A phase 2 trial of radiation therapy with concurrent paclitaxel chemotherapy after surgery in patients with high-risk endometrial cancer: a Korean Gynecologic Oncologic Group study.

Abstract

PURPOSE: A phase 2 study was completed by the Korean Gynecologic Oncologic Group

to evaluate the efficacy and toxicity of concurrent chemoradiation with weekly

paclitaxel in patients with high-risk endometrial cancer. METHODS AND MATERIALS:

Pathologic requirements included endometrial endometrioid adenocarcinoma stages

III and IV. Radiation therapy consisted of a total dose of 4500 to 5040 cGy in 5

fractions per week for 6 weeks. Paclitaxel 60 mg/m(2) was administered once

weekly for 5 weeks during radiation therapy. RESULTS: Fifty-seven patients were

enrolled between January 2006 and March 2008. The median follow-up time was 60.0

months (95% confidence interval [CI], 51.0-58.2). All grade 3/4 toxicities were

hematologic and usually self-limited. There was no life-threatening toxicity. The

cumulative incidence of intrapelvic recurrence sites was 1.9% (1/52), and the

cumulative incidence of extrapelvic recurrence sites was 34.6% (18/52). The

estimated 5-year disease-free and overall survival rates were 63.5% (95% CI,

50.4-76.5) and 82.7% (95% CI, 72.4-92.9), respectively. CONCLUSIONS: Concurrent

chemoradiation with weekly paclitaxel is well tolerated and seems to be effective

for high-risk endometrioid endometrial cancers. This approach appears reasonable

to be tested for efficacy in a prospective, randomized controlled study.