Whole abdominal radiotherapy versus combination chemotherapy with doxorubicin and cisplatin in advanced endometrial carcinoma (phase III): Gynecologic Oncology Group Study No. 122.

Although localized endometrial cancer is effectively treated with surgery and radiation therapy, the treatment of advanced disease remains problematic. With increasing utilization of primary surgical staging and therapy, the early identification of patients with tumor spread beyond the uterus is becoming routine. The impact of adjuvant radiotherapy and/or chemotherapy in these patients remains to be demonstrated. In several institutions, whole abdominal radiation therapy has been used with some success as adjuvant treatment in selected patients with advanced disease. The Gynecologic Oncology Group (GOG) has completed a phase II trial of the whole abdominal radiotherapy in this patient population. Although data analysis is not complete, the regimen employed appears to be tolerable and shows some evidence of efficacy. In previous GOG trials, cisplatin and doxorubicin have shown single-agent activity in patients with measurable, advanced endometrial cancer. Subsequently, the response rate with the combination of cisplatin and doxorubicin was found to be superior to that with doxorubicin alone. Because approximately 30%-50% of patients with extrauterine disease have systemic failure, the evaluation of combination chemotherapy with doxorubicin and cisplatin in the adjuvant setting seemed warranted. The current ongoing prospective, randomized trial (GOG No. 122) compares the survival and the progression-free interval and treatment failure patterns in patients with endometrial carcinoma of stage III or IV with up to 2 cm of residual disease when treated with either whole abdominal radiotherapy or a combination of doxorubicin and cisplatin. The incidence and type of acute and late adverse events observed with the two treatment regimens were determined and compared.