Real-world data (RWD) confirm Novartis' anticancer drug Votrient ) is safe and effective in patients with metastatic renal cell carcinoma (RCC)
.
Votrient is a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) that works by inhibiting the formation of new blood vessels that supply blood to tumors
.
The drug was approved for marketing in the United States and the European Union in October 2009 and June 2010, respectively
.
Votrient was originally a product of GlaxoSmithKline (GSK), but in 2014 it was packaged and sold in an asset swap transaction between GSK and Novartis
.
Votrient has been shown to be a potent first-line treatment for renal cell carcinoma (RCC) and is currently approved in several countries around the world
.
In China, Votrient was approved in 2017 for the first-line treatment of patients with advanced RCC, as well as for the treatment of patients with advanced RCC cancer who have received cytokine therapy
.
To further evaluate the efficacy and safety of Votrient in real-world clinical practice, we conducted a non-interventional multicenter study (APOLON) in patients receiving first-line Votrient therapy, evaluating progression-free survival (PFS), overall Survival (OS), investigator-assessed objective response rate (ORR), and tolerability
.
In addition, the impact of COVID-19 on patient care was also assessed
.
Eligible mRCC patients (N=217) were included for evaluation, with a median age of 69.
6 years
.
Patients were stratified according to the IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) risk score; 27.
1% were IMDC low risk, 52.
1% intermediate risk, and 20.
8% high risk
.
The proportions of patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) scores of 0, 1, and ≥2 were 43.
3%, 39%, and 17.
6%, respectively
.
Metastases mainly occurred in the lungs (64.
1%), bones (28.
6%), mediastinum (18%), and abdomen (17.
1%)
.
Median PFS was 10.
5 months (95% CI: 9-12.
4) for patients treated with Votrient, according to interim study results (30 months after enrollment): among them, median PFS was 11.
3 months for patients under 65 years of age (95%CI: 7-16.
3), the median PFS in patients 65 years and older was 9.
9 months (95%CI: 8.
9-12)
.
The median PFS was 18.
1 months (95%CI: 9.
9-23.
3), 11.
5 months (95%CI: 8.
7-14.
4), 6.
2 months in mRCC low, intermediate, and high risk patients, respectively, as assessed by the IMDC risk score month (95%CI: 3.
5-9.
5)
.
The results also showed that the median OS of mRCC patients treated with Votrient was 27.
3 months (95%CI: 24.
3-ND)
.
The investigator-assessed ORR was 48.
3%, with 6 patients achieving a complete response (CR, 3.
5%) and 77 patients achieving a partial response (PR, 44.
8%)
.
During the study, no new security incidents for Votrient were identified
.
Dose reductions and discontinuations due to adverse events occurred in 42% and 40.
9% of patients, respectively
.
Treatment-related serious adverse events were reported in 22.
2% of patients
.
When assessing the impact of COVID-19, the pandemic was found to have limited impact on patient care
.
Patient visits and teleconsultations were used for tumor assessment and follow-up
.
During the pandemic, only 5.
7% of patients did not seek medical care
.
Based on the above results, the researchers concluded that Votrient is safe and effective in mRCC patients in a real-world setting
.
In addition, the efficacy of Votrient in patients 65 years and older remained significant and was highly correlated with risk scores
.
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