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.

Manejo de la recidiva bioquímica en el cáncer de próstata según la Guías de Práctica Clínica / Management of prostate cancer biochemical recurrence in the clinical guidelines

OBJETIVO: Revisión de las Guías Clínicas que consideramos tienen un mayor impacto en la actividad urológica, para conocer y comparar sus recomendaciones en el diagnóstico y manejo de la recidiva bioquímica después de un tratamiento con intención curativa en el cáncer prostático ( prostatectomía radical o radioterapia). MÉTODOS: Hemos revisado las Guías Clínicas de la European Urological Assciation (EAU), American Urological Association (AUA), National Comprehensive Cancer Network (NCCN) y del National Institute for Health and Clinical Excellence (NICE), así como la evidencia científica en la que se basan. RESULTADOS: Ponemos de manifiesto en este artículo la complejidad del tema a tratar y las similitudes y disparidades entre ellas. La definición de recidiva varía si se trata de pacientes que han sido sometidos a prostatectomía radical o a radioterapia. En cuanto a los tratamientos, en el primer caso se decantan hacia la radioterapia precoz siendo en cambio más dispersas las recomendaciones en la recidiva bioquímica después de radioterapia. CONCLUSIÓN: Las Guías Clínicas suponen una magnífica ayuda al profesional para la toma de decisiones. Las Guías Clínicas formulan recomendaciones, con mayor o menor grado de evidencia y que han de ser periódicamente reevaluadas incorporando la evidencia científica que vaya apareciendo(AU)

OBJECTIVE: Review of the Guidelines which have major impact on the urological field, in order to compare and to know their recommendations in the diagnosis and management of biochemical relapse after a healing treatment of prostate cancer (radical prostatectomy or radiotherapy). METHODS: We review the Guidelines of the European Urological Association (EAU), the American Urological Association (AUA), of the National Comprehensive Cancer Network (NCCN) and those of the National Institute for Health and Clinical Excellence (NICE), as well as the scientific evidence on which they are based. RESULTS: In this paper we state the complexity of the subject being dealt with and coincidences and differences among them. The definition of relapse varies depending on whether the patient has undergone either radical prostatectomy or radiotherapy. Regarding treatment, in the first case early radiotherapy is the treatment of choice, but recommendations after radiotherapy are not so specific. CONCLUSION: Clinical Guidelines represent a great aid in decision making for the professional. Guidelines give recommendations with a higher o lower degree of scientific evidence and must be evaluated regularly to include new evidences which are coming through(AU)

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.