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Induction Chemotherapy and Chemoradiotherapy Combined to ASA vs. Placebo for High-Risk Rectal Cancer: Results of a Randomized Trial.
Ominelli, Juliana; Araujo, Rodrigo O de Castro; Valadão, Marcus; Padoan, Monica L A; Lopes Dos Santos, Victor M; Dutra, Jamille G; Torres, Claudia C; Barbosa, Monique A; Guimarães, Raquel; Carvalho, Juliana C Carneiro; Ferreira, Maria A; de Oliveira, Ivanir M; Small, Isabele; de Melo, Andréia C; Araujo, Luiz H.
Affiliation
  • Ominelli J; Division of Clinical Research, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil. Electronic address: juominelli@hotmail.com.
  • Araujo ROC; Department of Abdomino-Pelvic Surgery, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Valadão M; Department of Abdomino-Pelvic Surgery, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Padoan MLA; Division of Clinical Research, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Lopes Dos Santos VM; Division of Clinical Research, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Dutra JG; Division of Clinical Research, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Torres CC; Department of Radiology, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Barbosa MA; Department of Radiology, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Guimarães R; Department of Radiotherapy, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Carvalho JCC; Department of Radiotherapy, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Ferreira MA; Department of Endoscopy, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • de Oliveira IM; Department of Pathology, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Small I; Division of Clinical Research, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • de Melo AC; Division of Clinical Research, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
  • Araujo LH; Division of Clinical Research, Instituto Nacional de Câncer (INCA), Rio de Janeiro (RJ), Brazil.
Clin Colorectal Cancer ; 21(3): e196-e204, 2022 09.
Article in En | MEDLINE | ID: mdl-35668002
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.
Subject(s)
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Rectal Neoplasms / Induction Chemotherapy Type of study: Clinical_trials / Etiology_studies / Risk_factors_studies Limits: Humans Language: En Journal: Clin Colorectal Cancer Journal subject: GASTROENTEROLOGIA / NEOPLASIAS Year: 2022 Document type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Rectal Neoplasms / Induction Chemotherapy Type of study: Clinical_trials / Etiology_studies / Risk_factors_studies Limits: Humans Language: En Journal: Clin Colorectal Cancer Journal subject: GASTROENTEROLOGIA / NEOPLASIAS Year: 2022 Document type: Article