핵의학

  • [Lancet Oncol.] Diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study.

    [Lancet Oncol.] Diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study.유방암 에스트로겐 수용체영상 PET의 진단정확도

    울산의대 / 채선영, 안세현, 김성배, 문대혁*

  • 출처
    Lancet Oncol.
  • 등재일
    2019 Apr
  • 저널이슈번호
    20(4):546-555. doi: 10.1016/S1470-2045(18)30936-7. Epub 2019 Mar 4.
  • 내용

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    Abstract
    BACKGROUND:
    A biopsy of first recurrence or metastatic disease is recommended to re-evaluate oestrogen receptor status in patients with breast cancer and to select appropriate treatment. However, retesting for oestrogen receptor status with rebiopsy is not always feasible, depending on lesion location and the risk associated with biopsy, and in these cases clinicians continue to treat patients according to the oestrogen receptor status of the primary tumour. Consequently suboptimal therapy might be offered to these patients. We assessed the diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol (18F-FES) PET-CT to assess oestrogen receptor status in patients with recurrent or metastatic breast cancer.

    METHODS:
    We did a prospective cohort study at the Asan Medical Center, Seoul, South Korea. Eligible patients had breast cancer, with first recurrence or metastatic disease at presentation, were 19 years or older, and had an Eastern Cooperative Oncology Group performance status of 0-2. The primary objective was to show the agreement between qualitative 18F-FES PET-CT interpretation and the results of oestrogen receptor expression by immunohistochemical assay, a non-reference standard test. Whole-body 18F-FES PET-CT imaging was done after intravenous injection of 111-222 MBq of 18F-FES, with dosing primarily determined by radiation dosimetry analysis. 18F-FES uptake above background intensity was interpreted as positive. Efficacy was assessed in all patients with histologically confirmed recurrent or metastatic breast cancer who received 18F-FES and had PET-CT images available (intention-to-diagnose analysis), and safety was assessed in all patients who received 18F-FES. This study is registered with ClinicalTrials.gov, number NCT01986569.

    FINDINGS:
    Between Nov 27, 2013, and Nov 10, 2016, 93 patients were enrolled. Of the 85 patients included in the efficacy analysis, 47 (55%) were oestrogen receptor-positive and 38 (45%) were oestrogen receptor-negative. Positive status percent agreement between the 18F-FES PET-CT results and oestrogen receptor status by immunohistochemical assay was 76·6% (95% CI 62·0-87·7) and the negative status percent agreement was 100·0% (90·8-100·0). Patients who were oestrogen receptor-positive and had a positive 18F-FES PET-CT result had a significantly higher progesterone receptor expression than those who were oestrogen receptor-positive and had a negative 18F-FES PET-CT result (23 [68%] of 34 patients vs 0 of 11 patients; p<0·0001). The most common adverse event was procedural pain in nine (10%) of 90 patients injected with 18F-FES. No adverse events were related to the study drug except injection site pain in one (1%) patient. No serious adverse events were recorded.

    INTERPRETATION:
    The high negative percent agreement between 18F-FES PET-CT and oestrogen receptor status by immunohistochemical assay in this cohort suggests that positive 18F-FES uptake by recurrent or metastatic oestrogen receptor-positive breast cancer lesions could be an alternative to oestrogen receptor assays in this setting. Staging assessment should include 18F-FES PET-CT when retesting oestrogen receptor status is not feasible.

     


    Author information

    Chae SY1, Ahn SH2, Kim SB3, Han S1, Lee SH1, Oh SJ1, Lee SJ1, Kim HJ2, Ko BS2, Lee JW2, Son BH2, Kim J2, Ahn JH3, Jung KH3, Kim JE3, Kim SY4, Choi WJ5, Shin HJ4, Gong G6, Lee HS7, Lee JB8, Moon DH9.
    1
    Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
    2
    Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
    3
    Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
    4
    Convergence Medicine Research Center, Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
    5
    Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
    6
    Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
    7
    Department of Nuclear Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, South Korea.
    8
    Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
    9
    Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: dhmoon@amc.seoul.kr.

     

    관련정보보기

  • 연구소개
    재발/전이 병소를 가진 유방암 환자는 조직검사를 하여 재발/전이 병소의 여성호르몬수용체 양성/음성 여부를 평가해야 한다. 그러나, 조직검사를 하지 못하는 경우에는 재발/전이 전의 유방암 병소에서 얻은 여성호르몬수용체 결과에 따라 치료 방침을 정하게 된다. 따라서 재발/전이된 병소가 원발 부위와 여성호르몬수용체가 다를 경우 잘못된 치료를 하게 된다. 본 연구는 재발/전이 유방암 병소의 여성호르몬수용체 평가에 대한 FES 양전자단층 촬영과 조직검사간의 양성/음성 일치도를 평가한 3상 임상시험이다. 임상시험 결과 양성일치도는 77%, 음성일치도는 100%의 결과를 얻었다. 즉 FES 양전자단층촬영이 양성이면, 위음성 없이 모두 조직검사소견이 양성임을 의미한다. 위양성 환자들과 진양성 환자 간에는 매우 유의한 임상/조직학적 차이가 있어서, 위양성 환자가 진양성 환자와는 다른 임상적 특성을 가짐을 시사하는 소견도 얻었다. 결론적으로 재발/전이된 유방병소의 조직검사를 하지 못할 경우에는 FES 양전자단층촬영검사를 해야 한다.
  • 편집위원

    유방암 환자에서 재발 혹은 전이성 병변의 에스트로젠 수용체 발현 여부를 핵의학 영상으로 평가하고 이의 임상적 가치를 임상연구로 PET 영상기법을 이용한 여성호르몬 수용체 영상의 가치를 밝히고, personalized medicine에서 활용 가능성을 보여준 파일롯 연구로 유방암 관련 임상가 및 핵의학 전문가에게 관심을 끌 수 있는 연구로 보임.

    2019-05-28 17:35:32

  • 편집위원2

    FES PET을 prospective로 얻어, 기존의 병리학적인 조직검사 기반으로 수행하던 검사를 in vivo molecular imaging으로 정보를 획득할 수 있다는 가능성을 보여준 연구로서 핵의학 및 분자영상이 지향하는 바를 잘 설계한 연구결과입니다.

    2019-05-28 17:40:50

  • 편집위원3

    임상적으로 바로 적용 가능한 유용한 연구로 생각되며 나아가 유방암 병기설정에도 공식적으로 포함되기를 기대해 봅니다.

    2019-05-28 17:42:04

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