SISH/CISH or qPCR as alternative techniques to FISH for determination of HER2 amplification status on breast tumors core needle biopsies: a multicenter experience based on 840 cases.

BACKGROUND: Until now, FISH has been the gold standard technique to identify HER2 amplification status in ambiguous cases of breast cancer. Alternative techniques have been developed to increase the capacities of investigating HER2 amplification status. The aims of this multicenter study in a large series of breast cancer patients were to prospectively compare the level of performance of CISH, SISH, and qPCR alternative techniques on paraffin-embedded core biopsies with "gold standard FISH" for evaluation of HER2 amplification status. METHODS: This study was performed on 840 cases scored by immunohistochemistry (IHC): 0=317 (38%), 1+=183 (22%), 2+=109 (13%), 3+=231 (27%). Each of the 15 French centers participating in the study analyzed 56 breast carcinoma cases diagnosed on fixed paraffin-embedded core biopsies. HER2 amplification status was determined by commercially available FISH used as the reference technique with determination of the HER2/CEN17 ratio or HER2 copy number status. The alternative techniques performed on the same cases were commercially available SISH or CISH and a common qPCR method especially designed for the study including a set of 10 primer pairs: 2 for HER2 (exons 8 and 26), 5 to evaluate chromosome 17 polysomy TAOK1, UTP6, MRM1, MKS1, SSTR2 and 3 for diploidy control TSN, LAP3 and ADAMTS16. RESULTS: The concordance between IHC and FISH was 96% to 95% based on the HER2/CEN17 ratio (n=766) or HER2 copy number (n=840), respectively. The concordance of the alternative techniques with FISH was excellent: 97% and 98% for SISH (498 and 587 cases), 98% and 75% for CISH (108 and 204 cases) and 95% and 93% (699 and 773 cases) for qPCR based on the HER2/CEN17 ratio or HER2 copy number, respectively. Similarly, sensitivity ranged from 99% to 95% for SISH, 100% to 99% for CISH and 89% to 80% for qPCR. The concordance with FISH (ratio) in the 2+ cases was 89% for SISH, 100% for CISH and 93% for qPCR. CONCLUSION: These alternative techniques showed an excellent concordance with FISH in core biopsies allowing their use in routine clinical practice. This newly designed qPCR on paraffin-embedded core biopsies deserves special attention, as it is reliable, easy to perform and less expensive than ISH tests.

Communicate About Quality and Safety: Let's Think Outside the Box! Experience From a Cancer Center.

BACKGROUND AND OBJECTIVES: While the priority of caregivers in any health care establishment is patient care, they are often constrained by time and cannot fully devote themselves to projects aiming at improving the quality and safety of care. Although the culture of quality is widespread in health care establishments, the quality and safety department team must continue to improve existing procedures and develop new ones, in order to reinforce the take-home message that safety is of paramount importance. Since good communication is a key factor in the success of quality plans, the quality and safety team in our establishment is placing special emphasis on "out of the ordinary" activities that take professional carers out of their daily routines, arouse their curiosity, and increase their adherence to quality procedures. METHODS: The issues addressed during these activities are based on the year-round continuous assessment of in-house procedures. Only those that have been deemed essential for safe care are focused upon. Most of the activities that are implemented have already been tried and tested in the fields of industry and aviation, and they all have a fun, collaborative, and creative component. Their impact and effect are assessed by carrying out the same assessments as those used at the beginning on the project. RESULTS: These innovative activities, which have received strong support from the staff, have had a positive effect on interdepartmental cooperation, on the adherence to the new methods presented, and on ensuring that information is made available to the greatest number of professionals. They have allowed the staff to acquire and consolidate new professional knowledge and have promoted good practice. CONCLUSION: This new program of activities has considerably improved the safety culture within our establishment. While the relationship between the skills of professionals and patient safety is clear to all, the message needs to be delivered in an original way that makes a lasting impression, in addition to using "standard" communication methods such as plenary meetings. The bottom line is to get as many professionals as possible fully adherent to the culture of quality, since quality is everyone's business and health care procedures are constantly evolving. Based on our experience, we provide a set of activities that can be improved and adapted according to the setting in which it is used.