Department of Medical Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.
Department of Medical Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.
Radiother Oncol. 2022 Jun;171:69-76. doi: 10.1016/j.radonc.2022.04.013. Epub 2022 Apr 18.
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.
RAPIDO 试验表明，与常规放化疗相比，接受全新辅助治疗（TNT）的局部晚期直肠癌（LARC）患者的疾病相关治疗失败（DrTF）减少，病理完全缓解（pCR）增加。本研究检查了试验患者的健康相关生活质量（HRQL）、肠功能和迟发性毒性。
患者在短程放疗后接受术前化疗（EXP）或放化疗和可选术后化疗（STD）之间进行随机分组。STD 组分为接受（STD+）和不接受（STD-）术后化疗的患者。术后 3 年，患者接受 HRQL（EORTC QLQ-C30、QLQ-CR29 和 QLQ-CIPN20）和 LARS 问卷。在毒性评估（6、12、24 或 36 个月）之前经历 DrTF 事件的患者被排除在分析之外。
在 574 名合格患者中，有 495 份问卷返回（86%），有 453 份分析（79%在规定时间内完成）。EXP 组与所有 STD 患者相比，QLQ-C30、QLQ-CR29 或 LARS 评分无显著差异。与所有 STD 患者相比，EXP 组感觉相关症状明显更常见，但与 STD+患者相比则无显著差异。EXP 和 STD 组在所有时间点的任何等级和等级≥3 毒性的发生率均相似。在所有时间点，EXP 和 STD+组的 1-2 级神经毒性发生率明显高于 STD-组。
结果表明，与标准放化疗相比，LARC 的 TNT 在 DrTF 无患者中，在术后 3 年不会影响 HRQL、肠功能或导致更多等级≥3 毒性，同时改善 DrTF 和 pCRs。
