Abstract P5-21-07: Phase II study of eribulin in combination with pertuzumab plus trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer

DOI Web Site 被引用文献1件
  • H Kawaguchi
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • T Yamashita
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • N Masuda
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • M Kitada
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • K Narui
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • M Hattori
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • T Yoshinami
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • N Matsunami
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • K Yanagihara
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • T Kawasoe
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • T Nagashima
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • H Bando
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • H Yano
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • Y Hasegawa
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • R Nakamura
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • M Kashiwaba
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • S Morita
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • S Ohno
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan
  • M Toi
    Matsuyama Red Cross Hospital, Matsuyama, Ehime, Japan; Kanagawa Cancer Center, Yokohama, Kanagawa, Japan; NHO Osaka National Hospital, Osaka, Japan; Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan; Yokohama City University Medical Center, Yokohama, Kanagawa, Japan; Aichi Cancer Center, Nagoya, Aichi, Japan; Osaka International Cancer Institute, Osaka, Osaka, Japan; Osaka Rosai Hospital, Osaka, Japan; Kansai Electric Power Hospital, Osaka, Japan; Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan; Chiba University Hospital, Chiba, Japan; University of Tsukuba, Tsukuba, Ibaraki, Japan; Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Hirosaki Municipal Hospital, Horosaki, Aomori, Japan; Chiba Cancer Center, Chiba, Japan; Breastopia Miyazaki Hospital, Miyazaki, Japan; Graduate School of Medicine Kyoto University, Kyoto, Japan; The Cancer Institute Hospital of JFCR, Tokyo, Japan

抄録

<jats:title>Abstract</jats:title> <jats:p>Background: Pertuzumab provided overall and progression-free survival (PFS) benefits in HER2-positive metastatic breast cancer patients (pts) in the CLEOPATRA (Clinical evaluation of docetaxel, pertuzumab and trastuzumab) study. However, few studies have described the efficacy of other drugs in combination with pertuzumab plus trastuzumab. Here, we present a pre-specified analysis of eribulin in combination with pertuzumab plus trastuzumab as first- and second-line therapy for advanced or metastatic breast cancer (AMBC) in a multicenter, open-label phase II study (UMIN000012232, JBCRG-M03).</jats:p> <jats:p>Methods: HER2-positive AMBC with no or single prior chemotherapy for AMBC were enrolled. All pts were administered trastuzumab and taxane as adjuvant or first-line chemotherapy. Treatment consisted of eribulin 1.4 mg/m2 on days 1 and 8 of a 21-day cycle and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) plus pertuzumab (840 mg/body loading dose, then 420 mg/ body) once every 3 weeks, all administered intravenously. The primary endpoint was PFS, and secondary endpoints included overall response rate (ORR) and safety. PFS was determined using Kaplan–Meier analysis. Tumor response was assessed according to RECIST ver. 1.1.</jats:p> <jats:p>Results: Fifty pts were enrolled from November 2013 to April 2016. Forty-nine pts were eligible for safety analysis and the full analysis set (FAS) included 46 pts. The median age was 56 years (23–70), and 8 (16%) and 41 (84%) pts were treated in first- and second-line settings, respectively. Eleven pts (23.9%) were de-novo Stage 4, and 35 pts (76.1%) had progressed in metastatic disease after completion of local therapy. Median PFS was 9.3 months (M) (95% confidence interval [CI]: 6.4–12.3). Table 1 shows the efficacy data for each treatment line and includes ORR, complete response rate (CR), partial response rate (PR), stable disease rate (SD), progressive disease rate (PD), not evaluable rate (NE) and PFS in the FAS. The median relative dose intensities of eribulin, trastuzumab, and pertuzumab were 93.3% (77.0%–100%), 100% (96.0%–100%), and 100% (89.7%–100%), respectively, in the FAS. The grade 3/4 adverse events (AE) were neutropenia in 5 pts (10.2%), including 2 pts (4.1%) with febrile neutropenia; hypertension in 3 pts (6.1%), and other AEs in only one patient. The average of the ejection fraction did not decrease significantly. Symptomatic left ventricular systolic dysfunction was not observed.</jats:p> <jats:p>Conclusion: In pts with HER2-positive AMBC, first- and second-line therapy of eribulin in combination with pertuzumab plus trastuzumab demonstrated substantial antitumor activity with an acceptable safety profile. We are planning a phase III study comparing eribulin with taxanes in combination with pertuzumab plus trastuzumab for the treatment of HER2-positive AMBC.</jats:p> <jats:p>Efficacy data for each treatment lineTreatment LineTotal (n=46)First line (n=8)Second line (n=38)PFS (95% CI), months9.3 (6.4-12.3)20.8 (2.8-38.7)8.7 (7.2-10.2)ORR (%)28 (60.9)7 (87.5)21 (55.3)CR (%)8 (17.4)3 (37.5)5 (13.2)PR (%)20 (43.5)4 (50.0)16 (42.1)SD (%)11 (23.9)1 (12.5)10 (26.3)PD (%)5 (10.9)05 (13.2)NE (%)2 (4.3)02 (5.3)</jats:p> <jats:p>Citation Format: Kawaguchi H, Yamashita T, Masuda N, Kitada M, Narui K, Hattori M, Yoshinami T, Matsunami N, Yanagihara K, Kawasoe T, Nagashima T, Bando H, Yano H, Hasegawa Y, Nakamura R, Kashiwaba M, Morita S, Ohno S, Toi M. Phase II study of eribulin in combination with pertuzumab plus trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-21-07.</jats:p>

収録刊行物

  • Cancer Research

    Cancer Research 78 (4_Supplement), 2018-02-15

    American Association for Cancer Research (AACR)

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