{"doi":"10.1016/j.clgc.2021.03.019","title":"Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma","abstract":"INTRODUCTION: Combined axitinib and immuno-oncology (IO) therapy is approved for first-line advanced renal cell carcinoma. Overlapping toxicities represent a clinical challenge. Calculating the time to resolution (TTR) of common axitinib-related adverse events (AEs) after treatment interruption may help to identify AE etiology and determine appropriate management strategies. MATERIALS AND METHODS: Data from 5 randomized or single-arm axitinib monotherapy or combination studies were analyzed. Patients with histologically confirmed clear cell advanced renal cell carcinoma were pooled into 3 cohorts based on treatment received: axitinib monotherapy, axitinib + IO, and other tyrosine kinase inhibitor (TKI). Any grade and grade ≥3 treatment-emergent diarrhea, fatigue, hypertension, nausea, and palmar-plantar erythrodysesthesia syndrome were assessed. TTR was defined as the time from treatment interruption/discontinuation to resolution. RESULTS: The axitinib monotherapy cohort comprised 532 patients, the axitinib + IO cohort 541 patients, and the other TKI cohort 882 patients. Median TTR for all AEs (any grade) in the axitinib monotherapy cohort ranged from 1 to 3 days, except for fatigue (8 days). For diarrhea, hypertension, nausea, and palmar-plantar erythrodysesthesia syndrome, median TTRs were longer in the axitinib + IO (4-11 days) and other TKI (7-8 days) cohorts versus the monotherapy cohort. Results were similar when only AEs of grade ≥3 were considered. CONCLUSIONS: The TTR of monotherapeutic axitinib-related AEs is ≤3 days, except for fatigue, and generally shorter than for other single-agent TKIs and axitinib + IO. This has important implications for identifying AE etiology with combined axitinib-IO therapy and implementation of appropriate management strategies. ClinicalTrials.org identifiers: NCT00678392, NCT00920816, NCT02493751, NCT02684006, NCT02853331.","journal":"Clinical Genitourinary Cancer","year":2021,"id":177236,"datarank":0.8475963002245923,"base_score":3.044522437723423,"endowment":3.044522437723423,"self_citation_contribution":0.4566783656585135,"citation_network_contribution":0.39091793456607876,"self_endowment_contribution":0.4566783656585135,"citer_contribution":0.39091793456607876,"corpus_percentile":null,"corpus_rank":null,"citation_count":20,"citer_count":17,"citers_with_citation_signal":14,"citers_with_endowment":14,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9646,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02493751","NCT02853331","NCT02684006","NCT00920816"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":288144,"name":"Michael B. Atkins","orcid":"0000-0003-3901-9924","position":1,"is_corresponding":false},{"id":16405,"name":"Toni K. Choueiri","orcid":"0000-0002-9201-3217","position":2,"is_corresponding":false},{"id":720882,"name":"Despina Thomaidou","orcid":"0000-0003-3788-4623","position":3,"is_corresponding":false},{"id":721475,"name":"Brad Rosbrook","orcid":null,"position":4,"is_corresponding":false},{"id":721476,"name":"M. Thakur","orcid":null,"position":5,"is_corresponding":false},{"id":720883,"name":"Thomas E. Hutson","orcid":"0000-0002-4529-4212","position":6,"is_corresponding":false},{"id":105189,"name":"Brian I. Rini","orcid":"0000-0002-2212-080X","position":0,"is_corresponding":true}],"reference_count":20,"raw_metadata":null,"created_at":"2026-07-18T23:47:28.018172Z","pmid":"33947608","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}