Multicenter randomized, double-blind controlled trial to evaluate the efficacy of laser therapy for the treatment of severe oral mucositis induced by chemotherapy in children: laMPO RCT.

OBJECTIVES: To demonstrate the efficacy of laser photobiomodulation (PBM) compared to that of placebo on severe oral mucositis (OM) in pediatric oncology patients. The primary objective was the reduction of OM grade (World Health Organization [WHO] scale) 7 days after starting PBM. Secondary objectives were reduction of pain, analgesic consumption, and incidence of side effects. METHODS: One hundred and one children with WHO grade > 2 chemotherapy-induced OM were enrolled in eight Italian hospitals. Patients were randomized to either PBM or sham treatment for four consecutive days (days +1 to +4). On days +4, +7, and +11, OM grade, pain (following a 0-10 numeric pain rating scale, NRS) and need for analgesics were evaluated by an operator blinded to treatment. RESULTS: Fifty-one patients were allocated to the PBM group, and 50 were allocated to the sham group. In total, 93.7% of PBM patients and 72% of sham patients had OM grade < 3 WHO on day +7 (P = 0.01). A significant reduction of pain was registered on day +7 in the PBM versus sham group (NRS 1 [0-3] vs. 2.5 [1-5], P < 0.006). Reduced use of analgesics was reported in the PBM group, although it was not statistically significant. No significant adverse events attributable to treatment were recorded. CONCLUSIONS: PBM is a safe, feasible, and effective treatment for children affected by chemotherapy-induced OM, as it accelerates mucosal recovery and reduces pain.

Endoglin expression is associated with poor oncologic outcome in oral and oropharyngeal carcinoma.

CONCLUSIONS: The present preliminary results suggest that endoglin (CD105)-assessed micro-vessel density (MVD) in primary oral and oropharyngeal squamous cell carcinomas (SCCs) may identify patients at risk of disease recurrence or poor oncological outcome after treatment. OBJECTIVES: MVD is an independent prognostic indicator in several human malignancies. Endoglin antibodies have shown a greater specificity for tumour vasculature in comparison with pan-endothelial markers. The present explorative study evaluated endoglin expression and its prognostic role in oral and oropharyngeal SCCs. PATIENTS AND METHODS: The study considered 13 consecutive cases of oral and oropharyngeal SCC with lymph node metastases (pN+) and 13 consecutive pN0 cases. CD105-assessed MVD was calculated at 400x magnification. RESULTS: The mean MVDs were 3.6 and 3.1 in pN+ and pN0 groups, respectively (p>0.05). The mean CD105-assessed MVDs were 4.7 in the group with locoregional recurrence and 2.9 in the group without locoregional recurrence or post-treatment diagnosis of distant metastasis (p=0.01). The mean CD105-assessed MVD in primary oral and oropharyngeal SCCs with poor oncological outcome (recurrence of disease or occurrence of distant metastasis) was 4.3. The mean MVD in primary oral and oropharyngeal SCCs with good outcome was 2.9. Statistical analysis showed a significant difference between CD105-assessed MVD in poor and good outcome groups (p=0.02).