한빛사논문
- 조회1,149
Sun Young Chae MDa, †, Prof Sei Hyun Ahn MDb, †, Prof Sung-Bae Kim MDc, †, Sangwon Han MDa, Suk Hyun Lee MDa, Prof Seung Jun Oh PhDa, Sang Ju Lee PhDa, Hee Jeong Kim MDb, Beom Seok Ko MDb, Jong Won Lee MDb, Prof Byung Ho Son MDb, Jisun Kim MDb, Prof Jin-Hee Ahn MDc, Prof Kyung Hae Jung MDc, Jeong Eun Kim MDc, Seog-Young Kim PhDd, Woo Jung Choi MDe, Hee Jung Shin MDd, Prof Gyungyub Gong MDf, Hyo Sang Lee MDh, Jung Bok Lee PhDg, Prof Dae Hyuk Moon MDa,*
a Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
b Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
c Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
d Convergence Medicine Research Center, Department of Convergence Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
e Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
f Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
g Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
h Department of Nuclear Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, South Korea
† Contributed equally
*Correspondence to: Prof Dae Hyuk Moon, Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, South Korea
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.
논문정보
- Research article
- 2019년 03월 (BRIC 등록일 2019-03-20)
- 국내 연구진
- 의약학 > 응용의학
댓글 작성 로그인
팝업 닫기관련 링크
관련분야 연구자보기
소속기관 논문보기
관련분야 논문보기
