Avelumab-cetuximab-radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH).
Eur J Cancer
; 141: 21-29, 2020 12.
Article
em En
| MEDLINE
| ID: mdl-33125944
ABSTRACT
BACKGROUND:
Based on the hypothesis of synergistic effect of avelumab with cetuximab and radiotherapy, this new combination is tested in a randomised trial against two well-established standard of care (SOC) in locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN).METHODS:
This phase III trial comprises two cohorts of patients deemed fit to receive cisplatin (100 mg/m2 Q3W) (cohort 1) or unfit to cisplatin (cohort 2). The SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin in cohort 1 (arm A) and with weekly cetuximab in cohort 2 (arm D). In both cohorts, experimental arms (arms B and C) were IMRT with cetuximab and avelumab (10 mg/kg day 7 and every 2 weeks) followed by avelumab every two weeks for 12 months. A safety phase was planned among the first 41 patients in experimental arms by monitoring grade ≥IV adverse events (AEs) with an unacceptable rate of 35%.RESULTS:
Between September 2017 and August 2018, 82 patients with LA-SCCHN were randomised including 41 patients in experimental arms. All patients of experimental arms except one (arm C) received entire radiotherapy as planned. Most common grade ≥III AEs were mucositis, radio-dermatitis, and dysphagia. Grade ≥IV AEs occurred in 5/41 (12%) patients, all in arm C (no grade V). This rate was acceptable according to the hypotheses of the safety phase. In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.CONCLUSION:
The avelumab-cetuximab-RT combination was tolerable for patients with LA-SCCHN, and the approval was given for continuing the trial without modification. CLINICALTRIAL.GOV NCT02999087.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Anticorpos Monoclonais Humanizados
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Quimiorradioterapia
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Cetuximab
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Antineoplásicos Imunológicos
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Carcinoma de Células Escamosas de Cabeça e Pescoço
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Neoplasias de Cabeça e Pescoço
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Eur J Cancer
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
França