SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases.

BACKGROUND: Stereotactic radiosurgery (SRS) is a frequently chosen treatment for patients with brain metastases and the number of long-term survivors is increasing. Brain necrosis (e.g. radionecrosis) is the most important long-term side effect of the treatment. Retrospective studies show a lower risk of radionecrosis and local tumor recurrence after fractionated stereotactic radiosurgery (fSRS, e.g. five fractions) compared with stereotactic radiosurgery in one or three fractions. This is especially true for patients with large brain metastases. As such, the 2022 ASTRO guideline of radiotherapy for brain metastases recommends more research to fSRS to reduce the risk of radionecrosis. This multicenter prospective randomized study aims to determine whether the incidence of adverse local events (either local failure or radionecrosis) can be reduced using fSRS versus SRS in one or three fractions in patients with brain metastases. METHODS: Patients are eligible with one or more brain metastases from a solid primary tumor, age of 18 years or older, and a Karnofsky Performance Status ≥ 70. Exclusion criteria include patients with small cell lung cancer, germinoma or lymphoma, leptomeningeal metastases, a contraindication for MRI, prior inclusion in this study, prior surgery for brain metastases, prior radiotherapy for the same brain metastases (in-field re-irradiation). Participants will be randomized between SRS with a dose of 15-24 Gy in 1 or 3 fractions (standard arm) or fSRS 35 Gy in five fractions (experimental arm). The primary endpoint is the incidence of a local adverse event (local tumor failure or radionecrosis identified on MRI scans) at two years after treatment. Secondary endpoints are salvage treatment and the use of corticosteroids, bevacizumab, or antiepileptic drugs, survival, distant brain recurrences, toxicity, and quality of life. DISCUSSION: Currently, limiting the risk of adverse events such as radionecrosis is a major challenge in the treatment of brain metastases. fSRS potentially reduces this risk of radionecrosis and local tumor failure. TRIAL REGISTRATION: ClincalTrials.gov, trial registration number: NCT05346367 , trial registration date: 26 April 2022.

[Kidney transplant survival rates and surgical complications in kidney transplants in children; experiences in the Emma Children's Hospital AMC]. / Niertransplantaatoverleving en chirurgische complicaties bij kinderniertransplantaties; ervaringen in het Emma Kinderziekenhuis AMC.

OBJECTIVE: To describe surgical complications, and patient and kidney transplant survival rates in children who have had a kidney transplant. DESIGN: Retrospective. METHOD: Data were analysed concerning the children who had been treated with a renal transplantation in the period 1985-2001 because of terminal renal insufficiency in the Emma Children's Hospital of the Academic Medical Centre in Amsterdam, The Netherlands, with arbitrary end date October 7, 2002. RESULTS: In the study period, 55 primary kidney transplantations were performed on 24 girls and 31 boys. 13 living related and 42 post mortem transplantations were performed. The extra-peritoneal approach was performed in all recipients. Up to October 7, 2002, 14 surgical complications (25%) developed: 4 cases of renovascular thrombosis, 4 urinary leakages, 6 urethral strictures, 1 urethral necrosis, 5 haematomas and 3 lymphoceles. 6 patients lost their grafts due to surgical complications (11%); 4 due to thrombosis, 1 due to urethral necrosis and 1 due to haemorrhage or haematoma. Due to hypertension secondary to the underlying kidney disease 2 patients died within one year after transplantation from hypertensive encephalopathy and cerebral bleeding respectively. The one- and five-year graft survival was 83% and 74% for living related transplantations respectively, and for post mortem transplantations 78% and 68% respectively. The main causes of graft loss were chronic rejection (9/21; 43%), acute rejection (4/21; 19%), thrombosis (4/21; 19%) and surgical complications (2/21; 10%). Primary nonfunction was the only factor with a negative prognostic value for graft survival.