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Randomized Controlled Trial
. 2024 Jun:204:114044.
doi: 10.1016/j.ejca.2024.114044. Epub 2024 Apr 7.

Oncological outcomes after a pathological complete response following total neoadjuvant therapy or chemoradiotherapy for high-risk locally advanced rectal cancer in the RAPIDO trial

Wouter H Zwart  1 , Sofieke J D Temmink  2 , Geke A P Hospers  3 , Corrie A M Marijnen  4 , Hein Putter  5 , Iris D Nagtegaal  6 , Lennart Blomqvist  7 , Elma Meershoek-Klein Kranenbarg  8 , Annet G H Roodvoets  8 , Anna Martling  2 , Cornelis J H van de Velde  8 , Bengt Glimelius  9 , Koen C M J Peeters  8 , Boudewijn van Etten  10 , Per J Nilsson  2 ; Collaborative investigators
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Free article
Randomized Controlled Trial

Oncological outcomes after a pathological complete response following total neoadjuvant therapy or chemoradiotherapy for high-risk locally advanced rectal cancer in the RAPIDO trial

Wouter H Zwart et al. Eur J Cancer. 2024 Jun.
Free article

Abstract

Background: A pathological complete response (pCR) following chemoradiation (CRT) or short-course radiotherapy (scRT) leads to a favourable prognosis in patients with rectal cancer. Total neo-adjuvant therapy (TNT) doubles the pCR rate, but it is unknown whether oncological outcomes remain favourable and whether the same characteristics are associated with pCR as after CRT.

Methods: Comparison between patients with pCR in the RAPIDO trial in the experimental [EXP] (scRT, chemotherapy, surgery, as TNT) and standard-of-care treatment [STD] (CRT, surgery, postoperative chemotherapy depending on hospital policy) groups. Primary and secondary outcomes were time-to-recurrence (TTR), overall survival (OS) and association between patient, tumour, and treatment characteristics and pCR.

Results: Among patients with a resection within six months after preoperative treatment, 120/423 (28%) [EXP] and 57/398 (14%) [STD] achieved a pCR. Following pCR, 5-year cumulative TTR and OS rates in the EXP and STD arms were 8% vs. 7% (hazard ratio 1.04, 95%CI 0.32-3.38) and 94% vs. 93% (hazard ratio 1.41, 95%CI 0.51-3.92), respectively. Besides the EXP treatment (odds ratio 2.70, 95%CI 1.83-3.97), pre-treatment carcinoembryonic antigen (CEA) <5, pre-treatment tumour size <40 mm and cT2 were associated with pCR. Distance from the anal verge was the only characteristic with a statistically significant difference in association with pCR between the EXP and STD treatment (Pinteraction=0.042). pCR rates did not increase with prolonged treatment time.

Conclusions: The doubled pCR rate of TNT compared to CRT results in similar oncological outcomes. Characteristics associated with pCR are the EXP treatment, normal CEA, and small tumour size.

Keywords: Chemoradiation; Chemoradiotherapy; Complete response; Locally advanced rectal cancer; Pathological complete remission; Pathological complete response; RAPIDO trial; Total neoadjuvant therapy.

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Conflict of interest statement

Declaration of Competing Interest PJN reports honoraria from Ethicon, Johnson & Johnson, and Amgen. GAPH reports consulting fees from Roche, MSD, Amgen and Novartis; consulting fees and research support to their institution from Bristol Myers Squibb; and research support to their institution from Seerave Foundation. SJDT was fully funded, and AGHR and CJHvdV were partially funded by the EU’s Horizon Skłodowska Curie grant award (H2020MSCAITN2019, grant agreement number 857894; project acronym: CAST). BG reports research support from the Swedish Cancer Society. All other authors have declared no conflicts of interest. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The first authors had full access to all data and had final responsibility for the decision to submit for publication. All other authors report no conflicts of interest.

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