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Photo credit – MD Anderson Cancer Center |
The international study led by Dr. David Gershenson at MD Anderson Cancer Center and Charlie Gourley, PhD of the Centre for Ovarian Cancer Research in Edinburgh, UK involved 260 patients at 84 hospitals in the US and UK. The clinical trial results appeared in the Feb. 3, 2022 journal The Lancet.
The 260 women diagnosed with low-grade serous ovarian carcinoma were enrolled in the study between 2014 and 2018 with 130 randomly assigned to treatment with trametinib (Mekinist®), a drug that has been FDA approved for treatment of certain types of melanoma. The other 130 women were treated with current standard of care. Each of the women were then assessed for disease progression by imaging every eight weeks for 15 months, and then every three months there after.
Low-grade serous carcinoma accounts for approximately 5% of all cases of epithelial ovarian cancer and is often diagnosed at a younger age in advanced stages, with a relapse rate of more than 70%.
At the first 8 week assessment 78 percent of the trametinib group were progression free compared to 89 percent of the standard care group. However at the 15 month assessment the median progression-free survival was 13 months in the trametinib group compared to 7.2 months for the standard care group.
“Previous treatment recommendations for patients with low-grade serous carcinoma were based on studies that focused on the more common high-grade serous carcinoma, despite the subtypes having distinct developmental pathways, molecular biology and clinical behaviors," Dr. Geershenson said in a press release. "Now we have encouraging data for this specific group of patients. The results from our study show trametinib should be considered a new standard-of-care option for women with progressive or relapsed low-grade serous carcinoma.”
Sources: MD Anderson press release and the journal The Lancet
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