title: A phase II study of second-line neoadjuvant chemotherapy with capecitabine and radiation therapy for anthracycline-resistant locally advanced breast cancer.
abstract: OBJECTIVE
  According to data from Brazil's National Cancer Institute nearly 30% of the new patients who present with breast cancer have locally advanced disease. These patients are inoperable and tumor reduction is usually attempted with chemotherapy. First-line anthracyclin-based neoadjuvant chemotherapy is often effective; however, about 30% of the patients fail and to date there is no established second-line treatment. We have studied the concomitant use of radiation therapy and capecitabine in this setting, to determine the toxicity and efficacy of this regimen as a second-line neoadjuvant treatment.
  
  
  METHODS
  Twenty-eight patients with inoperable locally advanced breast cancer refractory to first-line anthracycline based treatment were enrolled between January 2003 and May 2004. Patients received radiation therapy (total dose 5000 cGy) and concomitant capecitabine (850 mg/m2) twice daily for 14 days every 3 weeks.
  
  
  RESULTS
  This treatment rendered 23 of the 28 patients (82%) operable. The 5 remaining patients did not undergo surgery because of disease progression. The median clinical tumor size decreased from 80 cm2 to 49 cm2. Microscopic residual disease was observed in 3 patients (13%) and another patient achieved a complete pathologic response. The median number of involved lymph nodes was 2 and treatment was well tolerated with no grade 3 or 4 events.
  
  
  CONCLUSIONS
  Our data indicate that second-line neoadjuvant treatment with radiation therapy and capecitabine is feasible, well tolerated, and effective in patients with locally advanced breast cancer refractory to primary anthracycline-based treatment. These results suggest that a randomized study should be done to compare radiotherapy alone to capecitabine combined with radiotherapy.
authors.affiliation: Oncology and Pathology Services, National Cancer Institute, Rio de Janeiro, Brazil. mfgaui@hotmail.com
authors.forename: Maria de Fátima Dias
authors.initials: MF
authors.lastname: Gaui
authors.forename: Gilberto
authors.initials: G
authors.lastname: Amorim
authors.forename: Roberto Alfonso
authors.initials: RA
authors.lastname: Arcuri
authors.forename: Guilherme
authors.initials: G
authors.lastname: Pereira
authors.forename: Denise
authors.initials: D
authors.lastname: Moreira
authors.forename: Célia
authors.initials: C
authors.lastname: Djahjah
authors.forename: Irene
authors.initials: I
authors.lastname: Biasoli
authors.forename: Nelson
authors.initials: N
authors.lastname: Spector
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use* / Q000633:toxicity; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy / Q000379:methods; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use / Q000633:toxicity; D019008:Drug Resistance, Neoplasm; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use / Q000633:toxicity; D006801:Humans; D008197:Lymph Node Excision; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D011960:Receptors, Estrogen / Q000032:analysis; D011980:Receptors, Progesterone / Q000032:analysis
chemical_list: D018943:Anthracyclines; D000964:Antimetabolites, Antineoplastic; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil