局部晚期、原发性可手术(cT3NxM0)直肠癌中加入奥沙利铂强化术前放化疗:对长期结果的影响。TAKO 05/ABCSG R-02 试验的 II 期结果。
Intensified preoperative chemoradiation by adding oxaliplatin in locally advanced, primary operable (cT3NxM0) rectal cancer : Impact on long-term outcome. Results of the phase II TAKO 05/ABCSG R‑02 trial.
机构信息
Department of Visceral, Transplant and Thoracic Surgery, Medical University of Innsbruck, Anichstr. 35, 6020, Innsbruck, Austria.
Department of Radio-Oncology, Feldkirch Hospital, Feldkirch, Austria.
出版信息
Strahlenther Onkol. 2018 Jan;194(1):41-49. doi: 10.1007/s00066-017-1219-5. Epub 2017 Nov 10.
PURPOSE
The major goals of preoperative treatment for locally advanced rectal cancers (LARCs) are improvement of local tumor control, tumor downsizing, and downstaging. Modifications with respect to standardized chemoradiation protocol, e. g., integrating oxaliplatin, are realized with the aim of improving primary tumor response and patient outcome.
PATIENTS AND METHODS
In this phase II multicenter study, patients with LARC of the mid- or lower rectum, cT3cNxcM0 as staged by MRI, were included and treated preoperatively with a combination of capecitabine and oxaliplatin following a standardized protocol during radiation. The focus of this long-term analysis was overall (OS) and disease-free survival (DFS).
RESULTS
A total of 60 patients (19 women, 41 men, median age 60.5 years) were initially enrolled, 1 patient was excluded (violation of study protocol), and 1 was patient lost of follow-up, leading to a total of 58 patients for long-term analysis. The 3‑year OS was 85.5%; 3‑year DFS 71.2%. Over time, 15 patients (25.9%) developed tumor recurrence (1 locoregional, 6.7%; 11 distant, 73.3%; 3 locoregional+distant, 20%). Recurrence-specific therapy was planned in the majority of patients, in 9 of 15 patients (60%) with a radical surgical approach. Of these, 4 patients (44.4%) are again tumor-free at the end of investigation. While tumor downsizing (T level) or pathologically complete response did not influence patient survival, lymph node negativity (LNneg) after preoperative chemoradiation showed significant influence.
CONCLUSION
LNneg after preoperative treatment for LARC significantly influences patient survival. A radical surgical approach for recurrent LARC (locoregional, distant) should be contemplated when possible as we were able to clearly demonstrate its importance and efficacy.
目的
局部晚期直肠癌(LARC)术前治疗的主要目标是提高局部肿瘤控制率、肿瘤缩小率和降期。通过修改标准化放化疗方案,例如加入奥沙利铂,旨在提高原发肿瘤的反应率和患者的预后。
方法
在这项 II 期多中心研究中,纳入了中低位直肠 LARC 患者,MRI 分期为 cT3cNxcM0,并按照标准方案在放疗期间接受卡培他滨和奥沙利铂联合治疗。本长期分析的重点是总生存期(OS)和无病生存期(DFS)。
结果
共纳入 60 例患者(19 例女性,41 例男性,中位年龄 60.5 岁),1 例患者因违反研究方案被排除,1 例患者失访,最终 58 例患者进行长期分析。3 年 OS 为 85.5%;3 年 DFS 为 71.2%。随着时间的推移,15 例(25.9%)患者发生肿瘤复发(1 例局部区域,6.7%;11 例远处转移,73.3%;3 例局部区域+远处转移,20%)。大多数患者计划进行肿瘤特异性治疗,15 例患者中有 9 例(60%)采用根治性手术。其中,4 例(44.4%)患者在调查结束时再次无肿瘤。虽然肿瘤缩小(T 分级)或病理完全缓解与患者生存无关,但术前放化疗后淋巴结阴性(LNneg)有显著影响。
结论
LARC 术前治疗后 LNneg 显著影响患者的生存。对于复发性 LARC(局部区域、远处),应考虑采用根治性手术方法,因为我们能够清楚地证明其重要性和疗效。
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