Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study (GOG122)

Disease site

Uterus

Publication month/year

January 2006

Study question

To compare whole-abdominal irradiation and chemotherapy in women with stage III or IV endometrial carcinoma

Type of study

Randomised controlled trial (RCT)

Interventions compared

Whole abdominal irradiation vs. doxorubicin-cisplatin chemotherapy

Experimental arm (Intervention)

Whole abdominal irradiation (WBI)
(30 Gy in 20 daily fractions plus 15 Gy boost)

Control arm

Doxorubicin 60mg/m2 and cisplatin 50 mg/m2 every 3 weeks for 7 cycles, followed by one cycle of cisplatin.

Primary outcome
  • Progression free survival (PFS)
  • Overall survival (OS)
Secondary outcome
  • Recurrence rate
  • Toxicity rate
Inclusion criteria
  • 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.
Exclusion criteria
  • Recurrent disease
  • Hematogenous metastasis
  • Inguinal lymph node involvement 
  • History of pelvic or abdominal radiation therapy or chemotherapy
Results
Whole Abdominal Irradiation Doxorubicin-Cisplatin Chemotherapy
Randomised(n) 202 194
Received treatment(n) 198 190
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%
Recurrence (%) 54% 50%
Toxicity rate (%) 3% 17%
Other results
  • 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.
Study conclusions
  • Chemotherapy significantly improved progression-free and overall compared with whole abdominal irradiation. 
  • Toxicity is a concern and more studies are needed.
Study limitations
  • 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
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