Biomarkers in Non-Small Cell Lung Cancers: Indian Consensus Guidelines for Molecular Testing

Prabhash, Kumar; Advani, Suresh H.; Batra, Ullas; Biswas, Bivas; Chougule, Anuradha; Ghosh, Mithua; Muddu, Vamshi; Sahoo, Tapan Kumar; Vaid, Ashok

doi:10.1007/s12325-019-00903-y

Cited by 17 publications

(13 citation statements)

References 109 publications

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“…The characteristics of the CPGs are summarized in Table 1. Seven CPGs were established for SCLC (10-16), 20 for NSCLC (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36), and 22 for lung cancer regardless of histological subtype . The number of published CPGs increased every year, with a total of 22 CPGs published in 2020.…”

Section: Characteristics Of Selected Guidelinesmentioning

confidence: 99%

Evaluation of the reporting quality of clinical practice guidelines on lung cancer using the RIGHT checklist

Yang¹,

Lü²,

Ma³

et al. 2021

Transl Lung Cancer Res

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Background: In recent years, the number of clinical practice guidelines (CPGs) for lung cancer has increased, but the quality of these guidelines has not been systematically assessed so far. Our aim was to assess the reporting quality of CPGs on lung cancer published since 2018 using the International Reporting Items for Practice Guidelines in Health Care (RIGHT) instrument. Methods:We systematically searched the major electronic literature databases, guideline databases and medical society websites from January 2018 to November 2020 to identify all CPGs for small cell and nonsmall cell lung cancer (NSCLC). The search and extraction were completed using standardized forms.The quality of included guidelines was evaluated using the RIGHT statement. We present the results descriptively, including a stratification by selected determinants.Results: A total of 49 CPGs were included. The mean proportion across the guidelines of the 22 items of the RIGHT checklist that were appropriately reported was 57.9%. The items most common to be poorly reported were quality assurance (item 17) and description of the role of funders (item 18b), both of which were reported in only one guideline. The proportions of items within each of the seven domains of the RIGHT checklist that were correctly reported were Basic information 75.9%; background 83.2%; evidence 44.5%; recommendations 55.4%; review and quality assurance 12.2%; funding and declaration and management of interests 42.9%; and other information 38.1%. The reporting quality of guidelines did not differ between publication years. CPGs published in journals with impact factor >30 tended to be best reported. Conclusions:Our results revealed that reporting in CPGs for lung cancer is suboptimal. Particularly the declaration of funding and quality assurance are poorly reported in recent CPGs on lung cancer.

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Section: Characteristics Of Selected Guidelinesmentioning

confidence: 99%

Evaluation of the reporting quality of clinical practice guidelines on lung cancer using the RIGHT checklist

Yang¹,

Lü²,

Ma³

et al. 2021

Transl Lung Cancer Res

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“…In NSCLC, the ALK gene rearrangement results in a fusion protein containing a dysregulated, constitutively active ALK kinase domain. 24,[60][61][62][63][64] Although evidence of ALK rearrangement is present in only 2-12% of all NSCLC cases, 42,[65][66][67] approximately 60% of patients will respond to targeted ALK inhibition 17 using therapies such as alectinib, brigatinib, ceritinib, crizotinib and lorlatinib. [68][69][70][71][72][73][74] Clinical characteristics associated with the ALK gene rearrangement include AdC histology, never-/light-smoking history and younger age.…”

Section: Alk Rearrangementsmentioning

confidence: 99%

“…Advanced polymerase chain reaction (PCR)-based methods, such as amplified refractory mutation system (ARMS)-PCR, real-time or quantitative PCR (qPCR), reverse transcriptase PCR (RT-PCR), Sanger sequencing (ideally paired with tumor enrichment) and NGS are the most common methodologies for examining EGFR mutation status (Tables 1 and 2). 14,17 Guidelines issued by CAP, IASLC and AMP strongly recommend against using total EGFR expression by immunohistochemistry (IHC) testing to select patients for EGFR-targeted TKI therapy. 81 The gold standard for analyzing mutations is direct sequencing.…”

