Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma: An Italian multicenter study (MOVIE-GOIRC 01-2014)

Rodolfo Passalacqua, Silvia Lazzarelli, Maddalena Donini, Rodolfo Montironi, Rosa Tambaro, Ugo De Giorgi, Sandro Pignata, Raffaella Palumbo, Giovanni Luca Ceresoli, Gianluca Del Conte, Giuseppe Tonini, Franco Morelli, Franco Nolè, Stefano Panni, Annalisa Guida, Ermanno Rondini, Paolo Andrea Zucali, Laura Doni, Elisa Iezzi, Caterina Caminiti

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Vinflunine is the only chemotherapeutic agent shown to improve survival in platinum-refractory patients with metastatic transitional cell carcinoma of the urothelium (TCCU) in a phase III clinical trial, which led to product registration for this indication in Europe. The aim of this study was to assess the efficacy of vinflunine and to evaluate the prognostic significance of risk factors in a large, unselected cohort of patients with metastatic TCCU treated according to routine clinical practice. Methods: This was a retrospective multicenter study. Italian cancer centers were selected if, according to the Registry of the Italian Medicines Agency (AIFA), at least four patients had been treated with vinflunine between February 2011 and June 2014, after first- or second-line platinum-based chemotherapy. The primary objective was to test whether the efficacy measured by overall survival (OS) in the registration study could be confirmed in routine clinical practice. Multivariate analysis was carried out using Cox proportional hazard model. Results: A total of 217 patients were treated in 28 Italian centers. Median age was 69 years (IQR 62-76) and 84% were male; Eastern Cooperative Oncology Group performance status (ECOG PS) was ≥ 1 in 53% of patients. The median number of cycles was 4 (IQR 2-6); 29%, 35%, and 36% received an initial dose of 320 mg/m2, 280 mg/m2 or a lower dose, respectively. Median progression-free survival (PFS) and OS for the entire population was 3.2 months (2.6-3.7) and 8.1 months (6.3-8.9). A complete response was observed in six patients, partial response in 21, stable disease in 60, progressive disease in 108, with a disease control rate of 40%. Multivariate analysis showed that ECOG PS, number of metastatic sites and liver involvement were unfavorable prognostic factors for OS. Toxicity was mild, and grade 3-4 adverse effects were mainly: neutropenia (9%), anemia (6%), asthenia/fatigue (7%) and constipation (5%). Conclusions: In routine clinical practice the results obtained with VFL seem to be better than the results of the registration trial and reinforce evidence supporting its use after failure of a platinum-based chemotherapy.

Original languageEnglish
Article number493
JournalBMC Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - Jul 19 2017

Fingerprint

Platinum
Multicenter Studies
Carcinoma
Urothelium
Survival
Transitional Cell Carcinoma
Multivariate Analysis
Asthenia
Drug Therapy
Phase III Clinical Trials
Constipation
Neutropenia
Proportional Hazards Models
Disease-Free Survival
Fatigue
Registries
vinflunine
Anemia
Retrospective Studies
Liver

Keywords

  • Effectiveness
  • Italian
  • Platinum-based chemotherapy
  • Real-life setting
  • Transitional cell carcinoma of the urothelium
  • Vinflunine

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Cite this

Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma : An Italian multicenter study (MOVIE-GOIRC 01-2014). / Passalacqua, Rodolfo; Lazzarelli, Silvia; Donini, Maddalena; Montironi, Rodolfo; Tambaro, Rosa; De Giorgi, Ugo; Pignata, Sandro; Palumbo, Raffaella; Ceresoli, Giovanni Luca; Del Conte, Gianluca; Tonini, Giuseppe; Morelli, Franco; Nolè, Franco; Panni, Stefano; Guida, Annalisa; Rondini, Ermanno; Zucali, Paolo Andrea; Doni, Laura; Iezzi, Elisa; Caminiti, Caterina.

In: BMC Cancer, Vol. 17, No. 1, 493, 19.07.2017.

