Erlotinib after first-line chemotherapy failed to improve PFS or OS in patients with ovarian cancer, according to study results.
Epidermal growth factor receptor (EGFR) is overexpressed in 55% to 98% of patients with advanced epithelial ovarian cancer, according to background information in the study.
Ignace B. Vergote, MD, PhD, director of the division of gynecologic oncology at the Catholic University of Leuven, and colleagues evaluated the efficacy of maintenance erlotinib — an EGFR tyrosine kinase inhibitor — after first-line chemotherapy in a randomized phase 3 study.
The study involved 835 patients from 125 institutions in 10 countries.
Eligible patients had high-risk FIGO stage I or stage II-IV epithelial ovarian, peritoneal or fallopian tube cancer and were not selected for EGFR expression, the researchers wrote.
All patients underwent six to nine cycles of first-line platinum-based chemotherapy and showed no signs of progression at the end of chemotherapy.
Patients then were randomly assigned to maintenance erlotinib 150 mg daily for 2 years (n=420) or observation (n=415).
The primary endpoint was PFS. Median follow-up was 51 months.
Median PFS among patients assigned to erlotinib was 12.7 months compared with 12.4 months in the observation arm (HR= 1.05; 95% CI, 0.90-1.23; P=.525).
The median OS among patients assigned to erlotinib arm was 50.8 months compared with 59.1 months in the observation group (HR=.99; 95% CI, 0.81-1.20; P=.903).
Twenty-five percent of patients assigned to erlotinib stopped treatment because of side effects; 67% of those treatment stoppages were due to rash, the researchers said.
- Vergote IB. Abstract #LBA5000.