Cabozantinib did not extend survival in patients with metastatic urothelial carcinoma
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CHICAGO —Cabozantinib did not significantly extend progression-free survival in patients with metastatic urothelial carcinoma who had undergone platinum-based chemotherapy, according to data presented at ASCO Annual Meeting.
“Cabozantinib is a multitargeted tyrosine kinase inhibitor of vascular endothelial growth factor receptor, AXL, MET and RET, among others, which has previously shown clinical activity in platinum-pretreated progressive urothelial cancer,” Robert J. Jones, MBChB, PhD, professor of clinical cancer research at University of Glasgow in Glasgow, U.K., said in the presentation. “We, therefore, investigated cabozantinib in patients unsuitable for inclusion in the precision medicine arms of a maintenance therapy platform trial in advanced urothelial cancer.”
In the randomized, double-blind, phase 2 clinical trial, Jones and colleagues included 61 patients with metastatic urothelial carcinoma who had completed four to eight cycles of platinum-based chemotherapy without disease progression. Participants were assigned to begin either 40 mg cabozantinib daily or matching placebo within 10 weeks of completing chemotherapy until progression. PFS served as the primary outcome measure, with OS as the secondary outcome measure.
The researchers found median PFS of 13.7 weeks (80% CI, 12.1- 23.3) with cabozantinib and 15.8 weeks (80% CI, 11.3-23.6) with placebo (adjusted HR, 0.89; 80% CI, 0.61-1.3; P = 0.35). No significant difference was found in OS, with the median OS being 75.5 weeks for cabozantinib and 82.9 weeks for placebo (HR, 0.8; P =0.25).
“Notably, 43% of patients receiving cabozantinib had to reduce the dose from 40 to 20 mg, although there were no treatment discontinuations due to toxicity,” Jones noted in the presentation.
Jones reported treatment-related adverse events as being mostly low-grade, with the most frequent events being more common with cabozantinib vs. placebo — fatigue (56.7% vs. 32.2%; P = 0.02), hypertension (43.3% vs. 12.9%; P < 0.01), nausea (30% vs. 19.4%; P = 0.37) and diarrhea (40% vs. 6.5%, P < 0.01).
“In conclusion, though underpowered, this study does not support further investigation of cabozantinib alone as a maintenance therapy after platinum-based chemotherapy in unselected patients with advanced urothelial cancer,” Jones said.
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Jones RJ, et al. Abstract LBA4505. Presented at: ASCO Annual Meeting, June 3-7, 2022, Chicago.
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