Efficacy
First-line setting
Median PFS with cabozantinib was 8.2 months (95% CI, 6.2 to 8.8) versus 5.6 months (95% CI, 3.4 to 8.1) with sunitinib.
Kaplan-Meier curve for PFSr
© J Clin Oncol 2017
The ORR with cabozantinib was 33% (95% CI, 23 to 44%) compared with sunitinib 12% (95% CI, 5.4 to 21%).r An updated analysis at a median follow up of 35.4 months found OS was 26.6 months (95% CI, 14.6 to not estimable) and 21.2 months (95% CI 16.3 to 27.4) respectively (difference not statistically significant, HR 0.80, 95% CI, 0.53 to 1.21).r
Kaplan-Meier curve for OSr
© Eur J Cancer 2018
A subgroup analysis at a median follow up of 25 months demonstrated improved PFS and ORR benefits for cabozantinib compared with sunitinib across all subgroups, including IMDC risk group, bone metastases, age, and tumour burden.r
A post hoc analysis evaluating Quality-adjusted Time Without Symptoms of disease or Toxicity of treatment (Q-TWiST) found that cabozantinib was associated with longer quality-adjusted survival compared with everolimus.r
Second-line setting
PFS was significantly prolonged with cabozantinib compared with everolimus (median 7.4 versus 3.8 months). Rate of disease progression or death was 42% lower for cabozantinib versus everolimus (HR 0.58, 95% CI, 0.45 to 0.75; p<0.0001).r
Kaplan-Meier curve for PFSr
© N Engl J Med 2015
The ORR was significantly higher with cabozantinib than with everolimus (21% versus 5%, p<0.001).r
An updated analysis at a median follow-up of 18 months found OS was significantly prolonged with cabozantinib compared with everolimus (median survival 21.4 months versus 16.5 months, HR 0.66; 95% CI, 0.53 to 0.83; p=0.00026).r
© Lancet 2016
A subgroup analysis demonstrated improved PFS, OS and ORR for cabozantinib compared with everolimus in patients with bone metastases.r
Quality of life was similar for patients allocated to cabozantinib or everolimus, except diarrhoea and nausea were worse for cabozantinib, and shortness of breath was worse for everolimus. The median duration of treatment was 7.6 months among patients who received cabozantinib, and 4.4 months among patients who received everolimus.r The median time to deterioration (TTD) was 5.5 months for cabozantinib compared with 3.7 months for everolimus (p<0.001), while the median TTD for patients with bone metastases was 5.6 months versus 1.9 months respectively (p<0.001).r