1100P - The phase II study of HMB/Arg/Gln against oral mucositis induced by chemoradiotherapy for head and neck cancer patients

Date 10 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Cancer in Adolescents
Supportive Care
Head and Neck Cancers
Presenter Tomoya Yokota
Citation Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374
Authors T. Yokota1, S. Hamauchi1, Y. Yoshida1, T. Yurikusa2, M. Suzuki2, A. Yamashita3, H. Ogawa4, T. Onoe4, K. Mori5, T. Onitsuka6
  • 1Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 2Division Of Dental And Oral Surgery, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 3Division Of Nutrition, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 4Division Of Radiation Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 5Clinical Trial Coordination Office, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 6Divisions Of Head And Neck Surgery, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP

Abstract

Background

Opioid-based pain control and systemic oral care program are effective for the chemoradiotherapy (CRT)-induced severe oral mucositis (OM) in patients with head and neck cancers (HNC). This phase II trial assessed the clinical benefit of beta-Hydroxy-beta-Methylbutyrate, Arginine, and Glutamine (HMB/Arg/Gln) in the prevention of CRT-induced OM in patients with HNC.

Methods

Patients with HNC who were scheduled to receive definitive or postoperative cisplatin-based CRT were enrolled. HMB/Arg/Gln was administered orally or per percutaneous endoscopic gastrostomy from the first day of CRT up to completion of CRT. All patients received opioid-based pain control and oral care programs we previously published. The primary endpoint was the incidence of grade ≥3 OM (functional/symptomatic) according to the Common Terminology Criteria of Adverse Events version 3.0. QOL (EORTC QLQ-C30/PROMS) and intake of nutrition at baseline and 50Gy were also assessed.

Results

From February 2015 to June 2016, 35 patients with HNC were enrolled. Sixteen patients (45.7%) developed grade ≥3 OM (i.e., functional/symptomatic). The incidence of grade ≤1 OM (functional/symptomatic) was 51.5% at 2 weeks and 82.9% at 4 weeks after completion of RT. Clinical examination revealed that 10 patients (28.6%) developed grade ≥3 OM. The incidence of grade ≤1 OM (clinical exam) was 80.0% at 2 weeks and 100% at 4 weeks after completion of RT. Only 5.7% of patients had unplanned breaks in radiotherapy, and all patients completed treatment. Adverse events related to HMB/Arg/Gln were increase in blood urea nitrogen and diarrhea, but were easily managed.

Conclusions

Addition of HMB/Arg/Gln to opioid-based pain control and oral care programs was feasible but still insufficient in reducing the incidence of severe CRT-induced oral mucositis. However, the benefit of HMB/Arg/Gln should not be neglected in terms of findings of clinical examination and the recovery from severe oral mucositis.

Clinical trial identification

UMIN000016453

Legal entity responsible for the study

None

Funding

Public Interest Incorporated Foundation- Shizuoka Industrial Foundation- Pharma Valley Center

Disclosure

All authors have declared no conflicts of interest.