Randomized phase III trial of pelvic radiotherapy versus cisplatin-based combined chemotherapy in patients with intermediate- and high-risk endometrial cancer JGOG 2008
Disease site
Uterine
Pubmed link
Publication month/year
November 2007
Study question
To establish an optimal adjuvant therapy for intermediate- and high-risk endometrial cancer patients
Type of study
Randomized Controlled Trial (RCT)
Interventions compared
Adjuvant pelvic radiation therapy (PRT) vs cyclophosphamide–doxorubicin–cisplatin (CAP) chemotherapy
Experimental arm (Intervention)
Chemotherapy (CAP)
Control arm
Pelvic radiation therapy (PRT)
Primary outcome
Overall survival (OS)
Secondary outcome
- Progression-free survival (PFS)
- The incidence of toxicity
Inclusion criteria
- 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
Exclusion criteria
- 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.
Results
| Control arm (PRT) | Intervention arm (CAP) | |
|---|---|---|
| Randomised(n0) | 193 | 192 |
| Received treatment(n0) | 186 | 188 |
| 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
Other results
- 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.
Conclusions
Adjuvant chemotherapy may be a useful alternative to radiotherapy for intermediate-risk endometrial cancer.
Study limitations
- 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.