Efficacy and safety of erlotinib HCl, an epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor, in patients with advanced ovarian carcinoma: results from a phase II multicenter study.

摘要: The aim of this single-arm, phase II study was to estimate the tumor response rate and safety profile erlotinib HCl (erlotinib, Tarceva™, OSI-774) monotherapy in patients with refractory, recurrent, HER1/EGFR-positive epithelial ovarian tumors, who had failed prior taxane and/or platinum-based chemotherapy. Thirty-four received 150 mg orally once daily for up 48 weeks or until disease progression dose-limiting toxicity. Two partial responses, lasting 8+ 17 weeks, giving an objective 6% (95% confidence interval [CI], 0.7–19.7%). Fifteen (44%) stable disease, (50%) progressive disease. Median overall survival 8 months CI, 5.7–12.7 months), a 1-year 35.3% 19.8–53.5%). Patients rash survived significantly longer than those without (P = 0.009), correlating grade. Erlotinib generally well tolerated. most frequent erlotinib-related adverse events were (68%) diarrhea (38%). marginal activity but appears more favorable typically experienced standard chemotherapeutic agents, which is encouraging these heavily pretreated patients. Combination chemotherapy other targeted agents should be considered.