Citations

AbstractBuilding on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

Abstract Purpose Proton therapy is currently used in the management of pediatric tumors to decrease late toxicities. However, one of the criticisms of proton therapy is the limited data regarding efficacy on disease control. The purpose of this study was to examine local and distant control rates after proton therapy for neuroblastoma. Methods and materials Eighteen patients with high‐risk ( n = 16) and locally recurrent neuroblastoma ( n = 2) were treated with curative intent and received proton therapy to the primary site and up to three post‐induction MIBG‐avid metastatic sites. Primary sites ( n = 18) were treated to 21–36 Gy (relative biological effectiveness [RBE]), and metastatic sites ( n = 16) were treated to 21–24 Gy (RBE). Local control and survival rates were calculated using the Kaplan–Meier method. Results With a median follow‐up of 60.2 months, two‐ and five‐year local control rates at the irradiated primary site were 94% and 87%, respectively. No failures at irradiated distant metastatic sites were observed. The five‐year progression‐free survival (PFS) was 64%, and the five‐year overall survival (OS) was 94%. The extent of surgical resection was not associated with local control, PFS, or OS. No radiation‐related nephropathy or hepatopathy was reported. Conclusions Excellent local control was achieved using proton therapy to the primary and post‐induction MIBG‐positive distant sites. The predominant site of failure is progression in post‐induction non‐MIBG‐avid distant sites. Although proton therapy provides high rates of local control with acceptable toxicity for neuroblastoma, further advances in systemic therapy are needed for the improved control of systemic disease.

Objectives To identify geriatric obesity interventions that can guide clinical recommendations. Design Systematic review using Medline (PubMed), Cochrane Central Register of Controlled Trials, Web of Science, CINAHL , EMBASE (Ovid), and Psyc INFO (Proquest) from January 1, 2005, to October 12, 2015, to identify English‐language randomized controlled trials. Participants Individuals aged 60 and older (mean age ≥65) and classified as having obesity (body mass index ≥30 kg/m 2 ). Interventions Behavioral weight loss interventions not involving pharmacological or procedural therapies lasting 6 months or longer. Measurements Two investigators performed the systematic review using the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses criteria and achieved a high concordance rate (97.3%) in summarizing the primary outcomes. The three primary outcomes were weight loss, physical performance, and quality of life. Results Of 5,741 citations, 19 were included. (Six studies were unique, and the remaining 13 were based on the same study population.) Duration ranged from 6 to 18 months (n = 405 participants, age range 66.7–71.1). Weight loss in the intervention groups ranged from 0.5 to 10.7 kg (0.1–9.3%). Five studies had a resistance exercise program accompanying a dietary component. Greater weight loss was observed in groups with a dietary component than those with exercise alone. Exercise alone led to better physical function but no significant weight loss. Combined dietary and exercise components led to the greatest improvement in physical performance measures and quality of life and mitigated reductions in muscle and bone mass observed in diet‐only study arms. Heterogeneous outcomes were observed, which limited the ability to synthesize the data quantitatively. Conclusions The evidence supporting geriatric obesity interventions to improve physical function and quality of life is of low to moderate quality. Well‐designed trials are needed in this population.