Prospective phase II study of neoadjuvant doxorubicin followed by cisplatin/docetaxel in locally advanced breast cancer

Med Oncol. 2010 Sep;27(3):571-7. doi: 10.1007/s12032-009-9251-7. Epub 2009 Jun 13.

Abstract

The objective of this study is to evaluate the efficacy and safety profile of the doxorubicin followed by cisplatin/docetaxel as primary chemotherapy for patients with locally advanced breast cancer (LABC). For this evaluation, 59 patients with LABC (T2-T4, N0-N2, M0) received three cycles of doxorubicin, followed by three cycles of cisplatin/docetaxel and followed by definitive surgery and locoregional radiotherapy with or without tamoxifen. The primary end point was pathologic complete response (pCR) in breast and axilla. Fifty-nine patients were evaluable for analysis: median age: 41 years, premenopausal: 68%, median tumor size: 6.0 cm (4-10), Stage IIB: 32% and IIIA/IIIB: 68%, both ER/PR positive: 53%, Her2/neu (3+) by IHC staining: 29%. Clinical complete response was seen in 44%, and clinical partial response was seen in 56%. Breast conserving surgery was performed in 44%, and MRM in 56%. pCR in the breast was 30.5%, in axilla was 37%, and pCR in both breast and axilla was 24%. Overall at follow-up of 60 months, the disease-free (DFS) and overall survival (OS) were 70 and 82%, respectively. The DFS and OS of patients who achieved complete pathologic response in breast and axilla were 78 and 100%, respectively, while 14 patients relapsed of which 46% were Her2 positive. Sequential combination of doxorubicin followed by docetaxel/cisplatin is a safe, feasible, and active combination, which offers the possibility of conservative surgery and is associated with high clinical and pathologic response rates, with promising and encouraging survival outcomes.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Breast Neoplasms / radiotherapy
  • Breast Neoplasms / surgery
  • Carcinoma / drug therapy*
  • Carcinoma / pathology
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Combined Modality Therapy
  • Disease-Free Survival
  • Docetaxel
  • Doxorubicin / administration & dosage
  • Estrogens
  • Female
  • Genes, erbB-2
  • Humans
  • Kaplan-Meier Estimate
  • Lymphatic Metastasis
  • Mastectomy, Modified Radical
  • Mastectomy, Segmental
  • Middle Aged
  • Neoadjuvant Therapy*
  • Neoplasms, Hormone-Dependent / drug therapy
  • Neoplasms, Hormone-Dependent / pathology
  • Progesterone
  • Prospective Studies
  • Radiotherapy, Adjuvant
  • Tamoxifen / administration & dosage
  • Taxoids / administration & dosage
  • Taxoids / adverse effects
  • Treatment Outcome
  • Young Adult

Substances

  • Estrogens
  • Taxoids
  • Tamoxifen
  • Docetaxel
  • Progesterone
  • Doxorubicin
  • Cisplatin