Sur Ranjan, Donde Bernard, Falkson Conrad, Ahmed Sheikh Nisar, Levin Victor, Nag Subir, Wong Raimond, Jones Glenn
Radiation Oncology Division, Department of Medicine, McMaster University, Hamilton, Ontario L8V 5C2, Canada.
Brachytherapy. 2004;3(4):191-5. doi: 10.1016/j.brachy.2004.09.004.
HDRILBT is one of the best methods of palliation for advanced esophageal cancer (AEC) by improving dysphagia-free survival (DFS) and overall survival (OS). This study examines if the addition of EBRT would further improve the outcome by improving DFS in AEC.
Patients with inoperable AEC were entered into a randomized prospective study. HDRILBT of 16 Gy/2 fractions/3 days was given initially to all patients. Following treatment, patients were randomized to receive no further treatment (Group A) or additional EBRT of 30 Gy/10 fractions/2 weeks (Group B) and were followed for 1 year. Statistical analysis of the data was done using the SAS statistical software package (SAS Institute, Cary, NC). Prognostic variables were analyzed using the chi(2) and log-rank tests and survival curves were drawn using the Kaplan-Meier method. Multivariate survival analysis was done using the Cox proportional hazards model.
Sixty patients were entered into the study. Patient and tumor characteristics were comparable among the groups. Of 30 patients in Group B, 2 refused additional EBRT (no dysphagia). At 6 months, >50% had DFS in both groups and this was comparable. There was no difference statistically (p >0.05) in the DFS and OS between the two groups at the end of 12 months. Median survival for Group A was 7.23 months and 7.5 months for Group B. Additional EBRT did not improve DFS or OS. Eleven patients developed strictures related to radiotherapy and were dilated successfully (Group A, 7; Group B, 4; p >0.05). Four patients had progressive luminal disease which progressed to fistula (Group A, 3; Group B, 1; p >0.05). There was no effect of any patient or treatment parameter on DFS. Presenting weight and ECOG score had an impact on OS.
From the preliminary analysis, additional EBRT to HDRILBT does not improve DFS or outcomes in inoperable AEC.
高剂量率近距离后装放疗（HDRILBT）是改善晚期食管癌（AEC）吞咽困难无进展生存期（DFS）和总生存期（OS）的最佳姑息治疗方法之一。本研究探讨追加外照射放疗（EBRT）是否会通过改善AEC的DFS进一步改善治疗结果。
无法手术的AEC患者进入一项随机前瞻性研究。所有患者最初均接受16 Gy/2次分割/3天的HDRILBT。治疗后，患者被随机分为不再接受进一步治疗（A组）或追加30 Gy/10次分割/2周的EBRT（B组），并随访1年。使用SAS统计软件包（SAS Institute，北卡罗来纳州卡里）对数据进行统计分析。使用卡方检验和对数秩检验分析预后变量，并使用Kaplan-Meier方法绘制生存曲线。使用Cox比例风险模型进行多变量生存分析。
60例患者进入研究。各组间患者和肿瘤特征具有可比性。B组30例患者中，2例拒绝追加EBRT（无吞咽困难）。6个月时，两组超过50%的患者有DFS，且具有可比性。12个月末，两组的DFS和OS无统计学差异（p>0.05）。A组的中位生存期为7.23个月，B组为7.5个月。追加EBRT未改善DFS或OS。11例患者出现与放疗相关的狭窄并成功扩张（A组7例；B组4例；p>0.05）。4例患者出现进行性管腔病变并进展为瘘管（A组3例；B组1例；p>0.05）。任何患者或治疗参数对DFS均无影响。就诊时体重和东部肿瘤协作组（ECOG）评分对OS有影响。
根据初步分析，在HDRILBT基础上追加EBRT并不能改善无法手术的AEC的DFS或治疗结果。
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