PURPOSE Luminal, human epidermal growth factor receptor 2–negative breast cancer represents the most common subtype of breast malignancies. Neoadjuvant strategies of operable breast cancer are mostly based on chemotherapy, whereas it is not completely understood which patients might benefit from neoadjuvant hormone therapy (NAHT). MATERIALS AND METHODS The SAFIA trial is a prospective multicenter, international, double-blind, neoadjuvant phase III trial, using upfront 21-gene Oncotype DX Breast Recurrence Score assay (recurrence score [RS] < 31) to select operable luminal human epidermal growth factor receptor 2–negative patients, for induction hormonal therapy HT (fulvestrant 500 mg with or without goserelin) before randomly assigning responding patients to fulvestrant 500 mg (with or without goserelin) plus either palbociclib (cyclin-dependent kinase 4/6 inhibitor) or placebo. The objectives of this interim analysis were to assess the feasibility of upfront RS determination on core biopsies in the Middle-East and North Africa region and evaluate the efficacy of induction NAHT in patients with an RS < 31. RESULTS At the time of this interim analysis, 258 patients with relative risk were accrued, including 202 patients (RS < 31% to 78.3%) treated with induction NAHT and 182 patients evaluable so far for response. The feasibility of performing the Oncotype DX assays on core biopsy specimens was optimal in 96.4% of cases. Overall, 93.4% of patients showed hormone sensitivity and no difference in NAHT efficacy was noticed between RS 0-10, 11-25, and 26-30. Interestingly, patients with high RS (26-30) showed a trend toward a higher major response rate ( P = .05). CONCLUSION The upfront 21-gene assay performed on biopsies is feasible in our population and has allowed us to select patients with high hormone sensitivity (RS < 31). This approach could be an alternative to upfront surgery without significant risk of progression, particularly during pandemic times.
e12009 Background: Oncotype-DX assay recurrence score (ODX-RS) cut-off values have recently changed in response to the results of the TAILOR-X trial. We aim to explore decisions for ACT based on physicians’ clinical assessment and on evolving ODX-RS. Methods: Patients who underwent ODX testing after curative surgical resection of estrogen receptor positive (ER+), Her2 non-over-expressed (Her2-) and lymph node negative (LN-) BC were included. Patients with micro-metastases to LNs were excluded. Data was collected retrospectively from the electronic records. Management of these patients was guided by the results of the old ODX-RS-1 (<18, 18-30 & ≥31) risk grouping. For the purpose of this study, treatment decisions were also assumed according to TAILOR-X results (ODX-RS-2). Decisions of 3 medical oncologists on ACT were solicited by blinding them to the RS values to investigate inter-physicians discrepancy and concordance with ODXA RS-1&2. Results: Sixty six consecutive patients fulfilled the inclusion criteria. Median age was 50.5 (range: 21-73) years. There was one male patient and 37 out of 65 females (56.9%) were pre-menopausal. Median tumor size was 21.5 (range: 10-55) mm and the grade were I, II and III in 6 (9.1%), 46 (69.7%) and 41 (21.2%) patients respectively. The 3 oncologists’ had discrepancies about ACT recommendations in 29 (44%) patients. Based on majority opinion (≥2 oncologists), ACT would have been recommended to 22/41 (53.7%) and 24/46 (52.2%) patients with low risk tumors according to ODXA RS-1 and ODXA RS-2 respectively. Similar number of patients (n=12) would have received ACT regardless of ODXA RS cut-off value (table). Conclusions: Decisions on ACT for patients with ER+/Her2-/LN- early BC should be guided by ODX-RS to prevent overtreatment and discrepancies in management. Broadly, ODXA RS-1 and ODXA RS-2 seem to guide ACT decisions in similar proportions of patients. Nevertheless minor differences exist and need to be studied in larger cohorts. [Table: see text]
The management of gastrointestinal and pancreatic (GEP) neuroendocrine tumors (NETs) has evolved over the recent decade. Primary renal NETs are extremely rare as neuroendocrine cells are not recognized in the normal renal parenchyma. We report a case of primary renal NET characterized by the initial diagnostic challenges. Recurrent and metastatic disease was managed along the lines of management of GEP-NETs, leading to prolonged progression-free survival.
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