Certain factors were associated with a greater
probability of neuroendocrine tumor progression, according to an evaluation of
Phase 3 study results.
Researchers examining the results of the RADIANT-2
study, which enrolled patients with advanced neuroendocrine tumors, observed
that elevated levels of the blood biomarker chromogranin A can predict which
patients are at-risk for neuroendocrine tumor progression and more likely to
require therapy.
Researchers also found that a combination of the drug
everolimus (Afinitor, Novartis) with octreotide acetate arrested neuroendocrine
tumor development longer vs. octreotide treatment alone.
“We have identified important prognostic factors
that can help physicians to better determine the optimal treatment for patients
with neuroendocrine tumors, which can have a widely variable course of
progression,” study researcher James Yao, MD, assistant professor
and deputy chair of gastrointestinal oncology at The University of Texas MD
Anderson Cancer Center, said in a press release. “The findings will also
improve our ability to stratify patients in future randomized trials on
neuroendocrine tumors.”
In the re-analysis of the RADIANT-2 study, researchers
examined the patient randomization between the everolimus plus octreotide
(n=216) and the octreotide plus placebo (n=213) arms of the study and found a
significant imbalance in the baseline chromogranin A biomarker (251 everolimus
group vs. 137 placebo group). Median PFS was significantly extended for
patients with nonelevated chromogranin A (27 months vs. 11 months;
P<.001) and nonelevated 5-hydroxyindoleacetic acid (17 months vs. 11
months; P<.001).
Additional analysis outlined that predictive factors for
PFS included baseline chromogranin A (HR=0.47; CI, 0.34-0.65), WHO performance
status (HR=0.69; CI, 0.52-0.90), bone involvement (HR=1.52; CI, 1.06-2.18), and
lung as primary site (HR=1.55; CI, 1.01-2.36). When adjusted for covariates, a
38% reduction in risk of progression was observed for patients receiving
everolimus plus octreotide (HR=0.62; 95% CI, 0.51-0.87).
For more information:
- Yao JC. Abstract # 157. Presented at: 2012 Gastrointestinal Cancers
Symposium; Jan. 19-21, 2012; San Francisco.
Disclosure: Researchers report receiving
consulting and advisory financial support from Endo, Genentech, Ipsen, Novartis
and Pfizer.