872TiP - ANZUP 1302: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer agents
Germ Cell Tumours
Therapy
Biological therapy
Presenter Anne Long
Citation Annals of Oncology (2014) 25 (suppl_4): iv280-iv304. 10.1093/annonc/mdu337
Authors A. Long1, G. Toner2, M. Stockler3, D.B. Thomson4, V. Gebski5, S. Yip3, M. King6, M. Friedlander7, D.I. Quinn8, N. Singhal9, F. Roncolato3, P. Grimison10
  • 1Germ Cell Tumours, Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), 2050 - Sydney/AU
  • 2Medical Oncology, Peter MacCallum Cancer Centre, Melbourne/AU
  • 3Nhmrc Clinical Trials Centre, University of Sydney, Sydney/AU
  • 4Medical Oncology, Princess Alexandra Hospital, Brisbane/AU
  • 5Biostatistics And Research Methodology, NHMRC Clinical Trials Centre, University of Sydney, 2050 - Sydney/AU
  • 6Psycho-oncology Co-operative Research Group (pocog), University of Sydney, Sydney/AU
  • 7Oncology, ANZGOG and Prince of Wales Clinical School, University of New South Wales, Sydney/AU
  • 8Norris Comprehensive Cancer Center, University of Southern California Norris Comprehensive Cancer Center, 90033 - Los Angeles/US
  • 9Medical Oncology, Royal Adelaide Hospital RAH Cancer Centre, Adelaide/AU
  • 10Medical Oncology, Chris O'Brien Lifehouse, Sydney/AU

Abstract

Background

Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). High-dose chemotherapy and more complex regimens (eg VIP, T-BEP) have failed to improve cure rates and are more toxic. Accelerating regimens of standard chemotherapy by giving them 2-weekly rather than 3-weekly has improved cure rates in other cancers where more complex or higher-dose regimens failed. Aim: To determine if accelerated BEP is superior to standard BEP as 1st line chemotherapy for intermediate and poor risk metastatic GCTs.

Trial design

Open-label, randomised, stratified 2-arm multicentre, 2 stage, phase 3 clinical trial. The primary endpoint for stage I of the trial (n = 150) is complete response rate, and for the complete trial (n = 500) is progression-free survival (PFS). A sample size of 150 and 500 patients gives >80% power to detect a 20% improvement in response rates and 7% absolute improvement in 2yr PFS, respectively. Participants: Males aged 16-45years with intermediate or poor-risk metastatic GCTs for 1st line chemotherapy. Planned expansion to include children aged 11+ and females. Regimen: Participants are randomised 1:1 to “standard BEP” or “accelerated BEP”:

Timing of BEP accelerated vs standard

Week 1 2 3 4 5 6 7 8 9 10 11 12
Standard EP EP EP EP
B B B B B B B B B B B B
Accelerated EP EP EP EP
B B B B B B B B B B B B

E-Etoposide 100mg/m2 D1-5; P-Cisplatin25mg/m2 D1-5; B-Bleomycin 30000 IU weekly; Peg G-CSF 6mg s/c given on D6 post EP in both arms Assessments: Weekly during BEP. Initial response assessment at 30-day safety assessment. Final response assessment at 6 months from randomisation or after all post-chemotherapy intervention is completed. Follow-up 3-monthly for 2 years from randomisation, then 6-monthly to 5 years, then annually. Tissue and blood collection for translational substudies Current status: In start-up phase or open to recruitment at 25 sites in Australia & New Zealand. International trial groups invited to participate. Email: p3bep@ctc.usyd.edu.au Webstite: http://www.anzup.org.au/

Disclosure

All authors have declared no conflicts of interest.