Clinical and Economic Impact of Upfront Next-Generation Sequencing for Metastatic NSCLC in East Asia

Loong, Herbert H. F.; Wong, Carlos K. H.; Chan, Catherine; R, Chang; Zhou, Zheng–Yi; Tang, Wenxi; Gibbs, Meaghan

doi:10.1016/j.jtocrr.2022.100290

Cited by 8 publications

(7 citation statements)

References 36 publications

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“… 63 , 66 - 68 Furthermore, it is essential to determine the effect of NGS-directed treatments on the financial sustainability of GBS health care services. 69 - 71 Additionally, cost-reducing methods are required to facilitate equitable access to novel therapies for all patients. We propose that the Department of Health within the China GBA should actively engage with industry stakeholders to ensure access to expanded programs and robust capping measures to efficiently introduce clinically effective targeted therapies supported by evidence-based medicine.…”

Section: Resultsmentioning

confidence: 99%

Consensus Statements on Precision Oncology in the China Greater Bay Area

Lam,

Cho,

et al. 2023

JCO Precision Oncology

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BACKGROUND Next-generation sequencing comprehensive genomic panels (NGS CGPs) have enabled the delivery of tailor-made therapeutic approaches to improve survival outcomes in patients with cancer. Within the China Greater Bay Area (GBA), territorial differences in clinical practices and health care systems and strengthening collaboration warrant a regional consensus to consolidate the development and integration of precision oncology (PO). Therefore, the Precision Oncology Working Group (POWG) formulated standardized principles for the clinical application of molecular profiling, interpretation of genomic alterations, and alignment of actionable mutations with sequence-directed therapy to deliver clinical services of excellence and evidence-based care to patients with cancer in the China GBA. METHODS Thirty experts used a modified Delphi method. The evidence extracted to support the statements was graded according to the GRADE system and reported according to the Revised Standards for Quality Improvement Reporting Excellence guidelines, version 2.0. RESULTS The POWG reached consensus in six key statements: harmonization of reporting and quality assurance of NGS; molecular tumor board and clinical decision support systems for PO; education and training; research and real-world data collection, patient engagement, regulations, and financial reimbursement of PO treatment strategies; and clinical recommendations and implementation of PO in clinical practice. CONCLUSION POWG consensus statements standardize the clinical application of NGS CGPs, streamline the interpretation of clinically significant genomic alterations, and align actionable mutations with sequence-directed therapies. The POWG consensus statements may harmonize the utility and delivery of PO in China's GBA.

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Section: Resultsmentioning

confidence: 99%

Consensus Statements on Precision Oncology in the China Greater Bay Area

Lam,

Cho,

et al. 2023

JCO Precision Oncology

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“…In the de novo disease setting, an exclusionary workflow approach of only carrying out NGS testing in samples from patients who have tested negative for EGFR has been proposed and modeled and was found to be cost- and time-saving for the overall population in Hong Kong. 46 In Singapore, however, a similar study indicated that upfront NGS in all patients may still be cost-effective, despite a high prevalence of EGFR -mutant LC. 47 This may be due to the relatively lower costs of NGS testing using an in-house, small-panel, multiplex-gene NGS assay.…”

Section: Dissection and Adaptation Of Esmo Guidelines For The Use Of ...mentioning

confidence: 99%

Recommendations for the use of next-generation sequencing in patients with metastatic cancer in the Asia-Pacific region: a report from the APODDC working group

et al. 2023

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“…Epidermal growth factor receptor ( EGFR ) gene variation in non–small cell lung cancer (NSCLC) is associated with outcomes of EGFR–tyrosine kinase inhibitor (TKI) therapy, and osimertinib is superior to chemotherapy for patients with advanced NSCLC who acquire the EGFR Thr790Met variant (T790M) after first- and second-generation EGFR-TKI therapy . Although osimertinib is now the preferred first-line option, given its greater efficacy and intracranial response, use of up-front first- and second-generation EGFR-TKIs followed by osimertinib for T790M-altered NSCLC continues to be prevalent in East Asia . Yet studies show that only 60% to 80% of NSCLCs undergo molecular testing, with access to adequate tumor DNA being a major barrier …”

