SESSION TYPE: Lung Cancer I
PRESENTED ON: Sunday, October 21, 2012 at 11:30 AM - 11:45 AM
PURPOSE: To demonstrate the positive predictive power of EarlyCDT®-Lung, a blood test that measures autoantibodies (AABs) to lung cancer (LC)-associated antigens, for detecting LC when a pulmonary nodule is identified by computed tomography (CT).
METHODS: An audit of clinical outcomes data revealed 108 patients with a pulmonary nodule who tested positive for at least 1 AAB above the clinical cut-off for EarlyCDT-Lung. Nine were lost to follow-up and 8 were diagnosed with a cancer other than lung cancer. Of the remaining 91 individuals, 60 had a nodule prior to EarlyCDT-Lung (PRE), and 31 had a nodule detected by CT after testing positive by EarlyCDT-Lung (POST). All patients provided HIPAA consent to access their health information.
RESULTS: Of the 91 patients, 23 have been diagnosed with LC at this time, demonstrating a positive predictive value (PPV) of 1in4. Considering only age and smoking history, the average 5-year risk of LC in patients with a nodule PRE or POST EarlyCDT-Lung was 4.17% versus 3.42%, respectively; the average nodule size detected PRE and POST was 16.2mm vs. 8.5mm, respectively. Of the 60 patients with nodules PRE, 21 were diagnosed with LC (PPV= 21/60, 1in3), versus 2 of 31 patients with a nodule POST (PPV=2/31, 1in15). Considering nodule size for all 91 patients: nodule <4mm (n=12), the PPV was 1/12 (1in12); 4-20mm (n=60), PPV was 11/60 (1in5.5); >20mm (n=14), PPV was 9/14 (1in1.6). (Nodule size was unknown for 5 patients.)
CONCLUSIONS: The PPV of EarlyCDT-Lung is enhanced when a patient has a pulmonary nodule. The difference in PPV for nodules identified PRE and POST EarlyCDT-Lung is explained by the difference in the size of nodules as well as calculated risk: as the size of the nodule increases, the PPV further increases.
CLINICAL IMPLICATIONS: The movement toward CT screening for early LC detection, given the NLST results, means the number of patients identified with a lung nodule is increasing. The high PPV of EarlyCDT-Lung makes it complementary to CT when a lung nodule is identified.
DISCLOSURE: Laura Peek: Employee: Laura Peek is an employee of Oncimmune USA LLC.
Lynn Fredericks: Consultant fee, speaker bureau, advisory committee, etc.: Lynn Fredericks received consulting fees from Oncimmune USA LLC.
William Jewell: Consultant fee, speaker bureau, advisory committee, etc.: William Jewell received consulting fees from Oncimmune USA LLC.
William Pingleton: Consultant fee, speaker bureau, advisory committee, etc.: William Pingleton received consulting fees from Oncimmune USA LLC.
John Robertson: Shareholder: John Robertson is a shareholder in Oncimmune Ltd., Consultant fee, speaker bureau, advisory committee, etc.: John Robertson received consultant fees from Oncimmune.
No Product/Research Disclosure InformationOncimmune USA LLC, De Soto, KS