Feasibility and reproducibility of the [3H]-thymidine labelling index in breast cancer. The SICCAB Group for Quality Control of Cell Kinetic Determination.

For several malignancies, autoradiographic evaluation of the S phase cell fraction by means of [3H]-thymidine ([3H]dT) has proved a valid prognostic tool which should be included in a 'risk factor profile system' to estimate prognosis in individual patients. However, its clinical implementation requires a methodological standardization, a high feasibility and an assessment of the reproducibility of results, within and between different laboratories. The recent availability of a kit for in vitro incubation with [3H]dT and histological fixation of solid tumour specimens has contributed to the methodological simplification and standardization of the technical procedure, increasing its feasibility in several institutions. For breast cancer, preliminary results from a quality control study promoted by the Italian Society of Basic and Applied Cell Kinetics (SICCAB) showed a high inter-observer reproducibility within (r = 0.96) and between different laboratories (r = 0.93). Moreover, on a series of 20 autoradiographic samples sent to 15 different institutions, only 2% of tumours shifted from one of the cell kinetic subgroups, defined using the median [3H]dT labelling index (LI) of 2.8% as a cutoff, to the other. In addition, a marked consistency of results was observed among the different Italian institutions involved in cell kinetic studies on breast cancers, both in terms of median [3H]dT LI values and basic correlations. Periodic assessment of the reproducibility of [3H]dT LI evaluation among different laboratories is needed, especially for institutions involved in multicentre clinical protocols based on cell kinetic characteristics.