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Abstract
Since high-grade malignant gliomas can seldom be treated curatively, the main aim of first line therapy is to improve progression free survival (PFS), to reduce morbidity, and to preserve, if not restore neurological functions and the capacity to perform daily activities. Focusing on a single clinical efficacy parameter in clinical trials may provide a potentially biased result, as for patients the overall result of treatment entails a more complex picture of weighing and balancing gains and losses on different outcome measures.
In this paper we address different clinical outcomes measures separately and we illustrate the value of multiple outcome measures using the results of a recent clinical trial comparing temozolomide with procarbazine in the treatment of Glioblastoma Multiforme. Compared with procarbazine, temozolomide not only prolonged PFS, but also maintained neurological functioning and performance status for a longer period of time, and also improved health-related quality of life (HRQL). All these statistically significant outcomes demonstrate a remarkable consistency. In addition, temozolomide showed a trend of extending overall survival over procarbazine.