Head & neck · 2021
Adjuvant radiation and cetuximab improves local control in head and neck cutaneous squamous cell carcinoma: Phase II study.
Клиническое исследование II фазыСтатьяПоддержка правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Kreinbrink Paul J, Mierzwa Michelle L, Huth Brad, Redmond Kevin P, Wise-Draper Trisha M, Casper Keith, Li Junan, Takiar Vinita
Аннотация
BACKGROUND: Cutaneous squamous cell carcinoma of the head/neck (CSCCHN) is common due to chronic sun exposure. As CSCCHN highly expresses EGFR, we prospectively studied postoperative concurrent cetuximab with radiotherapy for locally advanced CSCCHN (LA-CSCCHN).
MATERIALS AND METHODS: Single-institutional phase II trial of LA-CSCCHN (NCT XXXX). Adjuvant radiation was given with concurrent cetuximab. Primary endpoint of 2-year LRC and secondary objectives of 2-year disease-free survival (DFS) and 2-year OS were assessed by Kaplan-Meier analysis.
RESULTS: Twenty-four patients ages 47-88 (median 71 years) were treated from 2014 to 2017. Fourteen patients had T3/4 disease, 5 had N1 disease, and 7 were N2/3. At median follow-up of 42 months, median OS and DFS was not reached and 64 months. Two-year OS was 75%, 2-year DFS was 70.8%. LRC was 91.1% at 2 years. All grade 3 adverse events were related to skin toxicity (12.5% radiation-related dermatitis, 16.7% cetuximab-related rash).
CONCLUSIONS: LRC compares favorably to historical data examining postoperative radiation alone but requires further investigation.
MATERIALS AND METHODS: Single-institutional phase II trial of LA-CSCCHN (NCT XXXX). Adjuvant radiation was given with concurrent cetuximab. Primary endpoint of 2-year LRC and secondary objectives of 2-year disease-free survival (DFS) and 2-year OS were assessed by Kaplan-Meier analysis.
RESULTS: Twenty-four patients ages 47-88 (median 71 years) were treated from 2014 to 2017. Fourteen patients had T3/4 disease, 5 had N1 disease, and 7 were N2/3. At median follow-up of 42 months, median OS and DFS was not reached and 64 months. Two-year OS was 75%, 2-year DFS was 70.8%. LRC was 91.1% at 2 years. All grade 3 adverse events were related to skin toxicity (12.5% radiation-related dermatitis, 16.7% cetuximab-related rash).
CONCLUSIONS: LRC compares favorably to historical data examining postoperative radiation alone but requires further investigation.