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 median survival duration of 14 months in a series of 49 patients with metastatic or recurrent endometrial carcinoma treated by a combination of etoposide, 5-fluorouracil, and cisplatin. In order to increase response rate and survival duration, doxorubicin was added to this combination. From August 1992 to January 1996, 20 consecutive patients were treated with a monthly combination chemotherapy consisting of doxorubicin 30 mg/m2iv Day 1, 5-fluorouracil 600 mg/m2iv Days 1 to 3, etoposide 80 mg/m2iv Days 1 to 3, and cisplatin 35 mg/m2iv 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 (median 5). Two of 20 patients had complete response and 7 of 20 had partial response. The objective response rate was 45% (CI 95%: 23–68%). The median survival duration was 17 months. The median progression-free survival was 8 months. Major toxic effect was myelosuppression: 75% of 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 effective combination therapy in metastatic endometrial carcinoma but its toxicity is unacceptable.