Cross-Validation Study for Epidermal Growth Factor Receptor and KRAS Mutation Detection in 74 Blinded Non-small Cell Lung Carcinoma Samples: A Total of 5550 Exons Sequenced by 15 Molecular French Laboratories (Evaluation of the EGFR Mutation Status for the Administration of EGFR-TKIs in Non-Small Cell Lung Carcinoma [ERMETIC] Project—Part 1)

Beau‐Faller, Michèle; Degeorges, Armelle; Rolland, Estelle; Mounawar, Mounia; Antoine, Martine; Poulot, Virginie; Mauguen, Audrey; Barbu, Véronique; Coulet, Florence; Prétet, Jean‐Luc; Bièche, Ivan; Blons, Hélène; Boyer, Jean-Christophe; Buisine, Marie‐Pierre; Fraipont, Florence de; Lizard, Sarab; Olschwang, Sylviane; Saulnier, Patrick; Prunier-Mirebeau, Delphine; Richard, Nicolas; Danel, Claire; Brambilla, Élisabeth; Chouaïd, C.; Zalcman, Gérard; Hainaut, Pierre; Michiels, Stefan; Cadranel, Jacques

doi:10.1097/jto.0b013e318211dcee

Cited by 51 publications

(42 citation statements)

References 21 publications

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“…However, the ERMETIC study was designed to assess concordance of results between each centres (blinded cross validation study compared to an international reference lab) and between the different methods used in such centres (direct sequencing, PCR-based, Restriction fragment-length polymorphism, and high-resolution melting). This validation study showed good concordance rate suggesting that, despite some difference in sample processing and analyses, results are accurate [12,13].…”

Section: Biomarker Analysesmentioning

confidence: 88%

BioCAST/IFCT-1002: epidemiological and molecular features of lung cancer in never-smokers

et al. 2015

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Lung cancer in never-smokers (LCINS) (fewer than 100 cigarettes in lifetime) is considered as a distinct entity and harbours an original molecular profile. However, the epidemiological and molecular features of LCINS in Europe remain poorly understood.All consecutive newly diagnosed LCINS patients were included in this prospective observational study by 75 participating centres during a 14-month period. Each patient completed a detailed questionnaire about risk factor exposure. Biomarker and pathological analyses were also collected. We report the main descriptive overall results with a focus on sex differences.384 patients were included: 65 men and 319 women. 66% had been exposed to passive smoking (significantly higher among women). Definite exposure to main occupational carcinogens was significantly higher in men (35%versus8% in women). A targetable molecular alteration was found in 73% of patients (without any significant sex difference):EGFRin 51%,ALKin 8%,KRASin 6%,HER2in 3%,BRAFin 3%,PI3KCAin less than 1%, and multiple in 2%.We present the largest and most comprehensive LCINS analysis in a European population. Physicians should track occupational exposure in men (35%), and a somatic molecular alteration in both sexes (73%).

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Section: Biomarker Analysesmentioning

confidence: 88%

BioCAST/IFCT-1002: epidemiological and molecular features of lung cancer in never-smokers

et al. 2015

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“…Briefly, the median age was 63 yrs, 32% of patients were female, 87% were Caucasian, 18% had never smoked, 65% had adenocarcinoma and 8.4% had EGFR mutations (table 1). The patients' EGFR statuses were systematically sought: testing was carried out by sequencing in each centre, under a national quality assurance programme [19]. The GFPC0506 study was a phase III, randomised, multicentre trial comparing the CERs of docetaxel and pemetrexed as second-line treatments for NSCLC.…”

Section: Clinical Inputsmentioning

confidence: 99%

“…The study, entitled ''Evaluation of EGFR mutation status for EGFR-[tyrosine kinase inhibitor]TKI administration in nonsmall-cell lung carcinoma (ERMETIC)'', involved 16 French clinical centres, and pathology and medical laboratories. The project had three successive objectives: 1) to validate routine sequencing-based screening for EGFR and KRAS mutations on fixed paraffin-embedded tissues [19]; 2) to select and rank clinical, pathological and biological predictors of the response to EGFR-TKIs and the resulting clinical benefit in a large prospective patient cohort [8]; and 3) to determine the most cost-effective strategy for prescribing EGFRTKIs, with or without the use of EGFR biomarkers. The present study focuses on part 3 of the ERMETIC project.…”

