Classen Johannes, Schmidberger Heinz, Meisner Christoph, Souchon Rainer, Sautter-Bihl Marie-Luise, Sauer Rolf, Weinknecht Stefan, Köhrmann Kai-U, Bamberg Michael
Departments of Radiation Oncology and Medical Information Processing, University of Tübingen, Tübingen, Germany.
J Clin Oncol. 2003 Mar 15;21(6):1101-6. doi: 10.1200/JCO.2003.06.065.
A prospective multicenter trial was initiated to evaluate the role of modern radiotherapy with reduced treatment portals for stage IIA and IIB testicular seminoma.
Patients with stages IIA/B disease (Royal Marsden classification) were assessable for the trial. Staging comprised computed tomography of the chest, abdomen, and pelvis as well as analysis of tumor markers alpha-fetoprotein and beta human chorionic gonadotropin. Linac-based radiotherapy was delivered to para-aortic and high ipsilateral iliac lymph nodes. The total doses were 30 Gy for stage IIA and 36 Gy for stage IIB disease.
Between April 1991 and March 1994, 94 patients were enrolled for the trial by 30 participating centers throughout Germany. Seven patients were lost to follow-up. Median time to follow-up of 87 assessable patients was 70 months. There were 66 stage IIA and 21 stage IIB patients. One mediastinal and one field-edge relapse were observed in the stage IIA group. In the stage IIB group, there was one mediastinal and one mediastinal/pulmonary relapse. All patients were treated with a salvage regimen of platinum-based chemotherapy. Actuarial relapse-free survival at 6 years was 95.3% (95% confidence interval [CI], 88.9% to 100%) and 88.9% (95% CI, 74.4% to 100%) for stage IIA and IIB groups, respectively. Maximum acute side effects were 8% grade 3 nausea for stage IIA and 10% grade 3 nausea and diarrhea for stage IIB groups. No late toxicity was observed.
Radiotherapy for stages IIA/B seminoma with reduced portals yields excellent tumor control at a low rate of acute toxicity and no late toxicity, which supports the role of radiotherapy as the first treatment choice for these patients.
开展一项前瞻性多中心试验，以评估缩小治疗野的现代放疗在ⅡA期和ⅡB期睾丸精原细胞瘤治疗中的作用。
符合ⅡA/B期疾病（皇家马斯登分类法）的患者可纳入该试验。分期检查包括胸部、腹部和骨盆的计算机断层扫描以及肿瘤标志物甲胎蛋白和β人绒毛膜促性腺激素分析。采用直线加速器对腹主动脉旁和同侧高位髂淋巴结进行放疗。ⅡA期疾病的总剂量为30 Gy，ⅡB期疾病为36 Gy。
1991年4月至1994年3月期间，德国30个参与中心共94例患者纳入该试验。7例患者失访。87例可评估患者的中位随访时间为70个月。其中ⅡA期患者66例，ⅡB期患者21例。ⅡA期组观察到1例纵隔复发和1例野边缘复发。ⅡB期组有1例纵隔复发和1例纵隔/肺部复发。所有患者均接受了铂类化疗挽救方案。ⅡA期和ⅡB期组6年无病生存率分别为95.3%（95%置信区间[CI]，88.9%至100%）和88.9%（95%CI，74.4%至100%）。ⅡA期组最大急性副作用为8%的3级恶心，ⅡB期组为10%的3级恶心和腹泻。未观察到晚期毒性反应。
缩小野放疗治疗ⅡA/B期精原细胞瘤可实现良好的肿瘤控制，急性毒性发生率低且无晚期毒性反应，这支持放疗作为这些患者的首选治疗方法。
