Net Clinical Benefit Analysis of Radiation Therapy Oncology Group 0525: A Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma

被引：111

作者：

Armstrong, Terri S. ^{[1
]}

Wefel, Jeffrey S. ^{[1
]}

Wang, Meihua

Gilbert, Mark R. ^{[1
]}

Won, Minhee

Bottomley, Andrew ^{[3
]}

Mendoza, Tito R. ^{[1
]}

Coens, Corneel ^{[3
]}

Werner-Wasik, Maria ^{[2
]}

Brachman, David G. ^{[4
,5
]}

Choucair, Ali K. ^{[6
]}

Mehta, Minesh ^{[7
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[2] Thomas Jefferson Univ Hosp, Philadelphia, PA 19107 USA

[3] European Org Res Treatment Canc, Brussels, Belgium

[4] Arizona Oncol Serv Fdn, Phoenix, AZ USA

[5] Barrow Neurol Inst, Phoenix, AZ 85013 USA

[6] Mayo Clin, Jacksonville, FL 32224 USA

[7] Univ Maryland, Baltimore, MD 21201 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2013年 / 31卷 / 32期

关键词：

QUALITY-OF-LIFE; NORMATIVE DATA; NEUROCOGNITIVE FUNCTION; REPORTED OUTCOMES; EORTC QLQ-BN20; BRAIN; VALIDATION; SYMPTOMS;

D O I：

10.1200/JCO.2013.49.6067

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

Purpose Radiation Therapy Oncology Group trial 0525 tested whether dose-intensifying temozolomide versus standard chemoradiotherapy improves overall survival (OS) or progression-free survival (PFS) in newly diagnosed glioblastoma. Tests of neurocognitive function (NCF) and symptoms (using the MD Anderson Symptom Inventory-Brain Tumor module; MDASI-BT) and of quality of life (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ] -C30/BN20) examined the net clinical benefit (NCB) of therapy. Patients and Methods NCF tests (Hopkins Verbal Learning Test-Revised, Trail Making Test, and Controlled Oral Word Association), MDASI-BT, and EORTC QLQ-C30/BN20 were completed in a subset of patients. Multivariate Cox proportional hazard regression modeling determined the prognostic value of baseline and early change from baseline to cycle 1 for OS and PFS. Two-sample proportional test statistic was used to evaluate differences between treatments (dose-dense v standard-dose) on NCB measures from baseline to cycle 4 in stable patients. Results Overall, 182 patients participated in the study. Baseline NCF tests and the physical functioning quality of life scale were associated with OS and PFS. Baseline to cycle 1 in all NCB components were associated with OS and PFS. There was greater deterioration in the dose-dense arm from baseline to cycle 4 in the Global Health and Motor Function subscales (EORTC QLQ-C30/BN20) as well as in overall symptom burden, overall symptom interference, and activity-related symptom interference subscales (MDASI-BT). There were no between-arm differences in NCF. Conclusion Longitudinal collection of NCB measures is feasible in cooperative group studies and provides an added dimension to standard outcome measures. Greater adverse symptom burden and functional interference, as well as decreased global health and motor function were observed in patients randomly assigned to the dose-dense arm. Baseline and early change in NCB measures were associated with decreased rates of survival. (C) 2013 by American Society of Clinical Oncology

引用

页码：4076 / +

页数：10

共 21 条

[1]

Validation of the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) [J].

Armstrong, T. S. ;

Mendoza, T. ;

Gring, I. ;

Coco, C. ;

Cohen, M. Z. ;

Eriksen, L. ;

Hsu, Ming-Ann ;

Gilbert, M. R. ;

Cleeland, C. .

JOURNAL OF NEURO-ONCOLOGY, 2006, 80 (01) :27-+

[2]

Hopkins Verbal Learning Test Revised: Normative data and analysis of inter-form and test-retest reliability [J].

Benedict, RHB ;

Schretlen, D ;

Groninger, L ;

Brandt, J .

CLINICAL NEUROPSYCHOLOGIST, 1998, 12 (01) :43-55

[3]

Efficace, F ;

Bottomley, A .

EUROPEAN JOURNAL OF CANCER, 2002, 38 (14) :1824-1831

[4]

Fayers P., 2001, EORTC QLQ C30 SCORIN, V3rd ed.

[5]

Dose-Dense Temozolomide for Newly Diagnosed Glioblastoma: A Randomized Phase III Clinical Trial [J].

Gilbert, Mark R. ;

Wang, Meihua ;

Aldape, Kenneth D. ;

Stupp, Roger ;

Hegi, Monika E. ;

Jaeckle, Kurt A. ;

Armstrong, Terri S. ;

Wefel, Jeffrey S. ;

Won, Minhee ;

Blumenthal, Deborah T. ;

Mahajan, Anita ;

Schultz, Christopher J. ;

Erridge, Sara ;

Baumert, Brigitta ;

Hopkins, Kristen I. ;

Tzuk-Shina, Tzahala ;

Brown, Paul D. ;

Chakravarti, Arnab ;

Curran, Walter J., Jr. ;

Mehta, Minesh P. .

JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (32) :4085-+

[6]

The prognostic significance of patient-reported outcomes in cancer clinical trials [J].

Gotay, Carolyn C. ;

Kawamoto, Crissy T. ;

Bottomley, Andrew ;

Efficace, Fabio .

JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (08) :1355-1363

[7]

CLINICAL-SIGNIFICANCE - A STATISTICAL APPROACH TO DEFINING MEANINGFUL CHANGE IN PSYCHOTHERAPY-RESEARCH [J].

JACOBSON, NS ;

TRUAX, P .

JOURNAL OF CONSULTING AND CLINICAL PSYCHOLOGY, 1991, 59 (01) :12-19

[8]

Normative data for determining significance of test-retest differences on eight common neuropsychological instruments [J].

Levine, AJ ;

Miller, EN ;

Becker, JT ;

Selnes, OA ;

Cohen, BA .

CLINICAL NEUROPSYCHOLOGIST, 2004, 18 (03) :373-384

[9]

Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients [J].

Maringwa, J. ;

Quinten, C. ;

King, M. ;

Ringash, J. ;

Osoba, D. ;

Coens, C. ;

Martinelli, F. ;

Reeve, B. B. ;

Gotay, C. ;

Greimel, E. ;

Flechtner, H. ;

Cleeland, C. S. ;

Schmucker-Von Koch, J. ;

Weis, J. ;

Van Den Bent, M. J. ;

Stupp, R. ;

Taphoorn, M. J. ;

Bottomley, A. .

ANNALS OF ONCOLOGY, 2011, 22 (09) :2107-2112

[10]

Neurocognitive function and progression in patients with brain metastases treated with whole-brain radiation and motexafin gadolinium: Results of a randomized phase III trial [J].

Meyers, CA ;

Smith, JA ;

Bezjak, A ;

Mehta, MP ;

Liebmann, J ;

Illidge, T ;

Kunkler, I ;

Caudrelier, JM ;

Eisenberg, PD ;

Meerwaldt, J ;

Siemers, R ;

Carrie, C ;

Gaspar, LE ;

Curran, W ;

Phan, SC ;

Miller, RA ;

Renschler, MF .

JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (01) :157-165

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