Safety of targeted therapies (TTs) in metastatic renal cell carcinoma (mRCC) patients in haemodialysis (HD)

background. On the basis of few published data, sunitinib and sorafenib can be safely administered to patients (pts) with mRCC and end-stage renal disease on HD. Limited data regarding the use of mTOR inhibitors on HD are available, even though no influence of HD on serum concentration of these drugs has been reported. Aim of this study was to investigate the safety and tolerability of TTs in pts with mRCC on HD in an Italian population. patients and methods. Between July 2006 and December 2012, 37 pts with mRCC undergoing HD were treated with sunitinib, sorafenib, temsirolimus or everolimus in 17 Italian Institutions. We retrospectively reviewed the medical records of these pts to evaluate the administered doses of TTs and the treatmentrelated toxicities. results. Twenty-six males/11 females with a median age of 63 years (range 47-81) were analyzed. All pts were under HD, in 18 cases as a consequence of a bilateral nephrectomy. Sunitinib and sorafenib were administrated as first-line TTs in 24 pts: sunitinib at 50 mg daily for 4 weeks followed by a 2-week break in 6 pts, 37.5 mg daily in 7 pts, 25 mg daily in 2 pts and 12.5 mg daily in one patient with the same schedule. Sorafenib was administrated at 800 mg daily, continuously, in 4 pts, at reduced dose of 400 mg in 3 pts and 200 mg daily in one patient. Everolimus was administered at 10 mg daily, continuously, in 5 pts and at 5 mg in one pt; 7 pts received temsirolimus at 25 mg weekly. Everolimus was administered as second-line treatment in 5 pts and as fourthline in one patient. Temsirolimus was given as first-line treatment to 5 pts, as third-line to 2 pts. None of the pts had to change the number of dialysis sessions during TTs treatment. No unexpected adverse event (AE) and no grade 4 haematological or nonhaematological toxicity were reported. The most common grade 1-2 non-haematological treatment-related AE with TTs was fatigue (20/37 pts). A grade 3 dyspnea, due to interstitial pneumonia, in one pt treated with temsirolimus and a grade 3 cardiac ischaemia in one pt treated with sorafenib led to treatment discontinuation. The most frequent grade 1-2 haematologic toxicity was anemia (27/37 pts). A grade 3 anemia and thrombocytopenia were observed in 2 pts during treatment with everolimus and sunitinib without any need to discontinue treatment. conclusions. These data indicate that, in pts with mRCC in HD, TTs are not contraindicated, leading to no unexpected toxicity and showing a safety profile