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. 2019 Dec;121(12):1001-1008.
doi: 10.1038/s41416-019-0611-6. Epub 2019 Nov 13.

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

Magali Rouyer  1 , Stéphane Oudard  2 , Florence Joly  3 , Karim Fizazi  4 , Florence Tubach  5 , Jérémy Jove  1 , Clémentine Lacueille  1 , Stéphanie Lamarque  1 , Estelle Guiard  1 , Aurélie Balestra  1 , Cécile Droz-Perroteau  1 , Annie Fourrier-Reglat  1   6 , Nicholas Moore  7   8 ; FUJI Investigators
Collaborators, Affiliations

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

Magali Rouyer et al. Br J Cancer. 2019 Dec.

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.

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Conflict of interest statement

N.M. has received fees from Sanofi-Aventis for training in pharmacoepidemiology, independent from and before this study. He has received training or consulting fees from other pharmaceutical companies not involved in this study or in the treatment of prostate cancer. A.F.R. reports no conflicting interests. Bordeaux PharmacoEpi has several dozen ongoing studies financed by pharmaceutical companies outside the scope of this study. The salaries of Bordeaux PharmacoEpi employees (M.R., J.J., C.L., S.L., E.G., A.B., Cd.P.) are derived in part from the funding of this study, but they have no direct conflict of interest. S.O.: declares honoraria from Sanofi, Astellas, Janssen, Bayer. F.J.: declares scientific Board, consulting or lecture during symposium: Pfizer, Sanofi, Novartis, Bayer, Ipsen, Roche, Astra Zeneca, Tesaro, Astellas, Janssen, BMS, MSD; travelling: Tesaro, Janssen, Astra-Zeneca, BMS, Roche. K.F.: declares participation to advisory boards/honorarium for Astellas, AAA, Bayer, Clovis, Curevac, Incyte, Janssen, MSD, Orion, Sanofi. F.T. is head of the Centre de Pharmacoépidémiologie (Cephepi) of the Assistance Publique – Hôpitaux de Paris and of the Clinical Research Unit of Pitié-Salpêtrière hospital. Both these structures have received research funding, grants and fees for consultant activities from a large number of pharmaceutical companies, that have contributed indiscriminately to the salaries of its employees. She did not receive any personal remuneration from these companies.

Figures

Fig. 1
Fig. 1
Patient flowchart (CABA: cabazitaxel)
Fig. 2
Fig. 2
Overall and progression-free survival. a Overall survival. b Progression-free survival
Fig. 3
Fig. 3
Change in PSA concentrations during cabazitaxel treatment from pre-treatment values. Each line represents the on-treatment change in PSA in an individual patient, ranked from the largest increase (cropped at 100%) to the largest decrease. An increase of more than 100% in best PSA response concerned 33 patients of the 258 evaluable patients
See this image and copyright information in PMC

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