Annals of Oncology Advance Access originally published online on May 3, 2005
Annals of Oncology 2005 16(6):942-949; doi:10.1093/annonc/mdi183
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© 2005 European Society for Medical Oncology
Neoadjuvant phase II multicentre study of new agents in patients with malignant glioma after minimal surgery. Report of a cohort of 187 patients treated with temozolomide
1 Academic Unit of Radiotherapy and Oncology, The Institute of Cancer Research, London; 2 Neuro-Oncology Unit, The Royal Marsden NHS Trust, Sutton, Surrey; 3 Department of Neuropathology, Atkinson Morley Wing, St George's Hospital, London; 4 Computing Department, The Royal Marsden NHS Trust, Sutton, Surrey, UK; 5 S Raffaele Scientific Institute, Servizio di Radiochemoterapia, Milan, Italy; 6 Department of Oncology, Royal Sussex County Hospital, Brighton, UK
* Correspondence to: Prof. M. Brada, The Institute of Cancer Research and The Royal Marsden NHS Trust, Downs Road, Sutton, Surrey SM2 5PT, UK. Tel: +44-20-8661-3272; Fax: +44-20-8661-3127; Email: michael.brada{at}icr.ac.uk
Background:: The aim of this study was to assess the efficacy of new agents in patients with malignant glioma in a neoadjuvant setting not confounded by surgery. The first study of neoadjuvant temozolomide aimed to provide a benchmark for future evaluation of new treatments.
Patients and methods:: This was a multicentre phase II study of chemotherapy in patients with histologically verified glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) who had undergone biopsy alone. Patients were planned to receive two cycles of temozolomide at 200 mg/m2 orally daily for 5 days at a 28-day interval prior to radiotherapy. Response was assessed by two central observers on pre- and post-chemotherapy enhanced scans using bi-dimensional criteria and as progression-free survival (PFS) at the time of second assessment prior to radiotherapy. Withdrawal from the study due to worsening clinical condition was, in the absence of second imaging, assessed as progressive disease. Survival and quality of life (QOL) were secondary endpoints.
Results:: Between August 1999 and June 2002, 188 patients from 15 UK and two Italian centres were entered into the study and 187 were analysed. Overall, 162 patients were assessable for response; seven had partial and 25 had minimal response. The objective response rate was 20% [95% confidence interval (CI) 14–26%] and PFS prior to commencing radiotherapy was 64% (95% CI 57–72%). The median survival was 10 months, and 1-year survival 41%. The median survival of responders was 16 months compared to 3 months in patients with progressive disease (P <0.001 on multivariate analysis).
Conclusion:: The phase II study design of primary chemotherapy in patients with malignant glioma following biopsy alone is feasible and provides as objective a method of assessment of efficacy as is currently available. The baseline data on temozolomide provide a benchmark for assessment of efficacy of other agents and combinations.
Key words: temozolomide, malignant glioma, new agents
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