Concordance between HER-2 status determined by qPCR in Fine Needle Aspiration Cytology (FNAC) samples compared with IHC and FISH in Core Needle Biopsy (CNB) or surgical specimens in breast cancer patients.

Determining the status of HER2-neu amplification and overexpression in breast cancer is crucial for prognosis but mostly for treatment purposes. Standard techniques include the determination of IHC in combination with in situ hybridization techniques to confirm a HER2-neu amplification in case of IHC2+ using either a core-needle biopsy or a surgical specimen. qPCR has been also demonstrated to be able to determine HER2 status, mostly in core biopsies or in surgical specimens. Fine-needle aspiration is a reliable, quicker and less invasive technique that is widely used for diagnosis of invasive breast cancer. In this study, we assessed the performance of qPCR in invasive breast carcinomas to determine HER2-neu status by using fine-needle aspiration samples and comparing to standard IHC and FISH. From a total of 154 samples from patients who had nodular breast lesions and attended the 1-day-stop clinic at the Gustave Roussy from March 2013 to October 2014, qPCR was able to determine the HER2 status in a mean of 3.7 days (SD 3.1). The overall concordance with standard HER2-testing was very high: 97% (95% CI 0.94 to 0.99); sensitivity was 96% (0.87-1), specificity 98% (0.95-1) and positive and negative predictive values 88% (0.75-1) and 99% (0.98-1), respectively. In conclusion, our study demonstrates that qPCR performed using fine-needle aspiration samples from a primary tumour is a reliable and fast method to determine HER2/neu status in patients with early breast cancer.

Decision-making from multidisciplinary team meetings to the bedside: factors influencing the recruitment of breast cancer patients into clinical trials.

AIM OF THE STUDY: Our aim was to determine factors influencing physicians and breast cancer patients to respectively propose or accept participation in a clinical trial following proposals made during a multidisciplinary team meeting (MTM) in a Comprehensive Cancer Centre. PATIENTS AND METHODS: Consecutive patients considered eligible for a clinical trial by a breast cancer-specific MTM were included. A detailed analysis of factors predictive of the physician proposing the trial and the patient's acceptance and final inclusion was conducted. RESULTS: MTM proposed 547 inclusions in 25 clinical trials for 397 patients between March and September 2011. The physician proposed the scheduled clinical trial in only 39% of the cases. The patients accepted the proposal in 74% of the cases, and finally 29% were included. The main reason for non-inclusion was the physician's failure to propose the trial in 45-81%, depending on the type of study. The only factor predictive of both the physician proposing the trial and final inclusion was the type of study (both p < 0.001). Diagnostic/prognostic studies were the most frequently proposed trials. The professional status (of the subject) was predictive of acceptance (p = 0.03) with higher rates among retired patients and executives (84 and 76% respectively). CONCLUSION: The major reason for non-inclusion in clinical trials was the physician's failure to propose the trial, while the patient's professional status and the type of study influenced both physicians and patients. Educative measures mostly directed at physicians could be implemented to overcome such poor compliance.