Low-grade serous carcinoma of the ovary or peritoneum is characterized by MAPK pathway alterations and reduced chemosensitivity compared with high-grade serous carcinoma. In this study, the researchersMEK Inhibitor Trametinib and the Standard-of-Care Regimen for Recurrent LGSOCA comparison was conducted.
Specifically, researchers David M. Gershenson and colleagues from the MD Anderson Cancer Center at the University of Texas in Houston conducted an international, randomized, Phase 2/3 trial (NCT02101788) across 84 hospitals, enrolling patients aged 18 years or older with measurable recurrent LGSOC. These patients had received any number of prior regimens, including at least one platinum-based regimen, but not all five standard-of-care regimens. Eligible patients were randomly assigned to receive either once-daily oral trametinib or one of five standard-of-care treatment regimens (130 patients in each group).
In the study, the five standard care regimens were:Intravenous Paclitaxel, Intravenous Pegylated Liposomal Doxorubicin, Intravenous Topotecan, Oral Letrozole, Oral Tamoxifen.
Clinical Efficacy of Mekinist in the Treatment of Ovarian Cancer
Researchers found that a total of 217 progression-free survival events occurred in the preliminary analysis: 101 cases (78%) in the trametinib group and 116 cases (89%) in the standard care group.The median progression-free survival (PFS) was 13.0 months in the trametinib group and 7.2 months in the standard care group.。Compared with the standard care regimen, trametinib treatment reduced the risk of disease progression or death by 52% (hazard ratio [HR]=0.48; p<0.0001).
In terms of safety, the most common grade 3 or 4 adverse events in the trametinib treatment group were rash,
Anemia、
Hypertension, diarrhea, nausea, and fatigue, while the standard care group experienced abdominal pain, nausea, anemia, and vomiting. No treatment-related deaths occurred.
David M. Gershenson said in a statement: "The results of this study represent a significant advance in the treatment of women with this rare subtype of ovarian and peritoneal cancer." (Bioon.com)