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.

Cadaver donor kidney retransplantation in the pediatric patient: complications and long-term outcome.

PURPOSE: We compared the outcome of second and third kidney allografts with that of the first kidney allograft in pediatric recipients. MATERIALS AND METHODS: We classified 173 cadaveric kidney recipients into 2 groups. Group 1 comprised 120 first transplants and group 2 comprised 53 retransplants, including 43 second and 10 third transplants. We compared demographic characteristics and survival in groups 1 and 2. RESULTS: Group 1 consisted of 78 boys and 42 girls with a mean ± SD age of 11.5 ± 4.2 years. Group 2 consisted of 37 boys and 16 girls with a mean age of 10.4 ± 4.7 years. One, 5, 10 and 15-year graft survival rates were 78.7%, 64.3%, 54.5% and 50.7% for first transplants vs 82.8%, 57.8%, 57.8% and 41.3%, respectively, for retransplants (p = 0.757). Patient survival at 1, 5 and 15-year was 95.8%, 89.6%, 84.9% in the first transplant group vs 93.6%, 93.6% and 93.6%, respectively, in the retransplant group (p = 0.0.63). Graft survival was significantly higher in patients who did vs did not receive calcineurin inhibitors in the 2 groups (p = 0.02). CONCLUSIONS: Kidney retransplantation in the pediatric population can yield excellent long-term outcomes, especially in patients treated with calcineurin inhibitors.

[Results of the use of donors under 3 years of age for pediatric renal transplantation]. / Resultados de la utilización de donantes de edad inferior a 3 años en trasplante renal pediátrico.

OBJECTIVES: To evaluate the functional results and incidence of complications in a series of pediatric renal transplants using grafts from pediatric donors under 3 years of age. METHODS: We review a serious of 19 renal transplants consecutively performed in pediatric receptors with donors under the age of 3 years. We analyze immediate function, medical and surgical complications, and long and mid-term graft and patient survivals. RESULTS: We observed initial graft dysfunction in 9 patients (47.4%). Six patients had vascular complications (31.5%). More vascular complications appeared in kidneys preserved with EC solution (35.3%) in comparison with UW solution (23.5%) (p < 0.05). 1, 5, 10, and 12 year actuarial graft survivals were 57.8%, 41.4%, 35.5% and 35.5%, respectively. Based on preservation solution, 1, 5, and 10 year actuarial graft survivals for EC were 44%, 33% and 16%, respectively; results improved with UW solution up to 60%, 50%, and 50% respectively (p < 0.001). CONCLUSIONS: Kidneys from donors under the age of the 3 years in pediatric receptors suffer a high incidence of vascular complications offering a low graft survival on the long-term, being these facts more evident when simpler preservation solutions are employed.