Systematic review of adoption, reporting and impact of health-related quality of life in phase III non-inferiority trials of systemic oncology treatments.

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.

Catheter-related complications in onco-hematologic children: A retrospective clinical study on 227 central venous access devices.

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.