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confidence: 99%

Cost-effectiveness of three strategies for second-line erlotinib initiation in nonsmall-cell lung cancer: the ERMETIC study part 3

Borget¹,

Cadranel²,

Pignon³

et al. 2011

Eur Respir J

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Several clinical and biological parameters are known to influence the efficacy of second-line erlotinib therapy for nonsmall cell lung cancer (NSCLC), but their medico-economic impact has not been evaluated. The objective of this study was to compare the incremental costeffectiveness ratios of strategies for second-line erlotinib initiation in NSCLC: clinically guided initiation (nonsmoking females with adenocarcinoma received erlotinib; all other patients received docetaxel) and biologically guided selection (patients with epidermal growth factor receptor (EGFR) mutation received erlotinib; patients with wild-type EGFR or unknown status received docetaxel), compared with initiation with no patient selection (strategy reference).A Markov model was constructed. Outcomes (overall and progression-free survival), transition probabilities and direct medical costs (from the French third-party payer's perspective) were prospectively collected for individual patients treated with either erlotinib or docetaxel, from treatment initiation to disease progression. Published data were used to estimate utilities and post-progression costs. Sensitivity analyses were performed.The biologically and clinically guided strategies were both more efficient (incremental qualityadjusted life-yrs equal to 0.080 and 0.081, respectively) and less expensive (cost decrease equal to J5,020 and J5,815, respectively) than the no-selection strategy, and the biologically guided strategy was slightly less expensive than the clinically guided strategy. Sensitivity analyses confirmed the robustness of the results.The cost-effectiveness of second-line NSCLC treatment is improved when patients are selected on either clinical or biological grounds.

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“…Recent progress in molecular biology techniques has resolved this issue for EGFR mutations in metastatic NSCLC by using cost-effective and sensitive allele-specific PCR-based assays or nextgeneration sequencing. This latter technology raises the issue of cost-effectiveness and some discordance across different laboratories is still being observed [33].…”

Section: Biomarkers Of Platinum-based Chemotherapy Efficacymentioning

confidence: 99%

Predictive biomarkers in patients with resected non-small cell lung cancer treated with perioperative chemotherapy

et al. 2013

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The aim of this article is to summarise the published data on prognostic and predictive biomarkers for early-stage non-small cell lung cancer (NSCLC), and discuss how to integrate them into clinical trials. Large phase III trials have been published in resected NSCLC with biomarkers identifying subsets of patients benefitting from perioperative chemotherapy. Initial findings of predictive implications for the DNA repair protein, ERCC1, were not confirmed in a larger series of patients due to the versatility of the commercially available monoclonal ERCC1 antibody. Prediction of survival by RRM1 tumour expression was not confirmed in a prospective phase III trial in 275 patients with stage IV disease, precluding its use in early-stage NSCLC. BRCA1 mRNA tumour content also failed to predict platinum resistance in 287 stage IV NSCLC patients included in a phase II trial, and the results of a similar trial in early-stage patients are still pending. Of the several cDNA gene expression studies in early-stage NSCLC with non-overlapping prognostic signatures, few have been replicated in independent cohorts for prognostic value, and none received external validation for predictive value. Therefore, use of biomarkers predicting chemotherapy efficacy still needs additional validation before becoming routine practice in oncogenedriven pan-negative NSCLC patients. @ERSpublications Predictive biomarkers to tailor NSCLC perioperative chemotherapy are not validated yet and better tools are still needed

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Cited by 51 publications

References 21 publications

BioCAST/IFCT-1002: epidemiological and molecular features of lung cancer in never-smokers

BioCAST/IFCT-1002: epidemiological and molecular features of lung cancer in never-smokers

Cost-effectiveness of three strategies for second-line erlotinib initiation in nonsmall-cell lung cancer: the ERMETIC study part 3

Predictive biomarkers in patients with resected non-small cell lung cancer treated with perioperative chemotherapy

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