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Breast Cancer Research and Treatment

, Volume 109, Issue 3, pp 481–489 | Cite as

A randomized phase-III trial of docetaxel/capecitabine versus doxorubicin/cyclophosphamide as primary chemotherapy for patients with stage II/III breast cancer

  • Keun Seok Lee
  • Jungsil Ro
  • Byung-Ho Nam
  • Eun Sook Lee
  • Youngmee Kwon
  • Hye Soo Kwon
  • Ki Wook Chung
  • Han Sung Kang
  • Eun A Kim
  • Seok Won Kim
  • Kyung Hwan Shin
  • Seok-Ki Kim
Clinical Trial

Abstract

We aimed to determine the efficacies of a non-anthracycline-containing regimen, docetaxel/capecitabine (TX), in comparison with an anthracycline-containing regimen, doxorubicin/cyclophosphamide (AC), as primary chemotherapy for node-positive early stage breast cancer. In this phase-III single center randomized study, we randomized 209 women with axillary node positive, stage II/III breast cancer to receive four cycles of either TX or AC followed by surgery and cross-over to the other treatment as an adjuvant therapy. The primary endpoint was tumor pathologic complete response (pCR). Clinical response rates, toxicity profiles, disease free survival (DFS), and overall survival were secondary objectives. In total, 204 patients had clinical and radiological evaluation of response, and underwent surgery. Compared with AC, TX increased pCR in primary tumors (21% vs. 10%, respectively, P = 0.024) and clinical response (84% vs. 65%, P = 0.003). TX was associated with less nausea and vomiting, but more stomatitis, diarrhea, myalgia, and skin/nail changes than AC. With a median follow-up of 37 months, there was no significant difference in DFS by treatment groups (P = 0.932). Fewer patients developed recurrence who achieved pCR in lymph node (LN) (P = 0.025; hazard ratio, 0.189; 95% CI, 0.044–0.815) in the multivariate analysis. TX showed superior efficacies to AC with increased pathologic and clinical complete response rates. Although these findings did not translate into a gain in DFS, the patients who achieved pCR in LN developed significantly less recurrence.

Keywords

Breast cancer Capecitabine Clinical trial Docetaxel Phase III 

Notes

Acknowledgments

Supported in part by NCC Grant 0210150 and Korean Health 21 R&D Project Grant by Ministry of Heath and Welfare, Republic of Korea (0412-CR01-0704-0001). Sanofi-Aventis and Roche Korea provided the study drugs, Taxotere and Xeloda, respectively.

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Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Keun Seok Lee
    • 1
  • Jungsil Ro
    • 1
  • Byung-Ho Nam
    • 1
  • Eun Sook Lee
    • 1
  • Youngmee Kwon
    • 1
  • Hye Soo Kwon
    • 1
  • Ki Wook Chung
    • 1
  • Han Sung Kang
    • 1
  • Eun A Kim
    • 1
  • Seok Won Kim
    • 1
  • Kyung Hwan Shin
    • 1
  • Seok-Ki Kim
    • 1
  1. 1.Research Institute and HospitalNational Cancer CenterIlsan-gu, Goyang-si, Gyeonggi-doRepublic of Korea

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