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Darbepoetin alfa offers dose flexibility making treatment more convenient, he adds. Researchers randomly assigned 705 patients with chemotherapy-induced anaemia from 160 centres in Europe to either a fixed dose of 500 g darbepoetin alfa every 3 weeks or 2·25 g/kg darbepoetin alfa once a week. Of the 672 patients assessed, the incidence of transfusions was 19% for patients assigned treatment every 3 weeks and 28% for those assigned treatment once a week, after adjustment for stratification factors. The difference without adjustment was 6·8% in favour of the every-3-weeks group. Furthermore, haemoglobin profiles were identical between groups and more than 70% of patients achieved the recommended target range of 110–130 g/L. The safety profile was similar in both treatment groups. “The study is good news because the
drug allows for flexibility on a one-, two-, or three-week basis, depending on what type of chemotherapy is being given”, adds Jay Brooks (Ochsner Clinic Foundation, Baton Rouge, LA, USA).
Heather Lindsey
© Dr Tony Brain/Science Photo Library
Results from a phase III study show that darbepoetin alfa given as a fixed dose of 500 g once every 3 weeks is at least as effective in reducing redblood-cell transfusions as 2·25 g/kg of the drug given once a week in patients with chemotherapyinduced anaemia. The drug also increases haemoglobin to target concentrations, according to the study presented at the 10th congress of the European Hematology Association, Stockholm, Sweden; June 2–5, 2005. “If you look at the administration of chemotherapy in patients with solid tumours, more than 50% of regimens have a cycle length of 3 weeks”, says study author Johan Vansteenkiste (University of Gathuisberg, Belgium). An advantage of giving darbepoetinalfa every 3 weeks is that it can be given with these chemotherapies, helping to reduce patient visits and
Darbopoetin alfa reduces the amount of blood transfusions needed
Options improve for advanced colorectal cancer Results from a phase III study show that an oral regimen of capecitabine plus oxaliplatin (CAPOX) is as safe and effective as infusional fluorouracil and folinic acid plus oxaliplatin (FUFOX) in first-line treatment of metastatic colorectal carcinoma, according to German and US researchers presenting at the 2nd scientific and educational conference of the European Society for Medical Oncology, Budapest, Hungary; June 2–5, 2005. “This study is important for patients because the CAPOX regimen is more convenient to administer [and] patients will appreciate needing to come only twice in three weeks as outpatients to receive the 2-hour oxaliplatin dose”, says Hendrik-Tobias Arkenau (Royal Marsden Hospital, London, UK). From August, 2002, to August, 2004, 476 patients with advanced http://oncology.thelancet.com Vol 6 July 2005
colorectal cancer who had not previously received chemotherapy were randomly assigned to FUFOX (2000 mg/m2 fluorouracil given as a 24-h infusion, 500 mg/m2 folinic acid, 50 mg/m2 oxaliplatin on days 1, 8, 15, and 22 every 5 weeks) or to CAPOX (1,000 mg/m2 capecitabine twice daily on days 1–14, 70 mg/m2 oxaliplatin on days 1 and 8 every 3 weeks). All patients had measurable metastatic disease. Median follow-up was 35 weeks in both groups. To date, on the basis of 2541 treatment cycles (1026 for FUFOX and 1515 for CAPOX), toxic effects and response were much the same for both treatment groups. Median time without disease progression was 34·7 weeks in the FUFOX group and 30·3 weeks in the CAPOX group, a difference that was not significant. Moreover, both treatment groups
showed similar overall survival: 74·9 weeks for FUFOX and 70·9 weeks for CAPOX. “The fluorouracil infusion in combination with cytostatic agents like oxaliplatin or irinotecan in patients with colorectal cancer is complicated and needs support and a pump for the patient”, says coauthor Hans Joachim Schmoll, Martin-Luther University, Halle-Wittenberg, Germany. The results of the trial “are of major importance for the clinical routine, at least for those patients who would like to avoid intravenous infusional protocols, ports and pumps”, he adds. “We hope that oral capecitabine plus oxaliplatin will become the new standard treatment in first-line treatment for patients with metastatic colorectal carcinoma”, concludes Arkenau.
Xavier Bosch 449