A simple stratification factor prognostic for survival in advanced cancer: The good/bad/uncertain index

J. A. Sloan, C. L. Loprinzi, J. A. Laurine, P. J. Novotny, D. Vargas-Chanes, J. E. Krook, M. J. O'Connell, J. W. Kugler, M. T. Tirona, C. G. Kardinal, M. Wiesenfeld, L. K. Tschetter, A. K. Hatfield, P. L. Schaefer

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62 Scopus citations

Abstract

Purpose: This article summarizes the third step of a research program to identify variables that supplement the predictive power of the the Eastern Cooperative Oncology Group (ECOG) performance status (PS) for survival. The objective was to produce a simple, practical, stratification factor far phase III oncology clinical trials involving patients with advanced malignant disease. Patients and Methods: A questionnaire was administered to 729 patients with metastatic colorectal or lung cancers. Patients provided a Karnofsky index and appetite rating while physicians provided a survival estimate and the ECOG-PS. Scores far each item were categorized as having a positive, neutral, or negative indication for survival. A patient was classified as having a relatively good prognosis if three or more of the four items showed a positive indication, a bad prognosis if three or more items were negative, and an uncertain prognosis otherwise (Good/Bad/Uncertain [GBU] index). Results: The GBU index improved on the prognostic power of a Cox model quartile index and PS alone and increased the accuracy of survival classification estimates by 5% to 10% more than ECOG-PS alone. For patients with PS of 0 or 1, significant survival patterns exist between GBU groups (P = .002 and .0001, respectively). Conclusion: The GBU index may be recommended as a supplementary stratification factor for certain future phase III trials in metastatic lung or colorectal cancer where patient heterogeneity is a particular concern. The GBU represents a relatively modest increase to the cost and patient burden of a clinical trial given the additional control that is achieved over the potentially confounding concomitant to the treatment variable.

Original languageEnglish (US)
Pages (from-to)3539-3546
Number of pages8
JournalJournal of Clinical Oncology
Volume19
Issue number15
DOIs
StatePublished - Aug 1 2001

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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