Abstract
Induction
chemotherapy (IC) followed by chemoradiation (CRT) is an attractive approach in high-risk
locally advanced rectal cancer. Additionally, ASA has shown potential to improve outcomes
alongside CRT in rectal cancer. The ICAR trial aimed to evaluate the safety and efficacy
of IC followed by CRT with or without ASA on MRI tumor response.
Methods
Single-center, double-blind, randomized phase II trial to evaluate induction treatment
with CAPOX, followed by capecitabine-based chemoradiotherapy with ASA (arm 1) or placebo
(arm 2) in high-risk stage II-III rectal adenocarcinoma staged by MRI. The primary
endpoint was MRI tumor regression grade (mrTRG). Secondary endpoints were pathological
response, surgical outcomes, postoperative complications, treatment tolerance, DFS,
and OS.
Results
Between January 2018 and August 2019, 27 patients were eligible, 25 (92.5%) completed
IC, and 23 patients were randomly assigned (12 to ASA group; 11 to placebo group).
In the ASA arm, 3 pts (25%) presented distant disease progression at restaging. Seven
patients (30.4%) had cCR after neoadjuvant treatment. All 13 patients submitted to
surgery after neoadjuvant treatment underwent R0 resections except for 1 patient with
positive CRM, and 12 patients (92.3%) had sphincter preservation. After a median follow-up
of 34.9 months, the 2-year DFS was 83.1% and 3-year OS was 81.5%.
Conclusion
There was good compliance in both treatment arms and encouraging cCR rate. ASA during
CRT was safe but failed to improve on MRI tumor response. The study was closed due
to the absence of benefits.
Keywords
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Article Info
Publication History
Published online: May 13, 2022
Accepted:
May 6,
2022
Received in revised form:
April 26,
2022
Received:
March 4,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2022 Elsevier Inc. All rights reserved.
