NEW YORK (Reuters Health) – Fifteen years after postoperative pelvic radiotherapy for endometrial carcinoma, many women still suffer from urinary and bowel symptoms and have reduced physical functioning, according to long-term data from the PORTEC-1 trial.

Long-term results from the “Postoperative Radiation Therapy in Endometrial Carcinoma 1” trial also confirm that adjuvant pelvic external beam radiotherapy (EBRT) significantly reduces locoregional recurrences at 15 years, but has no impact on overall survival.

The findings support current recommendations to reserve EBRT for women with high-risk endometrial cancer and avoid it in women with low- and intermediate-risk tumors, Dr. Remi A. Nout, from Leiden University Medical Center, the Netherlands, and colleagues note in their report published March 28 in the Journal of Clinical Oncology.

Abandoning EBRT for the 55% of women who have endometrial cancer and low-intermediate risk features was the “correct decision,” they write. The significant long-term adverse impact of EBRT on health-related quality of life “cannot be justified in the absence of survival benefit and in the presence of effective salvage radiotherapy for the few low-intermediate risk patients who develop locoregional recurrence,” they say.

Dr. Nout and colleagues assessed outcome and health-related quality of life at 15 years in women with endometrial cancer treated with or without pelvic ERBT in the (PORTEC 1) trial.

Between 1990 and 1997, the PORTEC-1 trial randomly allocated 714 patients with stage IC grade 1 to 2 or IB grade 2 to 3 endometrial carcinoma to pelvic EBRT or no additional treatment after surgery.

The trial showed that EBRT provides a highly significant improvement in local tumor control but without a survival advantage. Furthermore, EBRT was associated with a high incidence of bowel and bladder symptoms at 2 years. It was concluded, therefore, that EBRT should be reserved for patients at relatively high risk of recurrence.

The 15-year data confirm a highly significant reduction in locoregional recurrences in women who received EBRT relative to those who did not (5.8% vs 15.5%; P < 0.001) but no significant difference in overall survival (52% vs 60%; P = 0.14). Moreover, among 246 women who completed health-related quality of life questionnaires, those treated with EBRT reported “significant (P < 0.01) and clinically relevant” higher rates of bowel and bladder problems, most notably urinary incontinence, diarrhea and fecal urgency and leakage, the researchers say. Perhaps most notable, they say, urinary incontinence was reported in 57.8% of women who underwent EBRT, compared with 38.2% of those who did not, which is in line with rates in the general population. The lingering bowel and bladder symptoms in women who had EBRT led to considerable limitations in daily activities and reduced physical functioning. These long-term data provide more evidence that EBRT should be reserved for endometrial carcinoma with high-intermediate risk features, Dr. Nout and colleagues conclude. For these patients, they note, the PORTEC-2 trial has shown that vaginal brachytherapy (VBT) is highly effective, with fewer adverse effects and better health-related quality of life. As a result of PORTEC-2, high-intermediate risk patients are currently treated with VBT, sparing them the risks and morbidity associated with EBRT, they note. Based on PORTEC-1 and 2, EBRT remains indicated as adjuvant therapy only for the 15% of patients with endometrial carcinoma who have high-risk features, the clinicians note. J Clin Oncol