Section: Egfr Testingmentioning

confidence: 99%

“…In general, patients with activating mutations, such as exon 19 deletions and exon 21 mutations (L858R), are more responsive to TKIs. Conversely, acquired resistance mutations, such as the exon 20 T790M substitution, which is detected using circulating tumor DNA (ctDNA), 17 is associated with poorer response to TKIs and disease progression within the first year of TKI treatment. 18 Osimertinib is a recent EGFR TKI which was developed in response to the resistant exon 20 T790M substitution.…”

Section: Introductionmentioning

confidence: 99%

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Testing for EGFR Mutations and ALK Rearrangements in Advanced Non-Small-Cell Lung Cancer: Considerations for Countries in Emerging Markets

Dalurzo¹,

Avilés‐Salas²,

Soares³

et al. 2021

OTT

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The treatment of patients with advanced non-small-cell lung cancer (NSCLC) in recent years has been increasingly guided by biomarker testing. Testing has centered on driver genetic alterations involving the epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements. The presence of these mutations is predictive of response to targeted therapies such as EGFR tyrosine kinase inhibitors (TKIs) and ALK TKIs. However, there are substantial challenges for the implementation of biomarker testing, particularly in emerging countries. Understanding the barriers to testing in NSCLC will be key to improving molecular testing rates worldwide and patient outcomes as a result. In this article, we review EGFR mutations and ALK rearrangements as predictive biomarkers for NSCLC, discuss a selection of appropriate tests and review the literature with respect to the global uptake of EGFR and ALK testing. To help improve testing rates and unify procedures, we review our experiences with biomarker testing in China, South Korea, Russia, Turkey, Brazil, Argentina and Mexico, and propose a set of recommendations that pathologists from emerging countries can apply to assist with the diagnosis of NSCLC.

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“…The biggest hurdles faced by clinicians are genetic data interpretation, finding genetic links for complex conditions, and lack of actionable genetic information. In certain cases of complex conditions, such as cancer, an array of genetic tests might be ordered to determine the genetic cause (Prabhash et al, 2019). However, no findings may come to light, thus posing a challenge for the patient and the clinician.…”

Section: Challenges and Limitationsmentioning

confidence: 99%

A Review on the Challenges in Indian Genomics Research for Variant Identification and Interpretation

et al. 2020

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Today, genomic data holds great potential to improve healthcare strategies across various dimensions-be it disease prevention, enhanced diagnosis, or optimized treatment. The biggest hurdle faced by the medical and research community in India is the lack of genotype-phenotype correlations for Indians at a population-wide and an individual level. This leads to inefficient translation of genomic information during clinical decision making. Population-wide sequencing projects for Indian genomes help overcome hurdles and enable us to unearth and validate the genetic markers for different health conditions. Machine learning algorithms are essential to analyze huge amounts of genotype data in synergy with gene expression, demographic, clinical, and pathological data. Predictive models developed through these algorithms help in classifying the individuals into different risk groups, so that preventive measures and personalized therapies can be designed. They also help in identifying the impact of each genetic marker with the associated condition, from a clinical perspective. In India, genome sequencing technologies have now become more accessible to the general population. However, information on variants associated with several major diseases is not available in publicly-accessible databases. Creating a centralized database of variants facilitates early detection and mitigation of health risks in individuals. In this article, we discuss the challenges faced by genetic researchers and genomic testing facilities in India, in terms of dearth of public databases, people with knowledge on machine learning algorithms, computational resources and awareness in the medical community in interpreting genetic variants. Potential solutions to enhance genomic research in India, are also discussed.

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Biomarkers in Non-Small Cell Lung Cancers: Indian Consensus Guidelines for Molecular Testing

Cited by 17 publications

References 109 publications

Evaluation of the reporting quality of clinical practice guidelines on lung cancer using the RIGHT checklist

Evaluation of the reporting quality of clinical practice guidelines on lung cancer using the RIGHT checklist

Testing for EGFR Mutations and ALK Rearrangements in Advanced Non-Small-Cell Lung Cancer: Considerations for Countries in Emerging Markets

A Review on the Challenges in Indian Genomics Research for Variant Identification and Interpretation

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