Academic Journal
Characterization and Management of Adverse Reactions From the CLEAR Study in Advanced Renal Cell Carcinoma Treated With Lenvatinib Plus Pembrolizumab.
| Τίτλος: | Characterization and Management of Adverse Reactions From the CLEAR Study in Advanced Renal Cell Carcinoma Treated With Lenvatinib Plus Pembrolizumab. |
|---|---|
| Συγγραφείς: | Motzer R; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., George S; Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA., Merchan JR; Department of Medicine, University of Miami Sylvester Comprehensive Cancer Center, Miami, FL, USA., Hutson TE; Department of Medical Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA., Song X; Clinical Research, Merck & Co., Inc., Rahway, NJ, USA., Perini RF; Clinical Research, Merck & Co., Inc., Rahway, NJ, USA., Xie R; Biostatistics, Eisai Inc., Nutley, NJ, USA., Bapat U; Clinical Research, Eisai Inc., Nutley, NJ, USA., Puente J; Department of Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid, Spain. |
| Πηγή: | The oncologist [Oncologist] 2023 Jun 02; Vol. 28 (6), pp. 501-509. |
| Τύπος έκδοσης: | Journal Article; Research Support, Non-U.S. Gov't |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Oxford University Press Country of Publication: England NLM ID: 9607837 Publication Model: Print Cited Medium: Internet ISSN: 1549-490X (Electronic) Linking ISSN: 10837159 NLM ISO Abbreviation: Oncologist Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2022- : Oxford : Oxford University Press Original Publication: Dayton, Ohio : AlphaMed Press, c1996- |
| Ιατρικοί όροι (MeSH): | Carcinoma, Renal Cell*/pathology , Kidney Neoplasms*/pathology , Hypertension*/chemically induced , Hypertension*/drug therapy, Phenylurea Compounds/adverse effects ; Fatigue/chemically induced ; Diarrhea/chemically induced ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Humans ; Antibodies, Monoclonal, Humanized ; Quinolines |
| Περίληψη: | Background: Lenvatinib plus pembrolizumab showed significantly improved progression-free and overall survival outcomes compared with sunitinib in patients with advanced renal cell carcinoma in the CLEAR study (NCT02811861). Here, we used CLEAR data to characterize common adverse reactions (ARs; adverse-event preferred terms grouped in accordance with regulatory authority review) associated with lenvatinib plus pembrolizumab and review management strategies for select ARs. Materials and Methods: Safety data from the 352 patients who received lenvatinib plus pembrolizumab in the CLEAR study were analyzed. Key ARs were chosen based on frequency of occurrence (≥30%). Time to first onset and management strategies for key ARs were detailed. Results: The most frequent ARs were fatigue (63.1%), diarrhea (61.9%), musculoskeletal pain (58.0%), hypothyroidism (56.8%), and hypertension (56.3%); grade ≥3 severity ARs that occurred in ≥5% of patients were hypertension (28.7%), diarrhea (9.9%), fatigue (9.4%), weight decreased (8.0%), and proteinuria (7.7%). Median times to first onset of all key ARs were within approximately 5 months (approximately 20 weeks) of starting treatment. Strategies for effectively managing ARs included baseline monitoring, drug-dose modifications, and/or concomitant medications. Conclusion: The safety profile of lenvatinib plus pembrolizumab was consistent with the known profile of each monotherapy; ARs were considered manageable with strategies including monitoring, dose modifications, and supportive medications. Proactive and prompt identification and management of ARs are important for patient safety and to support continued treatment. Clinicaltrials.gov Id: NCT02811861. (© The Author(s) 2023. Published by Oxford University Press.) |
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| Grant Information: | P30 CA008748 United States CA NCI NIH HHS |
| Contributed Indexing: | Keywords: adverse reactions; lenvatinib; management of adverse reactions; pembrolizumab; renal cell carcinoma |
| Molecular Sequence: | ClinicalTrials.gov NCT02811861 |
| Substance Nomenclature: | 0 (Phenylurea Compounds) DPT0O3T46P (pembrolizumab) 0 (Antibodies, Monoclonal, Humanized) EE083865G2 (lenvatinib) 0 (Quinolines) |
| Entry Date(s): | Date Created: 20230303 Date Completed: 20230608 Latest Revision: 20260127 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC10243770 |
| DOI: | 10.1093/oncolo/oyac269 |
| PMID: | 36866412 |
| Βάση Δεδομένων: | MEDLINE |
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