Study compares the effectiveness of selumetinib, chemotherapy in patients with advanced melanoma uveal -
In patients with advanced melanoma uveal the treatment with selumetinib agent, compared to chemotherapy resulted in improved progression-free survival time cancer and tumor response rate, but no improvement in overall survival, according to a study published in the June issue 18 JAMA . The slight improvement in clinical results was accompanied by a higher rate of adverse events.
The uveal melanoma arises from melanocytes in the choroid layer of the eye. There are approximately 1,500 new cases of uveal melanoma per year in the United States, which is separate biologically related skin melanoma. Selumetinib is an oral agent that can help inhibit the growth of cancer cells by blocking MEK1 / 2 A subgroup analysis from an earlier trial that included 20 patients with melanoma of the uvea suggested favorable results with selumetinib treatment, according to background information in the article.
Richard D. Carvajal, MD, of the Memorial Sloan Kettering Cancer Center, New York, and colleagues randomly assigned patients with metastatic uveal melanoma to receive selumetinib (n = 50; orally twice a day) or chemotherapy (n = 51; temozolomide orally daily for 5 every 28 days, or dacarbazine intravenously every 21 days) until disease progression, death, intolerable side effects, or withdrawal of consent. After analyzing the primary results, an additional 19 patients were registered and treated with 18 selumetinib without randomization, to complete the planned entry 0 patients.
The researchers reported that the median time to progression was seven weeks the chemotherapy group (median 8 weeks of treatment) and 15.9 weeks in the selumetinib group (median duration of treatment, 16.1 weeks). Survival without progression of 4 months was 8.5 percent with chemotherapy, and 43.1 percent with selumetinib. The median overall survival was 9.1 months with chemotherapy and 11.8 months with selumetinib, a difference that was not statistically significant.
The tumor regression was rare with chemotherapy, while 49 percent of patients randomized to selumetinib tumor regression achieved. adverse events related to treatment were observed in 97 percent of patients treated with selumetinib, with 37 percent requiring at least one dose reduction.
"In this study hypothesis generator of patients with melanoma of the uvea advanced, selumetinib compared to chemotherapy resulted in a modest improvement in survival time and the response rate of progression-free ;. However, no improvement in overall survival was observed improvement in clinical results was accompanied by a higher rate of adverse events. "the authors conclude.
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