title: Neoadjuvant capecitabine and docetaxel (plus trastuzumab): an effective non-anthracycline-based chemotherapy regimen for patients with locally advanced breast cancer.
abstract: BACKGROUND
  To evaluate capecitabine-docetaxel (XT), with trastuzumab (H) in human epidermal growth factor receptor 2 (HER2)-positive disease, in inoperable locally advanced breast cancer (LABC).
  
  
  METHODS
  Patients received up to six neoadjuvant 21-day cycles of capecitabine 900 mg/m(2) twice daily, days 1-14, plus docetaxel 36 mg/m(2), days 1 and 8. Patients with HER2-positive disease also received trastuzumab 6 mg/kg every 3 weeks. The primary end point was pathologic complete response (pCR) rate, evaluated separately in HER2-negative and HER2-positive cohorts. Secondary end points included clinical response rates and tolerability.
  
  
  RESULTS
  The pCR rate was 15% [95% confidence interval (CI) 7-28] in 53 patients receiving XT and 40% (95% CI 26-55) in 50 patients receiving HXT. After neoadjuvant therapy, 50 patients receiving XT and 45 receiving HXT underwent surgery. No unexpected toxicity was observed: the most common grade ≥3 adverse events were diarrhea/mucositis (30% and 20%, respectively) and grade 3 hand-foot syndrome (11% and 6%, respectively). Disease-free survival and overall survival were similar with XT and HXT after median follow-up of 22 months in the XT cohort and 21 months in the HXT cohort.
  
  
  CONCLUSIONS
  Neoadjuvant XT (HXT in HER2-positive disease) is highly effective in inoperable LABC, demonstrating pCR rates of 15% and 40%, respectively. This non-anthracycline-containing regimen offers obvious benefits in early disease, where avoidance of long-term cardiotoxicity is particularly important.
authors: Multidisciplinary Breast Center; Department of General Medical Oncology, University Hospitals Leuven, Leuven. Electronic address: hans.wildiers@uzleuven.be.
authors: H
authors: H
authors: Wildiers
authors: Multidisciplinary Breast Center.
authors: P
authors: P
authors: Neven
authors: Multidisciplinary Breast Center.
authors: M R
authors: MR
authors: Christiaens
authors: International Drug Development Institute, Louvain.
authors: P
authors: P
authors: Squifflet
authors: Multidisciplinary Breast Center.
authors: F
authors: F
authors: Amant
authors: Multidisciplinary Breast Center.
authors: C
authors: C
authors: Weltens
authors: Multidisciplinary Breast Center.
authors: A
authors: A
authors: Smeets
authors: Multidisciplinary Breast Center.
authors: E
authors: E
authors: van Limbergen
authors: Department of Medical Oncology, Ziekenhuis-Oost-Limburg, Genk.
authors: G
authors: G
authors: Debrock
authors: Department of Medical Oncology, AZ St-Lucas, Gent.
authors: V
authors: V
authors: Renard
authors: Department of General Medical Oncology, University Hospitals Leuven, Leuven.
authors: L
authors: L
authors: Van Eenoo
authors: Multidisciplinary Breast Center; Department of Medical Oncology, Imelda Ziekenhuis, Bonheiden, Belgium.
authors: W
authors: W
authors: Wynendaele
authors: Multidisciplinary Breast Center; Department of General Medical Oncology, University Hospitals Leuven, Leuven.
authors: R
authors: R
authors: Paridaens
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D043823:Taxoids / Q000008:administration & dosage; D000068878:Trastuzumab; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069287:Capecitabine; D003841:Deoxycytidine; D000077143:Docetaxel; D005472:Fluorouracil; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab; C508053:ERBB2 protein, human