Patients with Advanced Non–Small Cell Lung Cancer: Are Research Biopsies a Barrier to Participation in Clinical Trials?

Lim, Charles Henry; Sung, Mike; Shepherd, Frances A.; Nouriany, Nazanin; Sawczak, M.; Paul, Tuhina; Perera-Low, Nicole; Foster, Andrea; Zawisza, D.; Feld, Ronald; Liu, Geoffrey; Leighl, Natasha B.

doi:10.1016/j.jtho.2015.09.006

Cited by 56 publications

(47 citation statements)

References 17 publications

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“…The limitations of tumor biopsies have recently been supported by a study that demonstrated up to 30% of patients at a community-based academic center did not undergo guidelinerecommended molecular testing, despite an institutional reflex testing policy for tissue [66]. In addition, repeat tissue acquisition poses barriers to clinical trial enrollment, as demonstrated by a recent study retrospectively evaluating patient enrollment to 55 clinical trials at a single Canadian institution in which fewer patients received study treatment in trials mandating tissue specimens compared with trials that did not (55% vs. 83%; p , .001) [67]. Plasma cfDNA platforms offer promise in overcoming these challenges by rapidly genotyping treatment-naïve and -refractory patients and might eventually obviate the need for the repeat biopsies mandated by many clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Clinical Utility of Liquid Diagnostic Platforms in Non-Small Cell Lung Cancer

Levy

Cordova

et al. 2016

The Oncologist

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A firmer understanding of the genomic landscape of lung cancer has recently led to targeted, therapeutic advances in non-small cell lung cancer. Historically, the reference standard for the diagnosis and genetic interrogation for advanced-stage patients has been tissue acquisition via computed tomography-guided core or fine needle aspiration biopsy. However, this process can frequently put the patient at risk and remains complicated by sample availability and tumor heterogeneity. In addition, the time required to complete the diagnostic assays can negatively affect clinical care. Technological advances in recent years have led to the development of blood-based diagnostics or “liquid biopsies” with great potential to quickly diagnose and genotype lung cancer using a minimally invasive technique. Recent studies have suggested that molecular alterations identified in cell-free DNA (cfDNA) or circulating tumor DNA can serve as an accurate molecular proxy of tumor biology and reliably predict the response to tyrosine kinase therapy. In addition, several trials have demonstrated the high accuracy of microRNA (miRNA) platforms in discerning cancerous versus benign nodules in high-risk, screened patients. Despite the promise of these platforms, issues remain, including varying sensitivities and specificities between competing platforms and a lack of standardization of techniques and downstream processing. In the present report, the clinical applications of liquid biopsy technologies, including circulating tumor cells, proteomics, miRNA, and cfDNA for NSCLC, are reviewed and insight is provided into the diagnostic and therapeutic implications and challenges of these platforms.

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Section: Discussionmentioning

confidence: 99%

Clinical Utility of Liquid Diagnostic Platforms in Non-Small Cell Lung Cancer

Levy

Cordova

et al. 2016

The Oncologist

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“…Then, only the cases relating to subjects with locally advanced or metastasized diagnosis [15] eligible for the first line of treatment [3] were considered. It is estimated that 85% of these patients are eligible for the tissue biopsy [2], while the remaining 15% potentially to the liquid biopsy only. Among the patients who perform the tissue biopsy, the outcome may not be determinable in 30% of cases [16].…”

Section: Populationmentioning

confidence: 99%

Cost-Consequence Analysis of Three Different Diagnostic Strategies in the First- and Second-Line Treatment of Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

Gancitano

Ravasio²,

Dionisi

2018

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BACKGROUND: Unlike the tissue one, liquid biopsy is a less invasive diagnostic method for the assessment of possible mutations of the tumor, based on the analysis of circulating free DNA (cfDNA) present in the plasma component of the blood. Because blood samples are easily obtainable, plasma biopsy is a non-invasive method, supplementing the more traditional biopsy techniques.AIM: A cost-consequence analysis was conducted to compare the adoption of three different diagnostic strategies in the first- and second-line treatment of locally advanced or metastatic NSCLC: i) tissue strategy (only tissue biopsy for first and second line), ii) combined strategy (first line: tissue biopsy. If unknown, liquid biopsy; second line: liquid biopsy. If negative, tissue biopsy) and iii) potential strategy (first line: tissue biopsy. If unknown or tissue ineligible, liquid biopsy; secondline: liquid biopsy. If negative, tissue biopsy).METHODS: A decision-analytic model was developed considering the Italian NHS’s perspective. We only evaluated direct medical costs (tissue biopsy, management of complications associated with tissue and liquid biopsies) borne by the NHS. The CCA was conducted over a time horizon of 1 year, assuming that for each patient with mNSCLC the diagnosticpathway (first- and second-line treatment) ended within such period. Key variables were tested in the sensitivity analysis.RESULTS: Considering both the first and the second line of treatment, the potential strategy constitutes the cost-effective alternative, characterized by an average cost per correctly identified case (€ 685) lower than that estimated for the combined strategy (€ 732) or for the tissue strategy (€ 1,004). The potential strategy remains cost-effective, also considering the results referred to the first- or second-line treatment only.CONCLUSION: The choice of a correct diagnostic strategy is crucial in order to optimize cancer therapies in the first- and second-line treatment of locally advanced or metastasized NSCLC. The addition to the diagnostic pathway of the liquid biopsy would correctly identify a greater number of cases, supporting the prescription of the best oncological therapy.

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“…Actually, the number of clinical trials they have been able to facilitate so far is rather low compared to the investment [32]. Working on complex platforms, which are centred on the biology of the disease is challenging, as the current regulatory field in Europe is not ready to optimally accommodate them [33,34]. Europe should give consideration to developing solutions to efficiently sort patients and screen and provide access to European biology-based clinical trials which would be plugged into such coordinating infrastructure [35].…”

Section: A Proposal For Building a Large-scale Interconnected Platformentioning

confidence: 99%

Precision Medicine: From “Omics” to Economics towards Data-Driven Healthcare - Time for European Transformation

et al. 2017

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There is room for improvement for optimally bringing the latest science to the patient while taking into account patient priorities such as quality of life. Too often, regulatory agencies, governments, and funding agencies do not stimulate the integration of research into care and vice versa. Re-engineering the drug development process is a priority, and healthcare systems are long due for transformation. On one hand, patients need efficient access to treatments, but despite precision oncology approaches, efficiently shared screening platforms for sorting patients based on the biology of their tumour for trial access are lacking and, on the other hand, the true value of cancer care is poorly addressed as central questions such as dose, scheduling, duration, and combination are not or sub-optimally addressed by registration trials. Solid evidence on those parameters could potentially lead to a rational and wiser use of anti-cancer treatments. Together, optimally targeting patient population and robust comparative effectiveness data could lead to more affordable and economically sound approaches. The drug development process and healthcare models need to be interconnected through redesigned systems taking into account the full math from drug development into affordable care.

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Patients with Advanced Non–Small Cell Lung Cancer: Are Research Biopsies a Barrier to Participation in Clinical Trials?

Cited by 56 publications

References 17 publications

Clinical Utility of Liquid Diagnostic Platforms in Non-Small Cell Lung Cancer

Clinical Utility of Liquid Diagnostic Platforms in Non-Small Cell Lung Cancer

Cost-Consequence Analysis of Three Different Diagnostic Strategies in the First- and Second-Line Treatment of Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

Precision Medicine: From “Omics” to Economics towards Data-Driven Healthcare - Time for European Transformation

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