Genitourinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, USA.
J Hematol Oncol. 2008 Nov 7;1:22. doi: 10.1186/1756-8722-1-22.
At the plenary session of the 2008 annual meeting of the American Society of Clinical Oncology, updated results were presented from a large randomized phase III trial comparing adjuvant radiation therapy (RT) and one cycle of Carboplatin for the adjuvant treatment of Stage I seminoma. Results of this Medical Research Council (MRC) trial led its investigators to conclude that one cycle of carboplatin was equivalent in safety and efficacy and less toxic than RT. In this editorial, the trial's design, statistics, toxicity, and length of follow-up are discussed within the context of historical treatments of this disease. With a 1.3% increase in relapse rate (5.3% with carboplatin vs. 4.0% with radiation), a 3% or greater increase in relapse rate could not be excluded, the primary endpoint of the study. A decrease in second testicular germ cell tumors was observed, but was equivalent to the increase in relapse rate. Acute toxicity was generally less with carboplatin. However, the extent of late toxicity, including late second neoplasms, cannot be evaluated because of the short median follow-up. Carboplatin is not yet a standard of care. Surveillance-based strategies, including risk-adapted policies that limit RT to patients with the greatest likelihood of relapse remain prudent at this time.
在 2008 年美国临床肿瘤学会年会上的全体会议上，一项比较辅助放疗（RT）和卡铂一个周期用于 I 期精原细胞瘤辅助治疗的大型随机 III 期试验的更新结果被呈现。这项医学研究委员会（MRC）试验的结果使研究人员得出结论，卡铂一个周期在安全性和疗效方面与 RT 相当，毒性更小。在这篇社论中，讨论了该试验的设计、统计学、毒性和随访时间，以及该疾病的历史治疗方法。复发率增加了 1.3%（卡铂组为 5.3%，放疗组为 4.0%），不能排除复发率增加 3%或更高的可能性，这是该研究的主要终点。观察到第二个睾丸生殖细胞瘤的发生率下降，但与复发率的增加相当。卡铂的急性毒性通常较低。然而，由于中位随访时间较短，无法评估包括晚期第二肿瘤在内的晚期毒性的程度。卡铂还不是标准治疗方法。此时，基于监测的策略，包括对最有可能复发的患者限制 RT 的风险适应策略，仍然是明智的。
