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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

3417 - Cabazitaxel treatment in metastatic castration-resistant prostate cancer (mCRPC) clinical trials compared to usual care in CAPRI: an observational study in the Netherlands.

Date

22 Oct 2018

Session

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

Topics

Cytotoxic Therapy

Tumour Site

Prostate Cancer

Presenters

Hans Westgeest

Citation

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

Authors

H.M. Westgeest1, M. Kuppen2, A.J.M. van den Eertwegh3, J. Van Moorselaar4, N. Mehra5, I. van Oort6, A.C.M. van den Bergh7, J..L. Coenen8, K.K.H. Aben9, R. Somford10, R. de Wit11, A. Bergman12, J. Lavalaye13, C.A. Uyl-de Groot14, W.R. Gerritsen5

Author affiliations

  • 1 Medical Oncology, Amphia Ziekenhuis, 4819 EV - Breda/NL
  • 2 Institute For Medical Technology Assessment, Erasmus School of Health Policy and Management, 3062 PA - Rotterdam/NL
  • 3 Medical Oncology, VU Medical Center, Amsterdam/NL
  • 4 Urology, Vrije University Medical Centre (VUMC), 1081 HV - Amsterdam/NL
  • 5 Medical Oncology, Radboud University Medical Centre Nijmegen, 6500 HB - Nijmegen/NL
  • 6 Urology, Radboud University Medical Centre Nijmegen, Nijmegen/NL
  • 7 Radiation oncology, UMCG, Groningen/NL
  • 8 Medical Oncology, Isala Klinieken, 8025 AB - Zwolle/NL
  • 9 Iknl, Netherlands Comprehensive Cancer Organisation, Utrecht/NL
  • 10 Urology, Canisius Wilhelmina Ziekenhuis, Nijmegen/NL
  • 11 Medical Oncology, Erasmus MC Daniel den Hoed Cancer Center, 3075 EA - Rotterdam/NL
  • 12 Division Of Internal Medicine (mod) And Oncogenomics, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, 1066CX - Amsterdam/NL
  • 13 Nuclear Medicine, Antonius Ziekenhuis, Nieuwengein/NL
  • 14 Institute For Medical Technology Assessment, Erasmus University Rotterdam, 3062 PA - Rotterdam/NL
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Resources

Abstract 3417

Background

Cabazitaxel (CAB) has been shown in the TROPIC trial to improve overall survival (OS) in mCRPC patients after docetaxel (DOC). However clinical trial populations may not reflect the real world population. The objective is to compare patient characteristics and outcome of CAB within clinical trials and in standard of care (SOC) from data extracted from the CAPRI registry.

Methods

CRPC pts treated with CAB directly after DOC, before 1-1-2017, either within a clinical trial or as SOC were retrospectively identified and followed to 1-1-2018. For multivariable analyses, missing values were imputed by multiple imputation using the Monte Carlo Markov Chain method.

Results

Table: 817P

Baseline characteristics at start cabazitaxel (baseline period defined as 42 days before to 7 days after start of cabazitaxel). Total percentages may not equal 100 because of rounding.

Cabazitaxel 1st line post-docetaxel (n = 173)
Usual care (n = 109)Trial (n = 64)p-value
Age (years) Median (IQR) ≥75 years (%)68 (64-72) 1767 (64-72) 130.502
Period on ADT (months) Median (IQR)25 (18-37)30 (19-45)0.091
ALP (U/L) Median (IQR) Missing (%)222 (100-360) 18192 (97-366) 110.799
PSA (ug/L) Median (IQR) Missing (%)200 (65-567) 12209 (79-500) 80.711
Hemoglobin (mmol/L) Median (IQR) Missing (%)7.1 (6.3-7.8) 177.7 (6.7-8.1) 110.029
LDH (U/L) Median (IQR) Missing (%)328 (252-504) 26268 (209-397 14)0.010
ECOG performance (%) 0 1 >1 Missing16 49 9 2723 56 3 170.186
Visceral disease (%) No Yes Missing29 19 5245 11 440.038
Opioid use (%) No Yes Missing23 28 5041 27 330.140
Symptoms (%) No Yes Missing6 78 1617 72 110.033
Docetaxel cycles Median (IQR) Missing (%)7 (5-10) 110 (7-10) 30.002
Time since last docetaxel dose (months) Median (IQR) <6 months (valid %) Missing (%)2.2 (0.9-4.7) 86 53.9 (2.0-6.0) 74 50.001

From a total of 3,616 pts in the CAPRI database, we identified 356 pts treated with CAB, of which 173 pts were treated directly post-DOC. Trial pts had less symptoms and visceral disease, lower LDH, higher hemoglobin, received more DOC cycles and had a longer treatment-free interval since last DOC (see Table). The median number of CAB cycles was higher in trials compared to SOC (5 vs 4, p = 0.031). Median OS was 13.6 vs 9.6 months for trial pts and SOC, respectively (HR 0.73, p = 0.07). PSA response (≥ 50% decline) was 27 vs 11%, respectively (p = 0.210). However, after correction for prognostic factors, trial participation did not retain statistical significance (HR 0.94, p = 0.73), but longer period on ADT, lower LDH and absence of visceral metastases were significant for better OS. In addition, lower PSA and absence of symptoms had a trend for better OS.

Conclusions

The OS in the trial subgroup is in agreement with the OS of the TROPIC trial in a contemporary real world setting. However, the SOC pts had a trend for worse OS which may be explained by worse prognostic factors at CAB initiation. Accordingly, pts whose disease has progressed post-DOC should be carefully selected for treatment to ensure optimal outcomes.

Clinical trial identification

The CAPRI study is registered in the Dutch Trial Registry as NTR3591.

Legal entity responsible for the study

Institute for Medical Technology Assessment, Erasmus University Rotterdam.

Funding

The CAPRI registry was funded by Sanofi-Aventis Netherlands B.V., Janssen-Cilag B.V., Astellas Pharma B.V., and Bayer B.V. The funding organizations had no role in the design and conduct of the study, collection, management, analysis, interpretation of the data, and preparation, review, or approval of the abstract.

Editorial Acknowledgement

n.a.

Disclosure

A.J.M. van den Eertwegh: Study grant: Sanofi; Travel expenses, speaker fee, advisory board: Astellas. J. Van Moorselaar: Grants/research supports: Astellas, Ferring, Ipsen; Honoraria, consultation fees: Amgen, Astellas, AstraZeneca, Bayer, Janssen, Sanofi-Genzyme I. van Oort: Astellas, Janssen, Sanofi, Bayer. J.L. Coenen: Advisory board: Sanofi R. de Wit: Sanofi, Merck, Roche. A. Bergman: PI of one IIS sponsored by Sanofi. W.R. Gerritsen: Speaker fees: Astellas, Bavarian Nordic, Bristol-Myers Squibb, MSD, Janssen-Cilag; Advisory boards: Amgen, Astellas, Bayer, Bristol-Myers Squibb, Curevac, Dendreon, Janssen-Cilag, Merck (MSD), Morphosys, Sanofi; Ad hoc consultancy: Aglaia Biomedical Ventures, Psioxus Therapeutics. All other authors have declared no conflicts of interest.

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