Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Department of Surgery, SSORG - Scandinavian Surgical Outcomes Research Group, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Surgery, Gothenburg, Sweden.
Eur J Surg Oncol. 2023 Nov;49(11):106991. doi: 10.1016/j.ejso.2023.106991. Epub 2023 Jul 20.
In the past decade many changes in neoadjuvant treatment for patients with rectal cancer have taken place and are expected to impact complete response rates. The aim of this study was to investigate the impact on pathological, and overall, complete response rates in a nationwide population-based cohort, in relation to changes in neoadjuvant treatment and the start of a Watch & Wait (WoW) study.
A nationwide register study using prospectively collected data from the Swedish Colorectal Cancer Register between 2009 and 2020. Patients with rectal cancer stage I-III with a ypT0N0 in the resected specimen after neoadjuvant treatment and clinical complete responders from the yearly inclusion data of the national WoW study were included. Temporal changes in pathological and overall complete response rates were analysed, and differences in neoadjuvant treatment regimens over time and per region were studied.
Between 2009 and 2020 the pathological complete response rate for rectal cancer remained similar (Mann-Kendall tau of 0.091, p = 0.68) while the overall complete response rate increased significantly from 3.0% to 9.6% (Mann-Kendall tau of 0.818, p < 0.001). The pathological complete response rate for patients receiving short course radiotherapy followed by chemotherapy was reduced by 50% after the introduction of the WoW study.
During the studied time period the overall complete response rate increased significantly presumably due to changes in national neoadjuvant treatment regimens. Since the start of the national WoW study clinical complete response seem to partly replace pathological complete response.
在过去的十年中，直肠癌的新辅助治疗发生了许多变化，预计这些变化将影响完全缓解率。本研究旨在调查全国基于人群的队列中新辅助治疗变化和开始观察等待（WoW）研究对病理和总体完全缓解率的影响。
这是一项全国范围内的登记研究，使用 2009 年至 2020 年期间从瑞典结直肠癌登记处前瞻性收集的数据。纳入接受新辅助治疗后在切除标本中 ypT0N0 的局部 I-III 期直肠癌患者和全国 WoW 研究每年纳入数据中的临床完全缓解者。分析病理和总体完全缓解率的时间变化，并研究新辅助治疗方案随时间和按地区的差异。
2009 年至 2020 年间，直肠癌的病理完全缓解率保持相似（Mann-Kendall tau 为 0.091，p=0.68），而总体完全缓解率从 3.0%显著增加至 9.6%（Mann-Kendall tau 为 0.818，p<0.001）。在 WoW 研究引入后，接受短程放疗加化疗的患者的病理完全缓解率降低了 50%。
在研究期间，由于国家新辅助治疗方案的变化，总体完全缓解率显著增加。自从全国 WoW 研究开始以来，临床完全缓解似乎部分取代了病理完全缓解。
