Radiographic Progression-Free Survival and Clinical Progression-Free Survival as Potential Surrogates for Overall Survival in Men With Metastatic Hormone-Sensitive Prostate Cancer.

Purpose: Despite major increases in the longevity of men with metastatic hormone-sensitive prostate cancer (mHSPC), most men still die of prostate cancer. Phase III trials assessing new therapies in mHSPC with overall survival (OS) as the primary end point will take approximately a decade to complete. We investigated whether radiographic progression-free survival (rPFS) and clinical PFS (cPFS) are valid surrogates for OS in men with mHSPC and could potentially be used to expedite future phase III clinical trials.

Which patients with metastatic hormone-sensitive prostate cancer benefit from docetaxel: a systematic review and meta-analysis of individual participant data from randomised trials.

Background: Adding docetaxel to androgen deprivation therapy (ADT) improves survival in patients with metastatic, hormone-sensitive prostate cancer, but uncertainty remains about who benefits most. We therefore aimed to obtain up-to-date estimates of the overall effects of docetaxel and to assess whether these effects varied according to prespecified characteristics of the patients or their tumours.

Methods: The STOPCAP M1 collaboration conducted a systematic review and meta-analysis of individual participant data.

Long term pregnancy outcomes of women with cancer following fertility preservation: A systematic review and meta-analysis.

Objective: As cancer survivorship increases, there is higher uptake of fertility preservation treatments among affected women. However, there is limited evidence on the subsequent use of preserved material and pregnancy outcomes in women who underwent fertility preservation (FP) before cancer treatments. We aimed to systematically review the long-term reproductive and pregnancy outcomes in this cohort of women.

Development of a checklist of standard items for processing individual participant data from randomised trials for meta-analyses: Protocol for a modified e-Delphi study.

Individual participant data meta-analyses enable detailed checking of data quality and more complex analyses than standard study-level synthesis of summary data based on publications. However, there is limited existing guidance on the specific systematic checks that should be undertaken to confirm and enhance data quality for individual participant data meta-analyses and how to conduct these checks. We aim to address this gap by developing a checklist of items for data quality checking and cleaning to be applied to individual participant data meta-analyses of randomised trials.

Sharing individual participant data: through a systematic reviewer lens.

An increasing prevalence of data-sharing models, aimed at making individual participant data (IPD) from clinical trials widely available, should facilitate the conduct of systematic reviews and meta-analyses based on IPD. We have assessed these different data-sharing approaches, from the perspective of experienced IPD reviewers, to examine their utility for conducting systematic reviews based on IPD, and to highlight any challenges. We present an overview of the range of different models, including the traditional, single question approach, topic-based repositories, and the newer generic data platforms, and show that there are benefits and drawbacks to each.

A framework for prospective, adaptive meta-analysis (FAME) of aggregate data from randomised trials.

Background: The vast majority of systematic reviews are planned retrospectively, once most eligible trials have completed and reported, and are based on aggregate data that can be extracted from publications. Prior knowledge of trial results can introduce bias into both review and meta-analysis methods, and the omission of unpublished data can lead to reporting biases. We present a collaborative framework for prospective, adaptive meta-analysis (FAME) of aggregate data to provide results that are less prone to bias.

Prostate Radiotherapy for Metastatic Hormone-sensitive Prostate Cancer: A STOPCAP Systematic Review and Meta-analysis.

Background: Many trials are evaluating therapies for men with metastatic hormone-sensitive prostate cancer (mHSPC).

Objective: To systematically review trials of prostate radiotherapy.

Design, Setting, And Participants: Using a prospective framework (framework for adaptive meta-analysis [FAME]), we prespecified methods before any trial results were known.

Evidence Synthesis to Accelerate and Improve the Evaluation of Therapies for Metastatic Hormone-sensitive Prostate Cancer.

There are many ongoing randomised trials of promising therapies for metastatic hormone-sensitive prostate cancer (mHSPC), but standard systematic reviews may not synthesise these in a timely or reliable way. We demonstrate how a novel approach to evidence synthesis is being used to speed up and improve treatment evaluations for mHSPC. This more prospective, dynamic, and collaborative approach to systematic reviews of both trial results and individual participant data (IPD) is helping in establishing quickly and reliably which treatments are most effective and for which men.

Adding abiraterone to androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: A systematic review and meta-analysis.

