Patients with advanced renal cell carcinoma (aRCC) who received first-line axitinib plus checkpoint inhibitor therapy who experienced adverse events (AEs) that were managed with axitinib treatment modifications had numerically higher AE resolution/improvement rates and shorter time to resolution/improvement compared with no action, according to research presented at the International Kidney Cancer Symposium (IKCS) 2021.

The investigators conducted a retrospective physician-administered chart review to evaluate AEs and management strategies used in United States clinical practice among adult patients with aRCC who were treated with first-line axitinib plus a checkpoint inhibitor (avelumab or pembrolizumab) and experienced frequently reported axitinib-related AEs: fatigue, diarrhea, nausea, hypertension, or palmar-plantar erythrodysesthesia. Along with patient and AE characteristics, they described AE management strategies, no action vs axitinib modifications (defined as dose reduction and/or treatment interruption).Patient data was abstracted by 201 oncologists (67% community-based; 37% academic-based). Collectively, they included records from 481 patients (67% male; 74% White), with a median age of 63 years. Among the patients, 131 and 350 received axitinib plus avelumab and axitinib plus pembrolizumab, respectively. At chart abstraction, 83% of patients remained on first-line treatment.

Overall, 729 total AEs were documented. Of those, 52%, 33%, and 14% were classified as mild, moderate, and severe AEs, respectively. AE incidence varied by type: 48% fatigue, 38% diarrhea, 29% nausea, 22% hypertension, and 11% palmar-plantar erythrodysesthesia. Median time from treatment initiation to AE onset was 1 month (interquartile range, 0.3-2.0).

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Of all AEs, axitinib modification was used to manage 34% (251/729), while no action was taken for 27% (198/729). Of axitinib modifications for AE management, 60% were dose reductions and 49% were temporary discontinuations.

Regardless of severity,  significantly higher proportions of AEs were reported as resolved/improved when managed with axitinib modification compare with no action (all AEs: 84% vs 60%; P <.001; severe AEs: 81% vs 7%; P <.001).

For AEs with reported dates of resolution/improvement, median time to resolution/improvement from AE onset was shorter when managed with axitinib modification than with no action (all AEs: 18 vs 31 days; severe AEs: 16 vs 53 days).

Limitations of the study included potential unmeasured confounding and biases, inconsistent assessment of AE outcomes in retrospective studies of real-world clinical practice, possible missing data, and potential underreporting of actions to manage AEs.

“Patients whose AEs were managed with axitinib treatment modifications had higher AE resolution/improvement rates and shorter time to resolution/improvement compared to no action,” concluded the investigators. “This real-world study highlights the importance of proactive therapy management strategies to enable optimal axitinib [plus checkpoint inhibitor] treatment.”

Disclosure: This research was supported by Pfizer Inc. Please see the original reference for a full list of authors’ disclosures.


Zakharia Y, Thomaidou D, Chang R, et al. Adverse events (AE) management among advanced renal cell carcinoma (aRCC) patients receiving first-line (1L) axitinib + checkpoint inhibitor (CPI) therapy. Presented at IKCS 2021; November 5-6, 2021. Abstract N21.