Rectal Cancer Organ Preservation Tied to Less Fecal Incontinence Than TME

A watch-and-wait (WW) approach after total neoadjuvant therapy for rectal cancer was associated with clinically meaningful long-term quality-of-life (QOL) and bowel function benefits compared with total mesorectal excision (TME), according to a post hoc cohort study published in JAMA Network Open.

This unplanned analysis drew on the phase 2 CAO/ARO/AIO-12 and CAO/ARO/AIO-16 trials, which enrolled patients with cT3 to cT4 or node-positive rectal adenocarcinoma at 19 centers in Germany from 2015 to 2020.

Of 385 eligible patients, 56 entered WW after a clinical complete response (cCR), and 329 underwent immediate TME; the WW cohort had less-advanced cT disease and better baseline performance status. QOL was measured with the EORTC QLQ-C30 and QLQ-CR29 questionnaires and the Wexner fecal incontinence score; a difference of at least 5 points on EORTC scales was predefined as clinically meaningful. In longitudinal analyses from 6 months to 5 years, the WW group had significant, clinically meaningful advantages in fecal incontinence (adjusted difference, −21.2 points; 95% CI, −30.0 to −12.3), stool frequency, embarrassment, flatulence, and buttock pain, and in social, physical, and role functioning and global health status.

Similar differences were seen among patients who remained disease-free. At 5 years, 2 of 18 patients (11.1%) with sustained cCR reported severe stool incontinence, vs 9 of 17 (52.9%) baseline-matched TME patients and 16 of 27 (59.2%) patients with pathologic complete response. Urinary symptoms and male sexual interest showed no clinically meaningful differences, and erectile dysfunction worsened in men regardless of treatment. Salvage TME for local regrowth was required in 27 WW patients (48.2%).

The investigators said that, absent prospective randomized trials, the findings suggest long-term, clinically meaningful QOL benefits for organ preservation and that patient-reported QOL measures have become central to shared decision-making. Limitations they noted included the post hoc, exploratory design; declining questionnaire completion (89.9% at baseline vs 48.1% at 5 years), which may have caused selection bias; and the small WW group.

Source: Diefenhardt M, Fokas E, Kosmala R, et al. Organ preservation and quality of life after total neoadjuvant treatment in rectal cancer. JAMA Netw Open. 2026;9(10):e2639063. doi:10.1001/jamanetworkopen.2026.39063