1. 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.
- Author
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Susumu N, Sagae S, Udagawa Y, Niwa K, Kuramoto H, Satoh S, and Kudo R
- Subjects
- Adenocarcinoma pathology, Adenocarcinoma surgery, Antineoplastic Combined Chemotherapy Protocols adverse effects, Chemotherapy, Adjuvant, Cisplatin administration & dosage, Cisplatin adverse effects, Cyclophosphamide administration & dosage, Cyclophosphamide adverse effects, Doxorubicin administration & dosage, Doxorubicin adverse effects, Endometrial Neoplasms pathology, Endometrial Neoplasms surgery, Female, Humans, Middle Aged, Neoplasm Recurrence, Local pathology, Neoplasm Staging, Patient Compliance, Prognosis, Radiotherapy, Adjuvant, Risk Factors, Treatment Outcome, Adenocarcinoma drug therapy, Adenocarcinoma radiotherapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Endometrial Neoplasms drug therapy, Endometrial Neoplasms radiotherapy
- 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.
- Published
- 2008
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