Kosakowska Ewa, Pietrzak Lucyna, Michalski Wojciech, Kepka Lucyna, Polkowski Wojciech, Jankiewicz Malgorzata, Cisel Bogumila, Krynski Jacek, Zwolinski Jacek, Wyrwicz Lucjan, Rutkowski Andrzej, Stylinski Roman, Nawrocki Grzegorz, Sopylo Rafal, Szczepkowski Marek, Tarnowski Wieslaw, Bujko Krzysztof
Department of Gastroenterological Oncology, Maria Sklodowska-Curie National, Research Institute of Oncology, Warsaw, Poland.
I Department of Radiotherapy, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Rep Pract Oncol Radiother. 2020 Nov-Dec;25(6):1017-1022. doi: 10.1016/j.rpor.2020.08.002. Epub 2020 Aug 16.
To evaluate the role of oxaliplatin in neoadjuvant chemotherapy delivered after short-course irradiation.
Using oxaliplatin in the above setting is uncertain.
A subgroup of 136 patients managed by short-course radiotherapy and 3 cycles of consolidation chemotherapy within the framework of a randomised study was included in this post-hoc analysis. Sixty-seven patients received FOLFOX4 (oxaliplatin group) while oxaliplatin was omitted in the second period of accrual in 69 patients because of protocol amendment (fluorouracil-only group).
Grade 3+ acute toxicity from neoadjuvant treatment was observed in 30% of patients in the oxaliplatin group vs. 16% in the fluorouracil-only group ( = 0.053). The corresponding proportions of patients having radical surgery or achieving complete pathological response were 72% vs. 77% (odds ratio [OR] = 0.88; 95% confidence interval [CI]: 0.39-1.98; = 0.75) and 15% vs. 7% (OR = 2.25; 95% CI: 0.83-6.94; = 0.16), respectively. The long-term outcomes were similar in the two groups. Overall and disease-free survival rates at 5 years were 63% vs. 56% ( = 0.78) and 49% vs. 44% ( = 0.59), respectively. The corresponding numbers for cumulative incidence of local failure or distant metastases were 33% vs. 38% (hazard ratio [HR] = 0.89; 95% CI: 0.52-1.52; = 0.68) and 33% vs. 33% (HR = 0.78; 95% CI: 0.43-1.40; = 0.41), respectively.
Our findings do not support adding oxaliplatin to three cycles of chemotherapy delivered after short-course irradiation.
评估奥沙利铂在短程放疗后新辅助化疗中的作用。
在上述情况下使用奥沙利铂的效果尚不确定。
本事后分析纳入了一项随机研究框架内接受短程放疗和3个周期巩固化疗的136例患者亚组。67例患者接受FOLFOX4方案（奥沙利铂组），而在69例患者的第二个入组期，由于方案修订未使用奥沙利铂（仅氟尿嘧啶组）。
奥沙利铂组30%的患者出现新辅助治疗3级及以上急性毒性，而仅氟尿嘧啶组为16%（P = 0.053）。接受根治性手术或达到完全病理缓解的患者相应比例分别为72%和77%（优势比[OR]=0.88；95%置信区间[CI]：0.39 - 1.98；P = 0.75）以及15%和7%（OR = 2.25；95% CI：0.83 - 6.94；P = 0.16）。两组的长期结局相似。5年总生存率和无病生存率分别为63%和56%（P = 0.78）以及49%和44%（P = 0.59）。局部失败或远处转移累积发生率的相应数字分别为33%和38%（风险比[HR]=0.89；95% CI：0.52 - 1.52；P = 0.68）以及33%和33%（HR = 0.78；95% CI：0.43 - 1.40；P = 0.41）。
我们的研究结果不支持在短程放疗后进行的三个周期化疗中添加奥沙利铂。
