Abstract 5683
Background
Oral mucositis (OM) is the most common adverse event in patients with head and neck cancer (HNC) who are treated with chemoradiotherapy (CRT). Normal saline/ or benzydamine hydrochloride oral rinse might reduce OM incidence and severity. However, the need for interruption of CRT may occurred. A phase II study of steroid solution for stomatitis prophylaxis has been reported in patients with advanced stage breast cancer who was treated with mTOR inhibitor. We aimed to assess the efficacy of dexamethasone-based mouthwash for prevention of oral mucositis (OM) in HNC patients who were receiving with CRT.
Methods
In this phase II, double-blind, placebo-controlled study, we enrolled 27 patients with HNC who were treated with CRT. Those patients were randomized (1:1) to received dexamethasone-based mouthwash (0.5 mg in 10 ml of normal saline solution) (n = 14) versus placebo plus normal saline solution (n = 13) at a day before starting in CRT schedule (rinse for 2 min and spit, four time daily for 10 weeks). The primary endpoint was incidence- and severity of OM, which focused on pain score by 10 weeks evaluated in the full analysis.
Results
There was statistically significant difference in the incidence of WHO grade 2 OM at 3 weeks after randomization (23.1% placebo group vs 0% in dexamethasone-based solution group, p-value=0.003). At 6 weeks, 84.6% of patients in placebo group developed grade 2 or higher OM, and only 7.1% in dexamethasone-based solution group (p-value <0.001). Furthermore, pain score in patient with dexamethasone-based solution group was lower than placebo group significantly at 3 weeks until complete treatment.
Conclusions
Dexamethasone-based solution mouthwash significantly reduced the incidence and severity of oral mucositis in head and neck cancer patients receiving chemoradiotherapy, and could be a new standard of care for prevention of oral mucositis from chemoradiation treatment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Phramongkutklao College of Medicine/ Department of Medicine, Phramongkutklao Hospital.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1357 - Upfront atezolizumab chemoimmunotherapy-associated Immune-related adverse events in patients with advanced non-small cell lung cancer
Presenter: Francis Mogollon-Duffo
Session: Poster Display session 1
Resources:
Abstract
1851 - Nivolumab-induced and radiation recall pneumonitis in patients with non-small cell lung cancer: a multicenter real world analysis of 669 patients
Presenter: Nobuaki Mamesaya
Session: Poster Display session 1
Resources:
Abstract
851 - Retrospective analysis of immunotherapy prognostic scores in advanced NSCLC at Nottingham University Hospitals (UK)
Presenter: Cristina Lopez Escola
Session: Poster Display session 1
Resources:
Abstract
3639 - Applicability of lung immune prognostic index (LIPI) to predict efficacy of first-line pembrolizumab in advanced non-small-cell lung cancer (NSCLC)
Presenter: Xabier Mielgo Rubio
Session: Poster Display session 1
Resources:
Abstract
2950 - Delayed Onset Immune Related Adverse Effects (IRAEs) of Pembrolizumab in Non-Small Cell Lung Cancer
Presenter: Haixi Yan
Session: Poster Display session 1
Resources:
Abstract
3659 - Clinical implication of multiplex IHC and serologic biomarkers on Hyperprogression in NSCLC patients receiving Immune checkpoint blockers in real world.
Presenter: Joori Kim
Session: Poster Display session 1
Resources:
Abstract
4882 - Local ablative treatment and treatment beyond progression for oligo-progression in stage IV non-small cell lung cancer after tumor response to anti-PD1 treatment
Presenter: Florian Guisier
Session: Poster Display session 1
Resources:
Abstract
1358 - Atezolizumab in combination with chemotherapy for first-line treatment of advanced non-small cell lung cancer: A systematic review and meta-analysis of randomized controlled trials (RCTs)
Presenter: Francis Mogollon-Duffo
Session: Poster Display session 1
Resources:
Abstract
2170 - Prognostic Impact of Metastatic Sites for Pembrolizumab Efficacy as First-line therapy in Patients with PD-L1 tumor proportion score (TPS) ≥ 50% Advanced Non–Small Cell Lung Cancer: A Retrospective Multicenter Study
Presenter: Hayato Kawachi
Session: Poster Display session 1
Resources:
Abstract
3051 - Impact of visceral fat area as independent predictive factor in patients with advanced non-small cell lung cancer treated with nivolumab
Presenter: Yuki Sato
Session: Poster Display session 1
Resources:
Abstract