publication date: Mar. 30, 2018

Clinical Roundup

Sorafenib improves PFS in rare sarcomas, NIH-funded study shows

Interim results from a randomized clinical trial for patients with desmoid tumors or aggressive fibromatosis show that the drug sorafenib tosylate (Nexavar) extended progression-free survival compared with a placebo. Based on these interim results, the data and safety monitoring board overseeing the trial recommended that the primary results of the study be released.

The trial was sponsored by the NCI, designed and conducted by the Alliance for Clinical Trials in Oncology, and supported by Bayer HealthCare AG, which provided the study drug.

Sorafenib is approved by FDA for the treatment of some patients with advanced kidney, liver, and thyroid cancer. The drug was chosen for this trial because in earlier retrospective studies of patients treated with sorafenib, desmoid tumors shrank, and patients had a reduction in pain and other symptoms.

The phase III double-blind clinical trial, designated as A091105, enrolled 87 patients with DT/DF between March 2014 and December 2016. To be eligible, patients had to have disease that could not be removed surgically, that had grown, or that was causing symptoms and met specific criteria.

Patients were randomly assigned to one of two treatment arms: one group received sorafenib (400 mg/day), and the other received a matched placebo. Patients in both groups continued treatment until their tumors grew or they experienced adverse events from treatment. Patients whose tumors progressed while in the study were informed of their treatment assignment, and those who had been receiving a placebo were allowed to receive sorafenib.

The primary endpoint was progression-free survival. The trial was designed to target an improvement in median PFS from six months for placebo to 15 months for … Continue reading Sorafenib improves PFS in rare sarcomas, NIH-funded study shows

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