Feasibility Study of Weekly Nanoparticle Albumin-Bound Paclitaxel (150 mg/m2) Followed by Fluorouracil, Epirubicin, and Cyclophosphamide Therapy as Neoadjuvant Chemotherapy for HER2-Negative Breast Cancer

Clin Breast Cancer. 2018 Oct;18(5):374-379. doi: 10.1016/j.clbc.2018.01.002. Epub 2018 Jan 11.

Abstract

Background: Although several studies have shown efficacy of nanoparticle albumin-bound (nab) paclitaxel use as a neoadjuvant treatment in breast cancer, dosage and schedules were varied or used in combination and the data are still limited for weekly regimens. We evaluated the feasibility of weekly nab-paclitaxel followed by FEC (5-FU [fluorouracil], epirubicin, and cyclophosphamide) treatment feasibility as neoadjuvant chemotherapy for breast cancer.

Patients and methods: Thirty-three patients with no previous chemotherapy were enrolled to receive nab-paclitaxel 150 mg/m2 the first 3 of 4 weeks (3q4w) followed by FEC as neoadjuvant treatment. The trial was powered for analyses of feasibility.

Results: Twenty-five patients completed the treatment as per protocol, and the completion rate was 75.8% (95% confidence interval, 59.0-87.2; P = .44). The regimen completion group was younger than those with regimen incompletion (average 45.1 vs. 56.6 years). The pathological complete response (ypT0-is/N0) rate was 30.3% in 33 patients, which was higher in triple-negative patients (58.3%). Grade 3/4 neutropenia was seen in 48.5%, although there was no febrile neutropenia. Grade 3 peripheral neuropathy was seen in 33.3%.

Conclusion: Our study showed that weekly nab-paclitaxel 150 mg/m2 3q4w followed by FEC as neoadjuvant regimen might be sufficient in efficacy, although with a relatively high severe adverse event occurrence rate.

Keywords: Breast cancer; Nab-paclitaxel; Neoadjuvant chemotherapy; Peripheral neuropathy; Phase II.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Albumins / administration & dosage
  • Albumins / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Chemotherapy, Adjuvant / methods*
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / adverse effects
  • Epirubicin / administration & dosage
  • Epirubicin / adverse effects
  • Feasibility Studies
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Humans
  • Middle Aged
  • Nanoparticles
  • Neoadjuvant Therapy / methods*
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects
  • Receptor, ErbB-2

Substances

  • 130-nm albumin-bound paclitaxel
  • Albumins
  • Epirubicin
  • Cyclophosphamide
  • ERBB2 protein, human
  • Receptor, ErbB-2
  • Paclitaxel
  • Fluorouracil