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Introduction In 2012, Subcutaneous Trastuzumab (TSC) was introduced as an alternative to Intravenous Trastuzumab (TIV) for HER2+ breast cancer. The pivotal HannaH study demonstrated that TSC was non-inferior to TIV, was preferred by patients, and serious administration related reactions (ARRs) were not reported. However, the Summary of Product Characteristics (SPC) advises that patients be observed for ARRs for 6 hours post-first administration (and 2 hours post-subsequent administrations), similar to TIV. Aim To assess the frequency and tolerability of ARRs during the 6-hour observation period post first administration of TSC in patients with HER2+ breast cancer. Method: A retrospective audit of TSC was conducted in Southwest Ireland across five centers from 2014-2016. Patient charts were reviewed to record ARRs reported on the first-administration or at subsequent visit. In addition a subset of patients were interviewed regarding their recollection of ARRs with first or subsequent injections. Results: The study is ongoing having identified 192 patients. These centers have administered 2111 TSC injections in total, associated with 4998 hours of observation as per SPC. From the 385 injections given over the first two TSC administrations, 13 injections (3.4%) were associated with ARRs within 24 hours. Nine patients (2.3%) experienced injection site reactions immediately post injection, one injection site pain (0.3%), and one experienced petechiae on subsequent exposure (0.3%). Three patients experienced pyrexia and dry cough 24 hours post-injection and were hospitalized for respiratory tract infection. There were no reactions experienced between 2 and 6 hours post-first injection. There were no serious ARRs. Telephone interviews are ongoing and these results will be reported. Conclusion: ARRs related to TSC are usually immediate, mild and self-limiting. Observing patients for 6 hours post-first injection and 2 hours post-subsequent injections represents an inefficient use of healthcare resources. Citation Format: Karmali S, Hughes N, Kinneally A, Kroes J, Cook J, Killian M, Shafiq T, O'Mahony D, Bird B, O'Connor M, O'Reilly S, Galiauskas R, Murphy CG. A regional audit of 6-hour monitoring for administration related reactions during the first administration of subcutaneous trastuzumab [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P4-16-08.

Background: The phenotype of TNBC is defined by absence of estrogen (ER) and progesterone receptors (PR) and lack of amplification of the HER2 oncogene. It is an aggressive form of breast cancer, and despite sensitivity to contemporary chemotherapy, TNBC have a poorer prognosis than ER positive phenotypes, marked by early relapses. This study examines the concordance of receptor status in recurrences among patients with TNBC. Methods: After obtaining IRB approval, we identified patients with triple negative breast cancer treated at the University of Alabama at Birmingham between 1998 and 2010. Patient and tumor characteristics and disease status were recorded. Patients with ER, PR, or HER2 (3+) positivity on immunohistochemistry (IHC), or HER2 amplification by fluorescence in situ hybridization were excluded. Data regarding the receptor status of the recurrence, if known, was documented. Results: Five hundred and two women with TNBC were diagnosed at our institution between 1998 and 2010. Of these patients, 95/502 (19%) had recurrences. Twenty-seven (28%) were local, 18 (19%) were regional, 35 (37%) were distant, and 15 (16%) were both local-regional and distant. These women ranged in age from 33 to 84 years of age. Of the women with a recurrence, 78/95 (82%) had a biopsy confirming breast cancer recurrence. Of those biopsied, 33/78 (42%) had receptor studies performed, and of these, 30 included data for estrogen, progesterone and HER2 receptors. The remaining 3 had only IHC for estrogen receptors performed. Twenty-two/thirty (73%) had concordance on their biopsy with their initial TNBC status, whereas 8/30 (27%) women developed a pathologically discordant recurrence. Conclusion: In this single institution study of TNBC patients, approximately one quarter of patients developed a pathologically discordant distant recurrence noted at biopsy. It is unclear whether patients experiencing a pathologically discordant recurrence differ in prognosis from those with concordant recurrences. Further study is necessary to evaluate this and determine whether routine biopsy based on pathologic discordance rates and outcomes are warranted. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-11-07.

Introduction: The use of complementary and alternative medicine (CAM) in cancer patients has been documented in major cities across USA, Canada, Europe, Nigeria, and Saudi Arabia. These studies suggest that cancer patients on chemotherapy simultaneously use CAMs. In Ireland, there have been two studies in pediatric cancer centers that have documented the use of CAM. To our knowledge, no study has examined the use of CAM in the adult population in Ireland. Method: A cross-sectional survey was conducted at a single adult cancer center over a three-week period. The survey was offered to all oncology and hematology patients attending the medical day unit. Results: The survey was completed by 81 patients, 51 of them were females (63%). The majority (93.8%) of the patients in our sample were in the age range of 41-80. 47 (58%) of the patients reported using CAM concurrently with conventional chemotherapy. The average cost of CAM was under €20 per month, but five patients (6.2%) spent over €100 per month. The major reasons for taking CAM were to enhance quality of life (23.5%), improve psychological/emotional wellbeing (17.3%), improve immunity (16%), relieve side effects of cancer (9.9%), relieve side effects of treatment (8.6%), and to directly treat/cure cancer (2.5%). Patients using CAM reported their source of information as healthcare professionals (30.9%), family/friends (19.8%), media (13.6%), and CAM practitioners (2.5%). Out of 81 patients, only 27 (33.3%) discussed the use of CAM with a healthcare professional involved in their care, of which 18.2% asked regarding interactions with the conventional therapy, 18.2% asked regarding CAM effectiveness and the type to use, 16.7% asked advice whether to pursue it, and 15.2% asked regarding safety of CAM. From the 26 patients using CAM who did not discuss with HCP the reasons cited were that they were never asked by the HCP (25.9%), did not think it was important to discuss with the HCP (13.0%), and 61.1% did not specify their reason. Of the 81 patients, 18 consumed herbal products (13.6% green tea, 8.6% flax seed, 3.7% evening primrose, 2.5% soy supplements), 34 used dietary supplements (28.4% vitamins, 12.3% minerals, 3.7% fish oils), and 21 used other CAMs (8.6% massage, 7.4% meditation/mind-body technique, 7.4% acupuncture, 6.2% reflexology, 2.5% reiki). Conclusion: The use of CAM in adult cancer patients has not been well documented in Ireland. As demonstrated from the pilot study, adult cancer patients in Ireland do seek out CAMs when simultaneously receiving chemotherapy, highlighting the importance for physicians to explicitly ask all patients regarding their intentions of CAM in order to provide safe and evidence-based options. This cancer center appeared to not have patients pursuing ayurvedic or Chinese medicine. However, similar conclusions cannot be made for other urban centers with more diverse population mixes with differing cultural experiences and attitudes to CAM. Citation Format: Karmali S, Markey G, Killian M, Ahmed G, Bird BR, Murphy CG. Use of complementary and alternative medicine in cancer patients receiving chemotherapy in Ireland [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-14-05.