Cure rates for patients with poor- and intermediate-risk metastatic germ cell tumors lag behind those for patients with good-risk metastatic germ cell tumors; the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) aim to improve these cure rates. They are conducting a trial to determine if an accelerated chemotherapy regime is more effective than the existing standard protocol . For patients with metastatic germ cell tumors, cure rates are currently >90% in good-risk disease, 85% in intermediate-risk disease, and only 70% in poor-risk disease. These are the rates seen with current first-line therapy, comprised of four 3-weekly cycles of bleomycin, etoposide, and cisplatin (BEP). ANZUP aims to determine if shortening the treatment cycles in metastatic germ cell tumors will yield the same superior cure rates achieved by shortening the treatment cycles in other cancers. They have devised an accelerated treatment protocol that administers BEP in four 2-weekly cycles followed by 4 weekly doses of bleomycin. The ongoing phase 3 trial (NCT02582697) aims to randomize 500 participants aged 11–45 years who have poor- or intermediate-risk metastatic giant cell tumors of the mediastinum, ovary, retroperitoneum, or testis. This is the first trial of its kind to include both adults and children of both sexes. The trial consists of 2 stages; the primary endpoint for stage 1 is complete response (CR) and stage 1 analysis is expected to occur mid 2021. Interim analysis has identified no safety concerns to date. The primary endpoint for stage 2 is progression-free survival at 2 years. This interesting trial bears watching; the results may change standards of care.
- Subramaniam S. P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumors (GCTs). ASCO Genitourinary Cancers Symposium, 11-13 February 2021.