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Sorafenib plus chemotherapy increased PFS by 74% in advanced breast cancer
ECCO 15 – ESMO 34 Multidisciplinary Congress
Adding sorafenib to capecitabine improved PFS in patients with locally advanced or metastatic breast cancer, according to data from a randomized, double blind, phase-2 trial. Data were presented at the ECCO 15 – 34th ESMO Multidisciplinary Congress in Berlin.
“This is the first, large, randomized study that demonstrates significant clinical activity of sorafenib in breast cancer when given in combination with chemotherapy,” José Baselga, MD, chairman of the Medical Oncology Service and director of the Division of Medical Oncology, Hematology and Radiation Oncology at the Vall d'Hebron University Hospital in Barcelona, Spain, said in a press release.
In the study, SOLTI-0701, researchers enrolled 229 patients with HER2–negative tumors and <2 prior chemotherapy regimens for advanced or metastatic breast cancer. Patients were randomly assigned, based on visceral vs. nonvisceral disease, to capecitabine (Xeloda, Hoffmann La Roche) 1,000 mg/m2 twice daily for 14 of every 21 days with placebo (n=114) or with sorafenib (Nexavar, Bayer) 400 mg twice daily continuously (n=115). The primary endpoint was PFS; secondary endpoints included OS, time to progression, response rate, response duration and safety.
Median PFS was longer for capecitabine plus sorafenib vs. capecitabine alone (6.4 months vs. 4.1 months; HR=0.576; 95% CI, 0.410-0.809). Overall response rate was also higher for the combination arm (38% vs. 31%). To date, the researchers do not have data for OS.
There were no treatment-related deaths in the combination group and one treatment-related death in the capecitabine group. Grade-3 or -4 toxicities included hand–foot skin reaction (45% for combination vs. 13%), diarrhea (5% for both), dyspnea (5% vs. 4%), neutropenia (5% vs. 3%) and mucositis (1% vs. 4%).
Fifteen patients in the combination arm and nine in the capecitabine arm discontinued treatment due to adverse events, including hand–foot skin reaction and diarrhea.
“Our results showed that patients who received sorafenib plus capecitabine had a 74% improvement in the time they lived without their disease worsening compared to those who received the chemotherapy alone,” Baselga said. “This is a very positive study, and the magnitude of the benefit is such that it suggests that this agent will be an important addition to our therapeutic armory in breast cancer.”
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