POSTOPERATIVE RADIOTHERAPY IN STAGE-II AND STAGE-III RENAL ADENOCARCINOMA - A RANDOMIZED TRIAL BY THE COPENHAGEN-RENAL-CANCER-STUDY-GROUP
POSTOPERATIVE RADIOTHERAPY IN STAGE-II AND STAGE-III RENAL ADENOCARCINOMA - A RANDOMIZED TRIAL BY THE COPENHAGEN-RENAL-CANCER-STUDY-GROUP
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DOI：
10.1016/0360-3016(87)90283-5
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发表时间：
1987-05-01
影响因子：
7
通讯作者：
ENGELHOLM, SA
中科院分区：
文献类型：
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作者：
KJAER, M;FREDERIKSEN, PL;ENGELHOLM, SA
自1979年以来，大哥本哈根地区的11个泌尿外科和2个肿瘤科一直在研究术后放疗（XRT）在肾腺癌患者中的作用（根据荷兰改良的II期和III期分期）。肾切除术后，患者随机接受XRT（50戈伊，20 F至肾床，区域同侧和对侧淋巴结）或不接受进一步治疗。两组患者均随访至复发、死亡或术后5年。到1984年1月，72人被随机分组。治疗结果的更新显示：7/72例患者因重大方案违背而被排除在进一步分析之外，34/65例患者处于II期，31/65例患者处于III期。有43名男性和22名女性，中位年龄61岁，范围34-75岁; 33/65人随机接受观察，32/65人接受XRT。随访期间复发率为43%（28/65），两组间无差异。根据方案标准，27/32例随机分配至XRT组的患者完成了治疗。胃、十二指肠或肝脏的严重并发症发生率为12/27或44%，中位数为5个月。范围1-44个月。XRT之后在5/27或19%的患者中，放疗后并发症导致患者死亡。XRT组的中位生存期为26个月。26个月时的存活率，观察组有效率为62%。该差异在统计学上不显著。我们的结论是，在本研究中，II期和III期肾腺癌患者行肾切除术后，XRT对复发率和生存率没有任何有益的影响。此外，XRT与不可接受的并发症发生率相关，自1984年1月以来，该方案已关闭以进一步增加患者。
Since 1979, 11 urological and surgical departments and 2 oncological departments in the greater Copenhagen area have been investigating the role of postoperative radiotherapy (XRT) in patients with renal adenocarcinoma State II and III staging modified from Holland. After nephrectomy, patients were randomized to receive XRT (50 Gy in 20 F to the kidney bed, regional ipsi- and contralateral lymph nodes) or no further treatment. Patients in both arms were followed until relapse, death, or 5 years after operation. Seventy-two were randomized by January 1984. An update of the treatment results showed the following: 7/72 were excluded from further analysis because of major protocol violations, 34/65 were in Stage II and 31/65 in Stage III. There were 43 men and 22 women, median age 61 years, range 34-75; 33/65 were randomized in observation, 32/65 to XRT. Relapse was found in 28/65 or 43% during the follow-up period without any difference between the two groups. According to protocol criteria 27/32 randomized to XRT accomplished treatment. Significant complications from stomach, duodenum, or liver occurred in 12/27 or 44%, median 5 mo. range 1-44 mo. after XRT. In 5/27 or 19% the postirradiatory complications contributed to the death of the patients. The median survival in the XRT-group was 26 mo. The survival at 26 mo., in the observation group, was 62%. This difference is not statistically significant. We conclude that postoperative XRT, as given in the present study in patients nephrectomized for Stages II and III renal adenocarcinoma, is without any beneficial effect on relapse rate and survival. Moreover, XRT is associated with an unacceptable complication rate and the protocol has been closed for further patient accrual since January 1984.