1. Afatinib versus methotrexate as second-line treatment in Asian patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 3): an open-label, randomised phase III trial
- Author
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Guo, Y, Ahn, M-J, Chan, A, Wang, C-H, Kang, J-H, Kim, S-B, Bello, M, Arora, RS, Zhang, Q, He, X, Li, P, Dechaphunkul, A, Kumar, V, Kamble, K, Li, W, Kandil, A, Cohen, EEW, Geng, Y, Zografos, E, and Tang, PZ
- Subjects
Cancer ,Rare Diseases ,Dental/Oral and Craniofacial Disease ,Clinical Trials and Supportive Activities ,Clinical Research ,6.1 Pharmaceuticals ,6.2 Cellular and gene therapies ,Evaluation of treatments and therapeutic interventions ,6.4 Surgery ,Good Health and Well Being ,Adult ,Afatinib ,Aged ,Aged ,80 and over ,Antineoplastic Agents ,Asian People ,Carboplatin ,Cisplatin ,Disease Progression ,Disease-Free Survival ,Feasibility Studies ,Female ,Head and Neck Neoplasms ,Humans ,Male ,Methotrexate ,Middle Aged ,Neoplasm Recurrence ,Local ,Progression-Free Survival ,Squamous Cell Carcinoma of Head and Neck ,afatinib ,methotrexate ,HNSCC ,Asian ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
BackgroundTreatment options are limited for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) following progression after first-line platinum-based therapy, particularly in Asian countries.Patients and methodsIn this randomised, open-label, phase III trial, we enrolled Asian patients aged ≥18 years, with histologically or cytologically confirmed recurrent/metastatic HNSCC following first-line platinum-based therapy who were not amenable for salvage surgery or radiotherapy, and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0/1. Patients were randomised (2 : 1) to receive oral afatinib (40 mg/day) or intravenous methotrexate (40 mg/m2/week), stratified by ECOG performance status and prior EGFR-targeted antibody therapy. The primary end point was progression-free survival (PFS) assessed by an independent central review committee blinded to treatment allocation.ResultsA total of 340 patients were randomised (228 afatinib; 112 methotrexate). After a median follow-up of 6.4 months, afatinib significantly decreased the risk of progression/death by 37% versus methotrexate (hazard ratio 0.63; 95% confidence interval 0.48-0.82; P = 0.0005; median 2.9 versus 2.6 months; landmark analysis at 12 and 24 weeks, 58% versus 41%, 21% versus 9%). Improved PFS was complemented by quality of life benefits. Objective response rate was 28% with afatinib and 13% with methotrexate. There was no significant difference in overall survival. The most common grade ≥3 drug-related adverse events were rash/acne (4% with afatinib versus 0% with methotrexate), diarrhoea (4% versus 0%), fatigue (1% versus 5%), anaemia (
- Published
- 2019