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Improved Survival, Quality of Life, and Quality-Adjusted Survival in Breast Cancer Patients Treated With Efaproxiral (Efaproxyn) Plus Whole-Brain Radiation Therapy for Brain Metastases

Scott, Charles PhD*; Suh, John MD; Stea, Baldassarre MD; Nabid, Abdenour MD§; Hackman, John MS

American Journal of Clinical Oncology: December 2007 - Volume 30 - Issue 6 - p 580-587
doi: 10.1097/COC.0b013e3180653c0d
Original Article: Central Nervous System

Objective: To determine whether efaproxiral, an allosteric modifier of hemoglobin, improves quality of life and quality of survival in patients with primary breast cancer and brain metastases when used as an adjunct to whole-brain radiation therapy (WBRT).

Methods: Patients with brain metastases from breast cancer were randomly assigned to receive WBRT and either efaproxiral or no efaproxiral. The primary endpoint for this analysis was quality of life and quality-adjusted survival. Quality of life was assessed prior to initiation of WBRT and periodically in follow-up using the Spitzer Quality of Life Index (SQLI).

Results: A subgroup of 106 eligible breast cancer patients with baseline SQLI were randomized into this study and represent the target population discussed in this report. Treatment, age, and SQLI were significant predictors of survival. The addition of efaproxiral to WBRT reduced the death rate by 46% (P = 0.0086). Quality of life was improved in the WBRT + efaproxiral arm compared with the WBRT alone arm (P = 0.019). Quality-adjusted survival was statistically significantly improved by the addition of efaproxiral to WBRT (P = 0.001).

Conclusion: Survival, quality of life, and quality-adjusted survival were all improved in breast cancer patients with brain metastases receiving efaproxiral and WBRT compared with those receiving WBRT alone.

From the *CBS Squared, Inc., Fort Washington, Pennsylvania; †Cleveland Clinic Foundation, Brain Tumor Institute, Department of Radiation Oncology, Cleveland, Ohio; ‡Department of Radiation Oncology, University of Arizona, Tucson, Arizona; §Centre Hospitalier Universitarie de Sherbrooke, Service de Radio-Oncologie, Sherbrooke, PQ, Canada; and ∥Allos Therapeutics, Inc., Westminster, Colorado.

Reprints: Charles Scott, PhD, CBS Squared, Inc., P.O. Box 768, Fort Washington, PA 19034. E-mail: cbssquared@comcast.net.

© 2007 Lippincott Williams & Wilkins, Inc.