Quality of Life and Functional Outcomes in Patients With Locally Advanced Rectal Cancer Receiving Total Neoadjuvant Therapy Versus Concurrent Chemoradiation Therapy: An Analysis of the STELLAR Trial.

Abstract

To explore differences in the effects of total neoadjuvant therapy (TNT) and preoperative concurrent chemoradiation therapy (CRT) on quality of life and functional outcomes in patients with locally advanced rectal cancer. In the study, 591 patients with distal or middle-third, clinical primary tumor stage cT3 to 4 and/or regional lymph node-positive rectal cancer were randomly assigned (1:1) to receive short-term radiation therapy (25 Gy in 5 fractions) followed by 4 cycles of CAPOX (TNT group, n = 297) or standard CRT (50 Gy in 25 fractions concurrently with oral capecitabine) (CRT group, n = 294) before surgery. After a 6-year follow-up, the surviving patients were sent surveys, including the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, EORTC QLQ-CR29, and Wexner incontinence score questionnaires. Differences between the 2 groups were compared, and baseline data from the general population who completed the EORTC QLQ-C30 were also compared. The median follow-up was 77.38 (59.07-103.20) months, with 196 out of 414 surviving patients (47.3%) completing the questionnaire. Patients in the TNT group had better emotional function (94.16 ± 10.19 vs 90.17 ± 14.63, P = .031) but more severe diarrhea (12.46 ± 21.73 vs 6.74 ± 16.03, P = .036) than did those in the CRT group. However, the mean differences between the 2 groups were <5 points, which is not clinically significant, and there were no significant differences in other quality of life items. The Wexner incontinence scores were 5 (0-6) and 3 (0-6) for the TNT and CRT groups, respectively, with no significant difference between the groups (P = .357). Compared to the general population data from the completed EORTC QLQ-C30 assessment, the patients did not exhibit differences >5 points in terms of worse function or more severe symptoms. There were no significant differences in quality of life or anal function between patients receiving TNT and those receiving CRT. After 6 years, patients were able to maintain stability.