title: Phase II study of concurrent capecitabine and external beam radiotherapy for pain control of bone metastases of breast cancer origin.
abstract: BACKGROUND
  Pain 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.
  
  
  RESULTS
  Twenty-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/m(2) 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
  External 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01784393NCT01784393.
authors.affiliation: Institue of Oncology, Davidoff Cancer Center, Rabin Medical Center, Beilinson Campus, Petach Tikva, Israel.
authors.forename: Yulia
authors.initials: Y
authors.lastname: Kundel
authors.forename: Nicola J
authors.initials: NJ
authors.lastname: Nasser
authors.forename: Ofer
authors.initials: O
authors.lastname: Purim
authors.forename: Rinat
authors.initials: R
authors.lastname: Yerushalmi
authors.forename: Eyal
authors.initials: E
authors.lastname: Fenig
authors.forename: Raphael M
authors.initials: RM
authors.lastname: Pfeffer
authors.forename: Salomon M
authors.initials: SM
authors.lastname: Stemmer
authors.forename: Shulamith
authors.initials: S
authors.lastname: Rizel
authors.forename: Zvi
authors.initials: Z
authors.lastname: Symon
authors.forename: Bella
authors.initials: B
authors.lastname: Kaufman
authors.forename: Aaron
authors.initials: A
authors.lastname: Sulkes
authors.forename: Baruch
authors.initials: B
authors.lastname: Brenner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001859:Bone Neoplasms / Q000150:complications / Q000556:secondary / Q000628:therapy*; D001943:Breast Neoplasms / Q000150:complications / Q000473:pathology / Q000628:therapy*; D000069287:Capecitabine; D059248:Chemoradiotherapy / Q000009:adverse effects; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019583:Dose Fractionation, Radiation; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D010166:Palliative Care / Q000379:methods; D020266:Radiotherapy, Conformal / Q000009:adverse effects
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil