Curative chemoradiotherapy (CRT) for locally advanced head and neck cancer (LA-HNC) causes severe acute and late adverse reactions, including nutritional support dependence. The aim of this supplementary analysis of a previous single-arm phase II study of CRT with S-1 plus cisplatin for unresectable LA-HNC (JCOG0706) which demonstrated promising efficacy (Cancer Sci.2015;106:726) was to explore risk factors of laryngo-esophageal dysfunction-free survival (LEDFS) and nutritional support dependence over 12 months (NSD12M).
The study population comprised 45 patients (pts) in the JCOG0706. Risk factors of LEDFS and NSD12M were analyzed using Cox regression models and logistic regression models, respectively, with consideration to the pts’ laboratory data just before CRT. Radiation fields were reviewed to analyze the relationship between the extent of irradiated fields and functional outcomes.
Proportions of alive without nutritional support at registration and 2, 6, 12, and 24 months after registration were 82.2%, 35.6%, 68.9%, 77.8%, and 64.4%. All six pts who required nutritional support at 12 months remained tube feeding-dependent thereafter. With a median follow-up period of 3.5 years of all pts, 3-year LEDFS was 48.9%. For LEDFS, the hazard ratio was 0.42 in pts with nutritional support at registration (vs. without nutritional support; 95% confidence interval [CI] 0.17-1.04). For NSD12M, odds ratio was 6.78 in pts with hemoglobin less than the median value of 13.4 g/dL (vs. higher than or equal to the median; 95% CI 1.24-36.85); and was 6.00 in pts with albumin less than the median value of 3.9 g/dL (vs. higher than or equal to the median; 95% CI 1.11-32.54). Primary sites in disease-free pts with NSD12M were the oropharynx (N = 2) or hypopharynx (N = 1), and all their pharyngeal constriction muscles were irradiated with a curative dose of 70 Gy/35 fr.
Functional outcomes were affected by severe dysphasia requiring nutritional support before CRT, and lower pretreatment values of hemoglobin and albumin. These risk factors should therefore be taken into consideration in planning treatment strategy for pts with LA-HNC.
Clinical trial identification
Legal entity responsible for the study
National Cancer Center Research and Development Fund (23-A-16, 23-A-21, 25-B-2 and 26-A-4); Grants-in-Aid for Cancer Research (18-19, 20S-3,20S-6) from Ministry of Health, Labour and Welfare of Japan.
All authors have declared no conflicts of interest.