241P - First-line cabozantinib in metastatic renal cell carcinoma (mRCC): A real-world exploratory study from eastern India

Background

Cabozantinib is approved in first-line metastatic renal cell carcinoma (mRCC), as a single agent and in combination with nivolumab. In real-world setting, only a miniscule proportion of Indian patients with mRCC manage to afford nivolumab, and majority of the patients end up receiving first-line cabozantinib monotherapy. Unfortunately, even though cabozantinib has been approved for long time, there is no published data from India regarding the experience of first-line cabozantinib in mRCC.

Methods

From February 2022 to August 2023, consecutive patients of mRCC who were treated with first-line cabozantinib monotherapy, were prospectively followed. Response rates, survival outcomes and toxicity were analyzed for patients who received at least 3 months of cabozantinib. The adverse events were classified based on the CTCAE v 4.0.

Results

Of the 21 mRCC patients, 18 (86%) were males. Median age at diagnosis was 56 years (range: 35-72); and 20 (95%) patients had clear cell histology. Most common site of metastasis was lungs (n=14) followed by bone (n=12), non-regional lymph nodes (n=6) and liver (n=3). Two patients had favorable risk disease, whereas 15 had intermediate risk and 4 had poor risk disease according to IMDC risk criteria. Dose reductions due to toxicity were required in 8 (38%) patients. At initial evaluation (3 months after treatment initiation), 20 patients had disease control (partial response in 3 and stable disease in 17 patients), while one had progression of disease. At a median follow-up of 11.5 months (range: 3–19); median progression free survival was not reached (total number of progression events = 5) and all patients were surviving. Toxicities of cabozantinib were grade 1 or 2 in 12 patients and grade 3 or 4 in 7 patients. The most frequent grade 3-4 adverse events were diarrhea (n=3, 14.3%), hypertension (n=3, 14.3%), palmar-plantar erythrodysesthesia syndrome (n=2, 9.5%), stomatitis (n=1, 4.8%), and hepatic transaminitis (n=1, 4.8%).

Conclusions

Cabozantinib is a viable first-line option for Indian patients with mRCC. Keeping in mind the toxicity profile and need for dose reduction; starting with 40 mg daily dose and careful tailoring as per tolerance, seems to be practically more feasible in our setting.

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.