Dieckmann K P, Brüggeboes B, Pichlmeier U, Küster J, Müllerleile U, Bartels H
Urologische Klinik, Klinikum Benjamin Franklin, Freie Universität, Berlin, Germany.
Urology. 2000 Jan;55(1):102-6. doi: 10.1016/s0090-4295(99)00376-3.
Adjuvant radiotherapy produces excellent disease-free rates in clinical Stage I seminoma. However, concern is growing about side effects and late hazards of this treatment. Carboplatin has been suggested to supplant radiotherapy. To date, there is little experience with this drug in the adjuvant treatment of seminoma. In particular, it is unclear whether one or two courses should be administered.
In a nonrandomized study, 125 patients with pure clinical Stage I seminoma were given adjuvant carboplatin treatment (400 mg/m2). Ninety-three patients received one course and 32 two courses. The median follow-up time was 48 months. To assess gonadal toxicity, serial measurements of follicle-stimulating hormone (FSH) levels were done. To assess myelotoxicity, platelet counts at 3 and 4 weeks after treatment were monitored.
There were no relapses after two courses of carboplatin. After one course of carboplatin, eight relapses occurred (8.6%; 95% confidence interval [CI] 3.79% to 16.2%). All the relapses were located in the para-aortic region, and all the patients were rescued with cisplatin-based chemotherapy. The median time to recurrence was 16 months. The 5-year actuarial progression-free survival rate after one course was 91.1% (95% CI 85.25% to 97.01%). Younger patients (age groups: less than 30 years and 31 to 38 years) had relapses more frequently (P = 0.038) than those in the older age group (greater than 38 years). After 3 weeks, 32% of the patients had platelet counts below 150/nL. The median FSH level increased immediately after treatment, reaching a peak of 13.6 U/L. After 20 months, the median FSH level had returned to the normal range.
One adjuvant course of carboplatin was associated with low myelotoxicity and low gonadal toxicity; however, the recurrence rate was almost 9% and thus unsatisfactory. After two courses of carboplatin, no relapse was observed. Thus, the two-course regimen of carboplatin appears to be equivalent to radiotherapy, and because of its favorable toxicity profile, this regimen should be investigated in randomized trials.
辅助放疗在临床I期精原细胞瘤中可产生出色的无病生存率。然而，人们对这种治疗的副作用和远期危害的担忧日益增加。有人建议用卡铂取代放疗。迄今为止，该药在精原细胞瘤辅助治疗方面的经验很少。特别是，尚不清楚应给予一个疗程还是两个疗程。
在一项非随机研究中，125例单纯临床I期精原细胞瘤患者接受了辅助卡铂治疗（400mg/m²）。93例患者接受一个疗程，32例接受两个疗程。中位随访时间为48个月。为评估性腺毒性，进行了促卵泡生成素（FSH）水平的系列测量。为评估骨髓毒性，监测了治疗后3周和4周时的血小板计数。
两个疗程的卡铂治疗后无复发。一个疗程的卡铂治疗后，发生了8例复发（8.6%；95%置信区间[CI]3.79%至16.2%）。所有复发均位于腹主动脉旁区域，所有患者均通过基于顺铂的化疗挽救。复发的中位时间为16个月。一个疗程后的5年无进展生存率为91.1%（95%CI 85.25%至97.01%）。较年轻的患者（年龄组：小于30岁和31至38岁）比年龄较大的患者（大于38岁）复发更频繁（P = 0.038）。3周后，32%的患者血小板计数低于150/nL。治疗后FSH水平立即升高，达到峰值13.6U/L。20个月后，FSH中位水平恢复到正常范围。
一个疗程的辅助卡铂治疗骨髓毒性和性腺毒性较低；然而，复发率近9%，因此并不理想。两个疗程的卡铂治疗后未观察到复发。因此，卡铂的两疗程方案似乎等同于放疗，并且由于其良好的毒性特征，该方案应在随机试验中进行研究。
