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Clinical Trial
. 2008 Jan;108(1):226-33.
doi: 10.1016/j.ygyno.2007.09.029. Epub 2007 Nov 9.

Randomized Phase III Trial of Pelvic Radiotherapy Versus Cisplatin-Based Combined Chemotherapy in Patients With Intermediate- And High-Risk Endometrial Cancer: A Japanese Gynecologic Oncology Group Study

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Clinical Trial

Randomized Phase III Trial of Pelvic Radiotherapy Versus Cisplatin-Based Combined Chemotherapy in Patients With Intermediate- And High-Risk Endometrial Cancer: A Japanese Gynecologic Oncology Group Study

Nobuyuki Susumu et al. Gynecol Oncol. .

Abstract

Objective: To establish an optimal adjuvant therapy for intermediate- and high-risk endometrial cancer patients, we conducted a multi-center randomized phase III trial of adjuvant pelvic radiation therapy (PRT) versus cyclophosphamide-doxorubicin-cisplatin (CAP) chemotherapy in women with endometrioid adenocarcinoma with deeper than 50% myometrial invasion.

Methods: Among 385 evaluated patients, 193 patients received PRT and 192 received CAP. The PRT group received at least 40 Gy. The CAP group received cyclophosphamide (333 mg/m2), doxorubicin (40 mg/m2) and cisplatin (50 mg/m2) every 4 weeks for 3 or more courses.

Results: No statistically significant differences in progression-free survival (PFS) and overall survival (OS) were observed. The 5-year PFS rates in the PRT and CAP groups were 83.5% and 81.8% respectively, while the 5-year OS rates were 85.3% and 86.7% respectively. These rates were also not significantly different in a low- to intermediate-risk group defined as stage IC patients under 70 years old with G1/2 endometrioid adenocarcinoma. However, among 120 patients in a high- to intermediate-risk group defined as (1) stage IC in patients over 70 years old or with G3 endometrioid adenocarcinoma or (2) stage II or IIIA (positive cytology), the CAP group had a significantly higher PFS rate (83.8% vs. 66.2%, log-rank test P=0.024, hazard ratio 0.44) and higher OS rate (89.7% vs. 73.6%, log-rank test P=0.006, hazard ratio 0.24). Adverse effects were not significantly increased in the CAP group versus the PRT group.

Conclusion: Adjuvant chemotherapy may be a useful alternative to radiotherapy for intermediate-risk endometrial cancer.

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