Dr Merseburger on Real-World Avelumab/Axitinib Discontinuations in Advanced RCC

“[Treatment discontinuation] depends on what toxicity was displayed. We know some toxicities comes from the avelumab, and some were from [axitinib].”

Axel Merseburger, MD, PhD, professor of Urology and chairman of the Department of Urology at University Hospital, Schleswig-Holstein, Campus Lübeck, discusses factors that may influence the treatment discontinuation of first-line avelumab (Bavencio) plus TKI axitinib (Inlyta) in real-world patients with advanced renal cell carcinoma (RCC).

Findings from the prospective noninterventional AVION study (NCT04941768) evaluated real-world patients (n = 104) with advanced RCC treated with first-line avelumab plus axitinib in Belgium, Germany, Greece, and Russia. Patients enrolled on the study already received 1 or 2 doses of first-line avelumab/axitinib and further received treatment during the study.

In the overall patient population, 83.7% experienced adverse effects (AEs) of any grade; 34.6% had AEs of grade 3 or greater; and serious AEs were observed in 36.5% of patients. Treatment-related AEs (TRAEs) of any grade occurred in 67.3% of patients, and 20.2% had grade 3 or greater TRAEs. The most common type of any-grade TRAEs included diarrhea (26.0%), fatigue (13.5%), hypertension (10.6%), hypothyroidism (8.7%), dysphonia (8.7%), nausea (7.7%), palmar-plantar erythrodysesthesia syndrome (7.7%), pruritus (6.7%), decreased weight (5.8%), dyspnea (3.8%), and hypertensive crisis (2.9%).

Factors that may influence treatment discontinuation depend on the type of toxicity patients display, Merseburger began. He noted that diarrhea was mainly associated with the TKI axitinib; however, reducing the dose may be helpful. Because of axitinib’s short half-life, he explained that it’s easy to reduce the dose to mitigate toxicity. When patients experience AEs that do not improve, Merseburger emphasized that axitinib is stopped first after 3 or 4 days, and avelumab is stopped shortly after if no improvements are shown.

Of note, AEs leading to discontinuation of avelumab/axitinib occurred in 5.8% of patients. Specifically, AEs leading to discontinuation of avelumab were reported in 9.6%, and discontinuations of axitinib were reported in 14.4%. TRAEs leading to discontinuation of avelumab and axitinib were observed in 6.7% and 9.6% of patients, respectively.