The forum held on the evening of August 23 was an opportunity for those with an interest in genitourinary research to hear an overview of some of the latest trial research currently being conducted.
Mr Shomik Sengupta, Chair of the VCOG Urological Cancer Committee chaired the evening. Summaries of two studies presented are both below.
Accelerated BEP for advanced germ cell tumours: an Australian multicentre phase I/II trial
Presented by Dr Peter Grimison, a staff specialist in Medical Oncology at Royal
Prince Alfred Hosptial and Senior Lecturer at the University of Sydney
Background: Standard chemotherapy for advanced germ cell tumors is BEP (bleomycin, etoposide, cisplatin). Five-year survival is > 90% in good-risk disease, but only ~80% in intermediate and ~60% in poor risk disease. Accelerated (dose-dense) versions of standard regimens have proven more effective in other malignancies. We aimed to determine feasibility, tolerability and activity of an accelerated version of BEP.
Methods: Single arm, multi-centre, phase I/II trial (n=45 recruited). Target population was patients with advanced germ cell tumours and radiologically measurable disease. Patients with elevated serum tumour markers as only evidence of disease were ineligible.
Treatment was cisplatin 20mg/m2 and etoposide 100mg/m2 on days 1-5, and pegylated G-CSF 6mg on day 6, all repeated every 2 weeks for 4 cycles (3 cycles for good risk). Bleomycin was given at 30kIU weekly to a total 12 doses (9 doses for good risk). Primary endpoint was regimen feasibility.
Results: Results are presented for the first 41 patients enrolled from February 2008 to July 2010. Ten had poor risk disease (1 female), 15 intermediate risk, 16 good risk disease. Median follow-up is 14 months (range 2 to 27).
At least 36 (88%) were eligible to start a 4th cycle of BEP on schedule or with no more than 1 week delay. Adverse events are presented in table 1. Twenty-two of 41 patients (9 of 25 patients with intermediate or poor risk, 13 of 16 patients with good risk) achieved a complete response to chemotherapy +/- surgery. 4 of 41 patients have relapsed including one death.
One year progression-free survival is 80% for intermediate or poor risk disease, and 100% for good risk disease. One year overall survival is 93% for intermediate or poor risk disease, and 100% for good risk disease.
Conclusions: Feasibility and adverse events appears comparable to standard BEP. Efficacy data appears promising. Results from this trial and a similar study in the UK (Williams, ASCO 2008) provide the rationale for an international trial comparing accelerated versus standard versions of BEP.
Dr Grimison's presentation on Accelerated BEP for advanced germ cell
tumours: an Australian multicentre phaseI/II trial. (862kb)
Engage Study: the efficacy of a referral and physical activity program for survivors of prostate cancer
Presented by Assoc Prof Trish Livingston, is Associate Dean - Research in the Faculty of Health at Deakin University
Background: Despite the evidence that physical activity improves the health and wellbeing of prostate cancer survivors, many men don't engage in sufficient levels of activity. The primary aim of the ENGAGE study is to determine the efficacy of a referral and physical activity program among survivors of prostate cancer, in terms of increasing participation in physical activity.
Secondary aims are to determine the effects of the physical activity program on psychological wellbeing, quality of life and objective physical functioning. The influence of individual and environmental mediators on participation in physical activity will also be determined.
Methods/design: This study is a cluster randomised controlled trial. Clinicians of prostate cancer survivors will be randomised into either the intervention or control condition. Clinicians in the intervention condition will refer eligible patients (n=110) to participate in an exercise program, comprising 12 weeks of supervised exercise sessions and unsupervised physical activity.
Clinicians allocated to the control condition will provide usual care to eligible patients (n=110), which does not involve the recommendation of the physical activity program. Participants will be assessed at baseline, 12 weeks, 6 months, and 12 months on physical activity, quality of life, anxiety, depression, self-efficacy, outcome expectations, goals, and socio-structural factors.
Discussion: The findings of this study have implications for clinicians and patients with different cancer types or other chronic health conditions. It will contribute to our understanding on the potential impact of clinicians promoting physical activity to patients and the long term health benefits of participating in physical activity programs.
Download Trish Livingston's presentation on the Engage Study (233kb)