The 111 study: A single-arm, phase 3 trial evaluating one cycle of bleomycin, etoposide, and cisplatin as adjuvant chemotherapy in high-risk, stage 1 nonseminomatous or combined germ cell tumours of the testis
European Urology Feb 21, 2020
Cullen M, Huddart R, Joffe J, et al. - In order to find out whether one cycle of BE500P achieves similar recurrence rates to two cycles of BE360P, researchers centrally registered a total of 246 individuals with vascular invasion–positive stage 1 nonseminoma germ cell tumours of the testis (NSGCTT) or combined seminoma + NSGCTT in a single-arm prospective study. The primary outcome included 2-yr malignant recurrence; the intent was to exclude a rate of ≥ 5%. Individuals had regular imaging and tumour marker evaluation for 5 yr. Since undetectable cancers are often present elsewhere, removing the testicle fails to cure many patients with high-risk primary testicular cancer. Standard further treatment in Europe is two cycles of chemotherapy to eradicate these. This study displays one cycle has few adverse outcomes and comparable results to those seen with two cycles.
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