Addition of the drug armodafinil did not improve measures of fatigue in patients with gliomas undergoing treatment with radiotherapy, according to the results of a pilot study (abstract 2004) presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting.
Eudocia Quant Lee, MD, MPH, of Dana-Farber Cancer Institute, said that these results are similar to those presented by Shaw et al at the 2013 ASCO Annual Meeting that looked at armodafinil to treat fatigue in patients with any primary brain tumor and found no positive effective of the drug.
“Based on our analysis of complete cases, there is no statistically significant difference between groups in 42-day change in FACIT-F, FACT-G, Cancer Fatigue Scale, or Brief Fatigue Inventory,” Lee said. “These findings are consistent with prior randomized studies of other psychostimulants in cancer patients including primary brain tumors and even a recent study of modafinil in lung cancer patients published in JCO.”
Lee also pointed out that the data in the abstract for the meeting suggested an improvement in 42-day change in the Brief Fatigue Inventory (BFI) scores, but that the addition of data from four additional patients after abstract submission resulted in a non-significant P value
In the pilot study, Lee and colleagues enrolled 80 patients with grade II–IV glioma undergoing brain radiation. Patients were randomly assigned to armodafinil or placebo. Fifty-nine patients received treatment. Patients started treatment within 5 days of starting radiation and continued treatment for 8 weeks. Patients filled out questionnaires regarding quality of life and fatigue at baseline, day 22, day 43, and day 56.
The primary endpoint was the 42-day change in the Functional Assessment of Chronic Illness Therapy fatigue (FACIT-F) subscale scores. Lee presented results of the initial analysis based on patients with complete baseline and day 43 data.
“In terms of the primary endpoint, even though there was a slight trend toward improvement in the modafinil arm, the result was not statistically significant,” Lee said.
For the secondary endpoint, the researchers looked at the Cancer Fatigue Scale (CFS), the BFI, and the Functional Assessment of Cancer Therapy (FACT-G), which is an overall quality-of-life assessment looking at physical, social/family, emotional, and functional well-being. Again, there were no significant differences in 42-day change for patients in the two groups on any of these measures.
“Since it is reasonable to assume that the mechanism for missing data is related to the outcome measurement, for example, if the reason why there is missing data is because the patients who are most fatigued are the people who weren’t able to fill out the questionnaires, the conclusions for this study are incomplete without proper missing data analysis,” Lee said.
In her discussion of the study results, Jennifer L. Clarke, MD, MPH, of UCSF Helen Diller Family Comprehensive Cancer Center, said that as clinicians move toward trying to do more symptom-targeted treatments, studies such as this one are important despite its negative results.
“As we are trying to design these studies we must be thoughtful about trying to define an outcome in such studies that is clinically meaningful for the patient, not just a statistically significant numerical change in a number scale,” Clarke said.