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PSA response to cabazitaxel is associated with improved progression-free survival in metastatic castration-resistant prostate cancer: the non-interventional QoLiTime study

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Abstract

Purpose

To evaluate the association between prostate-specific antigen (PSA) response and progression-free and overall survival in men with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel.

Methods

Men with mCRPC receiving cabazitaxel (25 mg/m2, every 3 weeks) plus oral prednis(ol)one (10 mg/day) were enrolled in the non-interventional, prospective QoLiTime study. Main outcome measures were progression-free survival and overall survival, in all patients and in those who showed a ≥ 50 or a ≥ 30% decrease in PSA relative to baseline after four cycles of cabazitaxel, as well as quality-of-life parameters.

Results

Of the 527 men (median age 72 years), 266 received ≥ 4 cycles of cabazitaxel and had PSA response data. After four cycles, 34.6% of men achieved a PSA decrease ≥ 50% and 49.6% a decrease ≥ 30%. Median progression-free survival was 7.7 (95% CI 6.2, 9.5) months, and overall survival was 19.5 (95% CI 16.0, 30.9) months, corresponding to 1-year event rates of 39.4 and 78.8%, respectively. Median progression-free survival was longer in PSA responders versus non-responders (15.7 vs 5.5 months at 50% cut-off; 15.7 vs 5.3 months for 30% cut-off; both P < 0.0001). Overall survival (50% cut-off) was 23.3 months in responders and 16.0 months in non-responders (P = 0.068); corresponding data at the 30% cut-off are 21.7 and 16.0 months (P = 0.057). Overall, 55.4% of men experienced ≥ 1 adverse event, 59.6% of whom had a serious adverse event.

Conclusion

PSA response after four cycles of cabazitaxel is associated with improved progression-free survival in men with mCRPC treated with cabazitaxel plus prednis(ol)one.

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Acknowledgements

Study funding and medical writing were funded by Sanofi. Sophie Rushton-Smith, PhD (MedLink Healthcare Communications Ltd) provided medical writing services under direction of the authors.

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Authors and Affiliations

  1. Academic Hospital Braunschweig, Braunschweig, Germany

    Peter Hammerer

  2. Department of Urology and Uro-Oncology, Academic Hospital Braunschweig, Salzdahlumer Str. 90, 38126, Braunschweig, Germany

    Peter Hammerer

  3. Institute of Clinical Research, Frankfurt Am Main, Germany

    Salah-Eddin Al-Batran

  4. Alcedis GmbH, Gießen, Germany

    Christine Windemuth-Kieselbach

  5. Sanofi-Aventis Deutschland GmbH, Berlin, Germany

    Martin Keller

  6. University Hospital Mannheim, Mannheim, Germany

    Ralf-Dieter Hofheinz

Authors
  1. Peter Hammerer
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  2. Salah-Eddin Al-Batran
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  3. Christine Windemuth-Kieselbach
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  4. Martin Keller
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  5. Ralf-Dieter Hofheinz
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Contributions

PH collected the data and wrote the manuscript; S-EA-B and R-DH collected the data and edited the manuscript; CW-K performed statistical analysis and manuscript editing; MK contributed to project development and manuscript editing.

Corresponding author

Correspondence to Peter Hammerer.

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Ethical standards

The study was performed according to Good Epidemiological Practice. All patients provided written informed consent.

Conflict of interest

Peter Hammerer is an Advisor/Speaker for Amgen, Astellas, Janssen, Sanofi, and Takeda. Salah-Eddin Al-Batran has an advisory role for Sanofi, Merck, Roche, Celgene, Lilly, Nordic pharma and has received research grants from Sanofi, Merck, Roche, Celgene, Vifor, Medac, Hospira, and Lilly. Christine Windemuth-Kieselbach, Alcedis GmbH, was commissioned for the statistical analyses by Sanofi. Martin Keller is an employee of Sanofi-Aventis Deutschland GmbH. Ralf-Dieter Hofheinz has received honoraria and research grants from Sanofi-Aventis.

Funding

This study is sponsored by Sanofi. The sponsor provided financial support for the conduct of the research and/or preparation of the article and was involved in the study design, analysis, and interpretation of data and in the writing of the report.

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Hammerer, P., Al-Batran, SE., Windemuth-Kieselbach, C. et al. PSA response to cabazitaxel is associated with improved progression-free survival in metastatic castration-resistant prostate cancer: the non-interventional QoLiTime study. World J Urol 36, 375–381 (2018). https://doi.org/10.1007/s00345-017-2138-x

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  • DOI: https://doi.org/10.1007/s00345-017-2138-x

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