Research output: Contribution to journalArticle

Passalacqua, R, Lazzarelli, S, Donini, M, Montironi, R, Tambaro, R, De Giorgi, U, Pignata, S, Palumbo, R, Ceresoli, GL, Del Conte, G, Tonini, G, Morelli, F, Nolè, F, Panni, S, Guida, A, Rondini, E, Zucali, PA, Doni, L, Iezzi, E & Caminiti, C 2017, 'Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma: An Italian multicenter study (MOVIE-GOIRC 01-2014)', BMC Cancer, vol. 17, no. 1, 493. https://doi.org/10.1186/s12885-017-3466-3
Passalacqua, Rodolfo ; Lazzarelli, Silvia ; Donini, Maddalena ; Montironi, Rodolfo ; Tambaro, Rosa ; De Giorgi, Ugo ; Pignata, Sandro ; Palumbo, Raffaella ; Ceresoli, Giovanni Luca ; Del Conte, Gianluca ; Tonini, Giuseppe ; Morelli, Franco ; Nolè, Franco ; Panni, Stefano ; Guida, Annalisa ; Rondini, Ermanno ; Zucali, Paolo Andrea ; Doni, Laura ; Iezzi, Elisa ; Caminiti, Caterina. / Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma : An Italian multicenter study (MOVIE-GOIRC 01-2014). In: BMC Cancer. 2017 ; Vol. 17, No. 1.
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abstract = "Background: Vinflunine is the only chemotherapeutic agent shown to improve survival in platinum-refractory patients with metastatic transitional cell carcinoma of the urothelium (TCCU) in a phase III clinical trial, which led to product registration for this indication in Europe. The aim of this study was to assess the efficacy of vinflunine and to evaluate the prognostic significance of risk factors in a large, unselected cohort of patients with metastatic TCCU treated according to routine clinical practice. Methods: This was a retrospective multicenter study. Italian cancer centers were selected if, according to the Registry of the Italian Medicines Agency (AIFA), at least four patients had been treated with vinflunine between February 2011 and June 2014, after first- or second-line platinum-based chemotherapy. The primary objective was to test whether the efficacy measured by overall survival (OS) in the registration study could be confirmed in routine clinical practice. Multivariate analysis was carried out using Cox proportional hazard model. Results: A total of 217 patients were treated in 28 Italian centers. Median age was 69 years (IQR 62-76) and 84{\%} were male; Eastern Cooperative Oncology Group performance status (ECOG PS) was ≥ 1 in 53{\%} of patients. The median number of cycles was 4 (IQR 2-6); 29{\%}, 35{\%}, and 36{\%} received an initial dose of 320 mg/m2, 280 mg/m2 or a lower dose, respectively. Median progression-free survival (PFS) and OS for the entire population was 3.2 months (2.6-3.7) and 8.1 months (6.3-8.9). A complete response was observed in six patients, partial response in 21, stable disease in 60, progressive disease in 108, with a disease control rate of 40{\%}. Multivariate analysis showed that ECOG PS, number of metastatic sites and liver involvement were unfavorable prognostic factors for OS. Toxicity was mild, and grade 3-4 adverse effects were mainly: neutropenia (9{\%}), anemia (6{\%}), asthenia/fatigue (7{\%}) and constipation (5{\%}). Conclusions: In routine clinical practice the results obtained with VFL seem to be better than the results of the registration trial and reinforce evidence supporting its use after failure of a platinum-based chemotherapy.",
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year = "2017",
month = "7",
day = "19",
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TY - JOUR

T1 - Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma

T2 - An Italian multicenter study (MOVIE-GOIRC 01-2014)

