CHEMOTHERAPY PLUS SEQUENTIAL HORMONAL-THERAPY FOR ADVANCED AND RECURRENT ENDOMETRIAL CARCINOMA - A PHASE-II STUDY

We evaluated the therapeutic value of sequential cyclical hormonal the rapy (megestrol acetate, and tamoxifen citrate) plus single-agent chem otherapy (carboplatin) in the outpatient management of advanced or rec urrent endometrial cancer. Carboplatin (300 mg/m(2)) was administered every 4 weeks for six courses or until disease progression. In additio n, patients alternated megestrol acetate (80 mg orally twice daily) wi th tamoxifen citrate (20 mg orally twice daily) every 3 weeks. Thirtee n of 18 (72.2%) patients were considered evaluable. Four patients (30. 8%) had a complete response, six (46.2%) had a partial response, one ( 7.7%) had stable disease, and two patients (15.4%) progressed. Six of seven patients with vaginal disease responded. The median progression- free interval was 14 months for complete responders. Two patients (15. 4%) are alive with no evidence of disease at 41 and 59 months. Seven o f 13 patients experienced a hematologic toxicity (six grade 2, one gra de 3); all resolved within 2 weeks. Dose reduction of carboplatin to 2 00 mg/m(2) was required in one patient. No other toxicities were encou ntered. The median survival for all patients is 11 months, and is 33 m onths for complete responders. We conclude that a regimen of carboplat in plus sequential hormonal therapy shows promise in this pilot study for the treatment of advanced or recurrent endometrial cancer. (C) 199 6 academic Press, Inc.