Logo MSM

Call: +1.631.470.9640
Mon - Fri 10:00 am - 02:00 pm EST

Contact Us

Logo MSM Logo MSM Logo MSM

24 May 2021: Editorial

Editorial: 2021 European Society for Medical Oncology (ESMO) Recommendations on Laboratory Diagnostics for Gene Fusions and Mutations: A New Era in Targeted Therapy for -Altered Solid Tumors

Dinah V. Parums *

DOI: 10.12659/MSM.933206

Med Sci Monit 2021; 27:e933206

Abstract

ABSTRACT: During the past four decades, the identification of phenotypic changes in malignant tumor cells has been refined by the standardization of immunohistochemistry methods. Regulatory-approved companion diagnostics were initially developed for immunohistochemistry and to support early tumor tissue-based clinical trials. In the last decade, molecular profiling and gene sequencing data have identified specific molecular targets that have resulted in increasing drug development programs and regulatory approvals. As an example, RET-altered cancers include RET gene mutations and RET gene fusions. In January 2021, the European Society for Medical Oncology (ESMO) published new guidelines for routine clinical laboratory detection of targetable RET gene rearrangements and mutations. FDA approval has now been given for selpercatinib for RET fusion-positive NSCLC and papillary thyroid cancer, and RET mutation-positive thyroid cancer. This Editorial aims to present a brief overview of the evolution of personalized medicine in oncology and how the 2021 ESMO guidelines have anticipated the need to detect targetable RET-altered tumors using technology currently available in accredited clinical diagnostic laboratories.

Keywords: Editorial, Gene Rearrangement, Mutation, Immunohistochemistry, Polymerase Chain Reaction, Sequence Analysis, Protein

Conclusions

During the past four decades, the identification of phenotypic changes in malignant tumor cells has been refined by the standardization of immunohistochemistry methods. Twenty years ago, the development of regulatory-approved companion diagnostics occurred in parallel with initial clinical trials using human tumor tissue samples, initially from patients with NSCLC. In the past decade, molecular profiling and gene sequencing developments have taken personalized medicine to a new level, as shown by RET-altered cancers. The 2021 ESMO guidelines have anticipated the need to detect targetable RET gene rearrangements and mutations in patients with advanced malignancy using technology currently available in accredited clinical diagnostic laboratories.

References

1. Hirsch FR, Dziadziuszko R, Thatcher N: Epidermal growth factor receptor immunohistochemistry: Comparison of antibodies and cutoff points to predict benefit from gefitinib in a phase 3 placebo-controlled study in advanced non-small cell lung cancer: Cancer, 2008; 112(5); 1114-21

2. Parums DV: Current status of targeted therapy in non-small cell lung cancer: Drugs Today (Barc), 2014; 50(7); 503-25

3. Donovan MJ, Kotsianti A, Bayer-Zubek V: A systems pathology model for predicting overall survival in patients with refractory, advanced non-small-cell lung cancer treated with gefitinib: Eur J Cancer, 2009; 45(8); 1518-26

4. Donovan MJ, Kotsianti A, Bayer-Zubek V:: Companion Diagnostics, 2021

5. Donovan MJ, Kotsianti A, Bayer-Zubek V:: List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools), 2021

6. Arighi E, Borrello MG, Sariola H: tyrosine kinase signaling in development and cancer: Cytokine Growth Factor Rev, 2005; 16; 441-67

7. Subbiah V, Roszik J: Towards precision oncology in -aberrant cancers: Cell Cycle, 2017; 16; 813-14

8. Belli C, Penault-Llorca F, Ladanyi M: ESMO recommendations on the standard methods to detect fusions and mutations in daily practice and clinical research: Ann Oncol, 2021; 32(3); 337-50

9. Drilon A, Oxnard GR, Tan DSW: Efficacy of selpercatinib in fusion-positive non-small cell lung cancer: N Engl J Med, 2020; 383; 813-24

10. Wirth LJ, Sherman E, Robinson B: Efficacy of selpercatinib in -altered thyroid cancers: N Engl J Med, 2020; 383; 825-35

Coronavirus/Covid 19

08 September 2021 : Clinical Research

Acceptance of COVID-19 Vaccination and Its Associated Factors Among Cancer Patients Attending the Oncology ...

Med Sci Monit In Press; DOI: 10.12659/MSM.932788  

16 July 2021 : Review article

Silent Hypoxemia in Patients with COVID-19 Pneumonia: A Review

Med Sci Monit In Press; DOI: 10.12659/MSM.930776  

09 July 2021 : Database Analysis

A Simple Clinical Prediction Tool for COVID-19 in Primary Care with Epidemiology: Temperature-Leukocytes-CT...

Med Sci Monit In Press; DOI: 10.12659/MSM.931467  

In Press

20 Sep 2021 : Clinical Research

Comparison of the Use of Magnetic Resonance Imaging of Partial Anterior Cruciate Ligament Tears Using Maxim...

Med Sci Monit In Press; DOI: 10.12659/MSM.932228  

20 Sep 2021 : Clinical Research

Automated Boluses and Delayed-Start Timers Prolong Perineural Local Anesthetic Infusions and Analgesia Foll...

Med Sci Monit In Press; DOI: 10.12659/MSM.933190  

16 Sep 2021 : Clinical Research

A Retrospective Evaluation of Operative and Postoperative Outcomes in Patients with Spinal Metastases from ...

Med Sci Monit In Press; DOI: 10.12659/MSM.932995  

15 Sep 2021 : Clinical Research

Polish Medical Air Rescue Interventions Concerning Pregnant Women in Poland: A 10-year Retrospective Analysis

Med Sci Monit In Press; DOI: 10.12659/MSM.933029  

Most Viewed

20 Mar 2020 : Clinical Research

Social Capital and Sleep Quality in Individuals Who Self-Isolated for 14 Days During the Coronavirus Diseas...

DOI :10.12659/MSM.923921

Med Sci Monit 2020; 26:e923921

15 Apr 2020 : Clinical Research

Psychological Impact and Coping Strategies of Frontline Medical Staff in Hunan Between January and March 20...

DOI :10.12659/MSM.924171

Med Sci Monit 2020; 26:e924171

05 May 2020 : Review article

An Evidence Based Perspective on mRNA-SARS-CoV-2 Vaccine Development

DOI :10.12659/MSM.924700

Med Sci Monit 2020; 26:e924700

26 Apr 2020 : Clinical Research

Comparison of Prevalence and Associated Factors of Anxiety and Depression Among People Affected by versus P...

DOI :10.12659/MSM.924609

Med Sci Monit 2020; 26:e924609

Your Privacy

We use cookies to ensure the functionality of our website, to personalize content and advertising, to provide social media features, and to analyze our traffic. If you allow us to do so, we also inform our social media, advertising and analysis partners about your use of our website, You can decise for yourself which categories you you want to deny or allow. Please note that based on your settings not all functionalities of the site are available. View our privacy policy.

Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750