Table 2.
Response to treatment
| (A): Bone scan response and RECIST responsea | ||
|---|---|---|
| Method of response assessment | ||
| Responseb | Bone scan (n = 52), n (%) | RECIST (n = 52), n (%) |
| CR | 0 | 0 |
| PR | 20 (38.5) | 0 |
| SD | 6 (11.5) | 26 (50.0) |
| PD | 7 (13.5) | 7 (13.5) |
| Nonevaluablec | 19 (36.5) | 19 (36.5) |
| Bone scan response rate (90% CI), % | 38.5 (27.1–51.0) | |
| Overall response rate | 0 | |
| (B): Subgroup analysis of bone scan response by disease site | ||
|---|---|---|
| Response | Disease sites at baseline | |
| Bone only (n = 18), n (%) | Bone + other (n = 34), n (%) | |
| CR | 0 (0) | 0 (0) |
| PR | 11 (61.1) | 9 (26.5) |
| SD | 0 (0) | 6 (17.6) |
| PD | 2 (11.1) | 5 (14.7) |
| Nonevaluable c | 5 (27.8) | 14 (41.2) |
All responses are based on best overall response during the study period. The percentage calculations are based on intention‐to‐treat analysis using a denominator of 52 patients who received cabozantinib treatment in this trial.
Patients evaluable for bone scan response are defined as patients who received ≥6 weeks of cabozantinib and had at least one follow‐up bone scan evaluable for central review. Patients evaluable for RECIST response are defined as patients who received ≥6 weeks of cabozantinib and had at least one follow‐up computed tomography scan evaluable for central review.
The 19 patients nonevaluable for bone scan response include 16 patients who discontinued treatment prior to reevaluation date because of toxicity (4), disease progression (9), or patient withdrawal from trial including too ill to continue (1), difficulty traveling (1), and unrelated illness (1). An additional three patients did not have their bone scans sent for central review. All protocol‐defined nonevaluable patients are included in the intention‐to‐treat analysis.
Abbreviations: CI, confidence interval; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease.