Abstract 140P
Background
The 1st line treatment of metastatic renal cell carcinoma (mRCC) is either immuno-oncology drug (IO) with IO or IO + vascular endothelial growth factor - tyrosine kinase inhibitors (VEGF-TKIs). At progression, the 2nd line options are lenvatinib + everolimus (L+E) or cabozantinib which is based on older data from 1st line TKI era. The best treatment for patients who progress on 1st line IO combination is not clear. In this study, we report the efficacy and safety of (L+E) in patients with mRCC who progressed on IO + TKI combination.
Methods
This is a retrospective study of mRCC patients, treated at our center from October 2018 to June 2022 who had disease progression after IO + TKI combination. Patients were started on lenvatinib 18 mg and everolimus 5mg per day. As initial patients could not tolerate this dose, after 5 patients, the dose of lenvatinib was reduced to 14mg, with further dose adjustments according to tolerance.
Results
Of the 23 patients in our study; 4 were females and 19 were males. The median age was 54 years. 17 (73.9%) had intermediate risk and 6 (26.1%) had poor risk disease as per IMDC criteria. 11 (47.8%) received L+E as 2nd line, and 12 (52.2%) as 3rd line or beyond. 9 (39.1%) patients had partial response (PR), 9 (39.1%) had stable disease while 5 (21.8%) had progressive disease. Overall response rate was 39.1% and disease control rate was 78.2%. Median progression free survival (PFS) was 10 months while median overall survival (OS) was not reached. The overall survival rate at 1 year was 57.1%. 10 patients completed 1 year and 3 patients completed 2 years of treatment without progression, with the longest follow-up being 41 months. 4 patients showed PR even as 3rd line therapy after progressing on IO combination. Notable grade 3 adverse events were hypertension - 4 (17.4%), mucositis - 3 (13%), diarrhoea - 3 (13%) and hand-foot syndrome - 2 (8.6%) while lesser grades of dysphonia, fatigue and skin rash were seen. Only 2 patients continued on lenvatinib 18 mg, while the rest required dose reduction.
Conclusions
In this real-world experience, L+E showed substantial clinical activity in pre-treated mRCC patients, even after disease progression with IO combination. L+E combination is well tolerated with appropriate dose adjustment of lenvatinib.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
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