Abstract
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Journal of Clinical Oncology |
| Vol/bind | 27 |
| Udgave nummer | 27 |
| Sider (fra-til) | 4454-4461 |
| Antal sider | 8 |
| ISSN | 0732-183X |
| DOI | |
| Status | Udgivet - 2009 |
Bibliografisk note
Keywords: Aged; Antineoplastic Agents; Carcinoma, Transitional Cell; Disease Progression; Humans; Middle Aged; Palliative Care; Platinum Compounds; Survival Analysis; Urologic Neoplasms; Urothelium; VinblastineAdgang til dokumentet
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I: Journal of Clinical Oncology, Bind 27, Nr. 27, 2009, s. 4454-4461.
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
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TY - JOUR
T1 - 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
AU - Bellmunt, Joaquim
AU - Théodore, Christine
AU - Demkov, Tomasz
AU - Komyakov, Boris
AU - Sengelov, Lisa
AU - Daugaard, Gedske
AU - Caty, Armelle
AU - Carles, Joan
AU - Jagiello-Gruszfeld, Agnieszka
AU - Karyakin, Oleg
AU - Delgado, François-Michel
AU - Hurteloup, Patrick
AU - Winquist, Eric
AU - Morsli, Nassim
AU - Salhi, Yacine
AU - Culine, Stéphane
AU - von der Maase, Hans
N1 - Keywords: Aged; Antineoplastic Agents; Carcinoma, Transitional Cell; Disease Progression; Humans; Middle Aged; Palliative Care; Platinum Compounds; Survival Analysis; Urologic Neoplasms; Urothelium; Vinblastine
PY - 2009
Y1 - 2009
N2 - 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.
AB - 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.
U2 - 10.1200/JCO.2008.20.5534
DO - 10.1200/JCO.2008.20.5534
M3 - Journal article
C2 - 19687335
SN - 0732-183X
VL - 27
SP - 4454
EP - 4461
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 27
ER -