scholarly journals Bevacizumab for pediatric radiation necrosis

2020 ◽  
Vol 7 (4) ◽  
pp. 409-414 ◽  
Author(s):  
Lorena V Baroni ◽  
Daniel Alderete ◽  
Palma Solano-Paez ◽  
Carlos Rugilo ◽  
Candela Freytes ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Radiation Necrosis ◽  
Treatment Options ◽  
Mass Effect ◽  
Pediatric Brain Tumors ◽  
Controlled Clinical Trials ◽  
Wide Range ◽  
Fluid Attenuated Inversion Recovery ◽  
Pediatric Brain

Abstract Background Radiation necrosis is a frequent complication occurring after the treatment of pediatric brain tumors; however, treatment options remain a challenge. Bevacizumab is an anti-VEGF monoclonal antibody that has been shown in small adult cohorts to confer a benefit, specifically a reduction in steroid usage, but its use in children has not been well described. Methods We describe our experience with bevacizumab use for symptomatic radiation necrosis at 5 institutions including patients treated after both initial irradiation and reirradiation. Results We identified 26 patients treated with bevacizumab for symptomatic radiation necrosis, with a wide range of underlying diagnoses. The average age at diagnosis of radiation necrosis was 10.7 years, with a median time between the last dose of radiation and the presentation of radiation necrosis of 3.8 months (range, 0.6-110 months). Overall, we observed that 13 of 26 patients (50%) had an objective clinical improvement, with only 1 patient suffering from significant hypertension. Radiological improvement, defined as reduced T2/fluid-attenuated inversion recovery signal and mass effect, was observed in 50% of patients; however, this did not completely overlap with clinical response. Both early and late radiation necrosis responded equally well to bevacizumab therapy. Overall, bevacizumab was very well tolerated, permitting a reduction of corticosteroid dose and/or duration in the majority of patients. Conclusions Bevacizumab appears to be effective and well-tolerated in children as treatment for symptomatic radiation necrosis and warrants more robust study in the context of controlled clinical trials.

Clinical Trials in Pediatric Brain Tumors; Radiotherapy

2012 ◽  
pp. 183-197 ◽  
Author(s):  
Anna Skowronska-Gardas ◽  
Marzanna Chojnacka ◽  
Katarzyna Pedziwiatr
Keyword(s):  
Clinical Trials ◽  
Brain Tumors ◽  
Pediatric Brain Tumors ◽  
Pediatric Brain

Research in palliative care

2015 ◽  
Author(s):  
Stein Kaasa ◽  
Karen Forbes
Keyword(s):  
Palliative Care ◽  
Clinical Trials ◽  
Translational Research ◽  
Advanced Disease ◽  
Research Governance ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Wide Range

Research in palliative care is essential for maintaining standards and advancing knowledge and improving practice. It is challenging, sometimes daunting, often frustrating, but always exciting and rewarding when a study is successfully completed, whether the outcome is positive or negative. This chapter discusses a wide range of topics that will help those who are new to research to get started, to proceed and complete it, and contribute to improving outcomes for patients with advanced disease. Topics include, among others, collaborative and translational research, research governance, controlled clinical trials, evidence-based palliative care, and trial planning (including methodology, randomization, statistical considerations, protocol, access to patients, finance, administration, monitoring, and publication).

Ipilimumab (Ipi) expanded access program (EAP) for patients (pts) with stage III/IV melanoma: 10 mg/kg cohort interim results.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8508-8508 ◽  
Author(s):  
Omid Hamid ◽  
Wen-Jen Hwu ◽  
Jon M. Richards ◽  
Jeffrey S. Weber ◽  
Jedd D. Wolchok ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Options ◽  
Stage Iii ◽  
Controlled Clinical Trials ◽  
Serious Adverse Events ◽  
Safety Database ◽  
Expanded Access Program ◽  
Unresectable Stage ◽  
The Us ◽  
Access Program

8508 Background: The EAP (CA184-045), begun in 8/07, currently provides the largest safety database for Ipi outside of controlled clinical trials (CCTs) and included pts with brain metastases (BM) and primary ocular (OM) and mucosal (MM) melanoma. The EAP was amended in 10/08 to administer a 3 mg/kg dose based on the current label (Hodi et al. NEJM 2010). We now report interim data from pts treated in the US at 10 mg/kg from 8/07-10/08. Methods: Pts with unresectable Stage III or IV melanoma who progressed on at least 1 systemic therapy or had no alternate treatment options were eligible. Pts received 10 mg/kg Ipi i.v. q 3 wks up to 4 doses (induction) followed by 10 mg/kg q 12 wks (maintenance) until no longer clinically benefiting or unacceptable/unmanageable toxicity occurred. All serious adverse events (SAEs) and on-study deaths were collected; overall survival (OS) was assessed retrospectively. Results: Of 906 treated pts, 830 were included in the analysis; 39 from prior Ipi trials + 37 from sites whose IRB did not agree to collect OS were excluded. Pts got a median of 4 doses; 31% got ≥5 doses. ECOG 0/1/2 was 53%/39%/8% (1 pt was ECOG 3); 27% had BM, 5% had OM, and 4% MM. Primary reasons for discontinuation were disease progression (67%) and drug toxicity (11%). Incidence of drug-related SAEs was 27% with diarrhea 10%, colitis 8%, endocrinopathies 4%, and dermatitis 0.8%. 2 pts (0.24%) had on-study hepatitis SAEs, both considered drug-related and resulted in discontinuation. There were 3 (0.36%) drug-related intestinal perforations. 2 deaths (0.24%) were the outcome of drug-related SAEs; 1 multi-organ failure and 1 acute respiratory distress syndrome (both ≤70 days from last induction dose). 72 (9%) pts currently remain on treatment (i.e. >3 years). Available OS data showed that 138 pts (17%) were still at risk after 3 years. For 27% of pts the last known alive date was >30 days before data cutoff (with most >2 yrs). Conclusions: Data from the US EAP must be interpreted with caution compared to CCTs. To date, incidence of SAEs for hepatitis and intestinal perforation, and drug-related death at 10 mg/kg Ipi monotherapy is consistent with that seen in BMS clinical trials. Durable OS (>3 yrs) was observed in at least 17% of pts.

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