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Titolo:
Reproducibility of tumor response evaluation in patients with high-grade malignant non-Hodgkin's lymphoma
Autore:
Osby, E; Taube, A; Cavallin-Stahl, E; Hagberg, H; Bjorkholm, M;
Indirizzi:
Karolinska Hosp & Inst, Dept Med, Div Hematol, Stockholm, Sweden Karolinska Hosp & Inst Stockholm Sweden Div Hematol, Stockholm, Sweden
Titolo Testata:
MEDICAL ONCOLOGY
fascicolo: 2, volume: 18, anno: 2001,
pagine: 137 - 140
SICI:
1357-0560(2001)18:2<137:ROTREI>2.0.ZU;2-R
Fonte:
ISI
Lingua:
ENG
Soggetto:
INTEROBSERVER VARIABILITY; DISEASE; CRITERIA; CANCER; TRIALS;
Keywords:
non-Hodgkin's lymphoma; reproducibility; response evaluation; review committee;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
14
Recensione:
Indirizzi per estratti:
Indirizzo: Bjorkholm, M Karolinska Hosp, Dept Med, Div Hematol, S-17176 Stockholm, Sweden Karolinska Hosp Stockholm Sweden S-17176 Stockholm, Sweden
Citazione:
E. Osby et al., "Reproducibility of tumor response evaluation in patients with high-grade malignant non-Hodgkin's lymphoma", MED ONCOL, 18(2), 2001, pp. 137-140

Abstract

Estimation of complete response (CR) and partial response (PR) in patientswith non-Hodgkin's lymphoma (NI-IL) 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 I 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.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 02/04/20 alle ore 11:37:56