Combination of gemcitabine and cisplatin is highly active in women with endometrial carcinoma: results of a prospective phase 2 trial.

<bold>Background: </bold>The treatment of patients with advanced or recurrent endometrial cancer remains problematic, because chemotherapy and hormonal therapy have yielded low response rates and limited progression-free survival. Because the combination of gemcitabine and cisplatin demonstrated synergism in preclinical studies, the authors attempted to determine the efficacy and toxicity of this combination in women with advanced or recurrent endometrial cancer.<bold>Methods: </bold>A prospective, single-institution, phase 2 study was performed in women with histologically documented International Federation of Gynecology and Obstetrics (FIGO) stage III or IV or recurrent endometrioid endometrial carcinoma. Gemcitabine at a dose of 1000 mg/m2 and cisplatin at a dose of 35 mg/m2 were administered intravenously on Days 1 and 8 of each 21-day cycle; because of myelosuppression, the protocol was revised to gemcitabine at a dose of 900 mg/m2 and cisplatin at a dose of 30 mg/m2. Patients were treated until disease progression, unacceptable toxicity, or complete response.<bold>Results: </bold>A total of 21 patients were enrolled and received a median of 5 courses of therapy (range, 1-9 courses). The median age at the time of study enrollment was 62 years (range, 41-75 years). Of 20 evaluable patients, 2 (10%) had a confirmed complete response, 8 (40%) had a partial response, 6 (30%) had stable disease, and 4 (20%) developed progressive disease. The median progression-free survival was 7.5 months (range, 2.3-33.6 months), and the median overall survival was 18.2 months (range, 2.5-49.4 months). The development of toxicity mandated dose reductions in 16 of 20 patients (80%). Eighteen patients experienced grade 3 or 4 toxic effects (graded according to the Common Terminology Criteria for Adverse Events [version 3.0]).<bold>Conclusions: </bold>The objective response rate of 50% noted with gemcitabine and cisplatin combination chemotherapy merits the further development of this regimen in women with advanced or recurrent endometrial cancer. [ABSTRACT FROM AUTHOR]