ASCO GU 2019: Accelerated versus Standard BEP Chemotherapy for Adult and Pediatric Male and Female Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumors

San Francisco, CA ( Bleomycin, Etoposide, and Cisplatin (BEP) *4 as three weekly cycles are the standard of care first-line treatment for patients with metastatic germ cell with poor prognostic features. High dose chemotherapy and more complex regimens have failed to improve cure rates and are more toxic. Accelerating regimens of standard three weekly chemotherapy to 2-weekly cycles has improved cure rates in other malignancies. Phase 1 and 2 data have shown that it is safe and feasible to accelerate standard chemotherapy in germ cell tumors.

This study aimed to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic germ cell tumors.

This is an open-label, randomized, stratified, 2-arm, multicenter, 2-stage phase 3 trial (Clinical trial information: NCT02582697). Patients will be aged between 11 and 45, with intermediate or poor risk germ cell tumor, arising in testis, ovary, retroperitoneum, or mediastinum, who are considering first-line chemotherapy. A total of 150 patients are planned for stage 1, and 500 are planned for stage 2. The study scheme is shown in figure 1.

The primary endpoint will be progression-free survival, and the secondary endpoints include response following treatment completion, adverse events, health-related quality of life, treatment preference, delivered dose intensity, and overall survival.

The enrolment opened in February 2014 in 4 countries (USA, UK, Australia and New Zealand), with 67 sites involved, and 76 patients randomized so far.

Figure 1 – Trial scheme:
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Presented by: Alison Zhang, MBBS, FRACP, MMedSc, Department of Medical Oncology, Peter MacCallum Cancer Centre, Australia

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre, @GoldbergHanan at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA