Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma

Pfizer. Inc has conducted this randomised, open-label, phase 3 trial, patients with treatment-naive, measurable, clear-cell metastatic renal-cell carcinoma from 13 countries were stratified by Eastern Cooperative Oncology Group performance status, and then randomly assigned (2:1) by a centralised registration system to receive axitinib 5 mg twice daily, or sorafenib 400 mg twice daily. The primary endpoint was progression-free survival, assessed by masked independent review committee in the intention-to-treat population.

In previous clinical trials of patients with metastatic renal-cell carcinoma, patients treated with axitinib as second-line therapy had longer median progression-free survival than those treated with sorafenib. We therefore undertook a phase 3 trial comparing axitinib with sorafenib in patients with treatment-naive metastatic renal-cell carcinoma.

According to their findings, Axitinib did not significantly increase progression-free survival in patients with treatment-naive metastatic renal-cell carcinoma compared with those treated with sorafenib, but did demonstrate clinical activity and an acceptable safety profile.

Uveal melanoma arises from the uvea's melanocytes, the pigment cells that give the eye its color. Once the disease has spread-most metastases appear in the liver-existing treatments are largely ineffective. About 1,500 cases of uveal melanoma occur in the United States each year. Researchers found that 80 percent of patients with uveal melanoma had mutations to GNAQ or GNA11, genes that activate signals in the mitogen-activated protein kinase (MAPK) pathway. Inhibition of MEK, a key enzyme in the MAPK pathway, can inhibit the growth of uveal melanoma cells in the laboratory.

A therapy has been found that can delay progression of metastatic uveal melanoma. Results from a multicenter clinical trial show that a new drug called selumetinib increases progression-free survival. The findings were published in the online edition of JAMA(the Journal of the American Medical Association).

In 2013, Phase II, randomized trial of selumetinib was launched. One hundred and one patients with metastatic uveal melanoma at 15 centers in the United States and Canada were randomized to receive either selumetinib or standard chemotherapy. Those in the chemotherapy group could receive selumetinib at any time if they showed signs of disease progression. Median progression-free survival among patients receiving selumetinib was more than double that of patients receiving chemotherapy. Forty-nine percent of patients treated with selumetinib exhibited tumor regression, compared with none in the chemotherapy group. The vast majority of patients taking selumetinib experienced side effects, including rash, swelling, and visual changes. Most of the side effects were considered manageable.

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