Maintenance therapy in epithelial ovarian cancer (EOC): Could EGFR inhibitor- gefitinib be a candidate drug? A pilot study

Abstract

15046 Background: We aimed to evaluate the role of EGFR inhibitor, gefitinib among patients with advanced & recurrent EOC to prolong progression-free survival (PFS). Methods: Between Nov. 2004 and Dec. 2005, 32 patients (median age 45 years, range 33 to 63) have been recruited. The study subjects were - (i) eleven patients with EOC stage IIIC-IV who had gross residual disease (≥1 cm) after primary debulking surgery and had achieved complete response (CR) following six cycles of paclitaxel and carboplatin (Group-I) (ii) Group II - includes 21 patients who achieved CR following salvage chemotherapy for relapsed EOC (1st relapse- 8, 2nd- 8, 3rd -3 & 4th relapse in 2 patients). All Patients received gefitinib 250 mg once daily till evidence of relapse. Patients were examined every month and toxicity (CTC version II) was recorded. Serum CA-125 was done once in 2 months and CAT scan of abdomen & pelvis at 6 monthly interval. The study was approved by Institute Ethics Committee and informed written consent was obtained from each patient before starting Gefitinib. Results: The mean duration of treatment is -5.6 months (Gp-I: 7.7 months, Gp-II: 4.5 months). Toxicity was mild, mainly in the form of skin rash & diarrhoea. Skin rash occurred in 10 patients (31.3%); Group I - 8 patients (grade IV-2, III-2, I-4) & in 2 patients in group II (grade III-1, II-1). Diarrhoea occurred in 7 patients (22%); Group I-1, group II-6) all grade I. No pulmonary or hematological toxicity was observed. Currently, 18/32 patients are on Gefitinib (mean duration of treatment 6.1 months); in 12 patients gefitinib has been discontinued due to relapse (group I- 4, Group II-10). Among 10 patients with skin toxicity (Gp I-8, Gp II-2), 6 continue to be disease-free (Group I- 5, Group II-1) compared to 12 of 22 without skin toxicity. Conclusions: Toxicity to gefitinib was mild, and limited to skin and GIT. Correlation between EGFR expression vs. response can help in identifying patients who possibly might benefit with gefitinib therapy. No significant financial relationships to disclose.