Short-course adjuvant chemotherapy in high-risk stage I nonseminomatous germ cell tumors of the testis: A medical research council report
Short-course adjuvant chemotherapy in high-risk stage I nonseminomatous germ cell tumors of the testis: A medical research council report
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DOI：
10.1200/jco.1996.14.4.1106
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发表时间：
1996-04-01
影响因子：
45.3
通讯作者：
Jakes, R
中科院分区：
文献类型：
--
作者：
Cullen, MH;Stenning, SP;Jakes, R
目的：这项英国医学研究理事会(UK-MRC)的研究前瞻性地评估了辅助化疗在高危I期睾丸非精原细胞生殖细胞肿瘤(NSGCTT)中的疗效和长期毒性。患者和方法：符合条件的患者是那些经MRC监测研究证实具有大约50%复发风险的符合条件的患者。进行中央组织病理学复习。化疗方案为顺铂100 mg/m(2)，博莱霉素30 mg每周×3，依托泊苷120 mg/m(2)×3，每21天1次。中位随访时间为4年，93例患者随访至少2年。根据参考组织病理学家的说法，已经有两次复发，包括一名没有生殖细胞肿瘤(GCT)的患者。这名患者活着，患有活动性疾病，另一名已经死亡。有一人在治疗过程中发生脑血管事故后死亡。对治疗前和治疗后9个月以上的生育力、肺功能和听力测定的评估表明，没有临床上显著的变化。转移因子系数(KCO)平均下降至预测值的15%，但无一例出现症状性呼吸功能障碍。结论：114例高危I期NSGCTT患者接受两个疗程的BEP辅助化疗后，仅有2例复发。95%的可信区间(CI)排除了超过5%的真实复发率。在104名经组织病理学检查证实患有GCT的患者中，只有一人复发。辅助化疗没有明显的长期毒性，为监测或腹膜后淋巴结清扫术(RPLND)提供了一种有效的替代方案，并可能受到一些患者的青睐。(C)1996年，由美国临床肿瘤学会主办。
Purpose: This United Kingdom Medical Research Council (UK-MRC) study prospectively evaluated efficacy and long-term toxicity of adjuvant chemotherapy in high-risk stage I nonseminomatous germ cell tumors of the testis (NSGCTT).Patients and Methods: Eligible patients were those identified by the local histopathologist as having features confirmed in MRC surveillance studies to indicate an approximate 50% risk of relapse. Central histopathology review was undertaken. Chemotherapy consisted of two courses of cisplatin 100 mg/m(2), bleomycin 30 mg weekly x 3, and etoposide 120 mg/m(2) x 3, every 21 days (BEP).Results: One hundred fourteen eligible cases were enrolled. Median time of follow-up was 4 years, with 93 patients followed-up for at least 2 years. There have been two relapses, including one patient who did not have a germ cell tumor (GCT), according to the reference histopathologist. This patient is alive with active disease, the other has died. There was one death after a cerebrovascular accident during treatment. Assessment of fertility, lung function, and audiometry pretreatment and more than 9 months posttreatment indicated no clinically significant changes. A mean decrease in transfer factor coefficient (KCO) of 15% of the predicted value was noted, but no patient had symptomatic respiratory dysfunction.Conclusion: There have been only two relapses among 114 cases of high-risk stage I NSGCTT treated with two courses of adjuvant BEP chemotherapy. The 95% confidence interval (CI) excludes a true relapse rate of more than 5%. Of 104 patients confirmed on histopathology review to have GCT, there has been only one relapse. Adjuvant chemotherapy is free from significant long-term toxicity, offering an effective alternative to surveillance or retroperitoneal lymph node dissection (RPLND) followed by surveillance, and may be preferred by some patients. (C) 1996 by American Society of Clinical Oncology.