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A Simple Stratification Factor Prognostic for Survival in Advanced Cancer: The Good/Bad/Uncertain Index

2001; Lippincott Williams & Wilkins; Volume: 19; Issue: 15 Linguagem: Inglês

10.1200/jco.2001.19.15.3539

1527-7755

Jeff A. Sloan, Charles L. Loprinzi, John A. Laurine, Paul J. Novotny, Delfino Vargas Chanes, James E. Krook, Michael J. O’Connell, John W. Kugler, Maria Tria Tirona, Carl G. Kardinal, Martin Wiesenfeld, Loren K. Tschetter, Alan K. Hatfield, Paul Schaefer,

Lung Cancer Treatments and Mutations

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 for phase III oncology clinical trials involving patients with advanced malignant disease.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 for 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).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).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.