Table 3.
Patient PT1 | Baseline | C2D1* | C3D1* | CNS Progression/off study | ||
ctc csf | 328 | 76 | 117 | |||
CTC Blood | 0 | Not done | 0 | |||
CSF cytology | Positive | Negative | Positive | |||
MRI brain/spine | lesions present | Not done | Stable | |||
CTCAP | No lesions | Not done | No lesions | |||
Patient PT14 | Baseline | C2D1 | C3D1 | C5D1 | C7D1 | CNC Progression/off study |
CTC CSF | 22 | 13 | 13 | 2 | 9 | |
CTC Blood | 14 | 0 | 0 | 0 | 1 | |
CSF cytology | Atypical/Positive** | Negative | Atypical/Negative** | Negative | Atypical/Negative** | |
MRI brain/spine | No lesions | Not done | Stable | Stable | Stable | |
CT CAP | lesions present | Not done | Stable | Stable | Stable | |
Patient PT10*** | Baseline | C2D1 | C3D1 | CNS Progression/off study | ||
CTC CSF | 2 | 3 | 1 | |||
CTC Blood | 0 | 1 | 0 | |||
CSF cytology | Suspicious/Negative** | Negative | Negative | |||
MRI brain/spine | Lesions present | Not done | Stable | |||
CT CAP | Lesions present | Not done | Stable |
Abbreviations: CTC, circulating tumor cell, CSF, cerebrospinal fluid, MRI, magnetic resonance imaging, CT CAP, computer tomography
of chest/abdomen/pelvis.
Study specified assessments made prior to the start of cycle 2,3,5, and 7. Patients were taken off study for progression of disease
based on non-study scheduled clinical, cytologic, or radiologic assessments made during clinical follow up.
if the CSF cytology was atypical or suspicious, a repeat CSF study was conducted for a confirmatory testing.
PT10 had concurrent brain and spinal cord metastases.