(HealthDay News) — Trametinib may be a new option for standard-of-care treatment for recurrent low-grade serous ovarian carcinoma, according to a study published online Feb. 5 in The Lancet.
David M. Gershenson, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues conducted an international, randomized, phase 2/3 trial at 84 hospitals involving patients aged 18 years or older with recurrent low-grade serous carcinoma and measurable disease.
Participants had received an unlimited number of previous regimens, including at least one platinum-based regimen, but not all five standard-of-care drugs. Eligible patients were randomly assigned to oral trametinib once daily or one of five standard-of-care treatment options (130 patients to each group).
The researchers found that at the primary analysis, there were 217 progression-free survival events (101 and 116 [78 and 89 percent] in the trametinib and standard-of-care groups, respectively).
Median progression-free survival was 13.0 and 7.2 months in the trametinib and standard-of-care groups, respectively (hazard ratio, 0.48).
The most frequent grade 3 or 4 adverse events were skin rash, anemia, hypertension, diarrhea, nausea, and fatigue in the trametinib group and abdominal pain, nausea, anemia, and vomiting in the standard-of-care group. No treatment-related deaths occurred.
“While the results of this study represent a major advance in the treatment of women with this rare ovarian and peritoneal cancer subtype, we need to accelerate our efforts toward the discovery of additional novel drugs or regimens,” Gershenson said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including Novartis, which manufactures trametinib and provided funding for the study.