Neoadjuvant paclitaxel for operable breast cancer: multicenter phase II trial with clinical outcomes

Anticancer Res. 2008 Mar-Apr;28(2B):1239-44.

Abstract

Aim: To determine the efficacy of preoperative weekly paclitaxel for patients with operable breast cancer tumors greater than 3 cm.

Patients and methods: Paclitaxel 80 mg/m2 weekly x 3 times every 4 weeks for 3 cycles was administered to 53 patients. Twenty-two patients were stage 11, 26 stage III, 5 stage IV Median age (range) was 53 (24-73) years, and 32 patients were negative for estrogen receptor. Thirteen patients showed HER2 overexpression.

Results: Eligible cases composed of 53 patients for evaluation of response. Seven patients had a clinical complete response and 29 patients had a partial response. The overall response rate was 67.9%, including three patients with a pathological complete response. In 18 patients with HER2 overexpression, a clinical complete response was observed in 5, a partial response was observed in 9, and stable disease was found in 4. No treatment, related to grade 3 neutropenia, was given for 1 patient (2%). Other hematological and non-hematological toxicity was found in only 1 patient with fatigue.

Conclusion: Preoperative weekly paclitaxel induced a high clinical response rate with a high safety profile. HER2-overepressing tumors had a higher clinical response rate than non-HER2-overepxressing tumors (91% vs. 50%, respectively). Further studies are needed to determine whether an increase in the cycles of paclitaxel and/or adding anthracyclines may lead to higher pathological complete response and breast-conservation rates in the neoadjuvant setting.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic / administration & dosage*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / enzymology
  • Breast Neoplasms / pathology
  • Breast Neoplasms / surgery
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Humans
  • Middle Aged
  • Neoadjuvant Therapy
  • Neoplasm Staging
  • Paclitaxel / administration & dosage*
  • Receptor, ErbB-2 / biosynthesis
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Phytogenic
  • Receptor, ErbB-2
  • Paclitaxel