Randomized phase III trial of pelvic radiotherapy versus cisplatin-based combined chemotherapy in patients with intermediate- and high-risk endometrial cancer JGOG 2008
To establish an optimal adjuvant therapy for intermediate- and high-risk endometrial cancer patients
Type of study
Randomized Controlled Trial (RCT)
Adjuvant pelvic radiation therapy (PRT) vs cyclophosphamide–doxorubicin–cisplatin (CAP) chemotherapy
Experimental arm (Intervention)
Pelvic radiation therapy (PRT)
Overall survival (OS)
- Progression-free survival (PFS)
- The incidence of toxicity
- Patients under 75 years of age.
- WHO performance status of 0 to 3.
- FIGO stage IC–IIIC endometrial carcinoma with deeper than 50% myometrial invasion.
- Underwent an initial surgery, including total abdominal hysterectomy and bilateral salpingo-oophorectomy, with no residual tumor
- Absence of any prior chemotherapy, irradiation, or surgery for the treatment of any other cancer
- Patients with stage II or III without deeper than 50% myometrial invasion
- Patients with other active cancers
- Patients without adequate liver, renal, or bone marrow functions.
|Control arm (PRT)||Intervention arm (CAP)|
|5 years OS rate of all patients (%)||85.3% (LIR: 95.1% , HIR: 73.6%)||86.7% (LIR: 90.8% , HIR: 89.7%)|
|5 years PFS rate of all patients (%)||83.5% (LIR: 94.5% , HIR: 66.2%)||81.8% (LIR: 87.6% , HIR: 83.8%)|
|Recurrence rate (%)||15.5%||17.2%|
Notes on the table
LIR : Low-intermediate risk
HIR : High-intermediate risk
- Age (≥60 years) and tumor grade (G2/3) were the most important poor prognostic factors for both PFS and OS.
- The incidence of extra-pelvic recurrence was 13.5% in the PRT group and 16.1% in the CAP group.
Adjuvant chemotherapy may be a useful alternative to radiotherapy for intermediate-risk endometrial cancer.
- Demonstration of a true advantage of chemotherapy requires a large-scale RCT with stratification for risk factors including age and tumor grade prior to randomization
- Validation of a true efficacy of adjuvant chemotherapy for early-stage endometrial cancer, especially for LIR patients, requires a RCT of no-treatment vs. chemotherapy
- Further investigation of the use of chemotherapeutic agents in patients with HIR endometrial cancer or high-risk endometrial cancer is needed.