Weekly paclitaxel and concurrent pazopanib following doxorubicin and cyclophosphamide as neoadjuvant therapy for HER-negative locally advanced breast cancer: NSABP Foundation FB-6, a phase II study

Breast Cancer Res Treat. 2015 Jan;149(1):163-9. doi: 10.1007/s10549-014-3221-2. Epub 2014 Dec 27.

Abstract

This multicenter single-arm phase II study evaluated the addition of pazopanib to concurrent weekly paclitaxel following doxorubicin and cyclophosphamide as neoadjuvant therapy in human epidermal growth factor receptor (HER2)-negative locally advanced breast cancer (LABC). Patients with HER2-negative stage III breast cancer were treated with doxorubicin 60 mg/m(2) and cyclophosphamide 600 mg/m(2) for four cycles every 3 weeks followed by weekly paclitaxel 80 mg/m(2) on days 1, 8, and 15 every 28 days for four cycles concurrently with pazopanib 800 mg orally daily prior to surgery. Post-operatively, pazopanib was given daily for 6 months. The primary endpoint was pathologic complete response (pCR) in the breast and lymph nodes. Between July 2009 and March 2011, 101 patients with stage IIIA-C HER2-negative breast cancer were enrolled. The pCR rate in evaluable patients who initiated paclitaxel and pazopanib was 17 % (16/93). The pCR rate was 9 % (6/67) in hormone receptor-positive tumors and 38 % (10/26) in triple-negative tumors. Pre-operative pazopanib was completed in only 39 % of patients. The most frequent grade 3 and 4 adverse events during paclitaxel and pazopanib were neutropenia (27 %), diarrhea (5 %), ALT and AST elevations (each 5 %), and hypertension (5 %). Although the pCR rate of paclitaxel and pazopanib following AC chemotherapy given as neoadjuvant therapy in women with LABC met the pre-specified criteria for activity, there was substantial toxicity, which led to a high discontinuation rate of pazopanib. The combination does not appear to warrant further evaluation in the neoadjuvant setting for breast cancer.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Cyclophosphamide / administration & dosage*
  • Cyclophosphamide / adverse effects
  • Doxorubicin / administration & dosage*
  • Doxorubicin / adverse effects
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Indazoles
  • Lymph Nodes / drug effects
  • Middle Aged
  • Neoadjuvant Therapy
  • Neoplasm Staging
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Pyrimidines / administration & dosage*
  • Pyrimidines / adverse effects
  • Receptor, ErbB-2 / genetics
  • Sulfonamides / administration & dosage*
  • Sulfonamides / adverse effects

Substances

  • Indazoles
  • Pyrimidines
  • Sulfonamides
  • pazopanib
  • Doxorubicin
  • Cyclophosphamide
  • Receptor, ErbB-2
  • Paclitaxel
  • Fluorouracil