence/administration. In LUX-Head and Neck 1 (LH&N1; NCT01345682), second-line afatinib improved progression-free survival (PFS) versus methotrexate in patients with recurrent/metastatic HNSCC. We report adherence and safety across pre-specified and additional subgroups potentially linked to afatinib PFS benefit in LH&N1 (p16 status, smoking history), and afatinib adherence, safety and efficacy by administration (oral versus feeding tube; post-hoc analysis). METHODS: Patients were randomized (2:1) to afatinib (40 mg/day) or intravenous methotrexate (40 mg/m2/week). RESULTS: Among 320 afatinib-treated and 160 methotrexate-treated patients, 83-92% and 76-92% (of patients with data available) across all subgroups took ≥80% of treatment. Across p16 status and smoking history subgroups, the most common treatment-related adverse events (AEs) were diarrhea (70-91%), rash/acne (72-84%), stomatitis (34-73%) with afatinib; and included stomatitis (39-100%), fatigue (22-50%), nausea (19-36%) with methotrexate. Dose reduction decreased AE incidence/severity. Baseline characteristics were generally similar between oral/feeding tube (n = 276/n = 46) groups. 89%/89% (of patients with data available) took ≥80% of assigned afatinib. Median PFS was 2.6 versus 2.7 months (hazard ratio: 0.997; 95% confidence interval: 0.72-1.38). The most common afatinib-related AEs were: rash/acne (74% versus 74%), diarrhea (73% versus 65%), stomatitis (40% versus 30%). CONCLUSION: Subgroup analyses of LH&N1 demonstrate that afatinib has predictable and manageable safety across patient subgroups, with high treatment adherence, and is effective via oral and feeding tube administration.
Boehringer Ingelheim Investment Co Ltd Shanghai China
Boehringer Ingelheim Ltd Berkshire UK
Centre Antoine Lacassagne FHU OncoAge Université Côte d'Azur Nice France
Department of Head and Neck Medical Oncology National Cancer Center Hospital East Kashiwa Japan
Department of Medical Oncology Antwerp University Hospital Edegem Belgium
Department of Medical Oncology Hospital de Câncer de Barretos Barretos São Paulo Brazil
Department of Medical Oncology Institut de Cancérologie de l'Ouest Nantes France
Department of Medical Oncology Institut de Cancérologie de Lorraine Vandœuvre lès Nancy France
Department of Oncology AC Camargo Cancer Center São Paulo SP Brazil
Department of Oncology KU Leuven Leuven Cancer Institute Leuven Belgium
Department of Oncology Palacky University Medical School Olomouc Czech Republic
Institut du Cancer de Montpellier Val d'Aurelle Montpellier France
Klinische Abteilung für Onkologie Universitätsklinik für Innere Medizin Vienna Austria
Medical Department Charité Comprehensive Cancer Center Berlin Germany
Medical Oncology Centre Léon Bérard Lyon France
Moores Cancer Center University of California San Diego La Jolla CA USA
Service d'Oncologie Médicale Centre Georges François Leclerc Dijon Cedex France
Citace poskytuje Crossref.org
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