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Prognostic factors identified three risk groups in the LRF CLL4 trial, independent of treatment allocation.

ABSTRACT: Many prognostic markers have been identified in chronic lymphocytic leukemia, but there have been few opportunities to assess their relative importance in a large randomized trial. The aim of this study was to determine which of the available markers independently predicted outcome in patients requiring treatment and to use these to define new risk groups.A broad panel of clinical and laboratory markers, measured at randomization in patients entering the LRF CLL4 trial, was assessed with respect to treatment response, progression-free and overall survival, at a median follow-up of 68 months.Using the factors identified as independent predictors for progression-free survival, patients were subdivided into three risk groups: 6% had poor risk with known TP53 loss of greater than 10%; 72% had an intermediate risk without TP53 loss (? 10%) and with at least one of: unmutated IGHV genes and/or IGHV3-21 usage, 11q deletion, ?-2 microglobulin greater than 4 mg/L; 22% had a good risk (with none of the above and mutated IGHV genes). The 5-year progression-free survival rates for these three groups were 0%, 12% and 34%, respectively, and the corresponding 5-year overall survival rates were 9%, 53% and 79% (both P<0.00005 independent of treatment allocation). In the intermediate risk group 250 patients, with data for all three risk factors, were further subdivided into intermediate-low (one risk factor) or intermediate-high (2 or 3 risk factors). The 5-year progression-free survival rates were 18% and 7% (P=0.0001) and the 5-year overall survival rates were 68% and 40% (P<0.00005), respectively.This study demonstrates the role of biomarkers in prognosis and shows that, in patients requiring treatment, disease stage may no longer be an independent predictor of outcome. If validated independently, the risk groups defined here may inform the design of future trials in chronic lymphocytic leukemia.

SUBMITTER: Oscier D

PROVIDER: S-EPMC2948096 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

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Prognostic factors identified three risk groups in the LRF CLL4 trial, independent of treatment allocation.

Oscier David D Wade Rachel R Davis Zadie Z Morilla Alison A Best Giles G Richards Sue S Else Monica M Matutes Estella E Catovsky Daniel D

Haematologica 20100529 10

<h4>Background</h4>Many prognostic markers have been identified in chronic lymphocytic leukemia, but there have been few opportunities to assess their relative importance in a large randomized trial. The aim of this study was to determine which of the available markers independently predicted outcome in patients requiring treatment and to use these to define new risk groups.<h4>Design and methods</h4>A broad panel of clinical and laboratory markers, measured at randomization in patients entering ...[more]

PMID: 20511662

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Project description:Importance:It is not well understood whether prognostic factors in breast cancer are affected by specific treatment and vary by clinical outcome type compared with untreated patients. Objective:To identify independent clinical and molecular measurements associated with overall survival (OS) and recurrence-free survival (RFS) by homogeneous treatment in women with breast cancer. Design, Setting, and Participants:This prognostic study included 956 patients diagnosed with invasive breast cancer from hospital centers across 4 geographical regions of the United States who participated in the accreditation program of the Commission on Cancer of the American College of Surgeons from 1985 to 1997. The duration of follow-up ranged from 1 to 282 months. The study analysis was conducted from June 10, 2019, to March 18, 2020. Main Outcomes and Measures:Analysis of OS and RFS in patients who underwent chemotherapy, radiotherapy, or endocrine therapy alone compared with no systemic or locoregional therapy. Cox proportional hazards regression models were used to estimate independent performance and 95% CI of age, tumor size, number of positive nodes (nodal status), tumor grades 2 and 3, p53 status, estrogen receptor (ER) status, and ERBB2 (formerly HER2) status. Results:Among 956 participants, median age was 61 (range, 25-96) years. Age (adjusted hazard ratio [AHR], 2.24; 95% CI, 1.27-3.94; P?=?.01) and high grade (AHR, 2.05; 95% CI, 1.09-3.86; P?=?.02), in addition to nodal status and tumor size, were independently associated with OS and RFS, respectively, in untreated patients. p53 status (AHR, 2.11; 95% CI, 1.07-4.18; P?=?.03) and ER status (AHR, 0.46; 95% CI, 0.23-0.92; P?=?.03) were associated with higher and lower risks of death, respectively, whereas nodal status (AHR, 1.13; 95% CI, 1.06-1.20; P?<?.005), high grade (AHR, 4.01; 95% CI, 1.51-10.70; P?=?.01), and ERBB2 positivity (AHR, 2.67; 95% CI, 1.25-5.70; P?=?.01) were associated with the risk of recurrence after endocrine therapy. Tumor size (AHR for OS, 2.76 [95% CI, 1.79-4.31; P?<?.005]; AHR for RFS, 2.27 [95% CI, 1.23-4.18; P?=?.01]) and ERBB2 status (AHR for OS, 5.35 [95% CI, 1.31-21.98; P?=?.02]; AHR for RFS, 6.05 [95% CI, 1.48-24.78; P?=?.01]) were independently associated with radiotherapy outcomes, and nodal status was significantly associated with chemotherapy outcomes (AHR for OS, 1.06 [95% CI, 1.02-1.09; P?<?.005]; AHR for RFS, 1.05 [95% CI, 1.01-1.09; P?=?.01]). Conclusions and Relevance:In this study, independent prognostic factors were associated with specific treatment and weighted by the outcome category with reference to untreated patients within biological and clinical contexts.

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Prognostic factors identified three risk groups in the LRF CLL4 trial, independent of treatment allocation.

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Prognostic factors identified three risk groups in the LRF CLL4 trial, independent of treatment allocation.

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