Core biopsy in patients 18 years and younger is well-tolerated, has few risks, and is preferable to surgery in developing breasts, but the goal is to avoid any breast procedure whenever possible. We propose guidelines for pediatric breast imaging, follow-up, core biopsy and excisions.

Cancer therapy has undergone a drastic revolution in the past few decades with the introduction of several novel therapies, like immunotherapy (active and passive), stem cell-based therapies, and nanocarrier-based therapies. These therapies have addressed the issues of conventional cancer therapy (chemotherapy or radiotherapy), like specificity and off-target effects. Further, the introduction of such treatments has improved survival and converted a terminal disease into a more manageable condition. However, many clinical, ethical, and regulatory issues are raised with such novel additions. Several effective therapies are under research but could not come to market or are delayed due to regulatory concerns for marketing approval. The scope of this review encompasses the examination of these regulatory issues and discuss their possible solutions. A practical and flexible regulatory approach, harmonized globally, could help the patients suffering from a terminal illness to lead a quality life.

Background: The impact of age at diagnosis on clinical presentation and treatment delivery for triple negative breast cancer (TNBC) is unclear. Utilizing data from a prospective registry, the aim of this study was to further elucidate the age-dependent correlation between TNBC clinical-pathological features, and the implications of age-bias on treatment delivery and prognosis. Methods: 480 subjects with stage I-III TNBC were enrolled in an IRB approved multisite prospective registry between 2011 and 2016. Clinical, demographic, treatment information was collected and patients were followed for recurrence and survival. Patients were categorized as older (>60 years) or younger groups (<60 years). Recurrence free survival (RFS) and overall survival (OS) were estimated according to the Kaplan-Meier method and compared among groups by log-rank test. Results: 145 (30%) of 480 TNBC patients were older (> 60 years) at time of diagnosis. Compared to younger patients, older patients were more likely to present with screen detected vs symptomatic cancer (47% vs 25% p=<0.001), more likely to have node negative cancer (71% vs 61% p=0.030), stage I disease (42% vs 28% p=0.003), and low level (1-10%) ER or PR positivity (19% vs 12% p=0.046). Compared to the younger patients, older patients were less likely to have a BRCA1/2 mutation (6% vs 23% p=0.0002) but more likely to have a prior history of hormone positive breast cancer (7% vs 1% p=0.0002). Compared to younger counterparts, older patients were less likely to receive neo/adjuvant chemotherapy (93% vs 99% p=0.0006), and less likely to receive > 4 cycles of neo/adjuvant chemotherapy (61% vs 78%, p=0.0003). Three year RFS for the entire cohort was 80% and was identical for older and younger patients at 80%. Three year OS for the entire cohort was 87% and was similar for older and younger patients. On multivariable analysis only tumor size and nodal status significantly impacted RFS. Conclusions: A significant fraction (30%) of TNBC patients are older (> 60 years) at time of diagnosis. Despite presenting a with more favorable disease stage, older TNBC patients did not demonstrate better outcomes compared to the higher risk younger patients. The underlying reasons for this observation may be tumor biology differences between older and younger TNBC patients or perhaps could be related to underutilization of appropriate systemic chemotherapy (39% of older patients received < 4 cycles of chemotherapy). Further studies are warranted on this subject. Citation Format: Mina A, Lehn C, Wang YY, Klemp JR, O'Dea AP, Elia M, Hoffmann M, Crane G, Sheehan M, Madhusudhana S, Jensen RA, Godwin AK, Khan QJ, Kimler BF, Sharma P. Influence of older age on triple negative breast cancer (TNBC) clinical-pathological characteristics and outcomes [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-10-06.