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Pertuzumab regimen delayed onset of CNS metastases in breast cancer
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The addition of pertuzumab to trastuzumab and docetaxel delayed onset of central nervous system metastases in patients with metastatic HER-2–positive breast cancer, according to results of a randomized, double blind, placebo-controlled phase 3 study.
The CLEOPTATRA trial included 808 patients. Researchers randomly assigned 402 patients to pertuzumab (Perjeta, Genentech), trastuzumab (Herceptin, Genentech) and docetaxel every 3 weeks. The other 406 patients received placebo, trastuzumab and docetaxel.
Original analyses showed patients assigned to the pertuzumab arm demonstrated significantly longer OS and PFS. Median OS was 34.4 months in the pertuzumab arm vs. 26.3 months in the placebo arm, a difference that was statistically significant when analyzed with the Wilcoxon test (P=.0449).
Sandra M. Swain
In the current analysis, Sandra M. Swain, MD, FACP, medical director of Washington Cancer Institute at MedStar Washington Hospital Center, and colleagues evaluated the regimen’s effect on CNS metastases.
The overall incidence of CNS metastases was comparable between the pertuzumab arm (13.7%) and placebo arm (12.6%). However, patients assigned pertuzumab experienced significantly delayed median time to onset of CNS metastases as first site of disease progression (15 months vs. 11.9 months; HR=0.58; 95% CI, 0.39-0.85).
Among patients who developed CNS metastases as their first site of disease progression, those assigned pertuzumab demonstrated a trend toward favorable OS compared with those assigned placebo (HR=0.66; 95% CI, 0.39-1.11).
“Advances in systemic disease control and OS may result in an increase in the number of patients who will eventually develop central nervous system metastases; therefore, better treatment options for central nervous system disease are need to increase quality of life and prolong survival of these patients,” Swain and colleagues wrote. “Based on the results from CLEOPATRA, further investigation into the activity of HER-2–targeted antibodies in patients with central nervous system disease from HER-2–positive breast cancer is warranted.”
Disclosure: The study was funded by F. Hoffmann-La Roche and Genentech. The researchers report consultant/employment roles with and research funding/honoraria from Bristol-Myers Squibb, Celgene, Eisai, Genentech, Novartis, Pfizer, Puma, Sanofi-Aventis and Roche.
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