Abstract
Objective The aim of the study was to evaluate the toxicity, feasibility, and efficacy of concurrent capecitabine (Xeloda) with adjuvant radiotherapy in the treatment of high-risk breast cancer patients. Background Breast cancer ranks as the first malignancy affecting women. Patients with breast cancer have high risk of locoregional and/or distant failure: the locoregional failure rate is variable depending mainly on the disease stage and the adjuvant treatment. Different radiotherapy schedules are used in the adjuvant treatment of breast cancer. Concurrent chemoradiotherapy is the standard for many solid tumors; it is promising to be investigated in breast cancer. Patients and methods This study was conducted at the Clinical Oncology Department, Menoufia University Hospital, and included patients with a high risk of breast cancer after mastectomy and adjuvant chemotherapy. They were randomized to receive radiotherapy 40 Gy in 15 fractions through 3 weeks with or without concurrent capecitabine 825 mg/m 2 every 12 h on radiotherapy days. Patients were assessed for treatment regularity, toxicity, and recurrence. Results In this study, 100 patients were enrolled from April 2011 to October 2011 and followed up for 2 years; patients were randomized into 50 patients in each treatment group. Generally, the incidence of acute and late toxicities were comparable in both treatment groups with no incidence of grade III/IV early toxicity; only a mild increase in gastrointestinal side effects was noticed with capecitabine; however, 96% of the patients were able to finish their concurrent capecitabine therapy and all patients finished radiotherapy; no radiotherapy interruption occurred due to toxicity. Most of the late radiation adverse effects were grade I/II. Regarding efficacy, the concurrent capecitabine arm had better disease control locally and systemically and better disease-free survival, but the difference was statistically insignificant. Conclusion Concurrent capecitabine with postmastectomy hypofractionated radiotherapy is highly feasible, safe, and effective, but a longer follow-up is recommended.
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