The morbidity of treatment for patients with stage I endometrial cancer: Results from a randomized trial

Purpose: To compare the treatment complications for patients with Stage I e ndometrial cancer treated with surgery and pelvic radiotherapy (RT) or surg ery alone in a multicenter randomized trial. Methods and Materials: The Postoperative Radiation Therapy in Endometrial C arcinoma (PORTEC) trial included patients with endometrial cancer confined to the uterine corpus, either Grade 1 or 2 with more than 50% myometrial in vasion, or Grade 2 or 3 with less than 50% myometrial invasion. Surgery con sisted of an abdominal hysterectomy and oophorectomy, without lymphadenecto my. After surgery, patients were randomized to receive pelvic RT (46 Gy), o r no further treatment. A total of 715 patients were randomized. Treatment complications were graded using the French-Italian glossary. Results: The analysis was done at a median follow-up duration of 60 months. 691 patients were evaluable. Five-year actuarial rates of late complicatio ns (Grades 1-4) were 26% in the RT group and 4% in the control group (p < 0 .0001). Most were Grade 1 complications, with 5-year rates of 17% in the RT group and 4% in the control group. All severe (Grade 3-4) complications we re observed in the RT group (3%). Most complications were of the gastrointe stinal tract. The symptoms resolved after some years in 50% of the patients . Grade 1-2 genitourinary complications occurred in 8% of the RT patients, and 4% of the controls. Bone complications occurred in 4 RT patients (1%). Seven patients (2%) discontinued their RT due to acute RT-related symptoms. Patients with acute morbidity had an increased risk of late RT complicatio ns (p = 0.001). The 4-field box technique was associated with a lower risk of late complications (p = 0.06). Conclusion: Pelvic RT increases the morbidity of treatment in Stage I endom etrial cancer. In the PORTEC trial, severe complications occurred in 3% of treated patients, and over 20% experienced mild (mostly Grade 1) symptoms. Patients with acute RT-related morbidity had an increased risk of late comp lications. As pelvic RT in Stage I endometrial carcinoma was shown to signi ficantly reduce the rate of locoregional recurrence, but without a survival benefit, its use in the adjuvant setting requires careful patient selectio n (treating those at increased risk of relapse), and the use of treatment s chemes with the lowest risk of morbidity. (C) 2001 Elsevier Science Inc.