A multicenter phase II trial of gefitinib 500 mg/day in 193 patients with advanced epidermal growth factor receptor-positive solid tumors who had failed previous chemotherapy: Interim data

Abstract

3162 Background: 15 Belgian oncology centers are participating in an open-label Phase II trial of gefitinib (IRESSA) 500 mg/day in patients (pts) with advanced epidermal growth factor receptor-positive solid tumors who had failed ≥1 previous chemotherapy regimen and had no further chemotherapy treatment options. Here we report interim data. Methods: Pts received gefitinib 500 mg/day until disease progression. Objective tumor assessments, by RECIST, were made every 8 weeks and confirmed by repeat assessments ≥4 weeks later. Disease control rate (DCR) was defined as objective response (confirmed complete response or partial response [PR]) plus stable disease (SD) for ≥8 weeks. All adverse events (AEs) were reported and assessed by NCI-CTC version 2.0. Results: 193 pts have been enrolled with pancreatic cancer [21%], cervical cancer (CC) [19%], ovarian cancer (OC) [17%], sarcoma (S) [12%], cancer of unknown primary origin (U) [10%], hepatocellular carcinoma (HC) [9%], bladder cancer (BC) [7%], and endometrial cancer (EC) [4%]. At interim analysis, 184/193 pts were evaluable for response. DCR was 28%: 4 pts had PR (2 CC, 1 OC, 1 pancreatic cancer) and 48 pts had SD at 8 weeks (15 CC, 9 OC, 7 S, 5 pancreatic cancer, 5 HC, 3 EC, 2 BC, 2 U). 90% of AEs were mild to moderate. 12 NCI-CTC grade 3/4 drug-related AEs were reported in 9 pts (2 anorexia, 3 diarrhea, 3 vomiting, 1 vasculitic rash, 1 thrombocytopenia, 1 bacterial sepsis, 1 impaired liver function). All were NCI-CTC grade 3 except for 1 grade 4 anorexia. Dose reduction to 250 mg/day was required in 19% of pts. Conclusions: Gefitinib showed promising activity in pancreatic cancer, CC, and OC. Further trials of gefitinib in pancreatic cancer are ongoing. Our data in CC and OC support findings from previous gefitinib Phase I/II trials. Similar data were reported in a Phase II trial of gefitinib in advanced CC (Viens et al, Poster 1833 presented at ASCO 2003). Additionally, a Phase I trial with gefitinib reported disease control (SD) in OC (Ranson et al, J Clin Oncol 2002;20:2240–50). IRESSA is a trademark of the AstraZeneca group of companies Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca AstraZeneca AstraZeneca AstraZeneca