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

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

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Androstenes / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Bone Neoplasms / drug therapy*
  • Bone Neoplasms / pathology
  • Bone Neoplasms / secondary
  • Docetaxel / administration & dosage
  • Humans
  • Kaplan-Meier Estimate
  • Lymphatic Metastasis / drug therapy*
  • Lymphatic Metastasis / pathology
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Phenylthiohydantoin / administration & dosage
  • Phenylthiohydantoin / analogs & derivatives
  • Prednisone / administration & dosage
  • Progression-Free Survival
  • Prostatic Neoplasms, Castration-Resistant / drug therapy*
  • Prostatic Neoplasms, Castration-Resistant / epidemiology
  • Prostatic Neoplasms, Castration-Resistant / pathology
  • Taxoids / administration & dosage*
  • Treatment Outcome

Substances

  • Androstenes
  • MDV 3100
  • Taxoids
  • Docetaxel
  • Phenylthiohydantoin
  • cabazitaxel
  • abiraterone
  • Prednisone