Immunohistochemical assessment of Ki67 with antibodies SP6 and MIB1 in primary breast cancer: a comparison of prognostic value and reproducibility.

Aims: To compare SP6 and MIB1 antibodies for assessment of Ki67 in primary breast cancer with regard to prognostic value and reproducibility.

Methods And Results: A cohort of 237 premenopausal women with node-negative breast cancer, mainly (87%) not treated with adjuvant systemic therapy, was used. Assessment of Ki67 (SP6 and MIB1) was performed on tissue microarray by three different investigators. The seventh decile was applied for cut-off. Distant disease-free survival (DDFS) was chosen as endpoint and the follow-up was restricted to 5 years. Eighty-nine per cent of the samples were classified into the same proliferation group, irrespective of antibody used. For both antibodies, high Ki67 was associated with inferior DDFS in univariable analyses (SP6: HR 2.5, P = 0.01; and MIB1: HR 2.8, P = 0.004), but failed to reach statistical significance for DDFS in multivariable analyses adjusted for HER2, age, and tumour size (SP6: HR 2.0, P = 0.074; and MIB1: HR 2.2, P = 0.058). The agreement between different assessors was somewhat higher for MIB1 than for SP6 (κ 0.83-0.88 versus 0.72-0.77).

Conclusions: SP6 was not superior to MIB1, but the two antibodies were comparable in the assessment of Ki67. Both MIB1 and SP6 could therefore be considered for prognostic use in primary breast cancer.