A189
Toxicity results from the chemotherapy versus no chemotherapy comparison within BC2001 - a phase III randomised trial of standard versus reduced volume radiotherapy with or without synchronous chemotherapy in muscle invasive bladder cancer
Nicholas James1, Sayed Hussain1, Christine Rawlings2, Peter Jenkins3, Jean Tremlett4, Malcolm Crundwell5, Robert Huddart6, Emma Hall7, Shaun Rogers7
1University of Birmingham, Cancer Research UK Institute for Cancer Studies, Birmingham, UK, 2South Devon Healthcare NHS Trust, Department of Radiotherapy, Torquay, UK, 3Cheltenham General Hospital, Gloucestershire Oncology Centre, Cheltenham, UK, 4Sussex Cancer Centre, Department of Radiotherapy, Brighton, UK, 5Royal Devon and Exeter Hospital NHS Foundation Trust, Department of Urology, Exeter, UK, 6The Institute of Cancer Reserearch, Clinical Academic Radiotherapy, Sutton, UK, 7The Institute of Cancer Research, Clinical Trials and Statistics Unit, Sutton, UK
Background
BC2001 was a multicentre 2x2 factorial trial and investigated whether radiotherapy (RT) volume modification reduces late toxicity without detriment to tumour control and whether concomitant chemotherapy improves loco-regional control in management of muscle invasive bladder cancer.
Method
Patients were randomised to A) RT alone vs RT with concomitant 5-fluorouracil (5FU) (500mg/m2 daily for 5 days as continuous infusion weeks 1 and 4) and mitomycin C (MMC) day 1 (chemoRT); and B) RT to the tumour and whole bladder with 1.5cm margin vs. reduced volume RT where the tumour +1.5cm margin was treated to target dose and the remaining bladder received 80% target dose. Primary endpoint for this comparison was loco-regional control. Secondary endpoints included toxicity reported during treatment, at 6 and 12 months and annually thereafter.
Results
Between August 2001 and April 2008, 359 patients were recruited to the chemoradiotherapy comparison, (181 chemoRT; 178 RT alone). Median age was 73 (IQR 49-87) years, 80% were male, and 38% had WHO performance status of 1 or 2. Follow-up for late toxicity and loco regional control is ongoing.
G3/4 toxicity during treatment was reported by 60/171 chemoRT patients and 56/167 RT patients. Proportions suffering G3/4 non-haematological toxicities were similar in each arm, the most prevalent being nocturia (~15%) and dysuria (~5%). Proportions suffering G3/4 haematological toxicities were similar in each arm, thrombocytopaenia being most prevalent (< 5%).
Conclusion
ChemoRT with 5FU/MMC can be delivered without significant excess toxicity compared with RT alone. A complete analysis will be presented at the meeting.
