Preliminary results of a phase II study to evaluate gefitinib (ZD1839) combined with paclitaxel (P) and carboplatin (C) as second-line therapy in patients (pts) with ovarian carcinoma (OC)

Abstract

5015 Background: EGFR expression is increased in 35–70% of primary OC, and often correlates with poor prognosis. Gefitinib (Iressa, ZD1839) is an orally active EGFR-TKI (epidermal growth factor receptor tyrosine kinase inhibitor). Methods: Multicenter, open, non-comparative study in pts with platinum-resistant (relapsed <6 months) or platinum-sensitive (relapsed >6 months) OC, with measurable disease, or non-measurable disease with rising CA125, and after only one line-therapy with cisplatin or C, and P. Pts received gefitinib (500 mg/day), P (175 mg/m2), and C (AUC=5) every 3 weeks, for 6–8 cycles. After which, pts could continue to receive gefitinib. Response was assessed by RECIST or Rustin criteria. Results: Since April 2002, 41 pts (median age: 58 yrs (range 34–71)) and an ECOG performance status (0/1/2) of 27/14/0, were enrolled. In 40 assessed pts, 7 were non-evaluable for efficacy (early withdrawal (1), toxicity (2), no target lesions (4)). The overall response rates (CR and PR) were 25% and 71% in the resistant and sensitive groups, respectively. 182 cycles were administered. Of the 41 pts evaluable for safety, Gr 3/4 pts toxicities were: neutropenia (63%) including 1 febrile neutropenia); thrombocytopenia (10%); anemia (7%); diarrhea (27%); rash (10% ptes). Conclusions: Gefitinib combined with P and C has very promising activity as second-line treatment for OC and is generally well tolerated. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca