Concurrent chemoradiation (CCRT) is the standard treatment for patients with inoperable locoregionally advanced squamous cell carcinoma of the head and neck (HNSCC). CCRT can be associated with severe acute toxicity. Usually only the maximum grade of a limited selection of adverse events (AEs) is reported, without mentioning the evolution of toxicity over time. By the lack of the time factor, the global burden of toxicity experienced by the patient is not adequately reflected.
Adverse events (AEs) were prospectively scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 scoring system by 2 dedicated medical oncologists. AEs were evaluated at predefined time point from the start of CCRT up to 21 weeks after the start of CCRT. The cumulative toxicity load was measured by calculating the area under the curve (AUC) from AE score versus time functions. The AUC for each AE was obtained by multiplying the time and grade of each AE during that time. Mean AUC’s per patient category (i.e. HPV status, tobacco use, localisation of primary tumour and the use of ICT) were compared by Kruskal-Wallis testing.
Forty patients (31 men), mean age 62.15 years, were included. The primary tumour site was located in 42.5% at the oropharynx and 45% were p16-positive. The AEs, with exception of xerostomia, typically developed in the second and third week of CCRT, with the intensity and frequency increasing during the treatment. Two weeks after ending CCRT (week 9), the side effects decreased. AEs were recorded in 85% (radiation dermatitis), 97% (orofacial pain), 89.7% (stomatitis), and 97.5% (anorexia) of patients. Significant different mean AUCs were seen for hoarseness (non-oropharynx group, p = 0.027), alopecia (the use of ICT, p = 0.00014), sensory PNP (the use of ICT, p = 0.00016), diarrhea (the use of ICT, p = 0.021), nausea (p16 positive, p = 0.047), and hoarseness (p16 negative, p = 0.015). For tobacco use no significant differences were seen.
This prospective trial recorded the maximum intensity and frequency of the different AEs, but also the evolution over time and the global AE load. More prospective trials with a larger number of patients are required to confirm the results.
Clinical trial identification
Legal entity responsible for the study
University Hospital Antwerp.
Has not received any funding.
All authors have declared no conflicts of interest.