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Phase III trial of low-level laser therapy to prevent induced oral mucositis in head and neck cancer patients submitted to concurrent chemoradiation.

LBA5524 Background: Oral mucositis (OM) remains a limiting factor in in head and neck squamous cell carcinomas (HNSCC) patients (pts) treated with chemoradiation (CRT) leading to pain, dysphagia, and weight loss. Low-level laser therapy (LLLT) emerges as a promising, preventive therapy of CRT-induced OM. Yet, a definitive randomized trial supporting its use is lacking. This study was designed to assess the efficacy of LLLT in reducing the incidence and/or severity of OM.


METHODS
Assuming OM grade (G3) for placebo 0.4 (P0); LLLT 0.15 (P1) ; β=0.2; α=0.05, sample size was 94 pts. From Jun 2007 to Dec 2010, 47 LLLT and 47 placebo pts bearer of HNSCC of nasopharynx, oropharynx and hipopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. CRT consisted of conventional RT 70.2 Gy (1.8Gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 wks. Main endpoints were OM incidence and severity, RT interruptions due to OM and pain intensity. The LLLT used daily was a diode InGaAlP (660nm-100mW-4J/cm²). OM evaluation was done by WHO and OMAS scale.


RESULTS
Mean age was 54.6 and 87.2% of pts were male. Primary site: oropharynx (74 pts), nasopharynx (9 pts), hypopharynx (11 pts). In the LLLT arm the incidence of OM G 3/4 was only 6.4% versus 48% in the placebo arm; HR of 0.13 (IC 95%, p<0.001). Besides in the LLLT arm 51% of pts did not have ulcers versus 17% in placebo arm (p<0.001). LLLT pts had less severe pain (p=0.012), used less narcotic analgesic, HR 0.33 (IC 95%, p<0.001) and required less gastrostomia, HR 0.037 (IC 95%, p= 0.005). No LLLT pts had RT interrupted due to OM. EORTC QLQ-C30 and its specific head and neck module QLQ-H&N35 were applied. Results clearly favored the LLLT arm. In QLQ-C30 benefit was seen in both physical and emotional functioning (p=0.037), fatigue (p=0.011), pain (p=0.043); and in QLQ-H&N35, pain (p=0.007), swallowing (p=0.001) and trouble with social eating (p=0.026).


CONCLUSIONS
Our results indicate that upfront LLLT in HNSCC pts submitted to CRT is an effective tool in reducing G 3/4 OM, oral pain, use of narcotic and gastrostomia. QoL data supports the efficacy findings. Thereby LLLT should be the new standard of care in this setting.