ESMO 2016: Nintedanib Improves Progression-Free Survival but Not Overall Survival in Metastatic Colorectal Cancer
Nintedanib (Ofev) improves progression-free survival but not overall survival in patients with metastatic colorectal cancer who are not responding to standard therapies, according to the results of the phase III LUME-colon 1 trial presented by Van Cutsem et al at the 2016 European Society of Medical Oncology (ESMO) Congress in Copenhagen (Abstract LBA20_PR).
“Colorectal cancer is a frequent disease, and a large proportion of patients have metastases,” said lead author Eric Van Cutsem, MD, PhD, Head of Clinical Digestive Oncology at University Hospitals Leuven, Belgium. “Many patients progress to several different lines of treatment and then stop responding. There is a need to find new therapies for this big group of patients.”
LUME-Colon 1
Nintedanib is a multiple tyrosine kinase inhibitor with antiangiogenic activity. LUME-colon 1 was the first phase III trial of nintedanib in patients with metastatic colorectal cancer refractory to all available treatments including chemotherapy and biologic therapies. Patients had to be in good general condition (defined as performance status 0 and 1) and have good organ function.
The trial included 768 patients who were randomized 1:1 to nintedanib or placebo. All patients received best supportive care. The co–primary endpoints were progression-free survival and overall survival.
Nintedanib improved median progression-free survival compared to placebo (1.5 vs 1.4 months, hazard ratio = 0.58, 95% confidence interval [CI] = 0.49–0.69, P < .0001). There was no difference in overall survival between the two groups.
Disease control was improved with nintedanib compared to placebo (26% vs 11%, odds ratio = 2.96, 95% CI = 2.00–4.4, P < .0001).
Serious adverse events occurred in 39% of patients taking nintedanib and 35% on placebo. Some 14% of patients in the nintedanib group discontinued treatment due to adverse events, compared to 11% in the placebo group.
Dr. Van Cutsem said, “Nintedanib was well-tolerated and gave a significant increase in progression-free survival … but patients receiving nintedanib did not live longer, which was disappointing.”
Findings Interpreted
“The reason why patients on placebo survived longer than expected is not completely clear, but treatments taken after the trial that stopped their tumor from growing may have contributed to this finding,” continued Dr. Van Cutsem. “After the trial finished, patients were followed until death, and these subsequent treatments may have diluted the effect of nintedanib, leading to a loss in potential survival benefit.”
He concluded, “We are conducting additional analyses in molecular markers and subtypes of colorectal cancer to see if there is a group of patients who benefit from nintedanib after other therapies have failed.”
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