Abstract 931P
Background
The aim of this study is to clarify the prophylactic efficacy of topical steroids in basic nursing care for radiation dermatitis induced by chemoradiotherapy (CRT) in patients with head and neck cancer (HNC). J-SUPPORT 1602 study is a multicenter 2-arm, randomized, double-blinded, placebo-controlled phase III trial to confirm the superiority of addition of topical steroid to basic nursing care for radiation dermatitis induced by CRT in patents with HNC.
Methods
Eligible patients planned to receive bilateral neck irradiation (≥ 66 Gy) with concurrent cisplatin (≥ 200 mg/m2) as definitive or postoperative CRT. Patients were randomly assigned to either topical steroid or placebo when radiation dermatitis grade 1 was seen or the total radiation dose reached 30 Gy. The primary endpoint is frequency of ≥ grade 2 radiation dermatitis by NCI CTCAE v4.0. Grading of radiation dermatitis was performed by central review using photographs taken weekly by blinded trained physicians. Secondary endpoints include frequency of ≥ grade 3 radiation dermatitis, frequency of local infection, duration of grade 2/3/4 radiation dermatitis, and frequency of grade 2 radiation dermatitis at 2 weeks after the end of radiotherapy. Itching was assessed by NCI Patient-Reported Outcomes (PRO) version of CTCAE.
Results
A total of 211 patients were enrolled (ITT: steroid 106 and placebo 105). Frequency of ≥ grade 2 radiation dermatitis was 73.3% (95% CI: 64.6-81.9) in the steroid and 80.4% (95% CI: 72.7-88.1) in the placebo (p=0.23). Steroid significantly reduced frequency of ≥ grade 3 radiation dermatitis (13.9% vs 25.5 %, p=0.034). No relevant differences for adverse events or for CRT compliance were seen between groups. Table: 931P
| Placebo | Steroid | p-value | |
| ≥ grade 2 radiation dermatitis (%) | 80.4 | 73.3 | 0.23 |
| ≥ grade 3 radiation dermatitis (%) | 25.5 | 13.9 | 0.034 |
| Cumulative incidence of ≥ grade 2 radiation dermatitis (median, day) | 46 | 49 | 0.15 |
| ≤grade 1 radiation dermatitis at 2 weeks after radiotherapy (%) | 71.3 | 78.0 | 0.15 |
| Local infection (%) | 0 | 3 | 0.12 |
| Itching severity according to PRO-CTCAE (Severe/Very severe) (%) | 13 | 8 | 0.26 |
Conclusions
Topical steroid may be beneficial to a symptomatic management for radiation dermatitis induced by high-dose CRT rather than a prophylactic intervention.
Clinical trial identification
UMIN000027161.
Editorial acknowledgement
Legal entity responsible for the study
Japan Supportive, Palliative and Psychosocial Oncology Group.
Funding
The National Cancer Center Research and Development Fund (27-A-3) Hakujuji Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.