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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

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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.

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Acknowledgments

We would like to thank all participating patients and their families, and also to thank multidisciplinary team members and research coordinators at the individual centers. This study was supported by NCC Grant No 0610240 and was supported in part by the Korean Cancer Study Group (KCSG BR07-01). Paclitaxel, gemcitabine, and trastuzumab were kindly provided by CJ Cheiljedang CO., and Eli Lilly & CO, and Roche, respectively.

Disclosure

There were no conflict of interest between the authors and the analysis and the presentation of the data.

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Authors and Affiliations

  1. Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

    Seock-Ah Im

  2. Center for Breast Cancer, National Cancer Center, 111 Jeongbalsanro, Ilsan-gu, Goyang-si, Gyeonggi-do, 410-769, Republic of Korea

    Keun Seok Lee, Jungsil Ro, Eun Sook Lee, Youngmee Kwon, Han Sung Kang & Kyung Hwan Shin

  3. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

    Jin-Hee Ahn & Sung-Bae Kim

  4. Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

    Jin Seok Ahn & Young Hyuck Im

  5. Department of Internal Medicine, Seoul National University Bundang Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seongnam, Korea

    Jee Hyun Kim

  6. Department of Surgery, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

    Dong-Young Noh

  7. Department of Pathology, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

    In-Ae Park

  8. Department of Radiation Oncology, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

    Sung Whan Ha

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  1. Seock-Ah Im
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Correspondence to Jungsil Ro.

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Seock-Ah Im and Keun Seok Lee contributed equally to this study.

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Im, SA., Lee, K.S., Ro, J. et al. 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. Breast Cancer Res Treat 132, 589–600 (2012). https://doi.org/10.1007/s10549-011-1852-0

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