A phase II trial of a neoadjuvant platinum regimen for locally advanced breast cancer: pathologic response, long-term follow-up, and correlation with biomarkers

Clin Breast Cancer. 2009 Aug;9(3):166-72. doi: 10.3816/CBC.2009.n.027.

Abstract

Purpose: The purpose of this study is to determine the response, tolerability, and long-term outcome of a neoadjuvant platinum-containing regimen for locally advanced breast cancer (LABC) and to search for a correlation between pathologic complete response (pCR) and predefined biomarkers in this cohort.

Patients and methods: Patients with LABC received 8 cycles of either sequence A or B. Sequence A was doxorubicin 60 mg/m(2) and paclitaxel 175 mg/m(2) (AT) every 3 weeks x 4 followed by cisplatin (C) 60 mg/m(2) and paclitaxel 90 mg/m(2) (CT) every 2 weeks x 4. Sequence B was CT x 4 (with paclitaxel dose escalation) followed by AT x 4. In addition to estrogen receptor (ER) and HER2, immunohistochemistry for MDR-1, MRP-1, topoisomerase IIalpha (topo IIalpha), and p53 was performed.

Results: A total of 88 patients were evaluable for response and toxicity. Median follow-up was 97 months. The overall pCR rate was 21.5%. For subgroups ER+/HER2-, HER2+ and double negative (ER-/HER2-) disease, the pCR rates were 5.9%, 23.3%, and 35%, respectively (P = .006). Five-year overall survival for the entire cohort was 71.1%. Five-year overall survival was 88.1% (95% CI, 77.1%-99.1%) for the ER+/HER2- group compared with 68.5% (95% CI, 51.3%-85.7%) and 49.5% (95% CI, 27.4%-71.6%) in the HER2+ and "double-negative" group, respectively (P = .0077). Overexpression of topo IIalpha was correlated with pCR (P < .001). There were no toxic deaths.

Conclusion: A platinum-containing neoadjuvant regimen was well tolerated and achieved a pCR comparable to other recent studies of multiagent chemotherapy. Further studies tailored for specific breast cancer subtypes are required.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Antigens, Neoplasm / biosynthesis
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / chemistry
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Biomarkers, Tumor / biosynthesis*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / metabolism*
  • Breast Neoplasms / pathology
  • Cisplatin / administration & dosage
  • Cisplatin / chemistry
  • DNA Topoisomerases, Type II / biosynthesis
  • DNA-Binding Proteins / biosynthesis
  • Doxorubicin / administration & dosage
  • Doxorubicin / chemistry
  • Female
  • Humans
  • Middle Aged
  • Neoadjuvant Therapy*
  • Paclitaxel / administration & dosage
  • Paclitaxel / chemistry
  • Platinum / chemistry
  • Platinum / therapeutic use*
  • Treatment Outcome

Substances

  • Antigens, Neoplasm
  • Antineoplastic Agents
  • Biomarkers, Tumor
  • DNA-Binding Proteins
  • Platinum
  • Doxorubicin
  • DNA Topoisomerases, Type II
  • Paclitaxel
  • Cisplatin