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Novel therapy improved PFS for patients with advanced breast cancer
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SAN FRANCISCO — The novel therapy trastuzumab emtansine significantly improved PFS compared with capecitabine and lapatinib in patients with HER-2–positive advanced or metastatic breast cancer, according to results of a phase 3 study.
Trastuzumab emtansine (T-DM1, Roche) is an antibody drug conjugate that incorporates antitumor activities of trastuzumab with the potent cytotoxic agent emtansine, according to background information provided by researchers.
The study involved 978 patients with advanced breast cancer who underwent prior treatment with trastuzumab and a taxane.
Mark D. Pegram, MD, voluntary professor of medicine for the Sylvester Comprehensive Cancer at the University of Miami Hospital and Clinics, and colleagues randomly assigned patients to receive T-DM1 or combination therapy with capecitabine (Xeloda, Genentech) and lapatinib (Tykerb, GlaxoSmithKline).
Patients assigned to T-DM1 received 3.6 mg/kg IV once every 3 weeks. Patients assigned to the combination received capecitabine 1,000 mg/m² orally twice daily on days 1 to 14, plus lapatinib 1,250 mg orally once a day. Patients received treatment until disease progression or unmanageable toxicity.
Primary endpoints were PFS by independent review, OS and safety.
Median follow-up was 12.9 months for patients in the T-DM1 arm and 12.4 months for patients in the combination arm.
Results showed patients assigned to T-DM1 experienced significantly longer PFS (9.6 months vs. 6.4 months; HR=0.650; 95% CI, 0.549-0.771). The interim median overall survival boundary was not crossed (HR=0.617; P=.0003).
A second OS analysis showed the difference in OS has achieved statistical significance, Pegram said. The results of that analysis will be presented at a later date.
Study results showed T-DM1 was well tolerated. The researchers said 16.3% of patients assigned to T-DM1 required dose reductions compared with 53.4% of patients who received capecitabine and 27.3% of patients who received lapatinib.
Grade-3 or higher adverse events occurred in 40.8% of patients treated with T-DM1 compared with 57% of patients who received the combination therapy. However, grade-3 thrombocytopenia occurred at a higher rate in the T-DM1 arm than the combination arm (12.9% vs. 0.2%).
“T-DM1 should offer an important therapeutic option for patients with HER-2–positive metastatic breast cancer,” Pegram said at a presentation.
For more information:
Pegram MD. Abstract #98. Presented at: 2012 Breast Cancer Symposium; Sept. 13-15, 2012; San Francisco.
Disclosure: Pegram reports no relevant financial disclosures.
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Lori J. Goldstein, MD
I was pleased to see this updated study. The EMILIA study has now translated not just a PFS advantage but also an OS advantage. This is something we would not have predicted, but we have now confirmed. I look forward to their presentation at the upcoming European meetings. This offers another improvement in the treatment for patients with HER-2–positive metastatic breast cancer.
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