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@article{Gershenson:2022:10.1016/S0140-6736(21)02175-9,
author = {Gershenson, DM and Miller, A and Brady, WE and Paul, J and Carty, K and Rodgers, W and Millan, D and Coleman, RL and Moore, KN and Banerjee, S and Connolly, K and Secord, AA and O'Malley, DM and Dorigo, O and Gaillard, S and Gabra, H and Slomovitz, B and Hanjani, P and Farley, J and Churchman, M and Ewing, A and Hollis, RL and Herrington, CS and Huang, HQ and Wenzel, L and Gourley, C},
doi = {10.1016/S0140-6736(21)02175-9},
journal = {The Lancet},
pages = {541--553},
title = {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},
url = {http://dx.doi.org/10.1016/S0140-6736(21)02175-9},
volume = {399},
year = {2022}
}

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TY  - JOUR
AB  - 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 tr
AU  - Gershenson,DM
AU  - Miller,A
AU  - Brady,WE
AU  - Paul,J
AU  - Carty,K
AU  - Rodgers,W
AU  - Millan,D
AU  - Coleman,RL
AU  - Moore,KN
AU  - Banerjee,S
AU  - Connolly,K
AU  - Secord,AA
AU  - O'Malley,DM
AU  - Dorigo,O
AU  - Gaillard,S
AU  - Gabra,H
AU  - Slomovitz,B
AU  - Hanjani,P
AU  - Farley,J
AU  - Churchman,M
AU  - Ewing,A
AU  - Hollis,RL
AU  - Herrington,CS
AU  - Huang,HQ
AU  - Wenzel,L
AU  - Gourley,C
DO  - 10.1016/S0140-6736(21)02175-9
EP  - 553
PY  - 2022///
SN  - 0140-6736
SP  - 541
TI  - 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
T2  - The Lancet
UR  - http://dx.doi.org/10.1016/S0140-6736(21)02175-9
UR  - https://www.ncbi.nlm.nih.gov/pubmed/35123694
UR  - http://hdl.handle.net/10044/1/95217
VL  - 399
ER  -

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