Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, 91054 Erlangen, Germany.
Department of Pathology, Coburg Cancer Center, 96450 Coburg, Germany.
Cells. 2023 Jan 22;12(3):399. doi: 10.3390/cells12030399.
This study aimed to evaluate the benefit of additional administration of oxaliplatin during fluorouracil-based neoadjuvant radiochemotherapy (nRCT) in terms of pathologic complete remission (pCR), disease-free survival (DFS), and overall survival (OS) in patients with advanced rectal cancer. Between 2006 and 2021, 669 patients (pts) were diagnosed with locally advanced rectal cancer, of whom a total of 414 pts with nRCT were identified and included in the study. A total of 283 pts were treated by nRCT using concurrent chemotherapy with fluorouracil or capecitabine; 131 pts were treated using a combination of fluorouracil or capecitabine and oxaliplatin. Propensity score matching analyses (PSM) with 114 pts in each group were used to balance the patients' characteristics. OS, DFS, pCR-rate, and potential prognostic factors were compared between the two groups. The median follow-up time was 59.5 weeks in the fluorouracil-group and 43 weeks in the fluorouracil/oxaliplatin group ( = 0.003). After PSM, the pCR-rate (including sustained clinical complete remission) was 27% (31/114 pts) in the fluorouracil/oxaliplatin group and 16% (18/114 pts) in the fluorouracil-group ( = 0.033). There was no difference between these two groups for both 10-year OS and DFS neither before nor after PSM, respectively (OS: 72.6% vs. 55.4%, = 0.066, and 67.8% vs. 55.1%, = 0.703, and DFS: 44.8% vs. 46.8%, = 0.134, and 44.7% vs. 42.3%, = 0.184). Multivariate analysis identified regression grading according to Dworak grade 4 (HR: 0.659; CI: 0.471-0.921; = 0.015) and age over 60 years (HR: 2.231; CI: 1.245-4.001; = 0.007) as independent predictors for OS. In conclusion, the addition of oxaliplatin to fluorouracil during nRCT significantly improved pCR-rate without having an impact on survival.
这项研究旨在评估奥沙利铂在氟尿嘧啶为基础的新辅助放化疗（nRCT）期间的额外给药对晚期直肠癌患者的病理完全缓解（pCR）、无病生存（DFS）和总生存（OS）的获益。2006 年至 2021 年间，共诊断出 669 例局部晚期直肠癌患者，其中共有 414 例患者接受 nRCT，并将其纳入研究。共 283 例患者接受氟尿嘧啶或卡培他滨联合同期化疗 nRCT 治疗；131 例患者接受氟尿嘧啶或卡培他滨联合奥沙利铂治疗。使用 114 例患者的倾向评分匹配分析（PSM）来平衡患者的特征。比较两组之间的 OS、DFS、pCR 率和潜在的预后因素。氟尿嘧啶组的中位随访时间为 59.5 周，氟尿嘧啶/奥沙利铂组为 43 周（ = 0.003）。PSM 后，氟尿嘧啶/奥沙利铂组的 pCR 率（包括持续临床完全缓解）为 27%（31/114 例），氟尿嘧啶组为 16%（18/114 例）（ = 0.033）。两组之间的 10 年 OS 和 DFS 均无差异，无论在 PSM 前后（OS：72.6%比 55.4%， = 0.066，67.8%比 55.1%， = 0.703，DFS：44.8%比 46.8%， = 0.134，44.7%比 42.3%， = 0.184）。多变量分析确定了根据 Dworak 分级 4 进行的回归分级（HR：0.659；CI：0.471-0.921； = 0.015）和 60 岁以上年龄（HR：2.231；CI：1.245-4.001； = 0.007）是 OS 的独立预测因素。总之，在 nRCT 期间氟尿嘧啶中加入奥沙利铂可显著提高 pCR 率，而对生存无影响。
