Glenn J. Lesser, MD, Professor, Hematology & Oncology, Comprehensive Cancer Center, Wake Forest Baptist Health, discusses armodafinil for radiation-induced fatigue in patients with brain tumors.

Fortunately, Lesser says, researchers were able to look at a variety of endpoints in the phase II double-blind placebo-controlled study. Sleepiness, time spent sleeping, and other quality of life metrics standardized in the field were analyzed.

In the study, the group as a whole did not seem to benefit from armodafinil. However, the half of the population with lower initial quality of life scores did see a marked, statistically significant benefit when armodafinil was added to radiation therapy.

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Glenn J. Lesser, MD, Professor, Hematology & Oncology, Comprehensive Cancer Center, Wake Forest Baptist Health, discusses armodafinil for brain radiation-induced fatigue.

Dr. Lesser on Armodafinil for  Radiation-Induced Fatigue

Glenn J. Lesser, MD, Professor, Hematology & Oncology, Comprehensive Cancer Center, Wake Forest Baptist Health, discusses the background of the RTOG 0424 study, which analyzed temozolomide in high-risk low-grade gliomas.

The first results from the RTOG 0424 study were presented at the 2013 American Society of Clinical Oncology (ASCO) Meeting.

The trial aimed to answer the question of the role of temozolomide and radiation in newly-diagnosed patients with low-grade gliomas. Though there was a substantial amount of data regarding the role of radiation in this setting, only anecdotal data existed about the role of temozolomide. Temozolomide, Lesser notes, is the most active drug in high-grade tumors.

The RTOG 0424 trial was initially thought to be a large randomized trial but was toned down due to the absence of early data. The single-arm RTOG 0424 trial treated about 125 high-risk low-grad glioma patients with the standard therapy (for high-grade glioma): radiation with temozolomide followed by adjuvant monthly temozolomide for 6-12 cycles.

View more from the 2013 ASCO Annual Meeting

Glenn J. Lesser, MD, discusses the background of the RTOG 0424 study, which analyzed temozolomide in high-risk low-grade gliomas.

Glenn J. Lesser, MD

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Dr. Lesser on Armodafinil for Radiation-Induced Fatigue

Dr. Lesser on the Background of the RTOG 0424 Study