Hyperfractionated accelerated radiation therapy plus cetuximab plus cisplatin chemotherapy in locally advanced inoperable squamous cell carcinoma of the head and neck : Final 5year results of a phase II study.
Strahlenther Onkol
; 193(9): 733-741, 2017 Sep.
Article
em En
| MEDLINE
| ID: mdl-28500491
ABSTRACT
BACKGROUND:
Cetuximab (CET) is a potent inhibitor of the epidermal growth factor receptor and has been shown to have activity in squamous cell carcinoma of the head and neck (SCCHN). We conducted a single-arm phase II trial of a combination therapy comprising cisplatin (CIS), CET and hyperfractionated accelerated radiotherapy (HART). PATIENTS ANDMETHODS:
Patients with UICC stage III or IVA/B, M0 SCCHN were enrolled and treated with an initial dose of CET (400 mg/m2) and then with a weekly dosage of 250 mg/m2 during HART. HART was started with a prescribed dosage of 2.0 Gy per day for 3 weeks, followed by 1.4 Gy twice daily to a total dose of 70.6 Gy to the gross tumour volume. CIS (40 mg/m2) was administered weekly (days 1, 8, 15, 22, 29 and 36). The primary objective of the phase II study was to determine the 2year progression-free survival (PFS).RESULTS:
Between November 2007 and November 2010, a total of 74 patients were enrolled in the study, of whom 65 were evaluable (83% were men). Median age was 56 years (range 37-69 years). An Oropharyngeal primary tumour was diagnosed in 49%, T4a,b in 65% and N2/3 in 96% of the patients. Of these patients, 85% were smokers or ex-smokers. Complete remission (CR) was observed in 23 patients (35%). The most common toxicity grade was ≥3, including mucositis (58%) and dysphagia (52%). The 2 and 5year overall survival rates were 64 and 41%, the 2 and 5year PFS rates were 45 and 32%, and the 2 and 5year locoregional control rates were 47 and 33%, respectively.CONCLUSION:
The combination of weekly CIS with HART plus CET is a feasible regimen for these unfavourable smoking-induced cancers. However, the parallel US study (RTOG 0522) showed no advantage of the enhanced triple therapy compared to chemoradiotherapy alone.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Otorrinolaringológicas
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Carcinoma de Células Escamosas
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Protocolos de Quimioterapia Combinada Antineoplásica
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Neoplasias Orofaríngeas
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Cisplatino
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Fracionamento da Dose de Radiação
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Cetuximab
Tipo de estudo:
Observational_studies
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Prognostic_studies
/
Risk_factors_studies
Limite:
Adult
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Aged
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Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Strahlenther Onkol
Assunto da revista:
NEOPLASIAS
/
RADIOTERAPIA
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Alemanha