Section: Introductionmentioning

confidence: 99%

“…1,2 Although osimertinib is now the preferred first-line option, given its greater efficacy and intracranial response, use of up-front first-and secondgeneration EGFR-TKIs followed by osimertinib for T790Maltered NSCLC continues to be prevalent in East Asia. 3 Yet studies show that only 60% to 80% of NSCLCs undergo molecular testing, with access to adequate tumor DNA being a major barrier. 4,5 Thoracocentesis for cytological and molecular testing for malignant pleural effusion is recommended.…”

mentioning

confidence: 99%

Testing for EGFR Variants in Pleural and Pericardial Effusion Cell-Free DNA in Patients With Non–Small Cell Lung Cancer

Lee

Gai

et al. 2023

JAMA Oncol

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ImportanceMolecular testing in non–small cell lung cancer (NSCLC) is commonly limited by inadequate tumor sample. Plasma cell-free DNA (cfDNA) genotyping as a complementary test is specific but only moderately sensitive. Genotyping of cfDNA in pleural and pericardial effusion (PE-cfDNA) can further optimize molecular diagnostic yield and reduce the need for repeated biopsies.ObjectiveTo prospectively validate droplet digital polymerase chain reaction (ddPCR) for detection of sensitizing EGFR variants and acquired Thr790Met variant (T790M) from PE-cfDNA in patients with NSCLC.Design, Setting, and ParticipantsThis prospective diagnostic validation study was conducted between September 6, 2016, and January 21, 2021 at 2 major Hong Kong cancer centers. Patients with advanced NSCLC with both wild-type and variant EGFR status and exudative PE who underwent thoracocentesis or pericardiocentesis were randomly enrolled. Patients were either EGFR-tyrosine kinase inhibitor (TKI) naive (cohort 1) or EGFR-TKI treated but osimertinib naive (cohort 2). Enrolled patients underwent pleural- or pericardial-fluid and blood sampling for ddPCR EGFR testing. EGFR status results with ddPCR testing of PE-cfDNA and blood were compared with EGFR status in matched tumor biopsy or PE cell block samples.Main Outcomes and MeasuresSpecificity, sensitivity, and concordance of PE-cfDNA for detection of sensitizing EGFR variants and acquired T790M variation.ResultsAmong 171 patients (54% female) enrolled, there were 104 in cohort 1 and 67 in cohort 2. In cohort 1, 37% (38/102) were EGFR-variant positive; PE-cfDNA showed 97% sensitivity (95% CI, 92%-100%), 97% specificity (95% CI, 93%-100%), and 97% concordance (ĸ = 0.94, P &lt; .001) for the detection of sensitizing EGFR variants. It was more sensitive than plasma in detecting sensitizing EGFR variants (97% vs 74%, P &lt; .001). In cohort 2, 38% (15 of 40) were positive for the EGFR T790M variant; PE-cfDNA showed 87% sensitivity (95% CI, 69%-100%), 60% specificity (95% CI, 41%-79%), and 70% concordance (ĸ = 0.42, P = .004) for acquired T790M. The EGFR T790M variant was detected in 51% of PE-cfDNA vs 25% of PE cell block samples.Conclusions and RelevanceIn this diagnostic study, EGFR variants could be accurately detected from PE-cfDNA in patients with NSCLC. More EGFR T790M was detected in PE-cfDNA than in guideline-recommended PE cell block preparations. These results suggest that PE-cfDNA can complement plasma and tumor genotyping for detecting EGFR variants in patients with advanced NSCLC.

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Clinical and Economic Impact of Upfront Next-Generation Sequencing for Metastatic NSCLC in East Asia

Cited by 8 publications

References 36 publications

Consensus Statements on Precision Oncology in the China Greater Bay Area

Consensus Statements on Precision Oncology in the China Greater Bay Area

Recommendations for the use of next-generation sequencing in patients with metastatic cancer in the Asia-Pacific region: a report from the APODDC working group

Testing for EGFR Variants in Pleural and Pericardial Effusion Cell-Free DNA in Patients With Non–Small Cell Lung Cancer

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