Vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract: an evidence-based review of safety, efficacy, and place in therapy
| Autor: | Michael R. Harrison, Brant A. Inman, Joseph J. Fantony, Megan Van Noord, Steven C. Brousell |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Combination therapy Nausea medicine.medical_treatment Clinical Trials and Supportive Activities Clinical Sciences Review Neutropenia chemotherapy survival 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Maintenance therapy Clinical Research Internal medicine Medicine Adverse effect urothelial carcinoma Cancer Pharmacology Chemotherapy Vinflunine business.industry Evaluation of treatments and therapeutic interventions Hematology General Medicine Pharmacology and Pharmaceutical Sciences medicine.disease metastatic 030104 developmental biology chemistry 6.1 Pharmaceuticals 030220 oncology & carcinogenesis Reviews and References (medical) bladder cancer Patient Safety medicine.symptom business vinflunine Febrile neutropenia |
| Zdroj: | Core Evidence |
| Popis: | Author(s): Brousell, Steven C; Fantony, Joseph J; Van Noord, Megan G; Harrison, Michael R; Inman, Brant A | Abstract: Background:A systematic review and meta-analysis of the use of systemic vinflunine (VIN) in the treatment of urothelial carcinoma (UC) was performed to evaluate its efficacy based on current available clinical data. Methods:This review was prospectively registered at the International Prospective Register of Systematic Reviews, PROSPERO (registration CRD42016049294). Electronic databases including MEDLINE®, Embase®, Cochrane Central Register of Controlled Trials, and Web of Science were searched through December 2016. We performed a meta-analysis of the published data. Primary end points were progression-free survival (PFS) and overall survival (OS). Numerous secondary clinical outcomes were analyzed including response and toxicity data. Results:We identified 382 publications, of which 35 met inclusion criteria for this review representing 29 unique studies. A total of 2,255 patients received VIN for the treatment of UC in the included studies. OS and PFS were analyzed in a pooled Kaplan-Meier analysis. Response data were available for 1,416 VIN-treated patients with random effects proportion of complete response in 1%, partial response in 18%, and overall response rate of 21%. Toxicity analysis revealed fatigue (40.1%), nausea (33.9%), constipation (34.1%), and alopecia (26.0%) as the most prevalent overall non-hematologic adverse events (AEs). Most prevalent grade 3-4 AEs were fatigue (10.2%), abdominal pain (8.2%), myalgias (2.5%), and nausea (2.3%). Most common hematologic AEs of all grades were anemia (56.6%), neutropenia (46.0%), thrombocytopenia (25.5%), and febrile neutropenia (6.6%). Grade 3-4 hematologic AEs had the following pooled rates: neutropenia, 24.6%; anemia, 10.2%; febrile neutropenia, 5.4%; and thrombocytopenia, 3.0%. Conclusion:VIN has been explored as a combination first-line treatment as well as a single-agent second-line, third-line, and maintenance therapy for advanced and metastatic UC. In first-line treatment of UC, either as a maintenance agent after cisplatin or as a primary combination therapy, VIN may be a promising alternative to current treatments. Further studies are needed to compare first-line combination VIN regimens to the current standard of care in order to assess long-term survival outcomes. Second- and third-line VIN monotherapy does provide a proven, although limited, survival benefit in platinum-refractory patients. |
| Databáze: | OpenAIRE |
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