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Organ Preservation in Rectal Cancer Patients Treated with Total Neoadjuvant Therapy.

BACKGROUND
Retrospective studies suggest that watch-and-wait is a safe alternative to total mesorectal excision in selected patients with a clinical complete response after chemoradiotherapy.


OBJECTIVE
Determine the proportion of rectal cancer patients who may benefit from watch-and-wait.


DESIGN
Retrospective analysis of data from prospectively maintained databases.


SETTING
Comprehensive cancer center.


PATIENTS
Consecutive patients with stage II or III rectal adenocarcinoma treated with TNT using induction chemotherapy between 2012 and 2019 under the care of the same surgeon.


INTERVENTION
Induction-type total neoadjuvant therapy consisted of eight cycles of leucovorin-fluorouracil-oxaliplatin or five cycles of capecitabine-oxaliplatin before chemoradiotherapy. Patients with a clinical complete response were offered watch-and-wait, and patients with residual tumor were offered total mesorectal excision.


MAIN OUTCOMES AND MEASURES
Tumor response was assessed with a digital rectal exam, endoscopy, and MRI. Patient characteristics and recurrence-free survival were compared between the watch-and-wait group and the total mesorectal excision group.


RESULTS
A total of 88 patients were included in the analysis. One (1%) died during neoadjuvant therapy. Fifty-five patients (62.5%) had an incomplete clinical response and underwent surgery; 10 (18%) of the 55 developed distant metastasis, and 3 (5%) developed local recurrence. The remaining 32 patients (36.3%) had a cCR and underwent watch-and-wait. On average, patients in the watch-and-wait group were older and had smaller, more distal tumors compared with the surgery group. The median radiation dose, number of chemotherapy cycles, rate of adverse events, and length of follow-up did not differ substantively between the total mesorectal excision group and the watch-and-wait group. In the watch-and-wait group, 2 (6%) patients developed tumor regrowth, and one of them had distant metastasis. Recurrence-free survival was significantly higher in the watch-and-wait group.


LIMITATIONS
Generalizability, sample size, follow-up duration.


CONCLUSIONS
Approximately one-third of patients with stage II or III rectal cancer can benefit from a watch-and-wait approach with the aim of preserving the rectum if treated with induction-type total neoadjuvant therapy and followed by an experienced multidisciplinary team. See Video Abstract at http://links.lww.com/DCR/B688.