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Ado-trastuzumab emtansine extended PFS in pretreated HER-2–positive breast cancer
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Patients with HER-2–positive breast cancer that progressed after treatment with trastuzumab and lapatinib demonstrated superior PFS when treated with ado-trastuzumab emtansine compared with physician’s choice for therapy, according to results of the randomized, phase 3 TH3RESA trial.
Ian E. Krop, MD, PhD, of Dana-Farber Cancer Institute and Harvard Medical School, and colleagues enrolled 602 patients from 22 countries. All patients had previously been treated with trastuzumab (Herceptin, Genentech) and lapatinib (Tykerb, GlaxoSmithKline) in the advanced setting and taxane therapy in any setting.
Ian E. Krop
Krop and colleagues randomly assigned 404 patients to 3.6 mg/kg ado-trastuzumab emtansine (Kadcyla, Genentech) every 21 days. The other 198 patients received physician’s choice of therapy. Researchers stratified patients according to world region, number of previous advanced disease regimens and presence of visceral disease.
During the study, 44 patients assigned physician’s choice crossed over to the ado-trastuzumab emtansine arm.
Median follow-up was 7.2 months (interquartile range [IQR], 5-10.1) in the ado-trastuzumab emtansine arm and 6.5 months (IQR, 4.1-9.7) in the physician’s choice arm.
A higher percentage of patients assigned physician’s choice experienced a PFS event (65% vs. 54%).
Patients assigned ado-trastuzumab emtansine achieved significantly longer median PFS (6.2 months vs. 3.3 months; HR=0.528; 95% CI, 0.422-0.661). An interim analysis also indicated a trend toward improved OS with ado-trastuzumab emtansine (HR=0.552; 95% CI, 0.369-0.826).
Fewer patients assigned ado-trastuzumab emtansine experienced any grade ≥3 adverse event (32% vs. 43%). Rates of grade ≥3 neutropenia (2% vs. 16%), diarrhea (˂1% vs. 4%) and febrile neutropenia (˂1% vs. 4%) also were lower in the ado-trastuzumab emtansine arm. However, grade 3 thrombocytopenia occurred more frequently in the ado-trastuzumab emtansine arm (5% vs. 2%).
“[Ado-trastuzumab] emtansine should be considered as a new standard for patients with HER-2–positive advanced breast cancer who have previously received trastuzumab and lapatinib,” the researchers concluded.
Disclosure: The study was funded by Genentech.
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