Medical Ozone (O3) Oil or Gas Applications Heal Osteonecrosis of the Jaw (ONJ) in Patients Treated with Bisphosphonates (BPs). Preliminary Results of a Single Arm Study.

Abstract

Abstract Treatment of bone metastasis with BP is aimed at preventing skeletal related events (SREs) and rarely leads to ONJ (<1%) (Hoff, JBMR. 2008). Preventive dental care is a simple and effective way to reduce the risk reduction of ONJ in 75% of the cases (Ripamonti, Ann Oncol. 2009). To date, there are still no standardized therapy for the treatment of ONJ. We report the effect of localized of O3 oil or gas application in cancer patients (12 breast cancer, 4 prostate cancer, 2 lung cancer, 1 NHL, 3 multiple myeloma) with ONJ observed in our institution. Patients had previously received nitrogene-BPs treatment in the absence of odontoiatric preventive measures. All the patients were in had stable disease without progression; 10 of them had ONJ lesions ≤ to 2.5 cm.O3 oil suspension applications on ONJ lesions ≤ 2.5 cm was carried out with localized applications directly on the lesions; patients with larger lesions (≥ 2.5 cm) were treated with the ozone gas locally applied. All the patients received treatment of O3 oil every third day and all of them were treated with antibiotic therapy (azithromycin, 500 mg/day) 10 days prior the initiation of the treatment with O3 oil. The statistical analysis is based on a Simon two-stage design, the second stage is on-going. In this preliminary analysis we focus on 10 patients treated with O3 oil with a medium follow up of 8 months, and 12 patients on medical gas ozone.73% of the patients (n=16) showed complete response in terms of radiological lesion disappearance with complete reconstruction of oral tissue. Among them, fourteen patients developed spontaneous sequestrum with expulsion of the necrotic bone whereas in 2 patients with large extension of bone involvement surgical intervention was necessary.Seventy percent of the patients treated with O3 oil experienced a complete response after 4 applications whereas patients treated with gas needed 4 to 16 applications (depending on the severity of the lesion). No patients presented adverse events related to the use of ozone treatments. Six patients are still on treatment and are improving as well.According to these results few application of O3 oil suspension in patients with smaller lesions and gas medical ozone for wider lesions following antibiotic therapy can rapidly lead to complete healing of ONJ. Further cases and complete follow-up data are required. These data indicate that ONJ is a manageable condition which can be not only prevented by means previously dental examination but also healed with medical ozone applications. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5046.