Fakhrian K, Ordu A D, Haller B, Theisen J, Lordick F, Bišof V, Molls M, Geinitz H
Department of Radiation Oncology, Marien Hospital Herne, University Clinic of the Ruhr University Bochum, Hölkeskampring 40, 44625, Herne, Germany,
Strahlenther Onkol. 2014 Oct;190(11):987-92. doi: 10.1007/s00066-014-0661-x. Epub 2014 Apr 16.
To compare the outcomes of two neoadjuvant radiochemotherapy (N-RCT) regimens for squamous cell carcinoma of the esophagus (ESCC).
The standard N-RCT regimen for ESCC at our institution between 2002 and 2011 was a total dose of 45 Gy (1.8-Gy fractions) with concomitant cisplatin (20 mg/m(2), days 1-5 and 29-33) and 5-fluorouracil (5-FU; 225 mg/m(2), 24 h continuous infusion on days 1-33). During the same period, a phase I/II study comparing the standard ESCC N-RCT protocol with a regimen identical except for the replacement of cisplatin with weekly oxaliplatin (40-50 mg/m(2)) was performed at our center. The standard regimen was used to treat 40 patients; 37 received the oxaliplatin regimen. All patients subsequently underwent radical resection with reconstruction according to tumor location and two-field lymph node dissection.
Median follow-up time from the start of N-RCT was 74 months (range 3-116 months). The two patient groups were comparable in terms of demographic and baseline tumor characteristics. R0 resection was achieved in 37/39 patients (95 %) in the cisplatin-based N-RCT group, compared to 24/37 (65 %) in the oxaliplatin-based group (p = 0.002). A pathological complete response (pCR) was seen in the resection specimens from 18/39 patients (46 %) in the cisplatin-based N-RCT group and in 8/37 (22 %) oxaliplatin-group patients. In the cisplatin group, 2- and 5-year overall survival (OS) rates were 67 ± 8 % and 60 ± 8 %, respectively (median OS 103 months), compared to 38 ± 8 % and 32 ± 8 %, respectively, for the oxaliplatin group (median OS 17 months; hazard ratio, HR 0.452; 95 % confidence interval, CI 0.244-0.839; p = 0.012).
Oxaliplatin-based N-RCT resulted in poorer outcomes in ESCC patients and should not routinely replace cisplatin-based N-RCT.
比较两种新辅助放化疗(N-RCT)方案治疗食管鳞状细胞癌(ESCC)的疗效。
2002年至2011年期间,我院ESCC的标准N-RCT方案为总剂量45 Gy(每次1.8 Gy),同时使用顺铂(20 mg/m²,第1 - 5天和第29 - 33天)和5-氟尿嘧啶(5-FU;225 mg/m²,第1 - 33天持续静脉输注24小时)。同期,我院开展了一项I/II期研究,将标准ESCC N-RCT方案与除用每周一次的奥沙利铂(40 - 50 mg/m²)替代顺铂外其他相同的方案进行比较。标准方案治疗40例患者;37例接受奥沙利铂方案治疗。所有患者随后均根据肿瘤位置进行根治性切除及重建,并进行两野淋巴结清扫。
从N-RCT开始的中位随访时间为74个月(范围3 - 116个月)。两组患者在人口统计学和基线肿瘤特征方面具有可比性。基于顺铂的N-RCT组39例患者中有37例(95%)实现了R0切除,而基于奥沙利铂的组中为24/37例(65%)(p = 0.002)。基于顺铂的N-RCT组39例患者中有18例(46%)的切除标本出现病理完全缓解(pCR),奥沙利铂组8/37例(22%)患者出现pCR。顺铂组2年和5年总生存率(OS)分别为67±8%和60±8%(中位OS 103个月),而奥沙利铂组分别为38±8%和32±8%(中位OS 17个月;风险比,HR 0.452;95%置信区间,CI 0.244 - 0.839;p = 0.012)。
基于奥沙利铂的N-RCT在ESCC患者中疗效较差,不应常规替代基于顺铂的N-RCT。