Background: The present study reports on the efficacy and safety of adjuvant docetaxel in real-life patients with early-stage breast cancer. Methods: This is a prospective, multicenter, post-marketing study that evaluates the efficacy and safety of docetaxel-based regimens in patients with early breast cancer treated between 2007 and 2012. Results: A total of 698 female breast cancer patients receiving adjuvant docetaxel-based regimens were included in this study. Docetaxel monotherapy was administered in 4.2%, whilst most patients received polychemotherapy. Non-hematological adverse events included skin reactions in 32.7% of the subjects. Multiple adverse events were reported and most commonly included asthenia (66.5%), alopecia (43.4%), and diarrhea (24.2%). It is noteworthy that no fatal toxicities occurred. Several hematological adverse events were reported during treatment, with anemia being the most common. Conclusion: The results of this real-life experience, characterized by a relatively large sample size and long follow-up, confirm that docetaxel is effective and well tolerated in early-stage breast cancer patients.

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