دورية أكاديمية
Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab.
| العنوان: | Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab. |
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| المؤلفون: | Colombo N; Gynecologic Oncology Department, European Institute of Oncology IRCCS, Milan, Italy.; Department of Medicine and Surgery, University of Milan-Bicocca, Italy., Lorusso D; Division of Gynecologic Oncology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy., Monk BJ; HonorHealth Research Institute, University of Arizona, Creighton University, Phoenix, AZ, USA., Slomovitz B; Division of Gynecologic Oncology, Mount Sinai Medical Center, Miami Beach, FL, USA., Hasegawa K; Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan., Nogueira-Rodrigues A; Universidade Federal de Minas Gerais (UFMG), Brazilian Group of Gynecologic Oncology (EVA), Grupo Oncoclínicas, DOM Oncologia, Brazil., Zale M; Clinical Safety & Risk Management Late-Stage Oncology - Gynecologic Cancers, Merck & Co., Inc., Rahway, NJ, USA., Okpara CE; Clinical Research, Eisai Ltd., Hatfield, UK., Barresi G; Merck & Co., Inc., Switzerland., McKenzie J; Oncology Business Group, Eisai Inc., Nutley, NJ, USA., Makker V; Department of Medicine, Memorial Sloan Kettering Cancer Center; Weill Cornell Medical Center, New York, NY, USA. |
| المصدر: | The oncologist [Oncologist] 2024 Jan 05; Vol. 29 (1), pp. 25-35. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | 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 |
| أسماء مطبوعة: | Publication: 2022- : Oxford : Oxford University Press Original Publication: Dayton, Ohio : AlphaMed Press, c1996- |
| مواضيع طبية MeSH: | Endometrial Neoplasms*/drug therapy , Hypertension*/drug therapy , Hypothyroidism* , Musculoskeletal Diseases*/drug therapy , Musculoskeletal Diseases*/etiology, Female ; Humans ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Diarrhea/drug therapy ; Fatigue/etiology |
| مستخلص: | Background: Lenvatinib plus pembrolizumab significantly improved efficacy compared with chemotherapy in patients with advanced endometrial cancer (aEC) regardless of microsatellite instability status or histologic subtype, who had disease progression following prior platinum-based therapy, in Study-309/KEYNOTE-775. The safety profile of the combination was generally consistent with that of each monotherapy drug and of the combination in patients with endometrial cancer and other solid tumors. Given the medical complexity of patients with aEC, this paper aims to characterize key adverse reactions (ARs) of the combination treatment and review management strategies, providing a guide for AR management to maximize anticancer benefits and minimize treatment discontinuation. Materials and Methods: In Study-309/KEYNOTE-775, patients received lenvatinib (20 mg orally once daily) plus pembrolizumab (200 mg intravenously every 3 weeks) or chemotherapy (doxorubicin or paclitaxel). The incidence and median time to the first onset of ARs, dose modifications, and concomitant medications are described. Key ARs characterized include hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, weight decreased, proteinuria, and palmar-plantar erythrodysesthesia syndrome. Results: As expected, the most common any-grade key ARs included: hypothyroidism, hypertension, fatigue, diarrhea, and musculoskeletal disorders. Grades 3-4 key ARs with incidence ≥10% included: hypertension, fatigue, and weight decreased. Key ARs first occurred within approximately 3 months of treatment initiation. AR management strategies consistent with the prescribing information and the study protocol are discussed. Conclusion: Successful AR management strategies for lenvatinib plus pembrolizumab include education of the patient and entire treatment team, preventative measures and close monitoring, and judicious use of dose modifications and concomitant medications. Clinicaltrials.gov Id: NCT03517449. (© The Author(s) 2023. Published by Oxford University Press.) |
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| معلومات مُعتمدة: | P30 CA008748 United States CA NCI NIH HHS |
| فهرسة مساهمة: | Keywords: adverse reactions; endometrial cancer; lenvatinib; pembrolizumab |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03517449 |
| المشرفين على المادة: | DPT0O3T46P (pembrolizumab) EE083865G2 (lenvatinib) |
| تواريخ الأحداث: | Date Created: 20230731 Date Completed: 20240108 Latest Revision: 20240302 |
| رمز التحديث: | 20240302 |
| مُعرف محوري في PubMed: | PMC10769802 |
| DOI: | 10.1093/oncolo/oyad201 |
| PMID: | 37523661 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1549-490X |
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| DOI: | 10.1093/oncolo/oyad201 |