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Chapter 8
MATERIALS AND METHODS
Ethical considerations
This retrospective cohort study was approved by the Institutional Review Board of the Netherlands Cancer Institute (IRB18.374/IRBd18105). As this was a retrospective study based on chart review, no (written) informed consent was necessary.
Patient selection
A consecutive cohort of 128 patients treated with primary high-dose cisplatin-based CRT for a primary head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the Netherlands Cancer Institute from February 2008 to December 2015 was used for the analysis. Patient characteristics are presented in Table 1. Of the cohort of 128 patients, 90 (70%) were male, the mean age was 59 years (SD 7, ranging from 42 to 73) and 58 patients (45%) had an Adult Comorbidity Evaluation-27 (ACE-27) of 0. Most patients (i.e., 78, 61%) had an oropharyngeal carcinoma and 106 (83%) had stage IV disease. Ten patients (8%) lost more than 10% of their weight prior CRT and 33 (26%) had an abnormal diet (FOIS < 7) prior CRT.
Chemoradiotherapy treatment
According to protocol, all patients were immobilized during radiotherapy planning and treatment in supine treatment position in a custom-made head-and-neck mask. For planning, contrast-enhanced CT-scan simulation was performed. All patients were treated with intensity- modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). The radiation dose consists of 70 Gy to the primary tumor and the involved node(s) in N+ disease, given in 2 Gy per fraction, 5 fractions a week. Elective irradiation of the neck was given to a dose of 46 Gy in 23 fractions in case of sequential boost and to 54.25 Gy in 35 fractions in case of concomitant boost. Concomitant cisplatin was added to the radiotherapy in case of locally- advanced disease (T3/4, N2c/N3) or extra-capsular extension as assessed at MRI. Patients were scheduled for a 3-weekly intravenous high-dose concomitant cisplatin (100 mg/m2 on days 1, 22, and 43 of radiotherapy).