Overall and progression-free survival with cabazitaxel in metastatic castration-resistant prostate cancer in routine clinical practice: the FUJI cohort - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue British Journal of Cancer Année : 2019

Overall and progression-free survival with cabazitaxel in metastatic castration-resistant prostate cancer in routine clinical practice: the FUJI cohort

M. Rouyer
  • Fonction : Auteur
S. Oudard
  • Fonction : Auteur
F. Joly
  • Fonction : Auteur
K. Fizazi
  • Fonction : Auteur
F. Tubach
J. Jove
  • Fonction : Auteur
C. Lacueille
  • Fonction : Auteur
S. Lamarque
  • Fonction : Auteur
E. Guiard
  • Fonction : Auteur
A. Balestra
  • Fonction : Auteur
C. Droz-Perroteau
  • Fonction : Auteur
Fuji Investigators
  • Fonction : Auteur

Résumé

BACKGROUND: Cabazitaxel is a treatment of metastatic castration-resistant prostate cancer (mCRPC) after docetaxel failure. The FUJI cohort aimed to confirm the real-life overall and progression-free survival (OS, PFS) and safety of cabazitaxel. METHODS: Multicentre, non-interventional cohort of French mCRPC patients initiating cabazitaxel between 2013 and 2015, followed 18 months. RESULTS: Four hundred one patients were recruited in 42 centres. At inclusion, median age was 70, main metastatic sites were bones (87%), lymph nodes (42%) and visceral (20%). 18% had cabazitaxel in 2nd-line treatment, 39% in 3rd-line and 43% in 4th-line or beyond. All had prior docetaxel, and 82% prior abiraterone, enzalutamide or both. Median duration of cabazitaxel treatment was 3.4 months. Median OS from cabazitaxel initiation was 11.9 months [95% CI: 10.1-12.9]. In multivariate analyses, grade >/= 3 adverse events, visceral metastases, polymedication, and >5 bone metastases were associated with a shorter OS. Main grade >/= 3 adverse events were haematological with 8% febrile neutropenia. CONCLUSION: Real-life survival with cabazitaxel in FUJI was shorter than in TROPIC (pivotal trial, median OS 15.1 months) or PROSELICA (clinical trial 20 vs 25 mg/m(2), median OS, respectively, 13.4 and 14.5 months). There was no effect of treatment-line on survival. No unexpected adverse concerns were identified. STUDY REGISTRATION: It was registered with the European Medicines Agency EUPASS registry, available at www.encepp.eu, as EUPAS10391. It has been approved as an ENCEPP SEAL study.

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Dates et versions

hal-02896685 , version 1 (10-07-2020)

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Citer

M. Rouyer, S. Oudard, F. Joly, K. Fizazi, F. Tubach, et al.. Overall and progression-free survival with cabazitaxel in metastatic castration-resistant prostate cancer in routine clinical practice: the FUJI cohort. British Journal of Cancer, In press, 121 (12), pp.1001-1008. ⟨10.1038/s41416-019-0611-6⟩. ⟨hal-02896685⟩

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