Interobserver concordance of K i67 labeling index in breast cancer: J apan B reast C ancer R esearch G roup K i67 R ing S tudy

The standardized assessment of K i67 labeling index ( LI ) is of clinical importance to identify patients with primary breast cancer who could benefit from chemotherapy. In this study, we evaluated the interobserver concordance of K i67 LI assessment. Six surgical pathologists participated and all the slides were prepared from archival breast cancer tissues fixed in 10% buffered formalin for 24 h and stained with MIB ‐1. Three independent studies were conducted. In the first study, 30 stained slides were assessed using two different methods: the scoring system, with a positive rate scored from 1 (0–9%) to 10 (90–100%) by visual estimate; and the counting method, with approximately 1000 cells counted in hot spots. In the second study, 20 tumors with K i67 LI 5–25% were assessed, and in the third study, 15 printed photographs of stained slides were assessed to avoid variations by selecting different fields. In study 1, the counting system (intraclass correlation coefficient [ ICC ], 0.66 [95% confidence interval 0.52–0.78]) demonstrated a better correlation than the scoring system ( ICC , 0.57 [0.42–0.72]). In study 2, the assessment for K i67 LI of 5–25% demonstrated a correlation ( ICC , 0.68 [0.50–0.81]) similar to that of study 1 (unrestricted range of K i67 LI ). In study 3, the assessment of K i67 LI by counting yielded a good concordance ( ICC , 0.94 [0.88–0.97]). In conclusion, there was better concordance with the counting system, and concordance was high when the assessed field was predetermined, indicating that the selection of the evaluation area is critical for obtaining reproducible K i67 LI in breast cancer.