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Randomized Controlled Trial
. 2022 Jun:171:69-76.
doi: 10.1016/j.radonc.2022.04.013. Epub 2022 Apr 18.

Quality of life and late toxicity after short-course radiotherapy followed by chemotherapy or chemoradiotherapy for locally advanced rectal cancer - The RAPIDO trial

Esmée A Dijkstra  1 , Geke A P Hospers  2 , Elma Meershoek-Klein Kranenbarg  3 , Joke Fleer  4 , Annet G H Roodvoets  3 , Renu R Bahadoer  3 , Marianne G Guren  5 , Jolien J J Tjalma  6 , Hein Putter  7 , Rogier M P H Crolla  8 , Mathijs P Hendriks  9 , Jaume Capdevila  10 , Calin Radu  11 , Cornelis J H van de Velde  3 , Per J Nilsson  12 , Bengt Glimelius  11 , Boudewijn van Etten  13 , Corrie A M Marijnen  14
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Free article
Randomized Controlled Trial

Quality of life and late toxicity after short-course radiotherapy followed by chemotherapy or chemoradiotherapy for locally advanced rectal cancer - The RAPIDO trial

Esmée A Dijkstra et al. Radiother Oncol. 2022 Jun.
Free article

Abstract

Background and purpose: The RAPIDO trial demonstrated a decrease in disease-related treatment failure (DrTF) and an increase in pathological complete responses (pCR) in locally advanced rectal cancer (LARC) patients receiving total neoadjuvant treatment (TNT) compared to conventional chemoradiotherapy. This study examines health-related quality of life (HRQL), bowel function, and late toxicity in patients in the trial.

Materials and methods: Patients were randomized between short-course radiotherapy followed by pre-operative chemotherapy (EXP), or chemoradiotherapy and optional post-operative chemotherapy (STD). The STD group was divided into patients who did (STD+) and did not (STD-) receive post-operative chemotherapy. Three years after surgery patients received HRQL (EORTC QLQ-C30, QLQ-CR29 and QLQ-CIPN20) and LARS questionnaires. Patients who experienced a DrTF event before the toxicity assessments (6, 12, 24, or 36 months) were excluded from analyses.

Results: Of 574 eligible patients, 495 questionnaires were returned (86%) and 453 analyzed (79% completed within time limits). No significant differences were observed between the groups regarding QLQ-C30, QLQ-CR29 or LARS scores. Sensory-related symptoms occurred significantly more often in the EXP group compared to all STD patients, but not compared to STD+ patients. Any toxicity of any grade and grade ≥ 3 toxicity was comparable between the EXP and STD groups at all time-points. Neurotoxicity grade 1-2 occurred significantly more often in the EXP and STD+ group at all time-points compared to the STD- group.

Conclusion: The results demonstrate that TNT for LARC, yielding improved DrTF and pCRs, does not compromise HRQL, bowel functional or results in more grade ≥3 toxicity compared to standard chemoradiotherapy at three years after surgery in DrTF-free patients.

Keywords: Locally advanced rectal cancer; Quality of life; Total neoadjuvant treatment.

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Conflict of interest statement

Declaration of interests The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: 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. AGHR and CJHvdV were partially funded by the EU’s Horizon 2020 research and innovation programme under a Marie Skłodowska Curie grant award (H2020MSCAITN2019, grant agreement number 857894; project acronym: CAST). MPH reports consulting fees from MSD. JC reports consulting fees, travel expenses, and research support to their institution from Pfizer, Ipsen, and Eisai; consulting fees and research support to their institution from Bayer, Novartis, and Advanced Accelerator Applications; consulting fees from Sanofi, Exelixis, and Merck Serono; and research support to their institution from AstraZeneca. PJN reports honoraria from Ethicon and Johnson & Johnson. BG reports research support from the Swedish Cancer Society. All other authors declare no competing interests.

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