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Background: The use of central venous access devices (CVADs) is of paramount importance to safely deliver antiblastic and support therapies in children with cancer. Though, in pediatric patients, as much as in adults, CVADs are potentially associated with severe complications which may result in unscheduled interruption of therapy, hospitalization, increased morbidity/mortality, and increased cost of care., Methods: We have reviewed retrospectively our experience with CVADs in children with solid tumors and hematologic diseases, with the purpose of verifying if the adoption of well-defined insertion and maintenance bundles might be effective in reducing catheter-related complications, and in particular catheter-related thrombosis., Results: A total of 227 CVADs were analyzed: 175 peripherally inserted central catheters (PICCs), 50 centrally inserted central catheters (CICCs), and 2 femorally inserted central catheters. All CVADs were non-valved, non-cuffed power injectable polyurethane catheters; 81% were tunneled. Median dwelling time of CVADs was 172 days, for a total number of 39,044 catheter days. A very low incidence of both symptomatic catheter-related thrombosis (0.9%) and catheter-related blood stream infection (0.56 episodes per 1000 catheter days) was found. Unscheduled removal or guidewire replacement because of mechanic complications occurred in 15.7% of CVADs. There was no difference in terms of complications between PICCs and CICCs or between tunneled and non-tunneled catheters., Conclusions: Our experience with CVADs in oncologic and hematologic children suggests that catheter-related complications may be minimized by the adoption of appropriate insertion and maintenance bundles., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Quality of life (QoL) assessment and patient-reported outcomes appear to be crucial in the rationale and interpretation of non-inferiority (NI) trials. The aim of this study was to assess the inclusion of QoL among endpoints in phase III NI oncology trials and the relevance of QoL results in the reporting and interpretation of these studies., Materials and Methods: By PubMed search and hand-search of 11 selected journals, we identified phase III NI trials in adult patients affected by solid tumours, published between 2012 and 2021. Trials were classified according to 4 NI strategies: (1) different drugs; (2) alternative drug administration routes; (3) shorter treatment duration; (4) "deintensification" of treatment schedule. Three main endpoints were: (1) the proportion of publications including QoL among endpoints; (2) the proportion of primary publications reporting QoL results; (3) the proportion of trials with available QoL results actually favoring the experimental treatment out of trials declaring NI., Results: 106 publications were eligible. QoL was included among endpoints in 59 studies (55.7%), and QoL results were available in 40 primary publications (37.7%). In the 73 trials testing the NI of different drugs, QoL was included in 43 trials (58.9%) and QoL results were present in 31 publications (42.5%). Among the 74 trials formally demonstrating NI, only 19 trials (25.7%) had QoL results actually supporting the experimental treatment., Conclusions: In many NI trials in oncology, assessment and reporting of QoL are deficient. Furthermore, most trials formally claiming NI cannot count on QoL results actually supporting the experimental arm., Competing Interests: Declaration of Competing Interest The authors declare no support from any organisation for the submitted work; LM reports research grant from AstraZeneca and travel expenses from Janssen; FP reports honoraria from Bayer, Pierre Fabre, AstraZeneca, Incyte, Ipsen, Clovis, Astellas, Sanofi, institutional funding for work in clinical trials/contracted research from Roche, Bayer, AstraZeneca, Pfizer, Incyte, Tesaro/GlaxoSmithKline and Merck; MDM reports honoraria from AstraZeneca, Boehringer Ingelheim, Janssen, Merck Sharp & Dohme (MSD), Novartis, Pfizer, Roche, Takeda for consultancy or participation to advisory boards and direct research funding from Tesaro/GlaxoSmithKline, institutional funding for work in clinical trials/contracted research from Beigene, Exelixis, MSD, Pfizer and Roche; no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)