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Breast Cancer Research and Treatment

, Volume 132, Issue 3, pp 833–842 | Cite as

Pilot neoadjuvant trial in HER2 positive breast cancer with combination of nab-paclitaxel and lapatinib

  • Virginia G. Kaklamani
  • Kalliopi Siziopikou
  • Denise Scholtens
  • Mario Lacouture
  • Jennifer Gordon
  • Regina Uthe
  • Caitlin Meservey
  • Nora Hansen
  • Seema A. Khan
  • Jacqueline S. Jeruss
  • Kevin Bethke
  • Mary Cianfrocca
  • Steven Rosen
  • Jamie Von Roenn
  • Jeffrey Wayne
  • Vamsi Parimi
  • Borko Jovanovic
  • William Gradishar
Clinical Trial

Abstract

Lapatinib, a dual kinase inhibitor against epidermal growth factor receptor (EGFR) and human epidermal receptor two (HER2) has shown efficacy in treating HER2 positive breast cancer. Nanoparticle albumin bound (nab) paclitaxel was developed to reduce toxicities from paclitaxel and improve its efficacy. Thirty patients with stage I–III HER2 positive breast cancer were treated in the neoadjuvant setting with lapatinib 1,000 mg/day and nab-paclitaxel 260 mg/m2 every 3 weeks for four cycles. The primary end point of the trial was clinical response rate (cRR) with secondary end points including pathologic complete response rate (pCR), tolerability of the combination, and marker response. The cRR was 82.8% (24 patients) with six (20.7%) patients having complete clinical response, 18 (62.1%) having partial clinical response, and five (17.2%) stable disease. A pCR was observed in five of the 28 patients (17.9%). The most frequent grade 2 toxicities were neuropathy in nine patients (30%), fatigue in seven patients (23.3%), rash in 11 patients (36.7%), and bone pain in 10 patients (33.3%). There was no significant drop in the left ventricular ejection fraction (LVEF). Of the tissue markers examined, we were not able to find a predictor of response. The combination of lapatinib and nab-paclitaxel was well tolerated and provided good efficacy in women with HER2 positive breast cancer. This combination offers an alternative non-anthracycline-containing regimen for women with HER2 positive breast cancer.

Keywords

Lapatinib Nab-paclitaxel Breast cancer Neoadjuvant therapy HER2 

Notes

Acknowledgments

This clinical trial (ClinicalTrials.gov ID NCT00331630) was conducted through the support of GlaxoSmithKline. Abraxis BioScience Inc. provided nab-paclitaxel. Pathology Core Facility, Robert H. Lurie Comprehensive Cancer Center, where all staining was conducted, provided the necessary support.

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Copyright information

© Springer Science+Business Media, LLC. 2011

Authors and Affiliations

  • Virginia G. Kaklamani
    • 1
  • Kalliopi Siziopikou
    • 2
  • Denise Scholtens
    • 3
  • Mario Lacouture
    • 4
  • Jennifer Gordon
    • 5
  • Regina Uthe
    • 1
  • Caitlin Meservey
    • 1
  • Nora Hansen
    • 6
  • Seema A. Khan
    • 6
  • Jacqueline S. Jeruss
    • 6
  • Kevin Bethke
    • 6
  • Mary Cianfrocca
    • 1
  • Steven Rosen
    • 1
  • Jamie Von Roenn
    • 1
  • Jeffrey Wayne
    • 6
  • Vamsi Parimi
    • 7
  • Borko Jovanovic
    • 3
  • William Gradishar
    • 1
  1. 1.Division of Hematology/OncologyNorthwestern UniversityChicagoUSA
  2. 2.Department of PathologyNorthwestern UniversityChicagoUSA
  3. 3.Department of Preventive MedicineNorthwestern UniversityChicagoUSA
  4. 4.Department of DermatologyMemorial Sloan Kettering Cancer CenterNew YorkUSA
  5. 5.Department of DermatologyNorthwestern UniversityChicagoUSA
  6. 6.Department of SurgeryNorthwestern UniversityChicagoUSA
  7. 7.Pathology Core FacilityRobert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicagoUSA

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