Molecular profiling in Italian patients with advanced non-small-cell lung cancer: An observational prospective study

Gobbini, Elisa; Galetta, Domenico; Tiseo, Marcello; Graziano, Paolo; Rossi, Antonio; Bria, Emilio; Maïo, Massimo Di; Rossi, Giulio; Gregorc, Vanesa; Riccardi, Ferdinando; Scotti, Vieri; Ceribelli, Anna; Buffoni, L; Delmonte, Angelo; Franchina, Tindara; Migliorino, Maria Rita; Cortinovis, Diego; Pisconti, Salvatore; Bordi, Paola; Catino, Annamaria; Maiello, Evaristo; Arizio, Francesca; Novello, Silvia

doi:10.1016/j.lungcan.2017.06.009

Cited by 29 publications

(44 citation statements)

References 27 publications

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“…Recently, several reports reflecting the reality in different countries have been published. 8,22,[24][25][26] Most studies reported a high re-biopsy success rate, ranging from 75% to 97%, 6,7,9,11 similar to the results of our study. The rebiopsy complication rate is reported to be 1.3-5.8%, 10,11 which is similar to that of initial lung biopsy.…”

Section: Discussionsupporting

confidence: 90%

Feasibility of re‐biopsy and EGFR mutation analysis in patients with non‐small cell lung cancer

Kim

Kho

et al. 2018

Thoracic Cancer

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BackgroundIn cases of EGFR‐tyrosine kinase inhibitor (TKI) failure, re‐biopsy may be useful to understand resistance mechanisms and guide further treatment decisions. However, performing re‐biopsy is challenging because of several hurdles. We assessed the feasibility of re‐biopsy in advanced non‐small cell lung cancer (NSCLC) patients in real‐world clinical practice.MethodsWe retrospectively reviewed the clinical and pathologic data of advanced NSCLC patients who experienced disease progression after previous treatment with EGFR‐TKIs at a single tertiary hospital in Korea between January 2014 and December 2016. Re‐biopsy specimens included small biopsy, surgical tissue, or liquid‐based cytology. EGFR mutation was tested using peptide nucleic acid‐mediated clamping PCR.ResultsOf the 230 NSCLC patients that experienced progression after EGFR‐TKI therapy, 105 (45.7%) underwent re‐biopsy. Re‐biopsy was successfully performed in 94 (89.5%) patients, and 11 patients were diagnosed with no malignancy. The complication rate was 8.6%, including seven cases of pneumothorax. EGFR mutation testing was performed on 75 patients using re‐biopsy specimens. Of the 57 patients who had sensitizing mutations at diagnosis, T790M mutations were found in 19 (33.3%), while 38 (66.7%) had no T790M mutation. Multivariate analysis showed that the re‐biopsy group was younger (P = 0.002) and exhibited a previous response to EGFR‐TKIs (P < 0.001).ConclusionRe‐biopsy in advanced NSCLC is feasible in real world clinical practice, particularly in younger patients and those who achieved a previous response to EGFR‐TKIs.

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Section: Discussionsupporting

confidence: 90%

Feasibility of re‐biopsy and EGFR mutation analysis in patients with non‐small cell lung cancer

Kim

Kho

et al. 2018

Thoracic Cancer

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“…In the event of disease progression (secondline treatment), the strategy provides for the execution of a second tissue biopsy for all patients eligible for the tissue re-biopsy and the second-line treatment [3]. For the other patients eligible for treatment, but not for the tissue re-biopsy, no diagnostic investigation is provided.…”

Section: Methodsmentioning

confidence: 99%

“…From these, the cases of NSCLC were first calculated [3], and then those with a diagnosis of adenocarcinoma, squamous cell carcinoma or large cell carcinoma were identified [14]. 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.…”

Section: Populationmentioning

confidence: 99%

“…Among the patients who perform the tissue biopsy, the outcome may not be determinable in 30% of cases [16]. Finally, 40% of patients with a mNSCLC diagnosis are eligible to receive the second-line treatment [3]; of them, 82% are eligible for the tissue re-biopsy [5] and 100% for the liquid one. Table II shows the percentages of sensitivity and specificity associated with the COBAS ® test performed on tissue (tissue biopsy) or plasma (liquid biopsy) samples and considered here [17,18].…”

Section: Populationmentioning

confidence: 99%

“…Patients eligible for the second-line treatment (40.0%) 6,890 [3] Patients eligible for the tissue re-biopsy (82.0%) 5,650 [5] Patients eligible for the liquid biopsy (100.0%) 6,890 Assumption [17,18] determining the presence of DNA mutations, only the sampling of venous blood is provided for. Every single specialist outpatient service was then attributed a value, considering the respective fee refunded by the NHS [20].…”

Section: Second-line Treatmentmentioning

confidence: 99%

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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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High frequency of exon 20 S768I EGFR mutation detected in malignant pleural effusions: A poor prognosticator of NSCLC

et al. 2020

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Background: Lung cancer is the cause of a fourth of all cancer-related deaths. About a third of all lung adenocarcinoma tumours harbour mutations on exons 18 to 21 of the epidermal growth factor receptor (EGFR) gene. Detection of these mutations allows for targeted therapies in the form of EGFR Tyrosine kinase inhibitors. Recently, "liquid biopsies" have emerged as an alternative to conventional tissue mutation detection. Aim: In this pilot study, we attempted to optimize EGFR mutation detection from malignant pleural effusions (MPEs) as "liquid biopsies" when tissue biopsies were unavailable. Resulting mutations were then to be mapped on the EGFR gene and explored using cBioPortal, a public cancer genomic database. Methods and results: We first attempted a direct sequencing approach and showed that single nucleotide variants (SNVs) were likely to be missed in MPEs. We then switched to and optimized an EGFR mutant-specific quantitative polymerase chain reaction-based assay. This assay was piloted on n = 10 pleural effusion samples (one non-malignant pleural effusion as a negative control). 5/9 (55.55%) samples harboured EGFR mutations with 2/9 (22.22%) being exon 19 deletions and 3/9 (33.33%) the S768I mutation. The frequency of the S768I SNV in our study was significantly higher than that observed in other studies (0.2%). Utilizing cBioPortal data, we report that patients with S768I have a shorter median survival time (6 months vs 38 months), progression-free survival time (8 months vs 44 months) and lower tumor mutation count compared to patients with other EGFR mutations. Conclusions: The shorter survival of patients with the S768I SNV predicts aggressive disease and poor prognosis as a result of this mutation. Studies in larger cohorts and/or animal models are necessary to confirm these findings.

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Molecular profiling in Italian patients with advanced non-small-cell lung cancer: An observational prospective study

Cited by 29 publications

References 27 publications

Feasibility of re‐biopsy and EGFR mutation analysis in patients with non‐small cell lung cancer

Feasibility of re‐biopsy and EGFR mutation analysis in patients with 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

High frequency of exon 20 S768I EGFR mutation detected in malignant pleural effusions: A poor prognosticator of NSCLC

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