2012 Gastrointestinal Cancers Symposium
SAN FRANCISCO — Researchers identified that certain factors were associated with a greater probability of neuroendocrine tumor progression, according to data presented at the 2012 ASCO Gastrointestinal Cancers Symposium.
Researchers examining the results of a phase 3 study (RADIANT-2) of 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).
“This study adds to [Yao’s] previous work and allows providers further insight to appreciate which patient subset may appreciate further benefit from everolimus therapy,” said Morton S. Kahlenberg, MD, member of the 2012 Gastrointestinal Cancers Symposium News Planning Team. “Considering that care providers are increasingly limited by the small number of successful therapies for neuroendocrine tumors, [this] study is that much more meaningful.”
For more information:
- Yao JC. Abstract # 157. Presented at: ASCO 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.