title: A Randomized Phase II Trial of Capecitabine Plus Vinorelbine Followed by Docetaxel Versus Adriamycin Plus Cyclophosphamide Followed by Docetaxel as Neoadjuvant Chemotherapy for Breast Cancer.
abstract: OBJECTIVE
  Given the promising activity of capecitabine and vinorelbine in metastatic breast cancer, this randomized phase II trial evaluated the efficacy and safety of this combination as neoadjuvant chemotherapy in breast cancer.
  
  
  METHODS
  Patients with operable breast cancer (n=75) were randomly assigned to receive either four cycles of adriamycin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 3 weeks followed by four cycles of docetaxel 75 mg/m(2) every 3 weeks (AC-D) or four cycles of capecitabine 2,000 mg/m(2) (day 1-14) plus vinorelbine 25 mg/m(2) (days 1 and 8) every 3 weeks followed by four cycles of docetaxel 75 mg/m(2) (CV-D). The primary endpoint was pathologic complete response (pCR) in the primary breast (ypT0/is).
  
  
  RESULTS
  Most patients (84%) had locally advanced (n=41) or inflammatory breast cancer (n=22). pCR rates in the primary breast were 15% (95% confidence interval [CI], 7% to 30%) and 11% (95% CI, 4% to 26%) in the AC-D and CV-D groups, respectively. The overall response rates and 5-year progression-free survival rates in the AC-D and CV-D groups were 62% and 64%, and 51.3% (95% CI, 34.6% to 68.0%) and 30.2% (95% CI, 13.3% to 47.1%), respectively. Although both regimens were well tolerated, CV-D showed less frequent grade 3-4 neutropenia and vomiting than AC-D, whereas manageable diarrhea and hand-foot syndrome were more common in the CV-D group.
  
  
  CONCLUSIONS
  CV-D is a feasible and active non-anthracycline-based neoadjuvant chemotherapy regimen for breast cancer.
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Changhoon
authors: C
authors: Yoo
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Sung-Bae
authors: SB
authors: Kim
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Jin-Hee
authors: JH
authors: Ahn
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Jeong Eun
authors: JE
authors: Kim
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Kyung Hae
authors: KH
authors: Jung
authors: Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Gyung-Yub
authors: GY
authors: Gong
authors: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Byung-Ho
authors: BH
authors: Son
authors: Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Sei-Hyun
authors: SH
authors: Ahn
authors: Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Seung Do
authors: SD
authors: Ahn
authors: Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Hak-Hee
authors: HH
authors: Kim
authors: Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Hee Jung
authors: HJ
authors: Shin
authors: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors: Woo Kun
authors: WK
authors: Kim
keywords: Anthracyclines; Breast neoplasm; Capecitabine; Neoadjuvant therapy; Vinorelbine
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