Breast Cancer Research and Treatment

, Volume 132, Issue 2, pp 589–600

Phase II trial of preoperative paclitaxel, gemcitabine, and trastuzumab combination therapy in HER2 positive stage II/III breast cancer: The Korean Cancer Study Group BR 07-01

Authors

  • Seock-Ah Im
    • Department of Internal Medicine, Seoul National University Hospital, Cancer Research InstituteSeoul National University College of Medicine
  • Keun Seok Lee
    • Center for Breast CancerNational Cancer Center
    • Center for Breast CancerNational Cancer Center
  • Eun Sook Lee
    • Center for Breast CancerNational Cancer Center
  • Youngmee Kwon
    • Center for Breast CancerNational Cancer Center
  • Jin-Hee Ahn
    • Department of Oncology, Asan Medical CenterUniversity of Ulsan College of Medicine
  • Jin Seok Ahn
    • Department of Medicine, Samsung Medical CenterSungkyunkwan University School of Medicine
  • Jee Hyun Kim
    • Department of Internal Medicine, Seoul National University Bundang Hospital, Cancer Research InstituteSeoul National University College of Medicine
  • Han Sung Kang
    • Center for Breast CancerNational Cancer Center
  • Kyung Hwan Shin
    • Center for Breast CancerNational Cancer Center
  • Dong-Young Noh
    • Department of Surgery, Seoul National University Hospital, Cancer Research InstituteSeoul National University College of Medicine
  • In-Ae Park
    • Department of Pathology, Seoul National University Hospital, Cancer Research InstituteSeoul National University College of Medicine
  • Sung-Bae Kim
    • Department of Oncology, Asan Medical CenterUniversity of Ulsan College of Medicine
  • Young Hyuck Im
    • Department of Medicine, Samsung Medical CenterSungkyunkwan University School of Medicine
  • Sung Whan Ha
    • Department of Radiation Oncology, Seoul National University Hospital, Cancer Research InstituteSeoul National University College of Medicine
Clinical trial

DOI: 10.1007/s10549-011-1852-0

Cite this article as:
Im, S., Lee, K.S., Ro, J. et al. Breast Cancer Res Treat (2012) 132: 589. doi:10.1007/s10549-011-1852-0

Abstract

An addition of trastuzumab preoperatively to chemotherapy for human epidermal growth factor receptor 2 (HER2) positive breast cancer improved relapse-free survival (RFS). This study was designed to evaluate the efficacy and safety of preoperative paclitaxel, gemcitabine, and trastuzumab (PGH) combination for HER2-positive breast caner. Pathologically, proven node positive stage II/III breast cancer patients with adequate organ function and no history of anti-cancer therapy were eligible. Patients received weekly trastuzumab with paclitaxel 80 mg/m2 and gemcitabine 1,200 mg/m2 on days 1 and 8, every 3 weeks for 6 cycles. Postoperatively, patients completed trastuzumab for 1 year and hormone therapy for 5 years if indicated. All patients received postoperative radiation therapy. Of 53 enrolled patients with a median tumor of 5.3 (range, 2.0 to >12) cm; 43.4%, T3/T4; 75.4%, N2/N3; and 45.3%, positive hormone receptors. The pathologic complete response (pCR) rate was 58.5% in both tumor and lymph nodes. Grade 3/4 adverse events were neutropenia (32%), febrile neutropenia (0.6%), and transient elevation of AST/ALT (1.6%) during a total of 318 cycles. All patients maintained normal cardiac function. With a median follow-up of 40 months, 3-year RFS rate was 84% with 91.7% distant metastasis-free survival rates. Remarkable pCR rate was obtained with non-anthracycline-based PGH therapy for HER2-positive stage II/III breast cancer. Adverse events were mild with few incidences of febrile neutropenia.

Keywords

Preoperative chemotherapyTrastuzumabPaclitaxelGemcitabineHER2-positive Breast Cancer

Copyright information

© Springer Science+Business Media, LLC. 2011