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. 2015 Jul;47(3):406-15.
doi: 10.4143/crt.2014.073. Epub 2014 Nov 24.

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

Changhoon Yoo  1 , Sung-Bae Kim  1 , Jin-Hee Ahn  1 , Jeong Eun Kim  1 , Kyung Hae Jung  1 , Gyung-Yub Gong  2 , Byung-Ho Son  3 , Sei-Hyun Ahn  3 , Seung Do Ahn  4 , Hak-Hee Kim  5 , Hee Jung Shin  5 , Woo Kun Kim  1
Affiliations

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

Changhoon Yoo et al. Cancer Res Treat. 2015 Jul.

Abstract

Purpose: 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.

Materials and 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.

Conclusion: CV-D is a feasible and active non-anthracycline-based neoadjuvant chemotherapy regimen for breast cancer.

Keywords: Anthracyclines; Breast neoplasm; Capecitabine; Neoadjuvant therapy; Vinorelbine.

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Conflict of interest statement

Conflict of interest relevant to this article was not reported.

Figures

Fig. 1.
Fig. 1.
Consolidated Standards of Reporting Trials (CONSORT) diagram. AC-D, anthracycline and cyclophosphamide followed by docetaxel; CV-D, capecitabine and vinorelbine followed by docetaxel.
Fig. 2.
Fig. 2.
Progression-free survival (A) and overall survival (B). AC-D, anthracycline and cyclophosphamide followed by docetaxel; CV-D, capecitabine and vinorelbine followed by docetaxel.
Fig. 3.
Fig. 3.
Relative dose intensity of docetaxel. AC-D, anthracycline and cyclophosphamide followed by docetaxel; CV-D, capecitabine and vinorelbine followed by docetaxel.
See this image and copyright information in PMC

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