Summary. We have reviewed the outcome after relapse in a cohort of 505 children with acute lymphoblastic leukaemia (ALL) seen at a single institution. The majority of relapses (74%) occurred within 3 years from diagnosis, and most involved the bone marrow alone or with overt extramedullary relapse. Early relapse was more common in children with T-ALL and those with unfavourable cytogenetics. Factors influencing second remission included length of first remission and type of relapse. Children who had not received previous cranial irradiation had a superior survival. The German relapse score involving length of first remission, site of relapse and immunophenotype was highly predictive of outcome: event-free survival with 95% confidence intervals at 6 years for patients who received modern treatment [intensive chemotherapy or bone marrow transplantation (BMT)] was 78% (51-92%) for standard risk, 41% (33-49%) for intermediate risk and 19% (10-31%) for highest risk. Retrospective comparison of BMT with chemotherapy showed no difference in the intermediate-risk group but a possible advantage in the highest risk group. Follow-up of 235 patients who relapsed after chemotherapy and received a third course of treatment showed an extremely high early attrition rate, but a small number of patients survived in third remission. We conclude that new approaches are needed to individualize therapy in intermediate-risk patients and to improve the outcome for those in the highest risk group. Only a small number of children can be treated effectively in third remission.

ObjectiveThis study aimed to evaluate the effectiveness of flavoured tobacco product restriction policies in reducing availability of flavoured products in Massachusetts communities.MethodsData were obtained from surveys of tobacco retailers conducted from July 2015 to March 2017. On a community level, flavoured product availability was defined as the per cent of retailers during a given 3-month quarter that sold flavoured cigars/cigarillos, electronic cigarettes and/or e-liquids. Communities that implemented the policy during the study period were grouped into wave 1 (n=18; 1481 retail surveys) and wave 2 (n=20; 483 retail surveys) by date of policy implementation; communities without a flavoured product restriction served as the control group (n=234; 4932 retail surveys). A difference-in-difference analysis was used to compare the change in flavoured product availability in wave 1 and wave 2 communities 3 months pre-policy and post-policy implementation to the change over the same time periods in the control group.ResultsFrom pre-policy to post-policy implementation period, communities in both waves experienced significant reductions in flavoured product availability (ranging from 27.2% to 50.9%), even after adjusting for community-level characteristics. In both waves 1 and 2, reductions in flavoured product availability were significantly greater compared with comparison communities during the same time frame, adjusting for community-level characteristics.ConclusionsCompliance with flavoured product restriction policies is high among tobacco retailers throughout Massachusetts, regardless of community demographic and retail characteristics. Reduced availability of flavoured tobacco in the retail environment has the potential to reduce youth exposure, access and use of these products.

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BackgroundFlavoured tobacco products are widely available in youth-accessible retailers and are associated with increased youth initiation and use. The city of Boston, Massachusetts restricted the sale of flavoured tobacco products, including cigars, smokeless tobacco and e-cigarettes, to adult-only retailers. This paper describes the impact of the restriction on product availability, advertisement and consumer demand.MethodsBetween January and December 2016, data were collected in 488 retailers in Boston at baseline and 469 retailers at 8-month follow-up, measuring the type, brand and flavour of tobacco products being sold. Process measures detailing the educational enforcement process, and retailer experience were also captured. McNemar tests and t-tests were used to assess the impact of the restriction on product availability.ResultsAfter policy implementation, only 14.4% of youth-accessible retailers sold flavoured products compared with 100% of retailers at baseline (p<0.001). Flavoured tobacco product advertisements decreased from being present at 58.9% of retailers to 28.0% at follow-up (p<0.001). Postimplementation, retailers sold fewer total flavoured products, with remaining products often considered as concept flavours (eg, jazz, blue). At follow-up, 64.0% of retailers reported that customers only asked for flavoured products a few times a week or did not ask at all. Retailers reported that educational visits and the flavoured product guidance list aided with compliance.ConclusionTobacco retailers across Boston were largely in compliance with the regulation. Availability of flavoured tobacco products in youth-accessible retailers declined city-wide after policy implementation. Strong educational and enforcement infrastructure may greatly enhance retailer compliance.

SummaryThis paper describes the processes and procedures involved in planning, conducting and reporting monitoring activities for large clinical trials of investigational medicinal products, focusing on those conducted in resource-limited settings.