Abstract
BackgroundPain from bone metastases of breast cancer origin is treated with localized radiation. Modulating doses and schedules has shown little efficacy in improving results. Given the synergistic therapeutic effect reported for combined systemic chemotherapy with local radiation in anal, rectal, and head and neck malignancies, we sought to evaluate the tolerability and efficacy of combined capecitabine and radiation for palliation of pain due to bone metastases from breast cancer.Methodology/Principal FindingsTwenty-nine women with painful bone metastases from breast cancer were treated with external beam radiation in 10 fractions of 3 Gy, 5 fractions a week for 2 consecutive weeks. Oral capecitabine 700 mg/m2 twice daily was administered throughout radiation therapy. Rates of complete response, defined as a score of 0 on a 10-point pain scale and no increase in analgesic consumption, were 14% at 1 week, 38% at 2 weeks, 52% at 4 weeks, 52% at 8 weeks, and 48% at 12 weeks. Corresponding rates of partial response, defined as a reduction of at least 2 points in pain score without an increase in analgesics consumption, were 31%, 38%, 28%, 34% and 38%. The overall response rate (complete and partial) at 12 weeks was 86%. Side effects were of mild intensity (grade I or II) and included nausea (38% of patients), weakness (24%), diarrhea (24%), mucositis (10%), and hand and foot syndrome (7%).Conclusions/SignificanceExternal beam radiation with concurrent capecitabine is safe and tolerable for the treatment of pain from bone metastases of breast cancer origin. The overall and complete response rates in our study are unusually high compared to those reported for radiation alone. Further evaluation of this approach, in a randomized study, is warranted.Trial RegistrationClinicalTrials.gov NCT01784393NCT01784393
Highlights
Painful metastatic bone disease is a common complication of breast cancer
Metastatic lesions were found in the brain in one patient and in the liver in 6 patients
Eight patients (28%) were receiving capecitabine for treatment of the metastatic disease at the time of enrollment to the study; in these cases, the capecitabine dose was adjusted to 1400 mg/m2/day, in 2 divided doses, during the radiation days
Summary
Painful metastatic bone disease is a common complication of breast cancer. Systemic treatments, such as chemotherapy, hormonal therapy, and targeted biological therapies, may be effective, but the time to response ranges from several weeks to months. In a single institution study of 32 patients with gastrointestinal malignancies, Vaishampayan et al [17] reported very little toxicity with concurrent radiotherapy and capecitabine at a median dose of 1600 mg/m2/day (5 days a week) These findings were supported in phase II and III studies of rectal cancer wherein chemoradiation with capecitabine 1650 mg/m2/d for 14 days was found to be safe and well tolerated [18,26]. All of these studies focused on localized malignancies, and information on combined chemotherapy and radiation for palliation of pain from bone metastases, including those of breast cancer origin, is lacking. The aim of the present phase II prospective clinical trial was to test the effectiveness and safety of treatment with localized external beam radiotherapy and concurrent capecitabine in patients with painful bone metastases from breast cancer
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
