Abstract

e15182 Background: ONJ has been very rarely reported in patients (pts) suffering from bone metastases of renal cell cancer (RCC) treated with BPs, such as pamidronate (P) and zoledronic acid (Z). Recently reports of ONJ cases among cancer pts receiving TT agents (sunitinib, bevacizumab, sorafenib, etc) w/o BPs have been published, including few cases among RCC pts. TT agents have been consequently suspected to be a possible risk factor for ONJ. On December 2010, EMA (European Medicine Agency) issued two safety warnings about ONJ risk after sunitinib or bevacizumab treatment; in the “dear doctor” alert letters, manufacturers reported the following data about ONJ cases registered among patients treated on clinical trials or on post-marketing setting (in all types of cancer): 27 ONJ cases among 101.400 pts after sunitinib and 55 ONJ cases among 800.00 pts after bevacizumab worldwide. Methods: We conducted a limited survey, asking three Medical Oncology units and four referral Oral Medicine and Surgery centres (involved in ONJ tertiary care), in different regions of Italy, to look for ONJ and RCC in their database. Nineteen cases of ONJ in RCC pts have been found. Available details of oncologic and dental history have been collected so far of 16 pts; of further 3 cases data reporting authorization is ongoing. Results: Pts characteristics of 16 evaluated pts: sex: 13/3 M/F; median age 63 years (range 45-72). BP treatment: 13 Z, 1 P, 1 Z+P, 1 Ibandronate. BP treatment duration at the ONJ onset: 12 months (range 1-36). Latest TT treatment at the ONJ diagnosis time: sunitinib (13 cases), sorafenib (1), bevacizumab (1), deforolimus (1). Previous treatments: sorafenib (3), IL2, capecitabine. Site of ONJ: 9 in mandible, 4 in maxilla, 2 in both (1 unspecified). Possible risk factors or precipitating events, such as teeth extraction, oral surgery, dental implants, have been reported on 8/16 cases. Conclusions: Incidence of ONJ in RCC pts is largely underestimated in literature. In selected Italian centers, an unexpected rate of ONJ among RCC pts has been observed. We planned a new survey, enlarged to medical oncology units and oral care centers in all Italian regions.

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