Reproducibility of Tumor Response Evaluation in Patients with High-Grade Malignant non-Hodgkin's Lymphoma
| Autor: | Hans Hagberg, Eva Ösby, Adam Taube, Eva Cavallin-Stahl, Magnus Björkholm |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Endpoint Determination Phases of clinical research Tumor response Internal medicine Humans Medicine In patient Randomized Controlled Trials as Topic Retrospective Studies Observer Variation Reproducibility Hematology business.industry Lymphoma Non-Hodgkin Reproducibility of Results Cru General Medicine Middle Aged medicine.disease Survival Analysis Lymphoma Non-Hodgkin's lymphoma Treatment Outcome Female business Nuclear medicine |
| Zdroj: | Medical Oncology. 18:137-140 |
| ISSN: | 1357-0560 |
| Popis: | 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 patients60 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" (CR(U)), and PR. A discrepancy between RC 1 and 2 was found in 8/60 patients (13.3%), influencing the CR/CR(U) status in four of these patients. Two CR and two PR patients were reclassified as CR(U). Thus, CR/CR(U) 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/CR(U) 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink