The real world of avelumab/axitinib discontinuation in advanced renal cell carcinoma

First-line avelumab (Bavencio) combined with TKI inhibitorsAxitinib/axitinib (Axitinib) in the treatment of advanced renal cell carcinoma (RCC) Factors for discontinuation in patients. Results from the prospective, non-interventional AVION study (NCT04941768) evaluated patients (n=104) with advanced renal cell carcinoma receiving first-line avelumab plus axitinib in Belgium, Germany, Greece and Russia. Patients participating in the study had received 1 or 2 doses of first-line avelumab/axitinib and received further treatment during the study period.

Among the entire patient population,83.7% of patients experienced adverse reactions (AEs) of any grade; 34.6% of adverse events reached or exceeded grade 3; and 36.5% of patients experienced serious adverse events. Treatment-related adverse events (TRAEs) of any grade occurred in 67.3% of patients, and 20.2% of patients experienced grade 3 or higher TRAEs. The most common types of TRAEs of any grade included diarrhea (26.0%), fatigue (13.5%), hypertension (10.6%), hypothyroidism (8.7%), dysphonia (8.7 %), nausea (7.7%), palmoplantar dysesthesia syndrome (7.7%), pruritus (6.7%), weight loss (5.8%), dyspnea (3.8%) and hypertensive crisis (2.9%).

Factors that may influence treatment discontinuation depend on the type of toxicity the patient exhibits. He noted that diarrhea has been primarily associated with the TKI axitinib; however, dose reduction may be helpful. Due to the short half-life of axitinib, the dose can be easily reduced to mitigate toxicity. When patients experienced adverse events that did not improve, axitinib was first discontinued after 3 or 4 days, and if there was no improvement, avelumab was discontinued shortly thereafter.

Of note,Adverse events leading to discontinuation of avelumab/axitinib occurred in 5.8% of patients. Specifically, the reporting rate of adverse events leading to discontinuation of avelumab was 9.6% and the reporting rate of discontinuation of axitinib was 14.4%. Adverse reactions leading to discontinuation of avelumab and axitinib were observed in 6.7% and 9.6% of patients, respectively.

References:https://www.onclive.com/view/dr-merseburger-on-real-world-avelumab-axitinib-discontinuations-in-advanced-rcc