Table 2.
Prior treatment and brain lesion measurements over time for patients in the BM subgroup
| Longest diameter of lesion (mm) at baseline and time following treatment | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient | Prior BM treatmenta | Imaging methodb | Baseline | Week 6 | Week 12 | Week 18 | Week 24 | Week 30 | Week 36 | Week 42 | Week 48 | Week 54 | Week 60 | BOR in brain lesionc | BOR |
| 1 | RT | MRI | 9 | 9 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | SD | PR |
| 2 | Surgery, RT, capecitabine | CT | 43 | 25.1 | 15.9 | 12.6 | 12.0 | 10.6 | 10.9 | 8.0 | 7.9 | 10.2 | 10.0 | PR | PR |
| 3 | Surgery, RT | MRI | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | SD | PR |
| 4 | NR | CT | 46 | 38 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | SD | PR | |
| 5 | RT | CT | 12 | NR | CR | CR | CR | CR | CR | CR | PD | PR | PR | ||
| CT | 18 | NR | 12 | 8 | 7 | 7 | 7 | 7 | 12 | ||||||
| CT | 10 | NR | CR | CR | CR | CR | CR | CR | PD | ||||||
| 6 | RT | MRI | 13 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | PR | SD | |||
| 7 | NR | CT | 8 | 8 | 8 | 7 | 7 | 7 | SD | SD | |||||
| 8 | NR | MRI | 17.1 | 19 | 19 | 16 | 16 | 16 | SD | PR | |||||
| 9 | RT | MRI | 5.2 | 2.2 | 3.0 | 3.0 | PR | PR | |||||||
| 10 | Surgery, RT | MRI | 4.7 | 3.2 | 3.9 | 3.5 | PR | SD | |||||||
| 11 | RT | MRI | 23 | 15 | 13 | 13 | PR | PR | |||||||
| 12 | RT | MRI | 25 | 5 | 5 | 5 | PR | PR | |||||||
| 13 | RT | MRI | 5 | 5 | 5 | 5 | SD | SD | |||||||
| 14 | RT | MRI | 8 | 8 | 7 | SD | PR | ||||||||
| 15 | RT | CT | 10.8 | 6.9 | 4.8 | PR | SD | ||||||||
| 16 | RT | MRI | 7 | 9 | 13 | PD | SD | ||||||||
| 17 | RT | MRI | 5 | 5 | SD | SD | |||||||||
| 18 | Surgery, RT | None | N/A | N/A | PR | ||||||||||
| 19 | RT | None | N/A | N/A | PR | ||||||||||
| 20 | RT | SD | |||||||||||||
| 21 | RT | None | N/A | N/A | PR | ||||||||||
| 22 | NR | None | N/A | N/A | NE | ||||||||||
| 23 | Surgery | None | N/A | N/A | PD | ||||||||||
| 24 | NR | MRI | Data not available for this patient | CR | |||||||||||
Note: “RT” includes whole-brain RT, brain-directed stereotactic RT, and brain-directed radiosurgery. “Surgery” includes any brain-directed surgery (craniotomy, metastasectomy in brain, resection, or removal of brain lesion).
Abbreviations: BOR, best overall response; N/A, not applicable (no brain lesion present at baseline); NR, nothing reported; RT, radiotherapy (brain-specific).
aIncludes BM-specific treatment for past BMs and any at baseline. These data were collected retrospectively.
bImaging was performed per protocol every 6 weeks for subjects with baseline BMs. Measurements were not required per protocol but were performed by some sites and collected retrospectively. For subjects without measurements, imaging was performed, but measurements were either not taken or not provided by the study site.
cProvided by the investigator retrospectively.