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MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum
BJ. Monk, RN. Grisham, S. Banerjee, E. Kalbacher, MR. Mirza, I. Romero, P. Vuylsteke, RL. Coleman, F. Hilpert, AM. Oza, A. Westermann, MK. Oehler, S. Pignata, C. Aghajanian, N. Colombo, E. Drill, D. Cibula, KN. Moore, J. Christy-Bittel, JM. Del...
Language English Country United States
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
Grant support
P30 CA008748
NCI NIH HHS - United States
NLK
Free Medical Journals
from 2004 to 1 year ago
Open Access Digital Library
from 1999-01-01
PubMed
32822286
DOI
10.1200/jco.20.01164
Knihovny.cz E-resources
- MeSH
- Benzimidazoles adverse effects therapeutic use MeSH
- Progression-Free Survival MeSH
- Adult MeSH
- Doxorubicin analogs & derivatives therapeutic use MeSH
- Protein Kinase Inhibitors adverse effects therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Recurrence, Local drug therapy MeSH
- MAP Kinase Kinase 1 antagonists & inhibitors MeSH
- MAP Kinase Kinase 2 antagonists & inhibitors MeSH
- Young Adult MeSH
- Ovarian Neoplasms drug therapy enzymology pathology MeSH
- Fallopian Tube Neoplasms drug therapy enzymology pathology MeSH
- Paclitaxel therapeutic use MeSH
- Peritoneal Neoplasms drug therapy enzymology pathology MeSH
- Polyethylene Glycols therapeutic use MeSH
- Aged MeSH
- Cystadenocarcinoma, Serous drug therapy enzymology pathology MeSH
- Neoplasm Grading MeSH
- Topotecan therapeutic use MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Research Support, N.I.H., Extramural MeSH
PURPOSE: Low-grade serous ovarian carcinomas (LGSOCs) have historically low chemotherapy responses. Alterations affecting the MAPK pathway, most commonly KRAS/BRAF, are present in 30%-60% of LGSOCs. The purpose of this study was to evaluate binimetinib, a potent MEK1/2 inhibitor with demonstrated activity across multiple cancers, in LGSOC. METHODS: This was a 2:1 randomized study of binimetinib (45 mg twice daily) versus physician's choice chemotherapy (PCC). Eligible patients had recurrent measurable LGSOC after ≥ 1 prior platinum-based chemotherapy but ≤ 3 prior chemotherapy lines. The primary end point was progression-free survival (PFS) by blinded independent central review (BICR); additional assessments included overall survival (OS), overall response rate (ORR), duration of response (DOR), clinical-benefit rate, biomarkers, and safety. RESULTS: A total of 303 patients were randomly assigned to an arm of the study at the time of interim analysis (January 20, 2016). Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled. Secondary efficacy end points were similar in the two groups: ORR 16% (complete response [CR]/partial responses[PRs], 32) versus 13% (CR/PRs, 13); median DOR, 8.1 months (range, 0.03 to ≥ 12.0 months) versus 6.7 months (0.03 to ≥ 9.7 months); and median OS, 25.3 versus 20.8 months for binimetinib and PCC, respectively. Safety results were consistent with the known safety profile of binimetinib; the most common grade ≥ 3 event was increased blood creatine kinase level (26%). Post hoc analysis suggests a possible association between KRAS mutation and response to binimetinib. Results from an updated analysis (n = 341; January 2019) were consistent. CONCLUSION: Although the MEK Inhibitor in Low-Grade Serous Ovarian Cancer Study did not meet its primary end point, binimetinib showed activity in LGSOC across the efficacy end points evaluated. A higher response to chemotherapy than expected was observed and KRAS mutation might predict response to binimetinib.
Belgium and Luxemburg Gynaecological Oncology Group University Hospitals Leuven Leuven Belgium
Centre Hospitalier Régional et Universitaire de Besançon CHRU de Besançon Besançon France
Centre Léon Bérard Netsarc Network Université Claude Bernard Lyon 1 Lyon France
CHU Université catholique de Louvain Namur Sainte Elisabeth Namur Belgium
Dutch Gynaecological Oncology Group Amsterdam University Medical Centers Amsterdam the Netherlands
Istituto Nazionale Tumori Fondazione Pascale IRCCS Naples Italy
MD Anderson Cancer Center Houston TX
Memorial Sloan Kettering Cancer Center Weill Cornell Medical Center New York NY
Onkologisches Therapiezentrum am Krankenhaus Jerusalem Hamburg Germany
Princess Margaret Cancer Centre Toronto Ontario Canada
Servicio de Oncologıa Medica Fundacion Instituto Valenciano de Oncologıa Valencia Spain
Stephenson Cancer Center at The University of Oklahoma Health Sciences Center Oklahoma City OK
References provided by Crossref.org
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