Research in Context Panel:Evidence before this study: Preclinical data, epidemiological studies, and meta-analyses of randomised data from cardiovascular trials support the hypothesis that aspirin could be an effective adjuvant cancer therapy (Langley R, et al. Br J Cancer 2011;105(8):1107-13; Algra AM et al. Lancet Oncol 2012;13(5):518-27 ). Globally, several phase III studies are ongoing to assess this, though debate continues about the safety profile of aspirin particularly after radical therapy for gastrointestinal malignancies.Added value of this study: The Add-Aspirin trial (encompassing 4 individually powered phase III studies in gastro-oesophageal, colorectal, prostate and breast cancer) is the largest of the ongoing trials and includes a pre-defined feasibility analysis to assess the acceptability of randomisation, tolerability and toxicity based on an open label run-in phase prior to double-blind randomisation. The data show that aspirin is well tolerated after radical cancer therapy, acceptable to patients, and there is no evidence to suggest there is increased toxicity in the gastro-oesophageal cohort over other tumour-specific cohorts.Implications of all the available evidence: Aspirin is a low cost generic drug with the potential to have a large impact on cancer outcomes globally. Outcomes from gastro-oesophageal cancer remain poor and there is an imperative to complete recruitment to the ongoing trials as quickly as possible. The rationale and supporting evidence for evaluating aspirin as a potential anti-cancer therapy remains strong. More generally, a run-in approach may be useful in adjuvant (or prevention) studies for reducing the risk of non-adherence and participant attrition at a later date. ABSTRACT Background: Pre-clinical, epidemiological and randomised data indicate aspirin prevents tumour development and metastases leading to reduced cancer mortality, particularly for gastro-oesophageal and colorectal cancer. Randomised trials evaluating aspirin use after primary radical therapy are ongoing. To address concerns about toxicity particularly bleeding after radical treatment for gastro-oesophageal cancer, a pre-planned feasibility analysis was incorporated into the ongoing Add-Aspirin trial. Method: The Add-Aspirin protocol includes 4 phase III randomised-controlled trials evaluating the effect of aspirin on recurrence/survival after radical therapy in 4 tumour cohorts: gastro-oesophageal (GO), colorectal (CRC), breast and prostate. An open-label run-in phase (aspirin 100mg daily for 8 weeks) precedes double-blind randomisation (1:1:1 aspirin 300mg: aspirin 100mg: matched placebo). A preplanned analysis of feasibility, including recruitment, adherence, and toxicity was performed. The trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN74358648), and remains open to recruitment. Findings: After two years of recruitment (October 2015-October 2017), 3494 participants were registered on the trial (gastro-oesophageal 115, colorectal 950, breast...

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PCV13 has immunogenicity similar to PCV7 in response to the 7 common serotypes, and has generally higher immunogenicity in response to the 6 additional serotypes. PCV13 may provide added protection against pneumococcal disease caused by the additional 6 serotypes and does not interfere with immune responses to whole-cell pertussis and oral poliovirus vaccines. PCV13 has an acceptable safety profile in both infants and toddlers, comparable with that of PCV7.

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