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Chapter 7
MATERIALS AND METHODS
Ethical considerations
This study does not fall under de scope of the Medical Research Involving Human Subjects Act, which was confirmed by the medical research ethics committee of the Netherlands Cancer Institute (METC18.0589/N18TFC).
Patient selection
All patients treated with primary, cisplatin-based CRT for head and neck squamous cell carcinoma in the Netherlands Cancer Institute between January 2008 and October 2016, were included. Patients with previous treatment in the head and neck area (except neck dissections and skin malignancies), more than one primary tumor, or distant metastases were excluded.
Data collection
We extracted the following variables retrospectively from the medical file: gender, age, comorbidity including the Adult Comorbidity Evaluation-27 (ACE-27) index, tumor site-, T- and N-stage (AJCC 7th edition), general tumor stage, tumor human papilloma virus (HPV) status, tongue base involvement, and radiotherapy and chemotherapy doses. Clinical parameters, assessed prior to CRT at the first appointment, included Body Mass Index (BMI), weight loss (none, < or > 10% over six months), pain in the throat and/or mouth and dysphagia (patient-reported swallowing problems). Additionally, the Functional Oral Intake Scale (FOIS) was obtained, which is a validated tool reflecting functional oral intake, scored by health professionals on a seven-point ordinal scale with lower scores indicating more problems (1 = no oral intake; 7 = total oral intake without restrictions) (28). When not explicitly mentioned in the medical record, the FOIS was scored in retrospect. The timing of tube placement, tube type (nasogastric tube (NGT) or a percutaneous radiological gastrostomy (PRG)), and length of dependency were assessed, with time between tube placement and removal defined as length of dependency. Finally, neck dissections within the first 90 days after CRT were assessed.
Chemoradiotherapy, feeding tube policy and swallowing exercises
According to protocol, radiotherapy was given with 6 MV photons up to 70 Gray (Gy) in 35 fractions in seven weeks with sequential or simultaneous integrated boost according to the IMRT technique (either step and shoot or VMAT). Patients receiving sequential boost got an elective dosage of 46 Gy (23 fractions of 2 Gy) on the primary tumor and bilateral neck, with a total dosage of 70 Gy (35 fractions of 2 Gy) on the tumor and involved lymph nodes. Patients receiving simultaneous integrated boost were given an elective dosage of 54.25 Gy (35 fractions of 1.55 Gy) with a total dosage of 70 Gy (35 fractions of 2 Gy). Concurrent chemotherapy consisted of cisplatin. This was administered intravenously in low-dose (6mg/ m2 daily during the first five weeks of radiotherapy), intermediate-dose (40mg/m2 weekly), or high-dose (100mg/m2 at day 1, 22 and 43 of radiotherapy).