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

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Abstract

Novel molecular targets and promising targeted therapies have reshaped diagnostics in patients with advanced non-small cell lung cancer (NSCLC). Despite this progress, the implementation of molecular screening to identify predictive biomarkers in Indian clinical and pathology settings has been challenging due to operational and logistical constraints. This consensus guideline brings together medical oncologists, molecular pathologists and pathologists from India to provide a quick and competent reference for biomarker testing in NSCLC. The guideline summarizes the importance of targetable mutations in NSCLC such as epidermal growth factor receptor (EGFR), rearrangements in anaplastic lymphoma kinase and receptor tyrosine kinase encoded by ROS-1 gene, overexpression of programmed cell death ligand-1 and resistant EGFR mutations. It reaffirms recommendations from international working groups, discusses vulnerable pre-analytical procedures and provides a balanced review on the pros and cons of different diagnostic tests (immunohistochemistry, fluorescence in situ hybridization, polymerase chain reaction-based testing and next-generation sequencing). The document also provides an algorithm to aid diagnostic decision-making and a checklist to assess the quality of testing laboratories that will help the medical oncologists make an informed choice. Overall, these recommendations are based on evidence and clinical experience and will aid policymakers, oncologists, health care practitioners and pathologists who strive to implement molecular strategies and make informed decisions for improved care in NSCLC in India.

Funding: AstraZeneca Pharma India Limited.

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Acknowledgements

Springer Healthcare is not responsible for the validity of guidelines it publishes.

Funding

The preparation of this article and funding of the journal’s article processing charges was supported by AstraZeneca Pharma India Limited. All authors had full access to the information used to compile this work and take complete responsibility for the integrity and accuracy of these guidelines.

Medical Writing Assistance

The authors thank Priya Ganpathy from SIRO Clinpharm Pvt. Ltd. for providing medical writing assistance in the development of this manuscript. They also thank AstraZeneca Pharma India Ltd for funding this assistance.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosures

All named authors (Kumar Prabhash, Suresh Advani,Ullas Batra, Biswas Bivas, Anuradha Chougule, Mithua Ghosh, Krishna M Vamshi, T. P. Sahoo and A. K. Vaid) declare that they have no conflicts of interest regarding the publication of this article.

Compliance with Ethics Guidelines

This is a consensus guideline based on evidence obtained from published literature and does not contain any studies with human participants or animals performed by any of the authors.

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Authors and Affiliations

  1. Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Center, Mumbai, Maharashtra, India

    Kumar Prabhash & Anuradha Chougule

  2. Department of Medical Oncology, Jaslok Hospital and Research Centre, Mumbai, Maharashtra, India

    Suresh H. Advani

  3. Department of Thoracic Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India

    Ullas Batra

  4. Department of Medical Oncology, Tata Medical Center, Kolkata, West Bengal, India

    Bivas Biswas

  5. Department of Clinical Genomics and Translational Research, Triesta Sciences, Bengaluru, Karnataka, India

    Mithua Ghosh

  6. Department of Medical Oncology, Apollo Health City, Jubilee Hills, Hyderabad, Telangana, India

    Vamshi Krishna Muddu

  7. Department of Medical Oncology, Chirayu Medical College and Hospital, Bhopal, Madhya Pradesh, India

    T. P. Sahoo

  8. Department of Medical and Hemato-oncology, Cancer Institute, Medanta - The Medicity, Gurugram, Haryana, India

    Ashok K. Vaid

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  1. Kumar Prabhash
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Correspondence to Kumar Prabhash.

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Prabhash, K., Advani, S.H., Batra, U. et al. Biomarkers in Non-Small Cell Lung Cancers: Indian Consensus Guidelines for Molecular Testing. Adv Ther 36, 766–785 (2019). https://doi.org/10.1007/s12325-019-00903-y

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