Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Circulating Tumor Cell Assay to Non-Invasively Evaluate PD-L1 and Other Therapeutic Targets in Multiple Cancers

Version 1 : Received: 24 January 2022 / Approved: 25 January 2022 / Online: 25 January 2022 (11:31:05 CET)

How to cite: Page, R.; Patil, D.; Akolkar, D.; Murthy, S.S.; Bendale, K.; Patil, R.; Fulmali, P.; Fulmali, P.; Adhav, A.; Puranik, S.; Apurwa, S.; Datta, V.; Bose, C.; Schuster, S.; John, J.; Srinivasan, A.; Datar, R. Circulating Tumor Cell Assay to Non-Invasively Evaluate PD-L1 and Other Therapeutic Targets in Multiple Cancers. Preprints 2022, 2022010380 (doi: 10.20944/preprints202201.0380.v1). Page, R.; Patil, D.; Akolkar, D.; Murthy, S.S.; Bendale, K.; Patil, R.; Fulmali, P.; Fulmali, P.; Adhav, A.; Puranik, S.; Apurwa, S.; Datta, V.; Bose, C.; Schuster, S.; John, J.; Srinivasan, A.; Datar, R. Circulating Tumor Cell Assay to Non-Invasively Evaluate PD-L1 and Other Therapeutic Targets in Multiple Cancers. Preprints 2022, 2022010380 (doi: 10.20944/preprints202201.0380.v1).

Abstract

Biomarker directed selection of targeted anti-neoplastic agents such as immune check-point inhibitors, small molecule inhibitors and monoclonal antibodies form an important aspect of cancer treatment. Immunohistochemistry (IHC) analysis of the tumor tissue is the method of choice to evaluate the presence of these biomarkers. However, a significant barrier to biomarker testing on tissue is the availability of an adequate amount of tissue and need for repetitive sampling due to tumor evolution. Also, tumor tissue testing is not immune to inter- and intra-tumor heterogeneity. We describe the analytical and clinical validation of a Circulating Tumor Cell (CTC) assay to accurately assess the presence of PD-L1 22C3 and PD-L1 28.8, ER, PR and HER2, from patients with solid tumors to guide the choice of suitable targeted therapies. Analytically, the test has high sensitivity, specificity, linearity and precision. Based on a blinded case control study, the clinical sensitivity and specificity for PD-L1 (22C3 and 28.8) was determined to be 90% and 100% respectively. The clinical sensitivity and specificity was 83% and 89% for ER; 80% and 94% for PR; 63% and 89% for HER2 (by ICC); and 100% and 92% for HER2 (by FISH), respectively. The performance characteristics of the test support its suitability and adaptability for routine clinical use.

Keywords

Therapeutic biomarkers; circulating tumor cells; Immunocytochemistry; targeted therapy; Fluorescence in situ hybridization (FISH); Immune Checkpoint Inhibitors; Liquid Biopsy; Hormonal Treatments; Breast Cancer; Lung Cancer

Subject

MEDICINE & PHARMACOLOGY, Oncology & Oncogenics

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