Quality of life and patient-reported outcomes after non-surgical management of early-stage endometrial cancer and endometrial hyperplasia with atypia: a long-term follow-up of the feMMe phase II randomized clinical trial.

OBJECTIVE

Non-surgical, fertility-sparing management using a levonorgestrel intra-uterine device is a de-escalation strategy for selected patients with early-stage endometrial adenocarcinoma or endometrial hyperplasia with atypia. Although the oncologic outcomes of the feMMe trial have been reported, long-term patient-reported outcomes remain insufficiently characterized. This study evaluated long-term quality of life, self-efficacy, social support, and patient-reported experiences following conservative management.

METHODS

The feMMe trial (open-label, randomized phase II study) includes three treatment arms: levonorgestrel intra-uterine device alone, levonorgestrel intra-uterine device plus weight loss, and levonorgestrel intra-uterine device plus metformin. Participants were contacted 15.8 to 130.2 months after trial entry. Quality of life was assessed using the Functional Assessment of Cancer Therapy-General questionnaire. Self-efficacy and social support regarding physical activity and diet were evaluated using the Self-Efficacy and Social Support questionnaire. Post-treatment experiences were collected using structured self-report items. Analyses were descriptive and included non-parametric group comparisons and correlation analyses.

RESULTS

Forty-four participants completed long-term follow-up questionnaires. After a median follow-up of 63 months, overall quality of life was favorable; the mean (standard deviation) Functional Assessment of Cancer Therapy-General total score was 80.5 (16.4). Quality of life scores did not differ by treatment arm, baseline diagnosis, pathologic response, disease recurrence, or hysterectomy status. Self-efficacy for physical activity was more favorable among patients achieving pathologic complete response at trial completion (p =.002). Perceived social support for health-related behaviors was limited, with no significant correlations between self-efficacy and social support. A total of 32 (74.4%) of participants reported a positive treatment experience and 35 (85.4%) would recommend treatment with a levonorgestrel intra-uterine device.

CONCLUSIONS

Long-term quality of life and patient-reported outcomes following non-surgical management of early-stage endometrial adenocarcinoma and endometrial hyperplasia with atypia are favorable and comparable across conservative treatment strategies. These findings contribute to the understanding of long-term patient-reported outcomes after conservative management and underscore the importance of integrating survivorship-focused outcomes into shared treatment decision-making.