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| ORIGINAL ARTICLE
|Year : 2022 | Volume
| Issue : 5 | Page : 11-18
CONCORDANCE: A real-world evidence study to evaluate the concordance of detecting epidermal growth factor receptor (EGFR) mutation by circulating tumor DNA* versus tissue biopsy in patients with metastatic non-small cell lung cancer
Kumar Prabhash1, Bivas Biswas2, Sachin Khurana3, Ullas Batra4, Ghanashyam Biswas5, Suresh Hariram Advani6, Prabrajya N Mohapatra7, Senthil Rajappa8, Ajay Sharma9, Shekhar Patil10, Palanki Satya Dattatreya11, Rakesh Roy12, Sachin Almel13, Gautam Goyal14, Narayanankutty Warrier15
1 Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha Block, Parel, Mumbai, Maharashtra, India
2 Department of Medical Oncology, Tata Medical Center Trust, 14 MAR(EW), New Town, Kolkata, West Bengal, India
3 Department of Medical Oncology, All India Institute of Medical Sciences, Ansari Nagar East, Delhi, India
4 Department of Medical Oncology, Rajiv Gandhi Cancer Institute & Research Centre, Rohini, New Delhi, India
5 Department of Medical Oncology, Sparsh Hospitals and Critical Care (P) Ltd, Bhubaneswar, Odisha, India
6 Department of Medical Oncology, Sushrut Hospital, Chembur East, Mumbai, Maharashtra, India
7 Department of Medical Oncology, Apollo Gleneagles Hospitals 58, Kolkata, West Bengal, India
8 Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills, Hyderabad, Telangana, India
9 Department of Medical Oncology, Action Cancer Hospital, New Delhi, India
10 Department of Medical Oncology, Healthcare Global Enterprises Ltd, Bengaluru, Karnataka, India
11 Department of Medical Oncology, Omega Hospitals, Banjara Hills, Hyderabad, Telangana, India
12 Department of Medical Oncology, Saroj Gupta Cancer Centre & Research Institute, Thakurpukur, Kolkata, West Bengal, India
13 Department of Medical Oncology, P.D. Hinduja Hospital & Medical Research Centre, 908 9th floor Research Department Veer Savarkar Marg Mahim, Mumbai, Maharashtra, India
14 Department of Medical Oncology, Max Super Speciality Hospital, Room No 143 Basement 2 Phase 6 Sahibzada Ajit Singh Nagar, Chandigarh, Punjab, India
15 Department of Medical Oncology, MVR Cancer Centre & Research Centre, Vellalaserry NIT Poolacode Choolur, Kozhikode, Kerala, India
Background: Molecular tissue testing in non-small cell lung cancer (NSCLC) is done for the assessment of epidermal growth factor receptor (EGFR) mutation. EGFR mutation status is the basis for deciding the targeted treatment option for patients with metastatic NSCLC. The nonavailability of tissue samples and contraindications for biopsy pose a significant challenge. Hence, circulating tumor DNA (ctDNA) by liquid biopsy can be a viable alternative for NSCLC patients.
Methods: This study was conducted at 15 sites across India. EGFR mutation testing from plasma was done as part of the study at the central laboratory by the next-generation sequencing (NGS) method, and EGFR mutation test results from tissue samples (done as part of routine practice) were recorded for all the patients.
Results: Out of the total patients enrolled (N = 245), the majority (64.5%, n = 158) were men. The median age of patients was 58.0 (range: 26–84) years. The concordance between plasma and tissue testing was found to be 82.9% (95% confidence interval [CI]: 77.55, 87.45). The sensitivity and specificity of NGS were 68.4% (95% CI: 56.92, 78.37) and 90.1% [95% CI: 84.36, 94.21), respectively. Plasma testing detected 1.2% (n = 3) and tissue sample testing detected 2.4% (n = 6) positive status of exon 20 T790M EGFR mutation. Out of the total number of patients enrolled, 25 were tissue positive and plasma negative, while 16 were plasma positive and tissue negative.
Conclusions: This real-world study in Indian patients suggests that plasma testing for EGFR mutation analysis is a viable diagnostic option in newly diagnosed advanced/metastatic NSCLC patients. The noninvasive plasma procedure in patients without available/evaluable tumor sample may enable more patients to receive appropriate targeted therapies by providing clinicians with valuable insights into the patient's tumor mutation status.
ClinicalTrials.gov Identifier: NCT03562819
Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha Block, Parel, Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None
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