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

From the Mayo Clinic and Mayo Foundation, Rochester, MN; Altru Health Systems, Grand Forks, ND; Duluth Community Clinical Oncology Program, Duluth, MN; Allan Blair Cancer Center, Regina Saskatchewan, Canada; Ochsner Community Clinical Oncology Program, New Orleans, LA; Cedar Rapids Oncology Project Community Clinical Oncology Program, Cedar Rapids, IA; Sioux Community Cancer Consortium, Sioux Falls, SD; Illinois Oncology Research Association Community Clinical Oncology Program, Peoria, and Carle Cancer Center Community Clinical Oncology Program, Urbana, IL; and Toledo Community Hospital Oncology Program Community Clinical Oncology Program Toledo, OH.

Address reprint requests to Jeff A. Sloan, PhD, Mayo Clinic, 200 1st St, SW, Rochester, MN 55905; email: jsloan{at}mayo.edu

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 for 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 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).

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.

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic.

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