Integrating PROs in clinical practice has the potential to enhance patient-centered care. The online version of the User's Guide will be updated periodically.

Memantine was well tolerated and had a toxicity profile very similar to placebo. Although there was less decline in the primary endpoint of delayed recall at 24 weeks, this lacked statistical significance possibly due to significant patient loss. Overall, patients treated with memantine had better cognitive function over time; specifically, memantine delayed time to cognitive decline and reduced the rate of decline in memory, executive function, and processing speed in patients receiving WBRT. RTOG 0614, ClinicalTrials.gov number CT00566852.

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The likelihood of rupture of unruptured intracranial aneurysms that were less than 10 mm in diameter was exceedingly low among patients in group 1 and was substantially higher among those in group 2. The risk of morbidity and mortality related to surgery greatly exceeded the 7.5-year risk of rupture among patients in group 1 with unruptured intracranial aneurysms smaller than 10 mm in diameter.

Purpose To determine the safety and efficacy of gefitinib, an EGFR tyrosine kinase inhibitor, in combination with radiation for newly diagnosed glioblastoma (GBM) patients. Methods and Materials Between 3/21/2002 and 5/03/2004 RTOG 0211 enrolled 31 and 147 GBM patients in the phase I and II arms respectively. Treatment consisted of daily oral gefinitnib started at the time of conventional cranial radiotherapy (RT) and continued post RT for 18 months or until progression. Tissue microarrays from 68 cases were analyzed for EGFR expression. Results The maximum tolerated dose (MTD) of gefitinib was determined to be 500 mg in patients on non enzyme-inducing anticonvulsant drugs (non-EIAEDs). All patients in the phase II component were treated at a gefitinib dose of 500mg; patients receiving EIADSs could be escalated to 750mg. The most common side-effects of gefitinib in combination with radiation were dermatologic and gastrointestinal. Median survival was 11.5 months for patients treated per protocol. There was no overall survival benefit for patients treated with gefitinib + RT when compared to a historical cohort of patients treated with RT alone, matched by RTOG RPA class distribution. Younger age was significantly associated with better outcome. Per protocol stratification, EGFR expression was not found to be of prognostic value for gefitinib + RT treated patients. Conclusions The addition of gefitinib to RT is well tolerated. Median survival of RTOG 0211 patients treated with radiation therapy with concurrent and adjuvant gefitinib was similar to a historical control cohort treated with radiation alone.