Treatment > Radiation-Enhancing Agents

Meeting Abstract

Results from the phase III trial of motexafin gadolinium (MGd) in brain metastases

M P Mehta, P Rodrigus, C Terhaard, A Rao, J Suh, W Roa, WR Shapiro, M J Glantz, RA Patchell, MA Weitzner, L Souhami, A Bezjak, M Leibenhaut, R Komaki, C Schultz, R Timmerman, T Illidge, C Meyers, W J Curran, S Phan, J Smith, R Miller, M F Renschler

Univ of Wisconsin, Madison, WI; Verbeeten Inst., Tilburg, The Netherlands; Academic Hosp., Utrecht, The Netherlands; Kaiser Permanente, Los Angeles, CA; Cleveland Clinic, Cleveland, OH; Cross Cancer Inst, Edmonton, AB, Canada; Barrow Neurologic Institute, Phoenix, AZ; University of Massachusetts, Amherst, MA; University of Kentucky, Lexington, KY; H. Lee Moffitt Cancer Center, Tampa, FL; Montreal General Hosp, Montreal, QC, Canada; Princess Margaret Hosp, Toronto, ON, Canada; Radiological Assoc of Sacramento, Sacramento, CA; UT MD Anderson, Houston, TX; Medical College of Wisconsin, Milwaukee, WI; Indiana Univ, Indianapolis, IN; Wessex Cancer Ctr., Southampton, UK; Thomas Jefferson Univ, Philadelphia, PA; Pharmacyclics, Sunnyvale, CA

Methods. A prospective, randomized phase III trial of MGd and WBRT vs. WBRT was conducted.
Randomization and analysis were stratified by tumor type and recursive partitioning analysis (RPA) class.
Patients (Pts) were evaluated prior to randomization and then monthly for neurologic signs and symptoms, QOL, and neurocognitive function (NCF).
MRI was obtained at screening, at 2, 4 and 6 months, then quarterly.
Neurologic progression was determined by a blinded Events Review Committee requiring progression in 2 of 3 neurologic domains (NCF, neurologic exam, neurologic symptoms), using pre-specified criteria.

Results. 401 Pts with BM from lung cancer (62.6%), breast cancer (18.7%), melanoma (6%) or other cancers (12.7%), RPA class 1 (16%) or 2 (84%) were randomized to MGd + WBRT(193) or WBRT (Ctrl, 208).
Median OS was 5.2 mo (MGd) and 4.9 mo (Ctrl), (p=ns).
Median time to neurologic progression was 9.5 mo (MGd) and 8.3 mo (Ctrl), (p=ns).
For lung cancer pts, median OS was 4.9 mo (MGd) and 4.3 mo (Ctrl), (p=ns), and median time to neurologic progression was not reached for MGd and 7.4 mo for Ctrl, (unadjusted p=0.048).
For 214 RPA class 2 pts with lung cancer, median time to neurologic progression was not reached for MGd, and 6. 3 mo for Ctrl (unadjusted p=0.013).
Neurologic progression-free survival at one year was 20.1% (MGd) and 14.1% (Ctrl), and for lung cancer patients 18.6% (MGd) and 10.5% (Ctrl).

Conclusion. MGd did not confer an overall advantage in OS or time to neurologic progression for the entire cohort.
An improvement in time to neurologic progression was observed in lung cancer pts.

© Copyright 2002 American Society of Clinical Oncology