Hyperfractionated accelerated radiation therapy plus cetuximab plus cisplatin chemotherapy in locally advanced inoperable squamous cell carcinoma of the head and neck

Kuhnt, Thomas and Schreiber, Andreas and Pirnasch, Anett and Hautmann, Matthias G. and Hass, Peter and Sieker, Frank P. and Engenhart-Cabillic, Rita and Richter, Michael and Dellas, Kathrin and Dunst, Juergen (2017) Hyperfractionated accelerated radiation therapy plus cetuximab plus cisplatin chemotherapy in locally advanced inoperable squamous cell carcinoma of the head and neck. STRAHLENTHERAPIE UND ONKOLOGIE, 193 (9). pp. 733-741. ISSN 0179-7158, 1439-099X

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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 and methods Patients with UICC stage III or IVA/B, M0 SCCHN were enrolled and treated with an initial dose of CET (400 mg/m(2)) and then with a weekly dosage of 250 mg/m(2) 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/m(2)) was administered weekly (days 1, 8, 15, 22, 29 and 36). The primary objective of the phase II study was to determine the 2-year 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-year and 5-year overall survival rates were 64 and 41%, the 2-year and 5-year PFS rates were 45 and 32%, and the 2-year and 5-year 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.

Item Type: Article
Uncontrolled Keywords: PHASE-II; HUMAN-PAPILLOMAVIRUS; CANCER-PATIENTS; RADIOTHERAPY; TRIAL; PACLITAXEL; CARBOPLATIN; COMBINATION; SURVIVAL; Chemoradiotherapy; Toxicity; Smoking; Survival; Mucositis
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Strahlentherapie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 14 Dec 2018 13:15
Last Modified: 18 Feb 2019 14:34
URI: https://pred.uni-regensburg.de/id/eprint/1319

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