The patients were prospectively recruited at three tertiary head and neck centers in Sweden. Inclusion criteria were newly diagnosed, curable, untreated HNC with a performance status of 0 to 2 according to the ECOG/World Health Organization (WHO) classification [60 ]. Exclusion criteria included previous treatment for malignant neoplasms within the last 5 years (except for skin cancer), excessive alcohol use, cognitive impairment, and inability to understand Swedish. The Uppsala Regional Ethics Review Board reviewed and approved the study (No. 2014/447). Blood samples were coded and stored in the Uppsala Biobank (approved RCC 2015-0025). This study was carried out as part of a larger prospective study registered on ClinicalTrials.gov, NCT03343236.
All patients were under nutritional surveillance according to local protocols, and supplementary nutritional therapy was offered when indicated. All patients were classified according to the Union for International Cancer Control (UICC) 8 staging system. A study representative met with the included patients and collected blood samples before treatment, 7 weeks after the start of treatment, and 3 and 12 months after the end of treatment. Body weight was monitored at each visit, and the grade of mucositis was evaluated according to the WHO mucositis scale [61 ]. Height was measured and used for the calculation of body mass index (BMI) (kg/m2). Any history of smoking was recorded and documented as pack-years.
The study cohort consisted of 180 patients with HNC. The most common sites were the oropharynx (n = 81), the oral cavity (n = 53), and the larynx (n = 22). Patient characteristics are shown inTable 3 . Data from the first 30 patients in this study have previously been reported [16 (link)].
In terms of treatment, the patients were divided into 4 groups:
Cisplatin was administered concomitantly with radiation therapy to a total of 47 patients, in weekly doses of 40 mg/m2: 45 patients with oropharyngeal cancer, and 2 patients with laryngeal cancer. Most patients received 5 to 8 courses of cisplatin (n = 34), and the remainder received 1 to 4 courses (n = 13). In addition, 15 patients received weekly cetuximab (Cetux) and concomitant RT. Cetux was administered at a loading dose of 400 mg/m2 and then a weekly dose of 250/m2 in most cases. Two patients received 9 doses, five patients received 8 doses, four patients received 7 doses, and the remainder received 4–6 doses.
A total of 6 patients received brachytherapy in addition to conventional RT.
All patients were under nutritional surveillance according to local protocols, and supplementary nutritional therapy was offered when indicated. All patients were classified according to the Union for International Cancer Control (UICC) 8 staging system. A study representative met with the included patients and collected blood samples before treatment, 7 weeks after the start of treatment, and 3 and 12 months after the end of treatment. Body weight was monitored at each visit, and the grade of mucositis was evaluated according to the WHO mucositis scale [61 ]. Height was measured and used for the calculation of body mass index (BMI) (kg/m2). Any history of smoking was recorded and documented as pack-years.
The study cohort consisted of 180 patients with HNC. The most common sites were the oropharynx (n = 81), the oral cavity (n = 53), and the larynx (n = 22). Patient characteristics are shown in
In terms of treatment, the patients were divided into 4 groups:
Surgery only (Surg group), n = 24.
RT +/− surgery (RT group), n = 94.
RT and chemotherapy (cisplatin) +/− surgery (CRT group), n = 47.
RT and targeted therapy (EGFR monoclonal antibody) +/− surgery (RT Cetux group), n = 15.
Cisplatin was administered concomitantly with radiation therapy to a total of 47 patients, in weekly doses of 40 mg/m2: 45 patients with oropharyngeal cancer, and 2 patients with laryngeal cancer. Most patients received 5 to 8 courses of cisplatin (n = 34), and the remainder received 1 to 4 courses (n = 13). In addition, 15 patients received weekly cetuximab (Cetux) and concomitant RT. Cetux was administered at a loading dose of 400 mg/m2 and then a weekly dose of 250/m2 in most cases. Two patients received 9 doses, five patients received 8 doses, four patients received 7 doses, and the remainder received 4–6 doses.
A total of 6 patients received brachytherapy in addition to conventional RT.
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