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Organ-sparing therapy for early stage I/IIA rectal cancer aims to avoid dysfunction or permanent ostomy associated with total mesorectal excision (TME)
.
The purpose of this study was to determine the prognosis and organ preservation rates of patients with early-stage rectal cancer treated with neoadjuvant chemotherapy and transanal excision surgery (TES)
.
This is a phase 2 clinical trial of patients with clinical stage T1-T3abN0 low or median rectal adenocarcinoma eligible for endoscopic resection and receiving 3 months of chemotherapy
.
People with evidence of remission undergo transanal endoscopic surgery 2-6 weeks later
.
The primary endpoint was the protocol-specified organ preservation rate, defined as the proportion of patients whose tumors were downstaged to ypT0/T1N0/X and who avoided radical surgery
.
A total of 58 patients were enrolled, all received chemotherapy, and 56 of them underwent surgery
.
A total of 33/58 patients had tumor downstaging in surgical specimens to stage ypT0/1N0/X, resulting in an intent-to-treat protocol-designated organ retention rate of 57%
.
Of the 23 remaining patients recommended for TME according to protocol requirements, 13 declined and opted for observation, resulting in a 79% organ retention rate
.
Of the 10 patients who underwent TME, 7 had no histopathological residual disease
.
local recurrence free survival
The one-year local recurrence-free survival rate was 98%, the two-year local recurrence-free survival rate was 90%, and there were no distant recurrences or deaths
.
Changes in both quality of life and rectal function scores were small
.
In conclusion, three months of induction chemotherapy is expected to successfully reduce the clinical tumor stage of a considerable number of patients with early-stage rectal cancer, allowing for well-tolerated organ-sparing surgery
.
Original source:
Hagen F.
Kennecke, et al.
Neoadjuvant Chemotherapy, Excision, and Observation for Early Rectal Cancer: The Phase II NEO Trial (CCTG CO.
28) Primary End Point Results.
Journal of Clinical Oncology.
August 18, 2022.
https:// ascopubs.
org/doi/full/10.
1200/JCO.
22.
00184
