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).
Shalini Subramaniam, Guy C Toner, Martin R Stockler, Andrew James Martin, Farzana D Pashankar, Ben Tran, Mark Jeffery, Danish Mazhar, Robert A Huddart, Euan Thomas Walpole, Amanda Gwendolyn Stevanovic, David Wyld, Fritha J Hanning, Matthew James Wheater, Jay R Balagtas, Simon Troon, Alison Jane Birtle, Jeff D White, Peter S Grimison
JOURNAL OF CLINICAL ONCOLOGY | LIPPINCOTT WILLIAMS & WILKINS | Published : 2021
TPS390 Background: Bleomycin, etoposide, and cisplatin (BEP) given 3-weekly x 4 is standard first-line chemotherapy for metastatic GCT categorised as intermediate risk or poor risk. Acceleration of standard regimens by shortening the cycle length improved cure rates in other cancers. We aim to determine the superiority of accelerated BEP versus standard BEP in this setting. Methods: This open label, randomised, phase III trial is conducted seamlessly in 2-stages. The primary endpoint for stage I (n=150) is complete response (CR); and for stage II (n=500) is progression free survival at 2 years (PFS2y). These sample sizes provide >80% power with a two-sided type error rate of 5% to detect an..View full abstract