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Br J Cancer. 2019 Nov 13. doi: 10.1038/s41416-019-0611-6. [Epub ahead of print]

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

Author information

1
Bordeaux PharmacoEpi, CIC1401, University of Bordeaux, Bordeaux, France.
2
Medical Oncology Department, Hôpital Européen Georges Pompidou, Université Paris Descartes, Paris, France.
3
Medical Oncology Department, Centre François Baclesse, CHU Côte de Nacre, Caen, France.
4
Medical Oncology Department, Institut Gustave Roussy, Villejuif, France.
5
Sorbonne Université, AP-HP, Hôpital Pitié-Salpêtrière, Département Biostatistique Santé Publique et Information Médicale, Unité de Recherche Clinique PSL-CFX, Centre de Pharmacoépidémiologie (Cephepi), Inserm, UMR 1123 ECEVE, CIC-1421, Paris, France.
6
Inserm U1219, Bordeaux, France.
7
Bordeaux PharmacoEpi, CIC1401, University of Bordeaux, Bordeaux, France. nicholas.moore@u-bordeaux.fr.
8
Inserm U1219, Bordeaux, France. nicholas.moore@u-bordeaux.fr.

Abstract

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/m2, 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.

PMID:
31719685
DOI:
10.1038/s41416-019-0611-6

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