Increased Progression-Free Survival with Cabozantinib Versus Placebo in Patients with Radioiodine-Refractory Differentiated Thyroid Cancer Irrespective of Prior Vascular Endothelial Growth Factor Receptor-Targeted Therapy and Tumor Histology: A Subgroup Analysis of the COSMIC-311 Study
Authors' conclusion
Results indicate that cabozantinib benefits patients with RAIR DTC, regardless of prior lenvatinib or sorafenib treatments or histology.
Study context
- Population
- Patients with radioiodine-refractory (RAIR) differentiated thyroid cancer (DTC) who received 1–2 prior VEGFR-targeting tyrosine kinase inhibitors (lenvatinib or sorafenib required), refractory to or ineligible for radioiodine therapyrandomized 2:1
- Participants
- 258 patients
- Comparison
- Cabozantinib vs placebo
- Cabozantinibn = 170
- Placebon = 88reference
- Primary endpoint
- Progression-free survival (PFS) and ORR per RECIST v1.1 by blinded independent radiology committee, by prior therapy and histology
Methodological detailsphase 3, randomized 2:1, placebo-controlled, stratified by prior lenvatinib and age, blinded independent radiology committee
- Phase 3
- Randomized 2:1
- Placebo-controlled
- Stratified by prior lenvatinib and age
- Blinded independent radiology committee
Primary result
As reported in the abstract
median follow-up 10.1 months
Cabozantinib vs PlaceboEstimate (95% CI)
Median PFS 16.6vs 3.2 months; n = 96
HR (sorafenib only) 0.13(0.06–0.26)
Median PFS 5.8vs 1.9 months; n = 102
HR (lenvatinib only) 0.28(0.16–0.48)
Median PFS 7.6vs 1.9 months; n = 60
HR (both) 0.27(0.13–0.54)
Median PFS 9.2vs 1.9 months; n = 150
HR (papillary) 0.27(0.17–0.43)
Median PFS 11.2vs 2.5 months; n = 113
HR (follicular) 0.18(0.10–0.31)
Median PFS 11.2vs 2.5 months; n = 43
HR (oncocytic) 0.06(0.02–0.21)
Median PFS 7.4vs 1.8 months; n = 36
HR (poorly differentiated) 0.18(0.08–0.43)
- Objective response rate (ORR) cabozantinib vs placebo, sorafenib only
- 21% vs 0%
- ORR cabozantinib vs placebo, lenvatinib only
- 4% vs 0%
- ORR cabozantinib vs placebo, both
- 8% vs 0%
- ORR cabozantinib vs placebo, papillary
- 15% vs 0%
- ORR cabozantinib vs placebo, follicular
- 8% vs 0%
- ORR cabozantinib vs placebo, oncocytic
- 11% vs 0%
- ORR cabozantinib vs placebo, poorly differentiated
- 9% vs 0%
Safety
- Safety outcomes consistent with those previously observed for the overall population
Original publication
Increased Progression-Free Survival with Cabozantinib Versus Placebo in Patients with Radioiodine-Refractory Differentiated Thyroid Cancer Irrespective of Prior Vascular Endothelial Growth Factor Receptor-Targeted Therapy and Tumor Histology: A Subgroup Analysis of the COSMIC-311 Study. Thyroid. Published 7 December 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →