| Autor: |
Ösby, Eva, Taube, Adam, Cavallin-Ståhl, Eva, Hagberg, Hans, Björkholm, Magnus |
| Zdroj: |
Medical Oncology; Jun2001, Vol. 18 Issue 2, p137-140, 4p |
| Abstrakt: |
Estimation of complete response (CR) and partial response (PR) in patients with non-Hodgkin’s lymphoma (NHL) is associated with a number of potential sources of error. The aim of this study was to define the reproducibility of response evaluation performed by an independent review committee (RC). In a phase III study of patients >60 yr with aggressive NHL, 60 patients who were already evaluated by the independent review committee (RC 1) for response were randomized to three groups and re-evaluated (RC 2). The assessment was classified into one of seven mutually exclusive categories, where the important borderlines with regard to one of the major end-points of the study, the CR rate, were between CR, “CR uncertain” (CRU), and PR. A discrepancy between RC 1 and 2 was found in 8/60 patients (13.3%), influencing the CR/CRU status in four of these patients. Two CR and two PR patients were reclassified as CRU. Thus, CR/CRU was changed in 4/60 (6.7%). The reports of the local investigators were compared with that of RC 1 in 254 patients. The CR/CRU status was affected in 41 of these patients (16.1%). It is concluded that an independent RC is a major prerequisite for a uniform response evaluation in phase III clinical trials. However, the good RC reproducibility does not motivate a second assessment. Moreover, in the phase III setting end-points other than the CR rate, such as time to treatment failure, cause specific and overall survival are preferred. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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