(HealthDay News) — Combination treatment of lapatinib plus capecitabine is active in some patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer with progressive brain metastases, and warrants further study, according to a phase 2 study published online Nov. 2 in The Lancet Oncology.
Thomas Bachelot, M.D., from the Léon-Bérard Centre in Lyon, France, and colleagues conducted an open-label study in which 45 patients with HER2-positive metastatic breast cancer (with brain metastases not previously treated with whole brain radiotherapy [WBRT], capecitabine, or lapatinib) were treated in 21-day cycles with lapatinib (1,250 mg orally) every day and capecitabine (2,000 mg/m² orally) from day one to day 14.
The researchers found that, during a median follow-up of 21.2 months, 29 patients had an objective, but partial, central nervous system response (65.9 percent). Forty-nine percent of all patients (22 patients) experienced grade 3 or grade 4 treatment-related adverse events. The most common adverse reactions were diarrhea and hand-foot syndrome, each in nine patients. At least one severe adverse event occurred in 14 patients and treatment was discontinued in four patients because of toxicity; there were no toxic deaths.
“The combination of lapatinib and capecitabine — pending further clinical assessment to substantiate the clinical benefits — might change the management of selected patients with brain metastases, allowing delay to WBRT and its side-effects,” Bachelot and colleagues conclude. “This strategy deserves further assessment to confirm the clinical benefits for patients in terms of survival, cognitive function, and quality of life.”
Several authors disclosed financial ties to GlaxoSmithKline, which funded the study.