Table 1.
Patient and tumor characteristics. Clinical, pathology, and imaging data for all images patients is provided. All patients had received prior chemotherapy. Three patients were on trastuzumab during the study and 8 patients received it previously. There were 8 HER2(+) and 3 HER2(−) patients by pathology. One non-small cell lung cancer patient (011) had a well-defined right lung lesion on CT and 111In -CHX-A”-DTPA trastuzumab imaging but was HER2(−) by pathology based on a pericardial fluid sample, thus designated an imaging False Positive. Tissue from the right lung mass was submitted for review by was inadequate for HER2 analysis. Six of the tumors biopsied were the primary tumors, surgically excised prior to enrollment. Only 4 patients’ tissue samples were of the tumor imaged. Levels of “shed” HER2 Extracellular Binding Domain (EBD) in the plasma were measured; however, no correlation with either pathology or imaging HER2 findings was evident.
| Current Chemotherapy | Pathology HER2 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 001 | 52 | F | Breast | Femara | Paraspinal Mass | 6.1 | 53.3[0.4] | Left breast mass | 3+ | NA | + | + |
| 002 | 58 | F | Lung | Lapatinib + capecitabine | Left Upper Lung | 5.6 | 26.9[6.6] | Left breast mass | 3+ | NA | + | + |
| 003 | 67 | M | Lung | Erlotinib | Left Pleural Effusion | 3.5 | BLQa | Pleural fluid | 2+ | 2.8 | + | + |
| 004 | 53 | M | Breast | Tarceva | Posterior Left Lower Lung | 4.4 | 1215.1[58.1] | Left lung mass | 3+ | 4.3 | + | + |
| 006 | 68 | F | Breast | Gemcitabine, D + T | Left Lung Mass | 4.0 | 742.3[22.8] | Left breast mass | 3+ | 4.7 | + | + |
| 007 | 56 | F | Breast | none-in washout period | Liver | 3.0 | BLQ | Liver mass | 1/2+ | 1.6 | − | − |
| 009 | 48 | F | Breast | T + navelbine | Sternum | 1.5 | 38.9[0.58] | Sternal (mass FNA) | 3+ | 2.5 | + | + |
| 010 | 62 | F | Breast | s/p XRT, capecitabine | Right para-iliac node | 1.8 | BLQ | Left breast mass | 1 + | NA | − | − |
| 011 | 35 | F | Lung | AdHER2 Vaccineb | Right Upper Lung | 2.0 | BLQ | Pericardial effusion | 2+ | 1.22 | − | + |
| 012 | 43 | M | Bladder | AdHER2 Vaccineb | LLL/B ladder | 3.7 | 18.1[0.60] | Bladder | 3+ | 0.85 | + | + |
| 013 | 61 | F | Breast | D + T + P | Right Lung | 1.6 | BLQ | Left Breast | 3+ | NA | + | + |
Below Level of Quantification <8.2 pg/ml
Patients who received AdHER2 vaccine were also enrolled in a separate clinical trial: A Phase I Study of an Adenoviral Transduced Autologous Dendritic Cell Vaccine Expressing Human HER2/Neu ECTM in Adults with Tumors With 1–3+ HER2/Neu Expression. ClinicalTrials.gov ID: NCT01730118
(D = docetaxel T = trastuzumab P = pertuzumab).