open access

Vol 2, No 2 (2011)
Review paper
Published online: 2011-07-15
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The relations between therapy results and accepted evaluation criteria of progression free survival and event free survival — analysis on the basis of tyrosine kinase inhibitors use in patients with chronic myeloid leukemia

Krzysztof Lewandowski
Hematologia 2011;2(2):99-104.

open access

Vol 2, No 2 (2011)
REVIEW ARTICLES
Published online: 2011-07-15

Abstract

From many years a lot of attempts were undertaken to consolidate the criteria of evaluation of results of randomized clinical trials (RCT). Acceptation in 1996 and 2001 of precised standards of treatment efficacy evaluation (CONSORT, Consolidated Standards of Reporting Trials) significantly improved quality of reported RCT later on. Also Food and Drug Administration (FDA) data published in 2003 improved quality of reports by underlining the significance of overall survival (OS) and quality of life in study evaluating the efficacy of new drugs in cancer patients. FDA also suggested to introduce the surrogates of OS in patients with low probability of long term survival, between others progression free survival (PFS) or event free survival (EFS). Despite this, there is still a lot of discrepancies in terms of accepted therapy efficacy evaluation criteria in recently published clinical trials. It is especially evident in case of RCT evaluating the efficacy of tyrosine kinase inhibitors in patients with chronic myeloid leukemia. The discrepancies are related to the differences in defined criteria of PFS, EFS, and drug intolerance. It makes difficult to compare different drugs evaluated in RCT and may influence decision making process when therapy should be change.
Hematologia 2011; 2, 2: 99–104

Abstract

From many years a lot of attempts were undertaken to consolidate the criteria of evaluation of results of randomized clinical trials (RCT). Acceptation in 1996 and 2001 of precised standards of treatment efficacy evaluation (CONSORT, Consolidated Standards of Reporting Trials) significantly improved quality of reported RCT later on. Also Food and Drug Administration (FDA) data published in 2003 improved quality of reports by underlining the significance of overall survival (OS) and quality of life in study evaluating the efficacy of new drugs in cancer patients. FDA also suggested to introduce the surrogates of OS in patients with low probability of long term survival, between others progression free survival (PFS) or event free survival (EFS). Despite this, there is still a lot of discrepancies in terms of accepted therapy efficacy evaluation criteria in recently published clinical trials. It is especially evident in case of RCT evaluating the efficacy of tyrosine kinase inhibitors in patients with chronic myeloid leukemia. The discrepancies are related to the differences in defined criteria of PFS, EFS, and drug intolerance. It makes difficult to compare different drugs evaluated in RCT and may influence decision making process when therapy should be change.
Hematologia 2011; 2, 2: 99–104
Get Citation

Keywords

randomized clinical trials; PFS; EFS; OS; chronic myeloid leukemia; tyrosine kinase inhibitors

About this article
Title

The relations between therapy results and accepted evaluation criteria of progression free survival and event free survival — analysis on the basis of tyrosine kinase inhibitors use in patients with chronic myeloid leukemia

Journal

Hematology in Clinical Practice

Issue

Vol 2, No 2 (2011)

Article type

Review paper

Pages

99-104

Published online

2011-07-15

Bibliographic record

Hematologia 2011;2(2):99-104.

Keywords

randomized clinical trials
PFS
EFS
OS
chronic myeloid leukemia
tyrosine kinase inhibitors

Authors

Krzysztof Lewandowski

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