A phase II trial of radiation therapy with concurrent paclitaxel chemotherapy in high-risk endometrial cancer patients after staging operation: An interim analysis of a prospective multicenter trial (KGOG2001)
16069 Background: This is an interim report of a prospective multicenter phase II trial to evaluate 2-year disease free survival rate, toxicity, overall survival rate and recurrence rate in high-risk endometrial cancer patients who received concurrent chemoradiotherapy after staging operation. Methods: Thirty four patients with endometrial cancer from 17 medical centers in Korea have enrolled the study. The cell types were all endometrioid type and they had no prior chemotherapy. They were in either stage III or IV and all received staging operation including total hysterectomy, bilateral salpingo-oophorectomy, pelvic and paraaortic lymph node dissection and washing cytology. Concurrent chemoradiotherapy was performed with paclitaxel (60 mg/m2/weekly, 6 cycles) and external field irradiation (5 fractions/week, total 4,500–5,040 cGy). Primary end point was 2-year disease free survival rate. Overall survival rate and recurrence rate were secondary end points. Toxicity of the treatment was also evaluated. Results: The expected number of subjects to complete the trial is 56. The trial was activated on 5th June 2005 and median follow up period is 5.8 (0–11) months until December 2006. 19 patients (55.8%) have completed treatment regimen and 14 patients (41.1%) are still receiving treatment. 1 patient (2.9%) died during treatment of the disease and 1 patient (2.9%) was lost during the follow up period. Disease free survival is 94.1% (32/34) and no recurrence has occurred so far. Toxicities have occurred in 52.9% (18/34) with gastrointestinal symptoms (13/34, 38.2%) such as diarrhea and constipation being the most common ones. Conclusions: This interim report suggest a possibility that a concurrent chemoradiotherapy for high-risk endometrial cancer may be an optimal treatment option to improve disease free survival rate. [Table: see text]