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MGd Plus Whole Brain Radiation Therapy Prolongs Time to Neurologic Progression of NSCLC Brain Metastases

MGd Plus Whole Brain Radiation Therapy Prolongs Time to Neurologic Progression of NSCLC Brain Metastases

ATLANTA--Motexafin gadolinium
(MGd, Xcytrin) combined with
whole brain radiation therapy (WBRT)
prolongs time to neurologic progression
in non-small-cell lung cancer (NSCLC)
patients with brain metastases if treatment
starts within 3 weeks of the brain
metastasis diagnosis, according to data
from a phase III trial. Minesh P. Mehta,
MD
, presented the results at the American
Society of Clinical Oncology 42nd
Annual Meeting (abstract 7014).

All patients in the study, known as
SMART (Study of Neurologic Progression
With Motexafin Gadolinium and
Radiation Therapy), had NSCLC with
brain metastases. Patients were randomized
to receive WBRT 30 Gy in 10 fractions
or WBRT plus MGd 5 mg/kg/d for
10 days.

Patients were seen monthly for 8
months, then every 2 months, for standardized
neurologic examination and
treatstandardized
neurocognitive testing using
a battery of validated tests assessing
memory, verbal fluency, and executive
function.

The time to neurologic progression
endpoint measured major decline in neurologic
function, based on prespecified
events such as change in level of consciousness,
aphasia/dysphasia/dysarthria,
hemiparesis, new visual field defects,
ataxia, cranial nerve palsy, and neurocognitive
progression in all domains.

Patients were enrolled from centers in
North America, Europe, and Australia.
Most patients (81%) had multiple brain
metastases; 51% had extracranial metastases,
and 84% presented with neurologic
deficits.

Overall, mean time from brain metastases
diagnosis to randomization for
the MGd arm was 4.3 weeks vs 3.3 weeks
for controls, an imbalance that adversely
affected outcomes in the MGd arm.

Time to Progression
Dr. Mehta reported that median time
to progression (as measured from randomization)
in the intent-to-treat population
of 554 patients was 15.37 months in the MGd group vs 10.03 months in
the WBRT-alone group (HR 0.78,
P = .12). Analyses correcting for the imbalance
in treatment delay between
the two arms (by measuring
from time of brain metastasis
diagnosis) showed that median
time to neurologic progression
was 15.53 months for
those receiving MGd/WBRT
vs 10.2 months for controls (HR
0.75, P = .05).

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