228P - Real-world data on dose adjustment of cabozantinib in advanced renal cell carcinoma

Background

Cabozantinib, a novel TKI is an oral multitargeted inhibitor of VEGFR, MET and AXL kinases. The CABOSUN trial established the superiority of cabozantinib over sunitinib in newly diagnosed renal cell carcinoma (RCC) of intermediate or poor risk. Currently it is used as a single agent (intermediate risk) or in combination with nivolumab (intermediate and poor risk). However, data is lacking with respect to the real-world use patterns of cabozantinib.

Methods

In this study, we explored the use of single agent cabozantinib in advanced RCC in terms of dosing, effectiveness, tolerability, and toxicity profiles. This was a single center retrospective observational study from All India Institute of Medical Sciences, New Delhi, India. Data was collected retrospectively from prospectively maintained database. All eligible patients were aged 18 years or older, had measurable lesions, available case records, received at least 2 months of the drug and were evaluable for response.

Results

In total, 70 patients were identified with a median age of 53 years (interquartile, 47-65 years). Majority were males (81.4%). The different histologies were (clear cell 77.1%, papillary 11.4%, and translocation related 5.7%). 54.3% had prior nephrectomy. Majority had an IMDC score as intermediate (61.4%), followed by favorable (22.9%). Most common site of metastases was lung (60%) followed by bone (32.9%). Cabozantinib was started as the first line TKI in 60% (42/70), as 2^nd line in 74.2% (23/31). Starting dose was 60mg in 27%, and 40mg in 73%. Dose reductions of cabozantinib were seen in 40.7% in 1^st line, and 58.2% in 2^nd line. Re escalation was done in 24.2%. Most common reason for dose reduction was diarrhea (64.7%). 35.7% had a partial response and 2.9% had a CR. ORR for overall population was 39.1%. Overall median PFS was 7.2 months. Most common adverse events were diarrhea in 42.7%, Hand-Foot skin reaction in 27.6%, mucositis in 17.8% and hepatotoxicity in 5.1%.

Conclusions

This study showed the practical dosing strategies and modifications of cabozantinib in the real world setting and how it differed from actual literature. We hope this study would help oncologists make better informed decisions while prescribing cabozantinib in advanced RCC.

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.