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Ramucirumab plus docetaxel did not delay breast cancer progression
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SAN ANTONIO — The combination of ramucirumab and docetaxel failed to halt advanced breast cancer progression in HER-2–negative tumors, according to research presented at the San Antonio Breast Cancer Symposium.
“At the time this trial was designed, there were reasons to think an antiangiogenic strategy in breast cancer was actually going to help our patients, so there was a lot of hope,” John R. Mackey, MD, professor of oncology at the University of Alberta in Edmonton, said during a press conference. “At the end of the day, we have a negative trial here and we are hopeful we can go back to the tissue we have from the trial and find a biomarker because there is a signal here. We are seeing improvements in several endpoints. Some patients clearly are benefiting, but we do not understand the biology sufficiently.”
The phase 3 ROSE/TRIO-12 trial included 1,144 patients with nonoperable HER-2–negative breast cancer or HER-2–negative breast cancer that was locally recurrent or metastatic.
Patients were randomized 1:2 to docetaxel 75 mg/m2 plus placebo or docetaxel plus ramucirumab (IMC-1121B, Eli Lilly and Company) 10 mg/kg IV every 3 weeks.
Investigator-assessed PFS served as the primary endpoint.
Median follow-up was 16.2 months. At that time, median PFS was 9.5 months in the ramucirumab arm vs. 8.2 months in the control arm, a difference that was not statistically significant.
Ramucirumab also was associated with increased incidence of adverse events, and none of the defined subgroups demonstrated a benefit from treatment, Mackey said.
A final OS analysis will be conducted when the predetermined number of OS events are observed, Mackey said.
“I believe it’s still worth pursuing because, albeit the entire population does not benefit, I still think there is potentially a role for angiogenesis were we to find a predictive biomarker,” Mackey said.
For more information:
Mackey JR. Abstract #S5-04. Presented at: San Antonio Breast Cancer Symposium; Dec. 10-14, 2013; San Antonio.
Disclosure: The study was funded by Eli Lilly and Company. Mackey reports no relevant financial disclosures.
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Peter M. Ravdin, MD, PhD
We’re now recognizing that breast cancer is a really diverse disease. There are hints of certain markers that may actually predict particular benefit for angiogenic strategies, and they haven’t been included in the analysis that has been presented yet. So drugs that may, in general, have little value in breast cancer may be very effective in certain populations. This is still a work in progress.
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