التفاصيل البيبلوغرافية
| 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, David M, Miller, Austin, Brady, William E, Paul, James, Carty, Karen, Rodgers, William, Millan, David, Coleman, Robert L, Moore, Kathleen N, Banerjee, Susana, Connolly, Kate, Secord, Angeles Alvarez, O'Malley, David M, Dorigo, Oliver, Gaillard, Stephanie, Gabra, Hani, Slomovitz, Brian, Hanjani, Parviz, Farley, John, Churchman, Michael, Ewing, Ailith, Hollis, Robert L, Herrington, C Simon, Huang, Helen Q, Wenzel, Lari, Gourley, Charlie |
| المصدر: |
The Lancet, vol 399, iss 10324 |
| بيانات النشر: |
eScholarship, University of California |
| سنة النشر: |
2022 |
| المجموعة: |
University of California: eScholarship |
| مصطلحات موضوعية: |
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Clinical Research, Cancer, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Administration, Oral, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Ovarian Epithelial, Female, Humans, MAP Kinase Kinase 1, Middle Aged, Neoplasm Grading, Neoplasm Recurrence, Local, Ovarian Neoplasms, Paclitaxel, Progression-Free Survival, Pyridones, Pyrimidinones, Standard of Care, Treatment Outcome |
| جغرافية الموضوع: |
541 - 553 |
| الوصف: |
BackgroundLow-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.MethodsThis 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, and is ... |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
unknown |
| العلاقة: |
qt36f1n2dj; https://escholarship.org/uc/item/36f1n2djTest |
| الإتاحة: |
https://escholarship.org/uc/item/36f1n2djTest |
| حقوق: |
public |
| رقم الانضمام: |
edsbas.F00B484F |
| قاعدة البيانات: |
BASE |
