The safety and tolerability of FE 100 C-D chemotherapy in a non-trial population of node positive breast cancer compared to PACS-01 trial group; Salmaniya Medical Complex experience

Introduction: In our institution, adjuvant taxanes are currently offered to fit node-positive breast cancer patients who are either Her2 positive (any ER/PR) or triple negative (ER/PR/Her2 negative). The FE ₁₀₀ C-D (FE100C × 3 → docetaxel 100 mg/m ² × 3) regime, based on the PACS 01 trial1 is used. Materials and Methods: We retrospectively audited our experience with FE ₁₀₀ C-D at Salmaniya Medical Complex. Over a 2-year-period, 100 patients commenced adjuvant FE100C-D chemotherapy. Data was matched with the FE ₁₀₀ C-D arm of the PACS 01 trial. Results: Median age was 54 years. Twenty-six patients (26%) had ≥1 episode of febrile neutropenia (FN), including one fatal episode; 29% patients required treatment interruption ≥1 week; 30% patients had dose reductions; and 30% patients received < 90% dose intensity of docetaxel. Conclusion: The FN rate was substantially higher and docetaxel dose intensity substantially lower in our unselected sample of patients than in the trial population, this "real-life" data demonstrates the problems of applying clinical trial data to the more generalised patient population. Meanwhile, the routine use of prophylactic G-CSF support with this protocol is warranted.