Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

5022 - Association of Grade _3 neutropenia (NP) with outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care


Management of Systemic Therapy Toxicities;  Supportive Care and Symptom Management

Tumour Site

Prostate Cancer


Alexander Meisel


Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284


A. Meisel1, R. de Wit2, S. Oudard3, O. Sartor4, F. Stenner-Liewen5, Z. Shun6, A. Ozatilgan7, M. Eisenberger8, J.S. de Bono9

Author affiliations

  • 1 Internal Medicine - Hematology And Oncology, Stadtspital Ward; Department Of Nuclear Zurich, University Hospital Of Zurich; Institute Of Pharmaceutical Sciences, Federal Institute of Technology, 8037 - Zurich/CH
  • 2 Medical Oncology, Erasmus University Medical Center, Rotterdam/NL
  • 3 Service D'oncologie Médicale, Georges Pompidou European Hospital, Rene Descartes University, Paris/FR
  • 4 Medicine And Urology, Tulane Cancer Center, New Orleans/US
  • 5 Department Of Oncology, University Hospital of Basel, Basel/CH
  • 6 Biostatistics, Sanofi, Bridgewater/US
  • 7 Global Medical Oncology, Sanofi, Cambridge/US
  • 8 The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, 21287 - Baltimore/US
  • 9 Division Of Clinical Studies, Drug Development Unit, Royal Marsden NHS Foundation Trust/The Institute of Cancer Research, Sutton/GB


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 5022


Subset analysis of trials investigating taxanes in patients with mCRPC suggest an association between Grade ≥3 NP and disease outcomes. In the Phase 3 PROSELICA trial (NCT01308580), NP was more common in patients receiving cabazitaxel 25 mg/m2 (C25) vs cabazitaxel 20 mg/m2 (C20) - 73% vs 42%, respectively. Post hoc analyses of PROSELICA examined the relationship between incidence of NP, survival and response.


PROSELICA assessed the non-inferiority of C20 (n = 598) vs C25 (n = 602) in terms of overall survival (OS) in men with mCRPC. Prophylactic granulocyte colony-stimulating factor was given to patients with Grade ≥3 NP. OS and progression-free survival (PFS) were analyzed using Kaplan-Meier (KM) estimates and Cox proportional hazard models. Nominal p values were determined by log-rank tests. Prostate-specific antigen response rate (PSArr; defined as proportion of patients with a > 50 % PSA decline from baseline) was analyzed in the eligible population using KM estimates with Chi2 tests and odds ratios. OS, PFS and PSArr were correlated with Grade ≥3 NP occurrence and baseline neutrophilia (neutrophils ≥7000 G/l) by univariate analysis.


In the intent-to-treat (ITT) population, development of Grade ≥3 NP was associated with better PSArr, PFS and OS (p < 0.001; Table). The positive association was observed in both treatment arms and in poor-risk patients with baseline neutrophilia.Table: 811P

PopulationOutcomeGrade ≥3 NPNo Grade ≥3 NPHazard ratio/Odds ratiop value
ITT population (n = 1200)OS, months (mo)
PFS, mo3.72.80.790.0001
PSArr, % n = 107944.125.52.3<0.0001
C25 (n = 602)OS, mo15.312.20.770.009
PFS, mo3.53.50.840.07
PSArr, % n = 53846.
C20 (n = 598)OS, mo14.612.60.780.006
PFS, mo4.22.30.750.0008
PSArr, % n = 54140.721.32.5<0.0001
Neutrophilia (n = 174)OS, mo12.87.50.630.004
PFS, mo4.12.10.660.008
PSArr, % n = 15643.816.93.80.0002


Post hoc assessment of Grade ≥3 NP in PROSELICA was associated with improved survival and response to cabazitaxel independent of dose. These results are consistent with data obtained in the Phase 3 TAX327 (docetaxel) and TROPIC (cabazitaxel) trials. Funded by Sanofi.

Clinical trial identification


Legal entity responsible for the study




Editorial Acknowledgement

Editorial assistance was provided by Danielle Lindley of Meditech Media Ltd, funded by Sanofi.


Meisel: Advisor: Astellas, Roche, Celgene, Novartis, Vifor, Sanofi, Amgen, Merck; Expert testimony: Sanofi; Research funding: Bayer (himself), Merck (institution); Expenses: Amgen, Astellas, Sanofi, Servier, Roche, Boehringer Ingelheim; Intellectual property: Merck. R. de Wit: Consultancy, Speaker fees: Sanofi. S. Oudard: Consultancy, Advisory role, Honoraria, Expense: Sanofi, Astellas, Janssen, and Ipson; Research funding: Sanofi; Speakers bureau: Sanofi, Janssen. O. Sartor: Advisor: Bellicum Pharmaceuticals, Dendreon; Advisor, Expenses: Bayer, Johnson & Johnson, Medivation, Oncogenex, Sanofi, Tokai Pharmaceuticals, AstraZeneca, Progenics; Funding (Institute): Bayer, Johnson & Johnson, Sanofi, Dendreon, Endocyte, Innocrin Pharma, Progenics. F. Stenner-Liewen: Consultancy, Advisory role, Research, expenses: Sanofi. S. Guillonneau, A. Ozatilgan: Employee: Sanofi. M. Eisenberger: Honoraria, Consultancy, Advisory role: Sanofi, Pfizer, Astellas; Research: Sanofi; Expenses: Sanofi, Pfizer. J.S. de Bono: Honoraria: Sanofi; Advisor: Sanofi, AstraZeneca, GSK, Genentech, Roche, Merck; Speakers bureau: AstraZeneca/MedImmune; Research funding (Institute): AstraZeneca/MedImmune, GSK, Sanofi, Merck Sharp & Dohme, Genmab, Genentech; Patent on abiraterone acetate with prednisone.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.