Breast Cancer Drug Lapatinib (Tykerb/Tyverb) Fails Gastric Cancer Study
Overall survival similar to that of placebo (June 3)
A phase III trial of lapatinib (Tykerb/Tyverb; GlaxoSmithKline) in combination with chemotherapy in patients with HER2-positive advanced gastric cancer did not meet the primary endpoint of improved overall survival (OS) compared with placebo and chemotherapy.
The median OS for patients in the lapatinib-plus-chemotherapy group was 12.2 months compared with 10.5 months for the placebo-plus-chemotherapy group (hazard ratio [HR] = 0.91; P = 0.3492).
The randomized, double-blind study compared lapatinib and chemotherapy (oxaliplatin and capecitabine) with placebo and chemotherapy in patients with HER2-positive advanced gastric cancer in the first-line treatment setting. In addition to the primary endpoint of OS, secondary endpoints included progression-free survival (PFS), the response rate, and the duration of response.
The median PFS for patients in the lapatinib-plus-chemotherapy group was 6.0 months compared with 5.4 months for patients treated with placebo and chemotherapy. The response rates were 53% for patients in the lapatinib group versus 39% for those in the placebo group. In the lapatinib group, the duration of response was 7.3 months compared with 5.6 months in the placebo group.
The most commonly reported adverse events (AEs) in patients treated with lapatinib plus chemotherapy included diarrhea (58%), nausea (49%), vomiting (44%), decreased appetite (41%), fatigue (24%), rash (21%) and palmar-plantar erythrodysesthesia (20%). The most common AEs in patients treated with placebo and chemotherapy were nausea (43%), vomiting (36%), decreased appetite (32%), diarrhea (29%), fatigue (21%), and peripheral neuropathy (20%).
Tykerb/Tyverb (lapatinib) is not approved for the treatment of HER2-positive advanced gastric cancer.
Source: GSK; June 3, 2013.