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

• Published in: Radiotherapy and oncology Vol. 171; pp. 69 - 76
• Main Authors: Dijkstra, Esmée A., Hospers, Geke A.P., Kranenbarg, Elma Meershoek-Klein, Fleer, Joke, Roodvoets, Annet G.H., Bahadoer, Renu R., Guren, Marianne G., Tjalma, Jolien J.J., Putter, Hein, Crolla, Rogier M.P.H., Hendriks, Mathijs P., Capdevila, Jaume, Radu, Calin, van de Velde, Cornelis J.H., Nilsson, Per J., Glimelius, Bengt, van Etten, Boudewijn, Marijnen, Corrie A.M.
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier B.V 01-06-2022
• Subjects: Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Chemoradiotherapy - adverse effects; Chemoradiotherapy - methods; Humans; Locally advanced rectal cancer; Medicin och hälsovetenskap; Neoadjuvant Therapy - adverse effects; Neoadjuvant Therapy - methods; Neoplasm Staging; Neoplasms, Second Primary - etiology; Quality of Life; Rectal Neoplasms - pathology; Total neoadjuvant treatment; Total neoadjuvant treatment; Locally advanced rectal cancer; Quality of life
• ISSN: 0167-8140; 1879-0887; 1879-0887
• DOI: 10.1016/j.radonc.2022.04.013

•No difference in QLQ-C30, QLQ-CR29 and LARS results between the EXP and STD group.•Sensory related symptoms more often in the EXP group compared to the STD group.•Neurotoxicity grade 1–2 more often in the EXP compared to the STD group.•No difference in grade ≥3 neurotoxicity between the groups.•No difference in any type of toxicity between the EXP and STD group.
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.
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.
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.
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.