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Thomas Flaig, MD
Thomas Flaig, MD
Posted: Thursday, May 5, 2022
Although adding the oral tyrosine kinase inhibitor nintedanib to neoadjuvant gemcitabine and cisplatin in patients with muscle-invasive bladder was safe and improved overall survival at a median follow-up of 33.5 months, it neither improved the primary outcome of pathologic complete response nor the secondary endpoint of progression-free survival. Syed A Hussain, MD, of the University of Sheffield, United Kingdom, and colleagues published these results from the phase II NEOBLADE trial in The Lancet Oncology.
“We are particularly eager to explore the potential impact of adding this targeted cancer drug to the standard care of chemotherapy on those patients with alteration in specific biomarkers…. This is where the treatment has the biggest potential, as there is some evidence to suggest that by blocking these specific biomarkers, nintedanib may improve clinical outcome,” said Dr. Hussain in an institutional press release.
From December 2014 to September 2018, this double-blind trial enrolled 120 patients with locally advanced muscle-invasive bladder cancer. Patients were randomly assigned 1:1 to receive either oral nintedanib or placebo in addition to the typical neoadjuvant chemotherapy of intravenous gemcitabine and cisplatin.
After the median follow-up of 33.5 months, a pathologic complete response was seen in 37% of patients in the nintedanib group and in 32% of patients in the placebo group (odds ratio = 1.25, P = .28). Post hoc analysis revealed a median overall survival of 50.6 months in the placebo group, whereas this metric was not yet reached in the nintedanib group (hazard ratio = 0.45, P = .038).
Grade 3 or higher adverse events occurred in 93% of patients in the nintedanib arm and in 79% of those in the placebo arm. The most common grade 3 or higher toxicities were thromboembolic events and decreased neutrophil count. One patient in the placebo group died of a myocardial infarction, which was deemed to be related to treatment.
Disclosure: For a full list of authors’ disclosures, visit thelancet.com.
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