| Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. | |
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MedLine Citation:
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PMID: 19687335 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: Vinflunine (VFL) is a new microtubule inhibitor that has activity against transitional cell carcinoma of urothelial tract (TCCU). We conducted a randomized phase III study of VFL and best supportive care (BSC) versus BSC alone in the treatment of patients with advanced TCCU who had experienced progression after a first-line platinum-containing regimen. PATIENTS AND METHODS: The study was designed to compare overall survival (OS) between patients receiving VFL + BSC (performance status [PS] = 0: 320 mg/m(2), every 3 weeks; PS = 0 with previous pelvic radiation and PS = 1: 280 mg/m(2) subsequently escalated to 320 mg/m(2)) or BSC. RESULTS: Three hundred seventy patients were randomly assigned (VFL + BSC, n =253; BSC, n = 117). Both arms were well balanced except there were more patients with PS more than 1 (10% difference) in the BSC arm. Main grade 3 or 4 toxicities for VFL + BSC were neutropenia (50%), febrile neutropenia (6%), anemia (19%), fatigue (19%), and constipation (16%). In the intent-to-treat population, the objective of a median 2-month survival advantage (6.9 months for VFL + BSC v 4.6 months for BSC) was achieved (hazard ratio [HR] = 0.88; 95% CI, 0.69 to 1.12) but was not statistically significant (P = .287). Multivariate Cox analysis adjusting for prognostic factors showed statistically significant effect of VFL on OS (P = .036), reducing the death risk by 23% (HR = 0.77; 95% CI, 0.61 to 0.98). In the eligible population (n = 357), the median OS was significantly longer for VFL + BSC than BSC (6.9 v 4.3 months, respectively), with the difference being statistically significant (P = .040). Overall response rate, disease control, and progression-free survival were all statistically significant favoring VFL + BSC (P = .006, P = .002, and P = .001, respectively). CONCLUSION: VFL demonstrates a survival advantage in second-line treatment for advanced TCCU. Consistency of results exists with significant and meaningful benefit over all efficacy parameters. Safety profile is acceptable, and therefore, VFL seems to be a reasonable option for TCCU progressing after first-line platinum-based therapy. |
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Authors:
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Joaquim Bellmunt; Christine Th?odore; Tomasz Demkov; Boris Komyakov; Lisa Sengelov; Gedske Daugaard; Armelle Caty; Joan Carles; Agnieszka Jagiello-Gruszfeld; Oleg Karyakin; Fran?ois-Michel Delgado; Patrick Hurteloup; Eric Winquist; Nassim Morsli; Yacine Salhi; St?phane Culine; Hans von der Maase |
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Publication Detail:
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Type: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-08-17 |
Journal Detail:
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Title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology Volume: 27 ISSN: 1527-7755 ISO Abbreviation: J. Clin. Oncol. Publication Date: 2009 Sep |
Date Detail:
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Created Date: 2009-10-02 Completed Date: 2009-11-04 Revised Date: 2010-05-03 |
Medline Journal Info:
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Nlm Unique ID: 8309333 Medline TA: J Clin Oncol Country: United States |
Other Details:
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Languages: eng Pagination: 4454-61 Citation Subset: IM |
Affiliation:
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Department of Medical Oncology, University Hospital Del Mar, Passeig Mar?tim 25-29, E-08003 Barcelona, Spain. jbellmunt@imas.imim.es |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Antineoplastic Agents / administration & dosage* Carcinoma, Transitional Cell / drug therapy*, secondary Disease Progression Humans Middle Aged Palliative Care Platinum Compounds / administration & dosage Survival Analysis Urologic Neoplasms / drug therapy*, secondary Urothelium / pathology Vinblastine / administration & dosage, analogs & derivatives* |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Platinum Compounds; 162652-95-1/vinflunine; 865-21-4/Vinblastine |
| Comments/Corrections | |
Comment In:
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J Clin Oncol. 2010 May 1;28(13):e205-7; author reply e208
[PMID:
20159797
]
J Clin Oncol. 2009 Sep 20;27(27):4444-5 [PMID: 19687324 ] |
Erratum In:
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J Clin Oncol. 2010 Jan 1;28(1):182 Note: Winquist, Eric [added] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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