Medical Oncology Unit, Department of Precision Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
Department of Medical Oncology, Institut Jules Bordet - Université Libre de Bruxelles (ULB), Brussels, Belgium.
Cancer Treat Rev. 2021 May;96:102177. doi: 10.1016/j.ctrv.2021.102177. Epub 2021 Mar 16.
A few months ago, results from two randomised phase III trials of total neoadjuvant therapy (TNT) in locally advanced rectal cancer were presented (RAPIDO and PRODIGE 23), consistently showing better short- and long-term outcomes with TNT as compared with standard neoadjuvant long-course chemoradiotherapy (CRT) or short-course radiotherapy (SCRT). These results represent corroborating evidence in support of a practice that many centres had already implemented based on promising preliminary data. Also, they provide new, high-level evidence to endorse TNT as a new management option in the treatment algorithm of stage II-III rectal cancer in those centres where CRT and SCRT have long remained the only accepted standard neoadjuvant treatments. Having two consistently positive trials is certainly reassuring regarding the potential of TNT as a general treatment approach. Nevertheless, substantial differences between these trials pose important challenges in relation to the generalisability and applicability of their results, and translation of the same into practical clinical recommendations. In this article, we address a number of key questions that the RAPIDO and PRODIGE 23 trials have raised among the broad community of gastrointestinal oncologists, proposing an interpretation of the data that may help the decision making, and highlighting grey areas that warrant further investigation.
几个月前，两项局部晚期直肠癌全新辅助治疗（TNT）的随机 III 期临床试验结果（RAPIDO 和 PRODIGE 23）公布，结果显示 TNT 与标准新辅助长程放化疗（CRT）或短程放疗（SCRT）相比，在短期和长期结果方面均有更好的效果。这些结果为许多中心已经根据有前途的初步数据实施的实践提供了支持证据。此外，它们提供了新的高级别证据，支持 TNT 作为 II-III 期直肠癌治疗算法中的一种新的治疗选择，适用于 CRT 和 SCRT 一直是唯一公认的标准新辅助治疗的中心。两项一致积极的试验肯定会让人对 TNT 作为一种普遍治疗方法的潜力感到放心。然而，这些试验之间存在显著差异，对其结果的可推广性和适用性以及将其转化为实际临床建议带来了重要挑战。在本文中，我们针对 RAPIDO 和 PRODIGE 23 试验在广大胃肠肿瘤学家群体中提出的一些关键问题进行了讨论，提出了一种可能有助于决策的数据分析方法，并强调了需要进一步研究的灰色领域。
