Cancer Biomarkers in the era of precision oncology: Addressing the needs of patients and health systems.

Cancer Biomarkers are the key to unlocking the promise of precision oncology, selecting which patients will respond to a more personalised treatment while sparing non-responders the therapy-related toxicity. In this paper, we highlight the primacy of cancer biomarkers, but focus on their importance to patients and to health systems. We also highlight how cancer biomarkers represent value for money. We emphasise the need for cancer biomarkers infrastructure to be embedded into European health systems. We also highlight the need to deploy multiple biomarker testing to deliver the optimal benefit for patients and health systems and consider cancer biomarkers from the perspective of cost, value and regulation. Cancer biomarkers must also be situated in the context of the upcoming In Vitro Diagnostics Regulation, which may pose certain challenges (e.g. non-compliance of laboratory developed tests, leading to cancer biomarker shortages and increased costs) that need to be overcome. Cancer biomarkers must be embedded in the real world of oncology delivery and testing must be implemented across Europe, with the intended aim of narrowing, not widening the inequity gap for patients. Cancer patients must be placed firmly at the centre of a cancer biomarker informed precision oncology care agenda.

The Challenges of Precision Oncology Drug Development and Implementation.

The drivers of precision medicine are clear: for patients (and physicians)--more options, durable clinical benefit, reduced exposure to non-effective drugs and potential to leverage current scientific and technological advances; for the pharmaceutical industry--the potential to tackle core challenges in discovering and developing better and more efficacious medicines, to reduce rates of attrition in drug development and to reduce development costs; for healthcare systems and payers--improved efficiency through the provision of effective care and avoiding ineffective treatments. Oncology has been at the vanguard, the improvements gained in patient survival notable. However, the increasing number of molecular subgroups requires an equally increasing number (and new generation) of highly selective agents targeting inevitably lower incidence molecular segments. Innovative trial designs (umbrella/basket studies) are emerging as a patient-centric approach to drug development, and the rise in public-private partnerships, cross-industry, government and non-profit sector collaborations is enabling implementation of complex clinical trial designs. This poses significant challenges for healthcare systems and regulatory approval. Further substantial evolution of policy and processes, particularly regulatory requirements for approval for new therapeutics, are required.

Factors influencing intention to undergo whole genome screening in future healthcare: a single-blind parallel-group randomised trial.

OBJECTIVE: This study investigated the effect of biased information on beliefs about, and intention to undergo, whole genome sequencing (WGS) screening; and predictors of intention. METHODS: A single-blind parallel-group randomised trial was conducted in Australia, in 2011. Using Excel, 216 participants with English proficiency and no genetic testing experience were randomly allocated (1:1): a neutral information pamphlet or a biased version omitting screening limitations. Measures included: screening intention; Protection Motivation Theory (PMT) constructs; consideration of future consequences (CFC); uncertainty avoidance (UA); anticipated regret (AR). RESULTS: Intention decreased from pre to post-manipulation (p<.001, η(2)=.07, 95% CIs [4.41, 4.86], [3.99, 4.44], respectively). Biased participants (n=106) had higher response efficacy beliefs than neutral participants (n=102) (p<.001, η(2)=.04, 95% CIs [4.80, 5.10], [4.49, 4.79] respectively), but equal intention. The model explained 36.2% of the variance in intention; response efficacy (p<.001), response costs (p<.001), self-efficacy (p=.024), and UA (p=.019) were predictors. CONCLUSION: This is the first study investigating factors influencing anticipated WGS screening uptake. Omitting screening limitations may bias beliefs about screening efficacy and benefits. Uptake may be driven by perceived benefits and costs, self-efficacy beliefs, and uncertainty avoidance. PMT appears to be an appropriate psychosocial model for this setting.

Synoptic reporting improves histopathological assessment of pancreatic resection specimens.

AIM: We examined whether introduction of a standardised pancreatic cancer minimum data set improved the reporting of key pathological features across multiple institutions. METHODS: From seven different pathology departments that are members of the New South Wales Pancreatic Cancer Network, 109 free text reports and 68 synoptic reports were compared. RESULTS: AJCC stage could not be inferred from 44% of free text reports, whereas stage was reported in all 68 synoptic reports. In the free text reports 28 different names were used to designate margins. All margins were reported in only 12 (11%) of the free text reports compared with 64 (94%) of the synoptic reports (p = 0.0011). The presence or absence of lymphovascular or perineural invasion was reported in 72 (66%) and 92 (84%) of free text reports, respectively. In contrast, lymphovascular space and perineural invasion were reported in all synoptic reports (p = 0.0011 and p = 0.0058). CONCLUSION: We conclude that synoptic reporting of pancreatic resections without any other intervention increases the information contained within histopathology reports. Therefore, the introduction of minimal data set synoptic reports is a simple and feasible mechanism to immediately improve reporting for pancreatectomy specimens.