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11-10-2012 | Oncology | Article

Lenalidomide worsens survival, adverse events in prostate cancer


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medwireNews: A combination of lenalidomide plus docetaxel and prednisone treatment in patients with chemotherapy-naive prostate cancer leads to worse overall survival rates and increased toxicity compared with placebo, show study results.

The phase III, randomized placebo-controlled trial findings indicate that a shorter treatment duration, lower dose intensity, and earlier treatment discontinuation may have contributed to the lack of benefit with lenalidomide, say the researchers.

Furthermore, "all dose reductions were due to adverse events, except for two dose reductions of docetaxel due to other reasons," said Daniel Petrylak (Columbia University, New York, USA) in a media release from the European Society for Medical Oncology, Vienna, Austria, where he presented the research.

Petrylak and colleagues randomly assigned 1059 men (mean age 69 years) with prostate cancer, who had received no previous treatment with chemotherapy, to either lenalidomide 25 mg/day on days 1-14 of the 21-day treatment cycles, or to placebo on the same schedule. Both groups received docetaxel at 75 mg/m2 on day 1 of each cycle and prednisone 5 mg twice daily throughout.

After a median six and eight treatment cycles completed by lenalidomide and placebo groups, respectively, there were significantly more instances of neutropenia, febrile neutropenia, and diarrhea in the former than the latter group, report the researchers.

Specifically, 21.7% versus 16.3%, 11.8% versus 4.6%, and 7.0% versus 2.3% of lenalidomide- and placebo-treated patients experienced these toxicities, respectively.

Rates of pulmonary embolism, dyspnea, and pneumonia were also significantly higher in the lenalidomide than placebo group.

Furthermore, the median overall survival for lenalidomide-treated patients was 77 weeks, while the median had not yet been reached in the placebo group. Progression-free survival was shorter among lenalidomide-treated patients, at 45 versus 46 weeks, a significant difference.

Commenting on the research, Robert Jones (University of Glasgow, Scotland, UK) said: "I think we can entirely conclude that there is no future for this combination in prostate cancer. This had direct consequences for the patients who took part in the experimental arm of this study, whose care was compromised as a result."

medwireNews ( is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012

By Sarah Guy, medwireNews Reporter

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