AU - Passalacqua, Rodolfo

AU - Lazzarelli, Silvia

AU - Donini, Maddalena

AU - Montironi, Rodolfo

AU - Tambaro, Rosa

AU - De Giorgi, Ugo

AU - Pignata, Sandro

AU - Palumbo, Raffaella

AU - Ceresoli, Giovanni Luca

AU - Del Conte, Gianluca

AU - Tonini, Giuseppe

AU - Morelli, Franco

AU - Nolè, Franco

AU - Panni, Stefano

AU - Guida, Annalisa

AU - Rondini, Ermanno

AU - Zucali, Paolo Andrea

AU - Doni, Laura

AU - Iezzi, Elisa

AU - Caminiti, Caterina

PY - 2017/7/19

Y1 - 2017/7/19

N2 - Background: Vinflunine is the only chemotherapeutic agent shown to improve survival in platinum-refractory patients with metastatic transitional cell carcinoma of the urothelium (TCCU) in a phase III clinical trial, which led to product registration for this indication in Europe. The aim of this study was to assess the efficacy of vinflunine and to evaluate the prognostic significance of risk factors in a large, unselected cohort of patients with metastatic TCCU treated according to routine clinical practice. Methods: This was a retrospective multicenter study. Italian cancer centers were selected if, according to the Registry of the Italian Medicines Agency (AIFA), at least four patients had been treated with vinflunine between February 2011 and June 2014, after first- or second-line platinum-based chemotherapy. The primary objective was to test whether the efficacy measured by overall survival (OS) in the registration study could be confirmed in routine clinical practice. Multivariate analysis was carried out using Cox proportional hazard model. Results: A total of 217 patients were treated in 28 Italian centers. Median age was 69 years (IQR 62-76) and 84% were male; Eastern Cooperative Oncology Group performance status (ECOG PS) was ≥ 1 in 53% of patients. The median number of cycles was 4 (IQR 2-6); 29%, 35%, and 36% received an initial dose of 320 mg/m2, 280 mg/m2 or a lower dose, respectively. Median progression-free survival (PFS) and OS for the entire population was 3.2 months (2.6-3.7) and 8.1 months (6.3-8.9). A complete response was observed in six patients, partial response in 21, stable disease in 60, progressive disease in 108, with a disease control rate of 40%. Multivariate analysis showed that ECOG PS, number of metastatic sites and liver involvement were unfavorable prognostic factors for OS. Toxicity was mild, and grade 3-4 adverse effects were mainly: neutropenia (9%), anemia (6%), asthenia/fatigue (7%) and constipation (5%). Conclusions: In routine clinical practice the results obtained with VFL seem to be better than the results of the registration trial and reinforce evidence supporting its use after failure of a platinum-based chemotherapy.

AB - Background: Vinflunine is the only chemotherapeutic agent shown to improve survival in platinum-refractory patients with metastatic transitional cell carcinoma of the urothelium (TCCU) in a phase III clinical trial, which led to product registration for this indication in Europe. The aim of this study was to assess the efficacy of vinflunine and to evaluate the prognostic significance of risk factors in a large, unselected cohort of patients with metastatic TCCU treated according to routine clinical practice. Methods: This was a retrospective multicenter study. Italian cancer centers were selected if, according to the Registry of the Italian Medicines Agency (AIFA), at least four patients had been treated with vinflunine between February 2011 and June 2014, after first- or second-line platinum-based chemotherapy. The primary objective was to test whether the efficacy measured by overall survival (OS) in the registration study could be confirmed in routine clinical practice. Multivariate analysis was carried out using Cox proportional hazard model. Results: A total of 217 patients were treated in 28 Italian centers. Median age was 69 years (IQR 62-76) and 84% were male; Eastern Cooperative Oncology Group performance status (ECOG PS) was ≥ 1 in 53% of patients. The median number of cycles was 4 (IQR 2-6); 29%, 35%, and 36% received an initial dose of 320 mg/m2, 280 mg/m2 or a lower dose, respectively. Median progression-free survival (PFS) and OS for the entire population was 3.2 months (2.6-3.7) and 8.1 months (6.3-8.9). A complete response was observed in six patients, partial response in 21, stable disease in 60, progressive disease in 108, with a disease control rate of 40%. Multivariate analysis showed that ECOG PS, number of metastatic sites and liver involvement were unfavorable prognostic factors for OS. Toxicity was mild, and grade 3-4 adverse effects were mainly: neutropenia (9%), anemia (6%), asthenia/fatigue (7%) and constipation (5%). Conclusions: In routine clinical practice the results obtained with VFL seem to be better than the results of the registration trial and reinforce evidence supporting its use after failure of a platinum-based chemotherapy.

KW - Effectiveness

KW - Italian

KW - Platinum-based chemotherapy

KW - Real-life setting

KW - Transitional cell carcinoma of the urothelium

KW - Vinflunine

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U2 - 10.1186/s12885-017-3466-3

DO - 10.1186/s12885-017-3466-3

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