Non-operative Management of Rectal Cancer with Adjuvant Chemotherapy after Chemoradiotherapy (NORMANDY): Prospective Study
- Author:
Hyebin LEE
1
;
Hyung Ook KIM
;
Jason Joon Bock LEE
;
In-Gu DO
;
Heon-Ju KWON
;
Mi Sung KIM
;
Soo-Kyung PARK
;
Hyo-Joon YANG
;
Yoon Suk JUNG
;
Jung Ho PARK
;
Dong-Il PARK
;
Kyung Uk JUNG
;
Eo Jin KIM
;
Dong-Hoe KOO
;
Hungdai KIM
;
Ho-Kyung CHUN
;
Author Information
- Publication Type:Original Article
- From:Cancer Research and Treatment 2026;58(2):573-580
- CountryRepublic of Korea
- Language:English
-
Abstract:
Purpose:Non-operative management (NOM) has emerged as a promising organ-preserving strategy for patients with rectal cancer who achieve a clinical complete response (cCR) after neoadjuvant chemoradiotherapy (CRT). However, no standardized treatment protocol has been established for watch-and-wait strategies.
Materials and Methods:This prospective study evaluated oncological outcomes of NOM combined with 4 months of adjuvant capecitabine. Patients with resectable rectal cancer (≤ 8 cm from the anal verge, cT2-4 or N+) underwent CRT (50-54 Gy in 25-27 fractions with capecitabine). Eight weeks post-CRT, a multidisciplinary team assessed cCR. Patients achieving cCR received six cycles of capecitabine (2 weeks on/1 week off) and were actively monitored.
Results:Among 89 patients receiving CRT (2018-2023), 17 (19.1%) achieved cCR and were included. The median age was 65 years, and 64.7% were male. Eleven (64.7%) completed all six cycles of adjuvant therapy. After a median follow-up of 31.4 months, 11 patients (64.7%) remained disease-free. Local regrowth occurred in six patients (35.3%) with 2- and 4-year rates of 34.5% and 47.6%, respectively. Five underwent radical surgery, and one received transanal excision with systemic chemotherapy. At the time of assessment, 15 patients (88.2%) showed no evidence of disease, while two (11.8%) received palliative chemotherapy. All patients were alive.
Conclusion:NOM with adjuvant capecitabine showed promising oncological outcomes, offering an alternative to passive watch-and-wait approaches. Further refinement through multidisciplinary strategies is warranted.
