P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumours (GCTs).

Authors

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Danka Sinikovic Zebic

NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, NSW, Australia

Danka Sinikovic Zebic , Ben Tran , Andrew James Martin , Farzana D. Pashankar , Danish Mazhar , Robert A Huddart , Matthew Wheater , Euan Thomas Walpole , Elaine Dunwoodie , Darren R. Feldman , Alison Jane Birtle , David Wyld , Nicola Jane Lawrence , Martin R. Stockler , Peter S. Grimison

Organizations

NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, NSW, Australia, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia, Yale Cancer Center, Yale School of Medicine, New Haven, CT, Cambridge University Hospital NHS Foundation Trust, Cambridge, United Kingdom, Royal Marsden Hospital, Surrey, United Kingdom, University Hospital Southampton, Southampton, United Kingdom, Princess Alexandra Hospital, Brisbane, Australia, St James's University Hospital, Leeds, United Kingdom, Memorial Sloan Kettering Cancer Center, New York, NY, Royal Preston Hospital, Preston, United Kingdom, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia, Te Pūriri o Te Ora Cancer and Blood, Te Toka Tumai Auckland, Te Whatu Ora, Auckland, New Caledonia, Chris O'Brien Lifehouse, Sydney, NSW, Australia

Research Funding

Other Government Agency
Cancer Australia, Clinical Trials Awards and Advisory Committee (UK) and National Cancer Institute (USA)

Background: Bleomycin, etoposide, and cisplatin (BEP) given 3-weekly x 4 remains standard 1st line chemotherapy for intermediate or poor risk metastatic GCT. Accelerating standard regimens by shortening the cycle length to 2-weekly improved cure rates in other cancers. P3BEP will determine effects of accelerated versus standard BEP in this setting. This is the first international, randomized trial of chemotherapy for intermediate and poor-risk metastatic GCT to include adults and children of both sexes. Methods: This open label, randomized, phase 3 trial is conducted seamlessly in 2-stages. The primary endpoint for stage I (n = 150) was favourable response; and for stage 2 (n = 500) is progression free survival at 2 years (PFS2y). These sample sizes provide > 80% power with a 2-sided type I error rate of 5% to detect an absolute improvement of 21% in the favourable response rate (stage 1) and of 7% in the PFS2y (stage 2). The target population is males and females aged 11 to 45 with intermediate- or poor-risk metastatic GCT of the testis, ovary, retroperitoneum, or mediastinum. Participants are randomized (1:1) to 4 cycles of standard BEP (q3w) or accelerated-BEP (q2w) with cisplatin 20mg/m2 D1-5, etoposide 100mg/m2 D1-5, bleomycin 30 KIU weekly x 12, and pegylated G-CSF D6 or filgrastim daily (Figure 1). Study assessments occur at 30 days after completing chemotherapy, 6 months from randomisation, and after completion of all post-chemotherapy treatments (e.g. surgery). Tumour and blood samples are collected for translational substudies. Progress - As of Jan 2023, 241 participants have been recruited from 22 ANZ sites, 16 UK sites (led by Cambridge Clinical Trials Unit), and 55 USA sites (led by Children’s Oncology Group). The first planned interim analysis for safety (n = 76) identified no safety concerns. The stage I analysis of safety and activity (response rate) for the 1st 150 patients was reviewed by the IDSMC, which recommended continuation of the trial as per protocol. Clinical trial information: NCT02582697.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary Cancer—Prostate, Testicular, and Penile

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Germ Cell/Testicular Cancer

Clinical Trial Registration Number

NCT02582697

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr TPS5102)

DOI

10.1200/JCO.2023.41.16_suppl.TPS5102

Abstract #

TPS5102

Poster Bd #

194a

Abstract Disclosures