Are patients in clinical trials representative of the general population? Dose intensity and toxicities associated with FE100C-D chemotherapy in a non-trial population of node positive breast cancer patients compared with PACS-01 trial group.

PURPOSE: 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 (FE(100)C × 3→docetaxel 100mg/m(2) × 3) regime, based on the PACS 01 trial [Roche H, Fumoleau P, Spielmann M, et al. Sequential Adjuvant Epirubicin-Based and Docetaxel Chemotherapy for node positive Breast Cancer Patients: The FNCLCC PACS 01 Trial. J Clin Oncol 2006;24:5664-5671] is used. We retrospectively audited our experience with FE(100)C-D at The Beatson West of Scotland Cancer Centre and one representative district general hospital (DGH), Falkirk and District Royal Infirmary (FDRI). PATIENTS AND METHODS: Over a two year period, 101 patients commenced adjuvant FE(100)C-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 neutropaenia (FN), including one fatal episode. Twenty-nine percent of patients required treatment interruption ≥ 1 week. Thirty percent of patients had dose reductions. Thirty percent of 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 reference study.(1) This 'real-life' data illustrates the problems of applying clinical trial data to the more generalised patient population.