1228P - A circulating tumor cell (CTC) based assay for diagnostic immunocytochemistry profiling of lung cancer

Background

We present a unique immunocytochemistry-based organ-specific antibody profiling assay of CTCs in suspected lung tumors (TruBlood® Lung) for non-invasive diagnosis and histological subtyping and its utility in patients unable to undergo physical biopsies.

Methods

In a prospective blinded study, blood samples from suspected lung cancer patients (n= 99) were profiled for detection of CTCs. Along with EPCAM/CK/CD45, organ-specific antibody profiling with TTF1, CK7, Napsin A, CD45, p40, Synaptophysin, and Chromogranin was performed to detect lung adenocarcinoma, squamous cell carcinoma and neuroendocrine tumors (TruBlood® Lung). After unblinding, the performance was compared with histopathology of the corresponding tissue samples.

Results

Concordance analysis could be performed in ninety-three patients. Tissue HPE was inconclusive in 4 patients and CTC assay (TruBlood® Lung) could not be performed in 4 patients. The concordance rate between cancer diagnosis by the CTC assay and histopathology was 97.8% (91/93). Among cases identified to be positive for lung cancer on CTC assay (n=91), HPE subtyping of lung cancer could be performed in 83.5% of the cases (76/91). The CTC assay was able to detect presence of cancer but unable to assign a histological subtype (subtype indeterminate) in 16.4% of the cases (15/91). Among cases that were able to be subtyped by CTC assay, the concordance rate with HPE diagnosis was 93.4% (71/76), with concordant subtyping in 76.3% of the total evaluable cohort (71/93). Discordance with histological subtyping was seen in 6.5% (5/76) cases, with CTC assay failing to identify adeno-squamous (n=3), small cell (n=1) and squamous cell carcinoma (n=1) subtypes. Interestingly, in five cases of poorly differentiated carcinomas where conclusive histological subtyping was not possible on tissue HPE examination, CTC assay profiling was able to assign a subtype.

Conclusions

Our results demonstrate sensitivity of this CTC assay (TruBlood® Lung) to provide concordant HPE subtyping in 76.3% of the total evaluable cohort (71/93) and in 93.4% (71/76) of the cases subtyped by CTC assay. Thus, this assay can be useful in patients unable to undergo tissue sampling, to establish a diagnosis and conclude histopathological subtype.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Datar Cancer Genetics.

Funding

Has not received any funding.

Disclosure

R. Kurzrock: Financial Interests, Institutional, Other, Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance; as well as consultant and/or speaker fees and/or advisory board for Actuate Therapeutics, AstraZeneca, Bicara Therapeutics, Biological Dynamics, Caris, Daiichi Sankyo, Inc., Eisai, EOM Pharmaceuticals, Iylon, Merck, NeoGenomics, Neomed, Pfizer, Prosperdtx, Roche, TD2/Volastra, Turning Point Therapeutics, X-Biotech; has an equity interest in CureMatch Inc., CureMetrix, and IDbyDNA; serves on the Board of CureMatch and CureMetrix,and is a co-founder of CureMatch: Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance; Financial Interests, Personal, Other, Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance; as well as consultant and/or speaker fees and/or advisory board for Actuate Therapeutics, AstraZeneca, Bicara Therapeutics, Biological Dynamics, Caris, Daiichi Sankyo, Inc., EISAI, EOM Pharmaceuticals, Iylon, Merck, NeoGenomics, Neomed, Pfizer, Prosperdtx, Roche, TD2/Volastra, Turning Point Therapeutics, X-Biotech; has an equity interest in CureMatch Inc., CureMetrix, and IDbyDNA; serves on the Board of CureMatch and CureMetrix,and is a co-founder of CureMatch: Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance; Financial Interests, Personal and Institutional, Other, Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance; as well as consultant and/or speaker fees and/or advisory board for Actuate Therapeutics, AstraZeneca, Bicara Therapeutics, Biological Dynamics, Caris, Daiichi Sankyo, Inc., Eisai, EOM Pharmaceuticals, Iylon, Merck, NeoGenomics, Neomed, Pfizer, Prosperdtx, Roche, TD2/Volastra, Turning Point Therapeutics, X-Biotech; has an equity interest in CureMatch Inc., CureMetrix, and IDbyDNA; serves on the Board of CureMatch and CureMetrix,and is a co-founder of CureMatch: Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance; Non-Financial Interests, Other, Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance; as well as consultant and/or speaker fees and/or advisory board for Actuate Therapeutics, AstraZeneca, Bicara Therapeutics, Biological Dynamics, Caris, Daiichi Sankyo, Inc., Eisai, EOM Pharmaceuticals, Iylon, Merck, NeoGenomics, Neomed, Pfizer, Prosperdtx, Roche, TD2/Volastra, Turning Point Therapeutics, X-Biotech; has an equity interest in CureMatch Inc., CureMetrix, and IDbyDNA; serves on the Board of CureMatch and CureMetrix,and is a co-founder of CureMatch: Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance; Other, Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance; as well as consultant and/or speaker fees and/or advisory board for Actuate Therapeutics, AstraZeneca, Bicara Therapeutics, Biological Dynamics, Caris, Daiichi Sankyo, Inc., Eisai, EOM Pharmaceuticals, Iylon, Merck, NeoGenomics, Neomed, Pfizer, Prosperdtx, Roche, TD2/Volastra, Turning Point Therapeutics, X-Biotech; has an equity interest in CureMatch Inc., CureMetrix, and IDbyDNA; serves on the Board of CureMatch and CureMetrix,and is a co-founder of CureMatch: Dr. Kurzrock has received research funding from Biological Dynamics, Boehringer Ingelheim, Debiopharm, Foundation Medicine, Genentech, Grifols, Guardant, Incyte, Konica Minolta, Medimmune, Merck Serono, Omniseq, Pfizer, Sequenom, Takeda, and TopAlliance;. V. Datta, S. Murthy, A. Adhav, R. Chougule, D. Reismann: Financial Interests, Personal, Full or part-time Employment: Datar Cancer Genetics. S. Apurwa, D.S. Patil: Financial Interests, Institutional, Full or part-time Employment: Datar Cancer Genetics. R. Datar: Financial Interests, Personal and Institutional, Member of Board of Directors: Datar Cancer Genetics. T. Crook, G. Kaye, N. Plowman: Non-Financial Interests, Personal, Advisory Board: Datar Cancer Genetics. All other authors have declared no conflicts of interest.