Competing interests: MB has received consultancy fees from Roche and Pfizer and advisory fees from Speciality European Pharma, and he has attended advisory boards for Pharmion. JG has received advisory fees from Speciality European Pharma, honorariums from Sanofi-Aventis, and conference expenses from Bayer Pharmaceuticals, Sanofi-Aventis, AstraZeneca; he has also been principal investigator of trials funded by Boehringer Ingelheim, Immunicon, Cell Genesys, GPC Biotech, and Sanofi-Aventis. FM is chief investigator of a national trial partly funded by Pfizer. The Guideline Development Group complied with NICE’s policy on declarations of interests for bodies that produce guidance.