Oncofid-P-B: a novel treatment for BCG unresponsive carcinoma in situ (CIS) of the bladder: Results of a prospective European Multicentre study at 15 months from treatment start.

PURPOSE: This study reports the safety and efficacy of Oncofid-P-B, a novel compound under development by Fidia Farmaceutici S.p.A. with specific binding to CD44 receptor, in patients with CIS unresponsive or intolerant to BCG. MATERIALS AND METHODS: This is a phase 1 open-label, single arm, multicenter European study to assess safety, tolerability and efficacy of Oncofid-P-B administered in 20 patients with CIS ± Ta-T1, unresponsive or intolerant to BCG, unwilling or unfit for cystectomy. Oncofid-P-B was administered by intravesical instillation for 12 consecutive weeks (intensive phase) followed, in CR patients, by 12 monthly instillations (maintenance phase). The primary objective was the overall safety profile. Secondary objectives included: i) any evidence of antitumor activity, ii) patient's compliance, iii) systemic absorption. The CR was defined as a negative cystoscopy, negative biopsy of the urothelium and negative cytology. RESULTS: At the end of the intensive phase, 15 of the 20 enrolled patients (75%), achieved the CR. Patients still in CR after 3, 6, 9 and 12 months of maintenance phase were 13 (65%), 12 (60%), 9 (45%) and 8 (40%), respectively. Only seven (5 mild and 2 moderate) drug-related AEs were reported in three patients. No drug related serious AEs and no drug related withdrawals have been reported. In all plasma samples, the drug concentratiosn was below the LLOQ (1ng/ml). CONCLUSIONS: Oncofid-P-B is very safe, well tolerated and highly effective (75% CR) when administered weekly for up to 12 consecutive weeks (75% CR), with 40% CR still after 15 months from treatment start.

La formación de médicos y enfermeras del trabajo en España: una mirada histórica hasta llegar al presente / Training of occupational physicians and nurses in Spain: a historical review

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Superficial dorsal penile vein thrombosis: a little-known complication of subinguinal varicocelectomy.

OBJECTIVE: To describe the symptomatology, diagnosis and treatment of superficial thrombosis of the dorsal penile vein - the most common complication of subinguinal varicocelectomy - and analyse the possible mechanisms involved in the development of the condition. PATIENTS AND METHODS: The clinical records of 326 patients who underwent varicocele repair during the last 10 years was reviewed. The technique used was subinguinal varicocelectomy with arterial preservation. A mini-Doppler probe was used during surgery for artery identification. We report on the postoperative complications of varicocelectomy, with special attention to superficial dorsal penile vein thrombosis, and provide a detailed description of the anatomy of the superficial venous system of the penis. RESULTS: Complications usually associated with varicocele surgery occurred in less than 1% of patients. However, the most common complication in our series was superficial dorsal penile vein thrombosis, which occurred in 2.1% of patients. The use of the mini-Doppler probe allowed us to identify and preserve the arteries in all 326 patients. CONCLUSION: Subinguinal varicocelectomy with intra-operative use of a mini-Doppler probe is a rapid and safe technique. The outcomes and complications are similar to those reported for subinguinal microscopic varicocelectomy. Superficial dorsal penile vein thrombosis is a benign self-limited condition whose association with subinguinal varicocelectomy has not been previously reported.