SOLTI-0701 — A Double-Blind, Randomized Phase IIb Study of Capecitabine with or without Sorafenib in Advanced Breast Cancer
Slides from a presentation at SABCS 2009 and transcribed comments from a recent interview with Adam M Brufsky, MD, PhD (12/23/09)
Presentation discussed in this issue:
DR BRUFSKY: José Baselga and a group of European investigators presented the SOLTI-0701 trial analyzing first-line and second-line therapy. This trial was conducted in Spain, France and Brazil and comprised 220 patients with metastatic breast cancer. Patients were randomly assigned to receive capecitabine two weeks out of three, with or without sorafenib. The design of the trial is straightforward and similar to that of RIBBON 1 and RIBBON 2. Fairly substantial hand-foot syndrome and moderate diarrhea occurred, and as a consequence some patients were forced to discontinue therapy. Interestingly, sorafenib and capecitabine demonstrated a reduction in the risk of disease progression of almost 40 to 50 percent, with a progression-free survival of 6.4 months versus 4.1 months with placebo and capecitabine.
Overall the data are promising with a benefit in PFS in the experimental arm. There was an even greater benefit for patients receiving sorafenib in the first-line setting compared to those receiving it in the second-line setting. Remarkably, both the first-line and the second-line placebo arms maintained a 4.1-month progression-free survival. Though this is not a crucial point, one would typically expect the progression-free survival in the placebo arm to be greater in the first line than in the second line, but this was not the case.
Again, there is some promising activity with sorafenib, which will serve as the basis for a Phase III registrational trial. I believe the take-home message from this and the Gradishar study (see presentation 1 of this 5MJC issue) is that sorafenib has potential but is not yet ready for prime time.
Dr Brufsky is Associate Professor of Medicine and Associate Division Chief of Hematology/Oncology at the University of Pittsburgh, Co-Director of the Comprehensive Breast Cancer Center and Associate Director for Clinical Investigation at the University of Pittsburgh Cancer Institute in Pittsburgh, Pennsylvania.