Bedrikovetski Sergei, Fitzsimmons Tracy, Perry Joanne, Vather Ryash, Carruthers Scott, Selva-Nayagam Sudarsha, Thomas Michelle L, Moore James W, Sammour Tarik
Department of Surgical Specialties, Adelaide Medical School, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.
Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
ANZ J Surg. 2023 Jan;93(1-2):173-181. doi: 10.1111/ans.18021. Epub 2022 Sep 4.
This study aimed to assess short-term outcomes of a personalized total neoadjuvant treatment (pTNT) protocol, with treatment sequencing based on clinical stage at presentation.
A multidisciplinary pTNT protocol was implemented across two metropolitan hospitals. This consists of two-schema based on clinical stage: patients with distant failure risk were offered induction chemotherapy before chemoradiation (nCRT), and patients with locoregional failure risk received nCRT followed by consolidation chemotherapy. Patients underwent surgical resection unless a complete clinical response (cCR) was achieved, in which case non-operative management (NOM) was offered. A prospective cohort analysis of all patients with rectal cancer who underwent pTNT with curative intent between Jan 2019 and Aug 2022 was performed.
Of 270 patients referred with rectal cancer, 102 received pTNT with curative intent and 79 have completed their treatment thus far. Thirty-three patients (41.8%) received induction chemotherapy and 46 (58.2%) received consolidation chemotherapy per protocol. The percentage of patients with EMVI, resectable M1 disease, cT4 disease, and positive lateral lymph nodes were 54.4%, 36.7%, 27.8% and 15.2%, respectively. Overall, 32 (40.5%) patients had cCR and 4 (5.1%) pCR, and 40 (50.6%) patients had non-operative management. Grade 3 toxicity was reported in 10.1% of patients and only three patients (3.8%) experienced Grade 4 chemotherapy-related toxicity, with no treatment related mortality.
Early results with a defined two-schema pTNT protocol are encouraging and suggest that tailoring sequencing to disease risk at presentation may represent the optimal balance between local and distant disease control, as well as treatment toxicity.
本研究旨在评估一种个性化新辅助治疗（pTNT）方案的短期疗效，该方案的治疗顺序基于初诊时的临床分期。
在两家大都市医院实施了多学科pTNT方案。该方案由基于临床分期的两种模式组成：远处转移风险患者在放化疗（nCRT）前接受诱导化疗，局部区域转移风险患者接受nCRT后进行巩固化疗。除非达到完全临床缓解（cCR），否则患者均接受手术切除，若达到cCR，则给予非手术治疗（NOM）。对2019年1月至2022年8月间所有接受pTNT且有治愈意向的直肠癌患者进行了前瞻性队列分析。
在270例转诊的直肠癌患者中，102例有治愈意向并接受了pTNT，其中79例已完成治疗。按照方案，33例患者（41.8%）接受了诱导化疗，46例患者（58.2%）接受了巩固化疗。存在肠壁外血管侵犯（EMVI）、可切除的M1期疾病、cT4期疾病以及侧方淋巴结阳性的患者比例分别为54.4%、36.7%、27.8%和15.2%。总体而言，32例患者（40.5%）达到cCR，4例患者（5.1%）达到病理完全缓解（pCR），40例患者（50.6%）接受了非手术治疗。10.1%的患者报告有3级毒性反应，仅有3例患者（3.8%）出现4级化疗相关毒性反应，无治疗相关死亡病例。
既定的双模式pTNT方案的早期结果令人鼓舞，表明根据初诊时疾病风险调整治疗顺序可能代表了局部和远处疾病控制以及治疗毒性之间的最佳平衡。
