GOG 122 Study
Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study
Disease site
Uterus
Pubmed link
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