BACKGROUND Standard management in the UK for high-risk stage 1 nonseminoma germ cell tumours of the testis (NSGCTT) is two cycles of adjuvant bleomycin, etoposide (360 mg/m2), and cisplatin (BE360P) chemotherapy, or surveillance. OBJECTIVE To test whether one cycle of BE500P achieves similar recurrence rates to two cycles of BE360P. DESIGN, SETTING, AND PARTICIPANTS A total of 246 patients with vascular invasion-positive stage 1 NSGCTT or combined seminoma + NSGCTT were centrally registered in a single-arm prospective study. INTERVENTION One cycle comprising bleomycin 30000 IU on days 1, 8, and 15, etoposide 165 mg/m2 on days 1-3, and cisplatin 50 mg/m2 on days 1-2, plus antibacterial and granulocyte colony stimulating factor prophylaxis. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary endpoint was 2-yr malignant recurrence (MR); the aim was to exclude a rate of ≥5%. Participants had regular imaging and tumour marker (TM) assessment for 5 yr. RESULTS AND LIMITATIONS The median follow-up was 49 mo (interquartile range 37-60). Ten patients with rising TMs at baseline were excluded. Four patients had MR at 6, 7, 13, and 27 mo; all received second-line chemotherapy and surgery and three remained recurrence-free at 5 yr. The 2-yr MR rate was 1.3% (95% confidence interval 0.3-3.7%). Three patients developed nonmalignant recurrences with localised teratoma differentiated, rendered disease-free after surgery. Grade 3-4 febrile neutropenia occurred in 6.8% of participants. CONCLUSIONS BE500P is safe and the 2-yr MR rate is consistent with that seen following two BE360P cycles. The 111 study is the largest prospective trial investigating one cycle of adjuvant BE500P in high-risk stage 1 NSGCTT. Adoption of one cycle of BE500P as standard would reduce overall exposure to chemotherapy in this young population. PATIENT SUMMARY Removing the testicle fails to cure many patients with high-risk primary testicular cancer since undetectable cancers are often present elsewhere. A standard additional treatment in Europe is two cycles of chemotherapy to eradicate these. This trial shows one cycle has few adverse effects and comparable outcomes to those seen with two cycles.

中文翻译：

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111研究：一项单臂，3期试验，评估博莱霉素，依托泊苷和顺铂作为高危，睾丸1期非精原细胞瘤或合并生殖细胞肿瘤的辅助化疗的一个周期。

背景技术在英国，针对睾丸高危1期非精原细胞生殖细胞肿瘤（NSGCTT）的标准管理是博莱霉素，依托泊苷（360 mg / m2）和顺铂（BE360P）化疗或监测的两个周期的辅助治疗。目的测试一个BE500P周期是否达到与两个BE360P周期相似的复发率。设计，地点和参加者在单臂前瞻性研究中，共登记了246例血管侵犯阳性1期NSGCTT或合并精原细胞瘤+ NSGCTT的患者。干预一周期包括在第1、8和15天使用博来霉素30000 IU，在第1-3天使用依托泊苷165 mg / m2，在第1-2天使用顺铂50 mg / m2，以及预防细菌和粒细胞集落刺激因子。结果测量和统计分析主要终点为2年恶性肿瘤复发（MR）。目的是排除≥5％的比率。参与者进行了为期5年的常规成像和肿瘤标志物（TM）评估。结果与限制中位随访时间为49 mo（四分位间距为37-60）。排除了基线时TMs升高的10例患者。4例患者在6、7、13和27 mo出现MR。所有患者均接受了二线化疗和手术，其中3例在5年时仍无复发。2年MR率为1.3％（95％置信区间0.3-3.7％）。3例患者出现了非恶性复发，并伴有局部畸胎瘤分化，术后无病。6.8％的参与者发生3-4级发热性中性粒细胞减少。结论BE500P是安全的，其2年MR率与两个BE360P周期后观察到的一致。111研究是最大的前瞻性试验，研究了高危1期NSGCTT佐剂BE500P的一个周期。采用一个周期的BE500P作为标准，将减少这个年轻人群的化疗总暴露量。病人总结切除睾丸无法治愈许多高危原发性睾丸癌患者，因为其他地方经常会出现无法检测到的癌症。在欧洲，标准的附加治疗方法是根除两个周期的化学疗法。该试验表明，一个周期与两个周期所见的不良反应极少，且结果可比。病人总结切除睾丸无法治愈许多高危原发性睾丸癌患者，因为其他地方经常会出现无法检测到的癌症。在欧洲，一种标准的额外治疗方法是根除这两个周期的化学疗法。该试验表明，一个周期与两个周期所见的不良反应极少，且结果可比。病人总结切除睾丸无法治愈许多高危原发性睾丸癌患者，因为其他地方经常会出现无法检测到的癌症。在欧洲，标准的附加治疗方法是根除两个周期的化学疗法。该试验表明，一个周期与两个周期所见的不良反应极少，且结果可比。