Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study (GOG122)
To compare whole-abdominal irradiation and chemotherapy in women with stage III or IV endometrial carcinoma
Type of study
Randomised controlled trial (RCT)
Whole abdominal irradiation vs. doxorubicin-cisplatin chemotherapy
Experimental arm (Intervention)
Whole abdominal irradiation (WBI)
(30 Gy in 20 daily fractions plus 15 Gy boost)
Doxorubicin 60mg/m2 and cisplatin 50 mg/m2 every 3 weeks for 7 cycles, followed by one cycle of cisplatin.
- Progression free survival (PFS)
- Overall survival (OS)
- Recurrence rate
- Toxicity rate
- Patients with FIGO stage III or IV endometrial carcinoma of any histology
- Total abdominal hysterectomy and bilateral salpingo-oophorectomy with surgical staging performed, tumor resection, and no single site of residual tumor more than 2 cm were required for eligibility
- Patients with positive para-aortic lymph nodes were required to have negative scalene node biopsies and CT scans
- Adequate hematologic, renal, and hepatic function
- Normal cardiac ejection fraction and Zubrod performance status of 0-3.
- Recurrent disease
- Hematogenous metastasis
- Inguinal lymph node involvement
- History of pelvic or abdominal radiation therapy or chemotherapy
|Whole Abdominal Irradiation||Doxorubicin-Cisplatin Chemotherapy|
|Completed Treatment (%)||84.2%||63.4%|
|5-year PFS (%) in patients who received treatment||38%||50%|
|5-year OS (%) in patients who received treatment||42%||55%|
|Toxicity rate (%)||3%||17%|
- Greater acute toxicity was seen in chemotherapy
- Treatment probably contributed to the deaths of eight patients (4%) on the chemotherapy arm, and five patients (2%) on the whole abdominal irradiation arm.
- Chemotherapy significantly improved progression-free and overall compared with whole abdominal irradiation.
- Toxicity is a concern and more studies are needed.
- Whole abdominal irradiation may not be the most effective radiotherapy approach in patients with advanced endometrial carcinoma
- Data do not permit definitive subset analyses assessing heterogeneity of the treatment effect within smaller groups of patients