Clinical breast cancer · 2024
A Phase II Trial of Onapristone and Fulvestrant for Patients With ER+ and HER2- Metastatic Breast Cancer.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Kamaraju Sailaja, Fowler Amy M, Tarima Sergey, Chaudhary Lubna N, Burkard Mark E, Giever Thomas, Cheng Yee C, Parkes Amanda, Lange Carol A, Pipp-Dahm Michele, Hegeman Robert, Siddiqui Nauman, Stella Amy, Rajguru Saurabh, Twaroski Kyleigh, Zurbriggen Luke, Jorns Julie M, Rui Hallgeir, Keigley Quinton J, Perlman Scott B, Salem Kelley, Bradshaw Tyler J, Sahmoud Tarek, Wisinski Kari
Аннотация
BACKGROUND: The SMILE study is a multi-institutional phase II clinical trial to determine the efficacy and safety of an antiprogestin, onapristone, in combination with fulvestrant as second-line therapy for patients with ER+, PgR+/-, HER2- metastatic breast cancer. This study was terminated early and herein, we report patient characteristics, and outcomes.
METHODS: Eligibility criteria included disease progression on ≥2 lines of prior therapy, ECOG performance status ≤ 2, measurable disease per RECIST 1.1 criteria, and optional 18F-fluorofuranylnorprogesterone (18F-FFNP) PET/CT imaging.
RESULTS: Consented subjects received standard-dose fulvestrant plus onapristone 50 mg orally, twice daily, until disease progression, or unacceptable toxicity. The study enrolled 11 women from 2 sites within the Wisconsin Oncology Network from November 2021 through March 2023. Mean age of the subjects was 58.5 years. Other than grade 1 toxicities, the treatment was well tolerated. None of the 11 subjects met RECIST 1.1 definition of response. The median time to progression was 63 days. A total of 4 of 11 patients had stable disease as best response and 2 of them were on treatment for 5.5 and 7.7 months. Two of the 11 subjects underwent functional imaging with 18F-FFNP PET/CT before and 10 or 14 days after starting treatment. For both subjects, tumor uptake of 18F-FFNP was stable or increased in all target lesions while 18F-FFNP uptake in the uterus, a normal PgR-rich internal control organ, was decreased.
CONCLUSION: The study regimen was well-tolerated with no significant toxicities. Future studies may evaluate antiprogestins with various combinations such as targeted therapies.
METHODS: Eligibility criteria included disease progression on ≥2 lines of prior therapy, ECOG performance status ≤ 2, measurable disease per RECIST 1.1 criteria, and optional 18F-fluorofuranylnorprogesterone (18F-FFNP) PET/CT imaging.
RESULTS: Consented subjects received standard-dose fulvestrant plus onapristone 50 mg orally, twice daily, until disease progression, or unacceptable toxicity. The study enrolled 11 women from 2 sites within the Wisconsin Oncology Network from November 2021 through March 2023. Mean age of the subjects was 58.5 years. Other than grade 1 toxicities, the treatment was well tolerated. None of the 11 subjects met RECIST 1.1 definition of response. The median time to progression was 63 days. A total of 4 of 11 patients had stable disease as best response and 2 of them were on treatment for 5.5 and 7.7 months. Two of the 11 subjects underwent functional imaging with 18F-FFNP PET/CT before and 10 or 14 days after starting treatment. For both subjects, tumor uptake of 18F-FFNP was stable or increased in all target lesions while 18F-FFNP uptake in the uterus, a normal PgR-rich internal control organ, was decreased.
CONCLUSION: The study regimen was well-tolerated with no significant toxicities. Future studies may evaluate antiprogestins with various combinations such as targeted therapies.