Accurate determination of tumour human epidermal growth factor receptor type 2 (HER2) status is critical for optimal treatment of breast cancer. In October 2013, the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) issued joint updated guideline recommendations for HER2 testing in breast cancer, with a revised algorithm for interpretation of immunohistochemistry (IHC) and in situ hybridisation (ISH) results. This study investigates the impact on HER2 IHC categorisation, implication for reflex ISH testing and potential for identification of false negative IHC. HER2 IHC preparations on 251 invasive breast tumours, originally reported according to 2007 guidelines, were re-scored using 2013 guidelines and the diagnostic categories compared. The results of ISH testing on a separate cohort of 32 breast tumours reported as HER2 IHC 2+ following the introduction of the 2013 guidelines, that would have been designated 1+ according to 2007, were reviewed. Application of 2013 guidelines resulted in a decrease in tumours classified as HER2 negative (83/251 vs 144/251) and a comparable increase in those classified as equivocal (2+) (139/251 vs 80/251). Relatively few tumours were re-classified as positive (29/251 vs 27/251). Furthermore, 3/32 breast cancer cases (HER2 IHC 2+ as per 2013 guidelines, 1+ using 2007 guidelines) were HER2 ISH positive. Application of the 2013 guidelines increases the HER2 IHC equivocal (2+) category and requirement for reflex ISH testing. The reduced threshold for ISH testing identifies some patients with HER2 positive breast cancer whose tumours would have been categorised as HER2 negative according to the 2007 guidelines.
e21630 Background: Early detection of fever and prompt use of broad-spectrum antibiotics is crucial in neutropenic patients (pts). Episodic monitoring of temperature serves as standard-of-care (SOC) method in inpatient settings may suffer from delay in fever detection, whereas self-reported fever can be less reliable in the outpatient setting. Therefore, a continuous real time method of body temperature measurement may serve as a clinical decision support tool to improve outcomes. In this study, we proposed to test a device that continuously monitors body temperature. Methods: Pts admitted for stem cell transplant or high dose chemotherapy for leukemia were included. Body temperature was measured every 4 hours as SOC throughout hospital stay. Temperature Rise (TR) was defined as spikes above 100.4 °F. We used TempTraq patch (Blue Spark, Ohio), a FDA class II device, to monitor body temperature in real time. It transmits the data to a receiver (iPad or Smartphone) via Bluetooth to display body temperature data with the ability to set alerts. A questionnaire was designed to capture patient’s adherence, compliance and satisfaction. Results: The patches were applied every 24 hours on 10 pts throughout hospital stay. Body temperature was recorded remotely with 10 minutes intervals (14, 342 temperature measurements). There were 23 episodes of TR among all pts by SOC method, 21 of them were detected by the patch with a median of 140.1 minutes (range: 30-180 minutes) sooner than SOC. The patch data was successfully transmitted and displayed on the study iPad invariably. Ten out of 10 pts were able to wear the patch daily through hospital admission and felt the patch was easy to apply. Nine out of 10 pts felt the patch was comfortable and did not irritate their skin. Eight out of 10 pts were interested in wearing the patch for temperature monitoring in future. Eight out of 10 pts were completely satisfied with the patch. Conclusions: Our data suggest that real time body temperature measurement by the patch sensor used in this study is feasible and convenient. Also, it is able to detect the rise in temperature earlier in majority of cases. Further studies to assess reliability of this device in outpatient setting are warranted.
Background: The American Joint Commission Cancer (AJCC) Cancer Staging Manual 8th edition introduced a breast cancer (BC) Prognostic Stage (PS) that combines tumour grade, oestrogen (ER), progesterone (PgR), and human epidermal growth factor-2 (HER2) receptor status with Anatomic TNM Stage (AS). In a further modification, patients with early BC and an Oncotype DX® Recurrence Score (RS) < 11 are assigned to PS 1A irrespective of grade and size up to 5 cm. This study profiles the impact of these changes on staging in patients with early BC and RS < 11. Methods: A total of 127 patients, with primary BC and RS < 11, were identified from a consecutive series of 729 patients with ER-positive, HER2-negative, lymph node-negative, primary BC whose tumours were tested using the Oncotype DX® 21 multigene assay. Each patient was assigned AS, PS, and RS-modified PS, and staging categories were compared. Results: Applying AS, 100 patients were stage IA and 27 IIA. Applying PS, 89 were stage IA, 33 IB, 4 IIA, and 1 IIB. All patients were IA according to RS-modified PS. Comparing PS to AS, 26.7% of patients (n = 34) changed stage, 9.4% (n = 12) to a higher and 17.3% (n = 22) to a lower stage. RS-modified PS versus AS resulted in downstaging in 21.3% (n = 27). Comparing PS modified by RS to PS alone, 29.9% (n = 38) were downstaged. Conclusion: Application of PS and RS-modified PS results in tumour downstaging in approximately 20% of patients with early BC. Upstaging was observed in 9% of patients when staged according to PS and was primarily due to the impact of high histological grade.
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