The aim of the present study was to evaluate clinical activity, and the pharmacodynamic and pharmacokinetic profiles, of oral metronomic vinorelbine (VNR) plus dexamethasone (DEX) in metastatic castration-resistant prostate cancer (mCRPC) patients. Fourty-one patients (92 % chemotherapy-resistant) received 30 mg/day VNR p.o. thrice a week plus 1 mg/day DEX p.o. until disease progression. Plasma soluble B cell antigen 7 homolog 3 (sB7-H3), vascular endothelial growth factor (VEGF), and thrombospondin-1 (TSP-1), were measured by ELISA. Plasma VNR was detected using a LC-MS-MS system. The fraction of patients free of progression, defined by criteria of the Prostate Cancer Clinical Trials Working Group 2, at 3 months was 61 %. PSA decrease ≥50 % from baseline was observed in 35 % of patients. Median PFS and OS were 4 months (95 % CI, 2.8-6.9) and 17.5 months (95 % CI, 10.8-24.5), respectively. Toxicity was mild, and no grade 4 toxicities were found. The mean plasma VNR C ranged from 1 to 2.7 ng/ml (T 1.1 h) and no evidence of drug accumulation was found. A moderate relationship was found between plasma sB7-H3 and PSA values (r = 0.565; P = 0.0094) at the baseline. Increased PFS (11.3 vs. 2.8 months; P = 0.0298) was observed in patients with sB7-H3 levels <30.25 ng/mL. Plasma VEGF AUC increased in non-responders (P < 0.0001), whereas responders maintained higher plasma TSP-1 AUC (P = 0.0063). In conclusion, metronomic VNR plus DEX showed favourable activity, and a low toxicity profile, in mCRPC patients. Plasma sB7-H3, VEGF and TSP-1 levels are potential pharmacodynamic markers at the reached low plasma concentrations of vinorelbine metronomically administered.
Urinary lithiasis after renal transplantation is a relatively uncommon disease; the predisposing factors and the composition of calculi are identical to those of patients with native kidneys. We present a case of a 45-year-old woman with a staghorn stone in a left-sided transplanted kidney who was treated successfully by percutaneous nephrolithotomy (PCNL). After reviewing the literature, we conclude that PCNL in transplanted kidney is a feasible and safe procedure. The technical aspects of the procedure, such as patient position and the use of the ultrasound-guided caliceal puncture, are stressed.
The aim of the present study was to assess the effects of ipriflavone administration in the prevention of the rapid bone loss that follows ovariectomy in women. After 10-30 days from bilateral ovariectomy, patients received either the sole calcium supplementation (500 mg/day, n = 16) or ipriflavone (600 mg/day, n = 16) in addition to the same daily calcium supplement for 12 months. In calcium-treated subjects urinary hydroxyproline excretion, serum alkaline phosphatase and plasma bone Gla protein levels showed a substantial (p < 0.01) increase, while radial bone density significantly (p < 0.01) decreased 6 months after surgery. In ipriflavone treated group the patterns of biochemical markers indicated that ipriflavone can restrain the bone remodeling processes and radial bone density showed no significant modification during the 12 month study period. These results demonstrate that ipriflavone administration prevents the rapid bone loss that follows ovariectomy. Thus, ipriflavone can represent an attractive alternative for the prevention of osteoporosis in postmenopausal women who present contraindications to the estrogen replacement therapy.
The mineral content of bone was measured in 134 male patients who underwent ureterosigmoidostomy within the past 18 years. Moreover, the principal humoral indices of bone metabolism, together with hematic pH and alkaline reserve (BE) values were evaluated. This study showed that after approximately 6 years from a ureterosigmoidostomy there was significant bone demineralization. These data, supported by a parallel increase of serum osteocalcin, show that ureterosigmoidostomy represents a risk factor for osteoporosis especially in those patients who already have below normal values of bone mineral density prior to surgery.
A total of 208 patients with superficial transitional-cell carcinoma of the bladder (STCC) after transurethral resection were treated with 30 mg intravesical instillations of mitomycin C (MMC) weekly for 8 weeks, followed by monthly maintenance doses for 12 months. All patients were controlled with a urinary cytological examination every 2 months and with cystoscopy every 3 months. Mean follow-up was 47.8 and 49.3 months in the prophylaxis and control groups, respectively. The incidence of tumor recurrences at the 12th and 48th months was 29 and 44%, respectively, in the MMC group and 45 and 58%, respectively, in the control group. Progression evaluated by grade and stage was significantly higher in the control group. These data indicate that MMC appears to be effective in the prophylaxis of STCC, but the possibility of long-term relapse suggests maintenance of a longer therapy.
Authors report on a case of Pseudomonas prostatitis complicated with a prostatoperineal fistula in continuity with the urethra that has been successfully treated with human fibrin sealant (Tissucol).
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