دورية أكاديمية
Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial
| العنوان: | Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial |
|---|---|
| المؤلفون: | Gershenson, DM, Miller, A, Brady, WE, Paul, J, Carty, K, Rodgers, W, Millan, D, Coleman, RL, Moore, KN, Banerjee, S, Connolly, K, Secord, AA, O'Malley, DM, Dorigo, O, Gaillard, S, Gabra, H, Slomovitz, B, Hanjani, P, Farley, J, Churchman, M, Ewing, A, Hollis, RL, Herrington, CS, Huang, HQ, Wenzel, L, Gourley, C |
| المصدر: | 553 ; 541 |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2021 |
| المجموعة: | Imperial College London: Spiral |
| مصطلحات موضوعية: | 11 Medical and Health Sciences, General & Internal Medicine |
| جغرافية الموضوع: | England |
| الوصف: | BACKGROUND: Low-grade serous carcinoma of the ovary or peritoneum is characterised by MAPK pathway aberrations and its reduced sensitivity to chemotherapy relative to high-grade serous carcinoma. We compared the MEK inhibitor trametinib to physician's choice standard of care in patients with recurrent low-grade serous carcinoma. METHODS: This international, randomised, open-label, multicentre, phase 2/3 trial was done at 84 hospitals in the USA and UK. Eligible patients were aged 18 years or older with recurrent low-grade serous carcinoma and measurable disease, as defined by Response Evaluation Criteria In Solid Tumors version 1.1, had received at least one platinum-based regimen, but not all five standard-of-care drugs, and had received an unlimited number of previous regimens. Patients with serous borderline tumours or tumours containing low-grade serous and high-grade serous carcinoma were excluded. Eligible patients were randomly assigned (1:1) to receive either oral trametinib 2 mg once daily (trametinib group) or one of five standard-of-care treatment options (standard-of-care group): intravenous paclitaxel 80 mg/m2 by body surface area on days 1, 8, and 15 of every 28-day cycle; intravenous pegylated liposomal doxorubicin 40-50 mg/m2 by body surface area once every 4 weeks; intravenous topotecan 4 mg/m2 by body surface area on days 1, 8, and 15 of every 28-day cycle; oral letrozole 2·5 mg once daily; or oral tamoxifen 20 mg twice daily. Randomisation was stratified by geographical region (USA or UK), number of previous regimens (1, 2, or ≥3), performance status (0 or 1), and planned standard-of-care regimen. The primary endpoint was investigator-assessed progression-free survival while receiving randomised therapy, as assessed by imaging at baseline, once every 8 weeks for 15 months, and then once every 3 months thereafter, in the intention-to-treat population. Safety was assessed in patients who received at least one dose of study therapy. This trial is registered with ClinicalTrials.gov, NCT02101788, ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0140-6736 |
| العلاقة: | The Lancet; http://hdl.handle.net/10044/1/95217Test |
| DOI: | 10.1016/S0140-6736(21)02175-9 |
| الإتاحة: | https://doi.org/10.1016/S0140-6736Test(21)02175-9 http://hdl.handle.net/10044/1/95217Test |
| حقوق: | © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license (https://creativecommons.org/licenses/by/4.0Test/) ; https://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: | edsbas.A7A5A4B9 |
| قاعدة البيانات: | BASE |
| تدمد: | 01406736 |
|---|---|
| DOI: | 10.1016/S0140-6736(21)02175-9 |