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 Anti-Cancer Agents & Biologic Therapy
Germ Cell Tumours
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.