Table 3. Concordance Results From the Analyses Across All Categories, Best Response, and in the Dichotomized Response/Nonresponse Categories.
| Variable | CAR [n = 100], No (%) | All categories | Dichotomized | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| CR | PR | (Dichot) response | SD | PD | Indeter | Not doc | (Dichot) no-response | ||||
| Imaging response based on RECIST (n = 100) | CR | 0 (0.0) | 2 (2.0) | NA | 1 (1.0) | 0 | 0 | 0 | NA | Agreement, % (95% CI): 52 (41.8-62.1) | Agreement, % (95% CI): 71a (61.1-79.6) |
| PR | 1 (1.0) | 17 (17.0) | 8 (8.0) | 0 | 0 | 0 | κ statistics (95% CI): 0.29 (0.14-0.43) | κ statistics (95% CI): 0.37b (0.17-0.56) | |||
| (Dichot) response | NA | NA | 20 (20.0) | NA | NA | NA | NA | 9 (9.0) | NA | NA | |
| SD | 1 (1.0) | 15 (15.0) | NA | 24 (24.0) | 8 (8.0) | 0 | 1 (1.0) | NA | Unconfirmed agreement, % (95% CI): 58 (47.7-67.8) | Unconfirmed agreement, % (95% CI): 74 (64.3-82.3) | |
| PD | 0 | 4 (4.0) | 5 (5.0) | 11 (11.0) | 0 | 0 | |||||
| NE | 0 | 0 | 0 | 2 (2.0) | 0 | 0 | κ statistics (95% CI): 0.37 (0.22-0.52) | κ statistics (95% CI): 0.50 (0.33-0.67) | |||
| (Dichot) no-response | NA | NA | 20 (20.0) | NA | NA | NA | NA | 51 (51.0) | NA | NA | |
Abbreviations: CAR, clinician-assessed response; CR, complete response; NA, not applicable; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease.
a
In the analysis based on dichotomous disease control outcome (ever achieved SD or better vs not achieving at least SD), agreement was 82% (95% CI, 73.1%-89.0%) and κ statistics, 0.48 (95% CI, 0.25-0.70).
b
Analyses based on confirmed response, except when noted (N = 100).