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Lapatinib only benefited subgroup of patients with hepatocellular carcinomas
Patients with liver cancer who developed a rash during treatment with lapatinib, an effect attributable to epidermal growth factor receptor/HER-1 inhibition, had greater tumor response and longer survival, according to the findings of a phase-2 trial.
Researchers from Ohio State University conducted a multicenter trial to assess the efficacy and tolerability of 1,500 mg of lapatinib (Tykerb, GlaxoSmithKline) given orally for 28 days. Twenty-six patients were treated. Tumor and blood specimens were examined for expression of HER-2/neu/CEP17 signal pathway proteins.
Twelve percent of patients required a dose reduction. Seventy-three percent of patients reported diarrhea; 54%, nausea; and 42%, rash. Stable disease was observed in 40% of patients; 23% had stable disease for longer than 120 days and 8% had stable disease for longer than a year.
The median OS was 12.6 months (95% CI, 7.8-22.4) and the PFS was 1.9 months (95% CI, 1.8-3.6). The median PFS was 2.4 months for patients who developed a rash vs. 1.8 months for patients who did not; the difference was not statistically significant. The median OS was higher for patients with a rash (16.2 months) compared with patients who did not have a rash (8.7 months), and the difference was borderline significant (P=.07).
Researchers found no evidence of HER-2/neu somatic mutations, and no correlations were found between expression levels of proteins and PFS or OS.
Bekaii-Saab T. Clin Cancer Res. 2009;15:5895-5901.