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Age determined rate, clinical relevance of lapatinib-associated rash
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Age appeared to be the primary factor that determined the frequency and clinical relevance of lapatinib-related rash in patients with HER-2–positive early breast cancer, according to results of a phase 3 trial.
Researchers with the Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimization trial set out to assess the rate for rash, diarrhea and hepatic adverse events — as well as their association with age and pathologic complete response — in patients with HER-2–positive early breast cancer treated with lapatinib (Tykerb, GlaxoSmithKline).
The analysis included patients randomly assigned to lapatinib alone or lapatinib plus trastuzumab (Herceptin, Genentech). Treatment in both arms lasted for 6 weeks. All patients then underwent treatment with paclitaxel for 3 months, followed by surgery.
Researchers observed significantly higher rates of rash (47.9% vs. 74.4%; P<.0001) in patients aged 50 or younger compared with older patients.
Development of rash prior to paclitaxel treatment was independently associated with a higher likelihood of achieving pathologic complete response among patients aged older than 50 (OR=3.76; 95% CI, 1.69-8.34). Early rash was not independently associated with pathologic complete response in patients aged 50 years or younger (HR=0.92; 95% CI, 0.45-1.88).
“These findings, if further confirmed, would help identifying patients likely to derive the maximum benefit of primary lapatinib-based therapy,” the researchers wrote.
Disclosure: The researchers report employment or leadership roles with, consultant or advisory positions with, research funding and honoraria from, and stock ownership in GlaxoSmithKline. They also report honoraria and research funding from Genentech and Roche.
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