Vol 15, No 6 (2019)
Research paper
Published online: 2019-11-13

open access

Page views 644
Article views/downloads 747
Get Citation

Connect on Social Media

Connect on Social Media

Retrospective analysis of the efficacy and safety of cabazitaxel treatment in castration-resistant prostate cancer after docetaxel failure

Jakub Żołnierek1, Wojciech Poborski2, Wojciech Rogowski3, Bogumiła Arłukowicz-Czartoryska4, Karolina Skalska5, Małgorzata Gola6, Jakub Kucharz7, Piotr J. Wysocki8
Oncol Clin Pract 2019;15(6):281-288.

Abstract

Introduction. Cabazitaxel has been approved by the FDA and EMEA for the treatment of metastatic castration- resistant prostate cancer (mCRPC) after failure of docetaxel-based chemotherapy. Between June 2011 and November 2013 cabazitaxel was reimbursed for Polish mCRPC patients as a non-standard chemotherapy. The study objective was a retrospective analysis of the efficacy and safety data of mCRPC patients treated with cabazitaxel in this period.

Material and methods. Collection of retrospective data on 48 consecutive mCRPC patients treated with cabazitaxel after docetaxel failure. Data on baseline characteristics, cancer history, and the efficacy and safety of cabazitaxel treatment were collected. Progression-free survival (PFS) (radiological/clinical/biochemical) and overall survival (OS) were estimated by the Kaplan-Meier method. Objective response rate and clinical benefit were also assessed.

Results. Forty-eight patients were included. Median PFS was 4.2 (95% CI 3.4–5.1) months, and median OS was 15.1 (95% CI 12.7–17.4) months. OS since docetaxel initiation in patients treated with cabazitaxel as second-line chemotherapy (n = 47) was 28.7 (95% CI 25,3–32,1) months. OS rates at 1, 2, and 3 years after first cabazitaxel cycle were 65%, 25%, and 15%, respectively. In total, 289 cycles of cabazitaxel were administered (mean six per patient). There were 41 patients evaluable for biochemical response, 19/41 (46%) of whom had a PSA decrease of at least 50% from baseline, including 3/41 who had an initial PSA flare followed by a decrease of at least 50% from baseline. Adverse events comprised predominantly haematological (26 patients) and gastrointestinal (14 patients) toxicities. Ten SAEs were reported, including one death due to acute renal failure.

Conclusions. Treatment of mCRPC patients with cabazitaxel after docetaxel failure is an important therapeutic option with acceptable toxicity with respect to clinical stabilisation and possibly increased survival.

Article available in PDF format

View PDF Download PDF file

References

  1. Ferlay J, Autier P, Boniol M, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol. 2007; 18(3): 581–592.
  2. de Wit R. Chemotherapy in hormone-refractory prostate cancer. BJU Int. 2008; 101 Suppl 2: 11–15.
  3. Pond GR, Sonpavde G, de Wit R, et al. TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004; 351(15): 1502–1512.
  4. Petrylak DP, Tangen CM, Hussain MHA, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004; 351(15): 1513–1520.
  5. Berthold DR, Pond GR, Soban F, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008; 26(2): 242–245.
  6. Vrignaud P, Sémiond D, Lejeune P, et al. Preclinical antitumor activity of cabazitaxel, a semisynthetic taxane active in taxane-resistant tumors. Clin Cancer Res. 2013; 19(11): 2973–2983.
  7. de Bono JS, Oudard S, Ozguroglu M, et al. TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010; 376(9747): 1147–1154.
  8. Bahl A, Oudard S, Tombal B, et al. TROPIC Investigators. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol. 2013; 24(9): 2402–2408.
  9. Soest RV, Nieuweboer A, Morrée EDe, et al. 2564 The influence of prior novel androgen receptor targeted therapy on the efficacy of cabazitaxel in men with metastatic castration-resistant prostate cancer. European Journal of Cancer. 2015; 51: S499.
  10. ICH Harmonized Tripartite Guideline E2D: Post Approval Safety Data Management: Note for Guidance on Definitions and Standards for Expedited Reporting, 12 November 2003 (CPMP/ICH/3945/03)”.
  11. International Society for Pharmocoepidemiology, April 2007, ‘Guidelines for Good Pharmacoepidemiology Practices’.
  12. Good Epidemiological Practice (GEP) proper conduct in epidemiology research – IEA European Federation (April 2007).
  13. de Bono JS, Sartor O, Geffriaud-Ricouard C, Joulain F, Anders Widmark A, Cabazitaxel shows a consistently greater survival benefit compared to mitoxantrone in patients with mCRPC. NOWOTWORY Journal of Oncology, 2014, volume 64, number 1, 1–6.
  14. Bono JDe, Hardy-Bessard AC, Kim CS, et al. Phase III non-inferiority study of cabazitaxel (C) 20 mg/m2 (C20) versus 25 mg/m2 (C25) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel (D). Journal of Clinical Oncology. 2016; 34(15_suppl): 5008–5008.
  15. Bahl A, Masson S, Malik Z, et al. Final quality of life and safety data for patients with metastatic castration-resistant prostate cancer treated with cabazitaxel in the UK Early Access Programme (EAP) (NCT01254279). BJU Int. 2015; 116(6): 880–887.