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Sunitinib plus docetaxel not recommended for newly diagnosed breast cancer
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ASCO 2010 Annual Meeting
CHICAGO — A study examining the combination of the antiangiogenic agent sunitinib and docetaxel failed to meet its primary endpoint in women with newly diagnosed advanced breast cancer, bringing into question the overall strategy of combining taxanes with antiangiogenic tyrosine kinase inhibitors, according to a researcher presenting here.
Jonas Bergh, MD, from the department of oncology-pathology, Karolinska Institutet, and Cancer Center Karolinska, Stockholm, Sweden, presented the data during the 2010 ASCO Annual Meeting.
For the study, eligible patients, who had to be newly diagnosed with HER-2-negative metastatic or advanced breast cancer, were randomly assigned sunitinib plus docetaxel (n=296) or docetaxel alone (n=297), which Bergh noted was “standard care.” Prolonging PFS and OS were the primary endpoints of the study.
The median PFS in the sunitinib/docetaxel arm was 8.6 months vs. 8.3 months for the docetaxel arm (HR 0.9222). The median OS in the sunitinib/docetaxel arm was 24.8 months vs. 25.5 months for the docetaxel arm (HR 1.207). “The trend was going in the wrong direction,” Bergh said.
The endpoints of extending PFS and OS were not met. Also, there was a higher percentage of adverse events in the combination arm.
Bergh reported that overall response rate for sunitinib/docetaxel was 51% vs. 39% for docetaxel.
“The combination of sunitinib and docetaxel improved overall response rate, but despite this, it did not prolong PFS as a primary endpoint or OS compared with standard treatment when given as first-line treatment for advanced breast cancer,” Bergh said. “We saw more side effects in the combined arm. We saw more discontinuation in the combined arm.”
Bergh wrote in the abstract “strategies using antiangiogenic TKIs that increase RR but not OS may need to be revisited,” and echoed his concerns at the conclusion of the presentation: “You see with some of these antiangiogenics compounds … you have shrinkage of the tumor, but the downside is, in these preclinical models, you may increase the invasiveness of these cancer cells and they become more therapy resistant.” – by Joan-Marie Stiglich, ELS
For more information:
- Bergh J. #LBA1010. Presented at: the 2010 ASCO Annual Meeting; June 4-8; Chicago.
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