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    • br Discussion Unfortunately it was not possible to

    2019-06-28


    Discussion Unfortunately it was not possible to perfom a RCT comparing medical ozone gas therapy in respect to standard therapy because all our 24 patients had been previously treated with various cycles of antibiotic therapies before we could start the therapy with O3 gas. Moreover the patients needed to wait for a long time (Table 2) the approval of Ministry of Health in using medical O3 gas with the new indication for the treatment of patients with ONJ related to bisphosphonate treatments. With the data on the role of preventive measure in reducing the risk of ONJ in patients treated with BPs [1–7,14,44–46]and the efficacy and tolerability of ozone gas [51–53]and medical O3 oil in treating small ONJ lesions [47], we have another therapeutical option for treating ONJ lesions when they are >2.5cm. Our study shows that the topical insufflation of ozone medical gas on ONJ lesion >2.5cm is able to produce a sequestrum of the necrotic bone with 1. its spontaneous or not traumatic explusion and the healing of the gum mucosa followed by re-epithelization 2. or surgical removal of the necrotic bone and healing of the gum mucosa. This is an effective and original method, in the absence of observable toxicity. Thus medical O3 gas insufflations appears to be an effective and safe treatment for patients treated with BPs who developed ONJ lesions >2.5cm. Three are the most important results of our study and the result produced: Curiously, two patients with osteoporosis who completed the trial, requested the highest number of O3 gas insufflations and this fact needs further investigation. In conclusion, the preliminary results of this study demonstrate that medical O3 delivered as topical gas insufflation can be considered a promising, effective, safe and simple therapeutic option for the treatment of ONJ lesions>2.5cm.
    Acknowledgements
    Introduction Up to 75% of patients with advanced prostate cancer (PC) or breast cancer (BC) will develop bone metastases, which dysregulate normal bone metabolism [1]. Without antiresorptive therapies, most patients with bone metastases will experience potentially debilitating skeletal-related events (SREs: pathologic fractures, spinal cord compression, hypercalcemia, the need for surgery to bone, or severe bone pain requiring palliative radiotherapy) [1,2]. Zoledronic glut 1 (ZOL) is a nitrogen-containing bisphosphonate and potent osteoclast inhibitor. Treatment with ZOL reduces the risk of SREs and suppresses pathologic bone turnover in patients with multiple myeloma or bone metastases from solid tumors, including PC and BC [3–5]. Biochemical markers of bone turnover include enzymes and peptides released during the bone remodeling process, which can be measured in the urine or blood and are potentially useful for assessing the overall state of bone turnover [6]. For example, amino-terminal propeptide of type I collagen (P1NP), serum C-terminal cross-linking telopeptide of type I collagen (CTX), and urinary N-telopeptide (NTX) is physiologic byproducts of bone remodeling. Elevated levels of CTX or NTX are common in patients with osteolytic bone lesions; thus, these markers may reflect increased osteolysis (osteoclast-mediated bone resorption), which is more pronounced in BC. The bone formation marker P1NP is elevated in osteoblastic or mixed osteolytic–osteoblastic lesions, as occurs with PC. Other important markers of bone turnover include modulators of osteoclast activity, such as the receptor activator of nuclear factor-κB ligand (RANKL) and osteoprotegerin (OPG). Osteoprotegerin is a physiologic inhibitor of RANKL, an inducer of osteoclast activity. Elevated levels of bone turnover markers (e.g., NTX and CTX) have been associated with poor clinical outcomes in patients with cancer [7–9], including increased SRE risk [7,8]. Moreover, antiresorptive therapies have been shown to reduce bone turnover marker levels in patients with cancer [10,11]. Retrospective analyses of data from phase 3 trials of ZOL versus control (i.e., placebo for PC, pamidronate for BC) in patients with bone metastases from castration-resistant PC (N=314) or BC (N=379) showed that ZOL normalized NTX levels within 3months in most patients (70% PC, 81% BC) who had high baseline NTX levels (PC, n=193; BC, n=220) [11]. Moreover, ZOL-mediated normalization of NTX levels within 3months of treatment was associated with decreased risks of first SRE (40% decrease; P≤0.04) and death (PC, 59% decrease; P<0.0001) versus persistently increased NTX levels [11]. Further retrospective analyses of this trial database also showed that ZOL therapy was associated with improved survival in patients with aggressive bone disease [12]. Thus, modulating bone turnover with ZOL may improve clinical outcomes in patients with advanced cancer. Here we present results from the ZOTECT study (NCT00334139), which assessed the effect of ZOL therapy on bone turnover and potential correlations with disease outcomes.