Abstract：
OBJECTIVE: This study aimed to evaluate fulvestrant efficacy in women with estrogen receptor-positive low-grade gynecological cancers. The primary objective was to determine the response rate. Secondary objectives were progression-free survival, clinical benefit, duration of response, safety, tolerability, and quality of life.
METHODS: FUCHSia is an open-label, single-arm, prospective, multi-center phase II study. The study population included patients with recurrent/metastatic low-grade gynecological malignancies with estrogen receptor positivity who received a maximum of two lines of previous hormonal therapy. Patients received fulvestrant (FASLODEX, AstraZeneca) via two intramuscular injections (250 mg/5 mL each) in the gluteal muscle on day 1, day 15, day 29, and then every 28 days thereafter until disease progression, withdrawal from the trial due to any unacceptable adverse event, or withdrawal of patient consent.
RESULTS: A total of 15 patients (uterine sarcoma n=4; sex cord-stromal ovarian tumors n=3; endometrial carcinoma n=4; serous ovarian cancer n=4) were enrolled. Median follow-up was 48 weeks (interquartile range (IQR) 26-122) in the uterine sarcoma cohort, 63 weeks (IQR 28-77) for sex cord-stromal tumors, 19 weeks (IQR 17-21) for endometrial carcinoma, and 60 weeks (IQR 40-119) for serous ovarian cancer. One partial response according to Response Evaluation Criteria in Solid Tumors v1.1 was observed in one uterine sarcoma patient. No responses were observed in the other cohorts. However, stable disease was observed in three uterine sarcomas (median duration 12 weeks), three sex cord-stromal tumors (median duration 32 weeks), and four low-grade serous ovarian cancer patients (median duration 20 weeks), leading to a disease control rate of 100% for these tumor types. All patients with endometrial carcinoma showed progressive disease.
CONCLUSIONS: Fulvestrant may control tumor growth in recurrent/metastatic estrogen receptor-positive low-grade gynecological malignancies of specific histology. Further studies are needed to confirm these results.
METHODS: FUCHSia is an open-label, single-arm, prospective, multi-center phase II study. The study population included patients with recurrent/metastatic low-grade gynecological malignancies with estrogen receptor positivity who received a maximum of two lines of previous hormonal therapy. Patients received fulvestrant (FASLODEX, AstraZeneca) via two intramuscular injections (250 mg/5 mL each) in the gluteal muscle on day 1, day 15, day 29, and then every 28 days thereafter until disease progression, withdrawal from the trial due to any unacceptable adverse event, or withdrawal of patient consent.
RESULTS: A total of 15 patients (uterine sarcoma n=4; sex cord-stromal ovarian tumors n=3; endometrial carcinoma n=4; serous ovarian cancer n=4) were enrolled. Median follow-up was 48 weeks (interquartile range (IQR) 26-122) in the uterine sarcoma cohort, 63 weeks (IQR 28-77) for sex cord-stromal tumors, 19 weeks (IQR 17-21) for endometrial carcinoma, and 60 weeks (IQR 40-119) for serous ovarian cancer. One partial response according to Response Evaluation Criteria in Solid Tumors v1.1 was observed in one uterine sarcoma patient. No responses were observed in the other cohorts. However, stable disease was observed in three uterine sarcomas (median duration 12 weeks), three sex cord-stromal tumors (median duration 32 weeks), and four low-grade serous ovarian cancer patients (median duration 20 weeks), leading to a disease control rate of 100% for these tumor types. All patients with endometrial carcinoma showed progressive disease.
CONCLUSIONS: Fulvestrant may control tumor growth in recurrent/metastatic estrogen receptor-positive low-grade gynecological malignancies of specific histology. Further studies are needed to confirm these results.
摘要：
目的：本研究旨在评估氟维司群对雌激素受体阳性低度妇科肿瘤患者的疗效。主要目标是确定反应率。次要目标是无进展生存期，临床获益,响应的持续时间，安全,耐受性,和生活质量。
方法：FUCHSia是一个开放标签，单臂,prospective,多中心二期研究。研究人群包括雌激素受体阳性的复发性/转移性低度妇科恶性肿瘤患者，他们接受了最多两行先前的激素治疗。患者接受氟维司群(FASLODEX，阿斯利康）在第1天，第15天，第29天通过两次肌肉注射（每次250mg/5mL）在臀肌中，然后每28天进行一次，直到疾病进展，由于任何不可接受的不良事件而退出试验，或撤回患者同意。
结果：共纳入15例患者（子宫肉瘤n=4；性索间质卵巢肿瘤n=3；子宫内膜癌n=4；浆液性卵巢癌n=4）。在子宫肉瘤队列中，中位随访时间为48周（四分位距（IQR）26-122），性索间质肿瘤63周（IQR28-77），子宫内膜癌19周（IQR17-21），浆液性卵巢癌60周（IQR40-119）。在一名子宫肉瘤患者中观察到根据实体瘤v1.1中的反应评估标准的一个部分反应。在其他队列中未观察到应答。然而,在三个子宫肉瘤中观察到稳定的疾病（中位持续时间12周），三个性索间质肿瘤（中位持续时间32周），和四名低级别浆液性卵巢癌患者（中位病程20周），导致这些肿瘤类型的疾病控制率为100％。所有子宫内膜癌患者均表现为进行性疾病。
结论：氟维司群可以控制特定组织学的复发性/转移性雌激素受体阳性低度恶性妇科恶性肿瘤的肿瘤生长。需要进一步的研究来证实这些结果。
方法：FUCHSia是一个开放标签，单臂,prospective,多中心二期研究。研究人群包括雌激素受体阳性的复发性/转移性低度妇科恶性肿瘤患者，他们接受了最多两行先前的激素治疗。患者接受氟维司群(FASLODEX，阿斯利康）在第1天，第15天，第29天通过两次肌肉注射（每次250mg/5mL）在臀肌中，然后每28天进行一次，直到疾病进展，由于任何不可接受的不良事件而退出试验，或撤回患者同意。
结果：共纳入15例患者（子宫肉瘤n=4；性索间质卵巢肿瘤n=3；子宫内膜癌n=4；浆液性卵巢癌n=4）。在子宫肉瘤队列中，中位随访时间为48周（四分位距（IQR）26-122），性索间质肿瘤63周（IQR28-77），子宫内膜癌19周（IQR17-21），浆液性卵巢癌60周（IQR40-119）。在一名子宫肉瘤患者中观察到根据实体瘤v1.1中的反应评估标准的一个部分反应。在其他队列中未观察到应答。然而,在三个子宫肉瘤中观察到稳定的疾病（中位持续时间12周），三个性索间质肿瘤（中位持续时间32周），和四名低级别浆液性卵巢癌患者（中位病程20周），导致这些肿瘤类型的疾病控制率为100％。所有子宫内膜癌患者均表现为进行性疾病。
结论：氟维司群可以控制特定组织学的复发性/转移性雌激素受体阳性低度恶性妇科恶性肿瘤的肿瘤生长。需要进一步的研究来证实这些结果。
