PHASE-II TRIAL OF DOXORUBICIN, 5-FLUOROURACIL, ETOPOSIDE, AND CISPLATIN IN ADVANCED OR RECURRENT ENDOMETRIAL CARCINOMA

We have previously reported an overall response rate of 41% and a medi an survival duration of 14 months in a series of 49 patients with meta static or recurrent endometrial carcinoma treated by a combination of etoposide, 5-fluorouracil, and cisplatin. In order to increase respons e rate and survival duration, doxorubicin was added to this combinatio n. From August 1992 to January 1996, 20 consecutive patients were trea ted with a monthly combination chemotherapy consisting of doxorubicin 30 mg/m(2) iv Day 1,5-fluorouracil 600 mg/m(2) iv Days 1 to 3, etoposi de 80 mg/m(2) iv Days 1 to 3, and cisplatin 35 mg/m(2) iv Days 1 to 3 (AFEP). All patients were evaluable for response and toxicity. Median age was 62 years (range 45 -72). Two to eight cycles were delivered (m edian 5). Two of 20 patients had complete response and 7 of 20 had par tial response. The objective response rate was 45% (CI 95%: 23-68%). T he median survival duration was 17 months. The median progression-free survival was 8 months. Major toxic effect was myelosuppression: 75% o f grade 3 and 4 leukopenia and 20% of grade 3 and 4 thrombocytopenia. Seven patients (35%) developed infection and 4 (20%) were hospitalized once or more for toxicity. These results indicate that AFEP is an eff ective combination therapy in metastatic endometrial carcinoma but its toxicity is unacceptable. (C) 1997 Academic Press.