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.
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).


CONCLUSIONS
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.
Scott
Charles
C
CBS Squared, Inc., Fort Washington, Pennsylvania 19034, USA. cbssquared@comcast.net
Suh
John
J
Stea
Baldassarre
B
Nabid
Abdenour
A
Hackman
John
J
D000368:Aged; D000814:Aniline Compounds / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy / Q000532:radiotherapy* / Q000556:secondary*; D001943:Breast Neoplasms / Q000401:mortality* / Q000473:pathology; D016371:Cranial Irradiation; D005260:Female; D006801:Humans; D008875:Middle Aged; D010100:Oxygen / Q000008:administration & dosage; D011422:Propionates / Q000627:therapeutic use*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D011829:Radiation Dosage; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use*; D015996:Survival Rate
D000814:Aniline Compounds; D011422:Propionates; D011838:Radiation-Sensitizing Agents; C067396:efaproxiral; D010100:Oxygen