Melissa A Prah1, Jennifer M Connelly2, Scott D Rand1, and Kathleen M Schmainda1,3
1Radiology, Medical College of Wisconsin, Milwaukee, WI, United States, 2Neurology, Medical College of Wisconsin, Milwaukee, WI, United States, 3Biophysics, Medical College of Wisconsin, Milwaukee, WI, United States
Synopsis
Imaging response, in patients with recurrent glioblastoma (rGBM)
who are treated with bevacizumab (which decreases vascular permeability), is often
difficult to assess since decreased contrast agent uptake might falsely
underestimate lesion size or biologic activity. Alternatively, relative
cerebral blood volume (rCBV) has shown promise to identify true responders. Fractional
tumor burden (FTB) maps, which are derived from rCBV, allow spatially
quantifiable characterization of rGBM within lesion enhancement, and therefore
may provide additional value to post-treatment response-assessment. This work
demonstrates that patients with less than 75% FTB following treatment with
bevacizumab have a clear progression-free and overall survival benefit.
Purpose
Bevacizumab (BEV), an FDA-approved treatment for recurrent
glioblastoma (rGBM), is an anti-angiogenic agent that targets tumor blood
vessels. With BEV treatment vascular permeability decreases, which can also
result in decreased contrast agent uptake. This can give the potentially false impression
that lesion size or biologic activity have been reduced.1 This pseudo-response phenomenon
confounds the assessment of true treatment response.1 The search for an imaging biomarker to accurately predict
response to BEV has included the assessment of lesion volume (LV) and relative
cerebral blood volume (rCBV). An improved overall survival (OS) and
progression-free survival (PFS), at 6 months post-BEV, was reported for lesion
volume (LV) < 7.5cc.2 Relative cerebral blood
volume (rCBV) has also shown promise for predicting response to BEV.3,4 We extend and compare this promise to the
creation of fractional tumor burden (FTB) maps, which provide a measure of the
percent of enhancing LV that is tumor.
FTB is determined by applying a previously-identified rCBV threshold to
distinguish tumor from treatment effect.5,6 The potential of FTB to
predict post-BEV response, based on OS and PFS of patients with rGBM, is examined
and compared to previously determined LV levels.Methods
Written, informed consent was obtained from all participants
for this HIPAA-compliant, IRB-approved study. Participants were retrospectively
identified (from 2007-2011) and included those that received BEV for their rGBM,
underwent dynamic susceptibility contrast GRE-EPI (DSC: TE/TR=30ms/1.1sec,
0.05-0.1mmol/kg preload, 0.05-0.1mmol/kg dose during data collection) in
addition to FLAIR (TE/TR=151ms/10sec), and pre- and post-contrast T1w imaging (T1/T1+C;
TE/TR=20ms/450ms). All imaging was performed 20-60 days following BEV
initiation. Imaging data was excluded if the enhancing lesion was <1cc. Standardized7 and leakage-corrected8 rCBV maps (sRCBV) were created from DSC using IB Neuro™ (Imaging Biometrics,
Elm Grove, WI). T1, T1+C, and sRCBV were rigidly co-registered with FLAIR.9 LV was determined using
the delta T1 method where, after standardization, T1 images are subtracted from
T1+C images.10 Within the enhancing LV,
FTB maps were created using the previously-identified sRCBV threshold of 3575.6 OS and PFS survival
were calculated from the date of BEV initiation. PFS was determined based on
progression of FLAIR and T1+C as determined by an experienced neuroradiologist using
all available follow-up exams. If no progression was observed, date of death
was used if death occurred within 2 months of last non-progressive MRI. PFS and
OS were compared using the Kaplan-Meier method and stratified for FTB by an
empirically chosen threshold of 75% and for LV using the published threshold of
7.5cc.2 Clinically documented
Karnofsky Performance Status (KPS) scores at the time of BEV initiation were
compared for both FTB and LV stratification using Mann-Whitney t-test. Significance
was set at P<0.05 and statistical analyses were performed using Prism
(GraphPad Software, La Jolla, CA). Results
A total of 24 participants met the inclusion criteria. Previous treatment included biopsy or
resection, followed by irradiation with or without chemotherapy. Average age of
the 13 male and 11 female participants was 51 (range=30-68) years. MRI was
acquired an average of 36 (range=20-56) days following BEV initiation. Example
parameter maps are displayed in Figure 1. All participants
had expired at the time of analysis and all but 1, who was lost to follow-up
and therefore censored, had a progressive event. Average KPS was 68
(range=40-90) at the time BEV was initiated. In Figure
2, KPS was not significantly different between the low and high LV (P=0.5169)
or FTB (P=0.8985) groups. Survival results are shown in Figures 3 and 4. FTB less than 75% could statistically distinguish long
from short survivors for both PFS (161 vs. 55 days; P=0.0006) and OS (326 vs.
129 days; P=0.0002). LV less than 7.5cc was not predictive of either PFS
(P=0.2813) or OS (P=0.4159). Unexpectedly, although not significant, those with
higher LV tended to have longer survival. This may suggest that those with
smaller LV were more prone to pseudo-response in this study, providing further
evidence for the potential value of FTB. Discussion and Conclusion
These results demonstrate that there is a potential role for
FTB to characterize response to BEV in patients with rGBM. Patients with an FTB
of less than 75% survived longer and progressed later, whereas a LV less than
7.5cc did not indicate any survival benefit. Interestingly, the two patients
with the longest PFS (553 days) and OS (775 days) were among those with the
lowest FTB at 29% and 22%, respectively. FTB may provide clinicians a spatially
quantifiable means to more timely and accurate assessment of BEV response.Acknowledgements
NIH/NCI R01 CA082500, NIH/NCI U01 176110, Advancing a
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