Background: There is a need to synthesise the results of numerous randomised controlled trials evaluating the addition of therapies to androgen deprivation therapy (ADT) for men with metastatic hormone-sensitive prostate cancer (mHSPC). This systematic review aims to assess the effects of adding abiraterone acetate plus prednisone/prednisolone (AAP) to ADT.

Methods: Using our framework for adaptive meta-analysis (FAME), we started the review process before trials had been reported and worked collaboratively with trial investigators to anticipate when eligible trial results would emerge.

Postoperative radiotherapy for non-small cell lung cancer.

Background: The role of postoperative radiotherapy (PORT) in the treatment of patients with completely resected non-small cell lung cancer (NSCLC) was not clear. A systematic review and individual participant data meta-analysis was undertaken to evaluate available evidence from randomised controlled trials (RCTs). These results were first published in Lung Cancer in 2013.

Postoperative radiotherapy for non-small cell lung cancer.

Background: The role of postoperative radiotherapy (PORT) in the treatment of patients with completely resected non-small cell lung cancer (NSCLC) was not clear. A systematic review and individual participant data meta-analysis was undertaken to evaluate available evidence from randomised controlled trials (RCTs). These results were first published in Lung Cancer in 2013.

Addition of docetaxel or bisphosphonates to standard of care in men with localised or metastatic, hormone-sensitive prostate cancer: a systematic review and meta-analyses of aggregate data.

Background: Results from large randomised controlled trials combining docetaxel or bisphosphonates with standard of care in hormone-sensitive prostate cancer have emerged. In order to investigate the effects of these therapies and to respond to emerging evidence, we aimed to systematically review all relevant trials using a framework for adaptive meta-analysis.

Methods: For this systematic review and meta-analysis, we searched MEDLINE, Embase, LILACS, and the Cochrane Central Register of Controlled Trials, trial registers, conference proceedings, review articles, and reference lists of trial publications for all relevant randomised controlled trials (published, unpublished, and ongoing) comparing either standard of care with or without docetaxel or standard of care with or without bisphosphonates for men with high-risk localised or metastatic hormone-sensitive prostate cancer.

Uptake of systematic reviews and meta-analyses based on individual participant data in clinical practice guidelines: descriptive study.

Objective: To establish the extent to which systematic reviews and meta-analyses of individual participant data (IPD) are being used to inform the recommendations included in published clinical guidelines.

Design: Descriptive study.

Setting: Database maintained by the Cochrane IPD Meta-analysis Methods Group, supplemented by records of published IPD meta-analyses held in a separate database.

Neoadjuvant chemotherapy plus surgery versus surgery for cervical cancer.

Background: A previous systematic review found that giving neoadjuvant chemotherapy before surgery improved survival compared with radiotherapy. However, the role of neoadjuvant chemotherapy followed by surgery versus surgery alone is still unclear.

Objectives: To assess the role of neoadjuvant chemotherapy in women with early or locally-advanced cervical cancer.

Neoadjuvant chemotherapy plus surgery versus surgery for cervical cancer.

Background: A prior systematic review found that giving neoadjuvant chemotherapy before surgery improved survival compared with radiotherapy. However, the role of neoadjuvant chemotherapy followed by surgery versus surgery alone is still unclear.

Objectives: To assess the role of neoadjuvant chemotherapy in women with early or locally advanced cervical cancer.

Systematic review of therapeutic interventions in human prion disease.

Background: The potential threat of a large outbreak of variant Creutzfeldt-Jakob disease initiated a proliferation of research into the understanding and treatment of human prion disease. However, clinical research is at an early stage with a pressing need for objective evaluation of treatments to inform the design of future studies.

Methods: We aimed to summarize existing research on outcomes of patients with prion disease, considering any published clinical study and patient series with data on disease progression.

A systematic review and meta-analysis of the literature: chemotherapy and surgery versus surgery alone in non-small cell lung cancer.

Background: The effectiveness of preoperative chemotherapy in the treatment of non-small cell lung cancer has remained unclear despite the conduct of several randomized controlled trials (RCTs).

Methods: A systematic review and meta-analysis was carried out to assess the effectiveness of preoperative chemotherapy in non-small cell lung cancer. This involved identifying eligible RCTs and extracting aggregate data from the abstracts or reports of these RCTs.