Whole abdominal radiotherapy in the adjuvant treatment of patients with stage III and IV endometrial cancer: a gynecologic oncology group study.

OBJECTIVE: To evaluate toxicity, survival, and recurrence-free interval in women with loco-regionally advanced endometrial carcinoma treated with postoperative whole abdominal radiation therapy. METHODS: Whole abdominal irradiation with pelvic plus or minus para-aortic boost was initiated within 8 weeks of total abdominal hysterectomy, bilateral salpingo-oophorectomy, pelvic washings, and selective pelvic and para-aortic node sampling in eligible, consenting patients. RESULTS: Of 180 evaluable patients entered on the study with surgically staged III and IV endometrial carcinoma maximally debulked to less than 2 cm, 77 had typical endometrial adenocarcinoma and 103 had high-risk histology, either papillary serous or clear cell carcinoma. Patients with typical endometrial adenocarcinoma were significantly younger and had significantly fewer poorly differentiated cancers. Proportionally, there were twice as many non-Whites with high-risk histologies as non-Whites with typical endometrial adenocarcinoma. Forty-five percent of patients with typical endometrial adenocarcinomas had positive pelvic nodes compared to 51% of those with high-risk histologies. Both histologic groups had similar distribution for performance status, para-aortic node positivity, site and extent of disease, and International Federation of Gynecology and Obstetrics (FIGO) stage. The frequency of severe or life-threatening adverse effects among 174 patients evaluable for radiation toxicity included 12.6% with bone marrow depression, 15% GI, and 2.2% hepatic toxicity. The recurrence-free survival rates were 29% and 27% (at 3 years) for the typical endometrial adenocarcinoma and high-risk histologies, respectively. The survival rates were 31% and 35%, respectively. No patient with gross residual disease survived. CONCLUSION: Whole abdominal irradiation in maximally resected advanced endometrial carcinoma has tolerable toxicity, and it is suggested that the outcome may be improved by this adjunctive treatment in patients with completely resected disease.

Phase II evaluation of oral trimetrexate in mixed mesodermal tumors of the uterus: a gynecologic oncology group study.

OBJECTIVES: This is a Phase II group-wide study of the Gynecologic Oncology Group to determine the toxicity and objective response rate of trimetrexate (TMTX) in patients with advanced, persistent, or recurrent mixed mesodermal tumors of the uterus who have failed higher priority treatment protocols. METHODS: TMTX was administered orally at a dose of 5 mg/m(2) BID for 5 days and repeated in 14 days. The maximum total dose was 50 mg/m(2)/week given every other week. The minimum treatment period was one course. Patients who had a complete response, partial response, or stable disease were continued on treatment for at least three courses. RESULTS: Twenty-eight patients were entered into the study. Three patients were ineligible based on review of pathologic materials. Twenty-five patients were evaluable for toxicity, and 21 were evaluable for response, as 4 patients did not complete one course of therapy. Eleven patients had heterologous mixed mesodermal tumor (MMT) and 10 had homologous MMT. Of the 25 evaluable for toxicity, one patient had grade 4 platelet toxicity. No patient had grade 4 neutropenia, while 4 patients had grade 3 decrease in absolute neutrophil count. One patient had grade 3 gastrointestinal toxicity, while 2 had grade 4 toxicity. There were no complete responses noted and only one partial response, for an overall response rate of 4.8%. The duration of the partial response was 15.2 months. CONCLUSION: Oral TMTX has insignificant activity in the treatment of advanced, persistent, and recurrent uterine MMT at the dose and schedule administered.