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Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial.

Spathis A, Fife K, Blackhall F et al.
J Clin Oncol 2014; 32: 1882-1888


In this study, 208 patients were enrolled with advanced bronchial carcinoma who had received no tumour therapy in the previous 4 weeks. The basic condition for inclusion was a Fatigue Scale (Numerical Rating Scale NRS 0-10) of > 5. The patients were given either 100 mg modafinil from day 1 to day 14, then 200 mg from day 15 to day 28, or placebo for the whole period. The primary endpoint was the improvement in fatigue as measured with the FACIT questionnaire (Functional Assessment of Chronic Illness Therapy) on day 0 and day 28. A total of 160 patients were included in the modified intention-to-treat analysis. The primary endpoint of the trial could not be reached. The fatigue values in the modafinil arm rose from 5.29 to 8.02 (95 % CI: 2.57) and in the placebo arm from 5.09 to 7.65 (95 % CI: 2.54). Thus, there was an overall improvement in fatigue, but no evident difference between the two treatment arms. There were also no significant differences in the secondary outcome parameters. There was no clear difference in the toxicity profiles of modafinil and placebo, although markedly more patients in the modafinil arm discontinued the study (modafinil, N=30; placebo, N=16, P=002).

Editor’s Comments: Dr. Karin Jordan

This is yet another well performed randomised study on modafinil with a negative outcome, in addition to the several other negative studies that are already available. In an accompanying editorial in the JCO, the current guidelines of the National Cancer Institute are in fact called into question. This also applies of course to the current ASCO guidelines, although the full version of these was not yet available when the editorial was published. This contains the clear recommendation that the guidelines should be re-evaluated. Nevertheless, as indeed the authors of the editorial postulate, is must still be assumed that specific subgroups benefit from therapy with pyschostimulants. The use of psychostimulants is still “off-label”. Moreover, the EMA has taken a clear position about the use of modafinil. Use in adults is only justified in cases of excessive drowsiness during the day. The background was the occurrence of severe psychiatric side effects and skin toxicities under modafinil therapy, extending to Stevens-Johnson syndrome.

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