Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial

@article{Bono2010PrednisonePC,
  title={Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial},
  author={J. Bono and S. Oudard and M. Ozguroglu and S. Hansen and J. Machiels and I. Koc{\'a}k and G. Gravis and I. Bodrogi and M. Mackenzie and Liji Shen and M. Roessner and S. Gupta and A. Sartor},
  journal={The Lancet},
  year={2010},
  volume={376},
  pages={1147-1154}
}
BACKGROUND Cabazitaxel is a novel tubulin-binding taxane drug with antitumour activity in docetaxel-resistant cancers. We aimed to compare the efficacy and safety of cabazitaxel plus prednisone with those of mitoxantrone plus prednisone in men with metastatic castration-resistant prostate cancer with progressive disease after docetaxel-based treatment. METHODS We undertook an open-label randomised phase 3 trial in men with metastatic castration-resistant prostate cancer who had received… Expand
Case report: responses to cabazitaxel in metastatic castration-resistant prostate cancer after extensive docetaxel treatment.
TLDR
Two patients with extensive mCRPC, heavily pretreated, are described who experienced dramatic responses with PSA decline, improvement in tumor-related disseminated intravascular coagulation (DIC), and stabilization of visceral disease with cabazitaxel, illustrating that meaningful responses with low toxicity can be achieved in aggressive m CRPC despite significant prior exposure to taxanes. Expand
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TLDR
The data suggest that taxane-platinum combinations have a clinically beneficial role in advanced prostate cancer and a randomised phase 3 study is planned. Expand
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TLDR
Cabazitaxel should be considered the preferred treatment option over abiraterone or enzalutamide in the metastatic hormone-sensitive prostate cancer setting and are reflective of the Japanese patient population. Expand
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TLDR
Aflibercept in combination with docetaxel and prednisone given as first-line chemotherapy for men with metastatic castrate-resistant prostate cancer resulted in no improvement in overall survival and added toxicity compared with placebo. Expand
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This randomised, open-label, international, phase 3 trial aimed to assess whether custirsen in combination with cabazitaxel and prednisone increases overall survival in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel. Expand
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There was no significant difference between the ipilimumab group and the placebo group in terms of overall survival in the primary analysis, but there were signs of activity with the drug that warrant further investigation. Expand
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TLDR
CBZ/prednisone administered weekly to 'unfit' mCRPC patients appears to be as effective as classical standard 3-week scheme but with significantly lower toxicities and better tolerance. Expand
Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA.
  • S. Oudard, K. Fizazi, +13 authors O. Sartor
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2017
TLDR
C20 and C25 did not demonstrate superiority for OS versus D75 in patients with chemotherapy-naïve mCRPC, and Cabazitaxel and docetaxel demonstrated different toxicity profiles, with overall less toxicity with C20. Expand
Efficacy and safety of abiraterone acetate plus prednisone vs. cabazitaxel as a subsequent treatment after first-line docetaxel in metastatic castration-resistant prostate cancer: results from a prospective observational study (CAPRO)
TLDR
Second-line AAP for patients with mCRPC is the most common treatment strategy after progression with a docetaxel-based regimen, and when controlling for potential confounders, patients receiving this treatment showed no differences in PFS and OS in comparison to those receiving CP, although these latter results should be confirmed in randomized controlled trials. Expand
A multicenter phase I study of cabazitaxel, mitoxantrone, and prednisone for chemotherapy-naïve patients with metastatic castration-resistant prostate cancer: A department of defense prostate cancer clinical trials consortium study.
TLDR
The maximally tolerated dose of the combination of cabazitaxel, mitoxantrone, and prednisone led to durable tumor responses in most patients and the approved single-agent doses of mitoxanrone and cabazItaxel were safely combined. Expand
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References

SHOWING 1-10 OF 20 REFERENCES
Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer.
TLDR
The improvement in median survival of nearly two months with docetaxel and estramustine, as compared with mitoxantrone and prednisone, provides support for this approach in men with metastatic, androgen-independent prostate cancer. Expand
Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points.
  • I. Tannock, D. Osoba, +8 authors K. Murphy
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 1996
TLDR
Chemotherapy with mitoxantrone and prednisone provides palliation for some patients with symptomatic hormone-resistant prostate cancer and most responding patients had an improvement in quality-of-life scales and a decrease in serum prostate-specific antigen (PSA) level. Expand
Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer.
TLDR
When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plusprednisone. Expand
A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients.
TLDR
XRP6258 was active and well tolerated in this group of MBC patients with taxane-resistant disease, and these results support the further clinical development of this agent. Expand
Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone.
TLDR
DE had superior clinical efficacy with similar global quality of life and pain palliation in the MP arm with a consistent lack of statistically significant global QOL differences for the two arms. Expand
Phase I and Pharmacokinetic Study of XRP6258 (RPR 116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3 Weeks in Patients with Advanced Solid Tumors
TLDR
The general tolerability and encouraging antitumor activity in taxane-refractory patients warrant further evaluations of XRP6258. Expand
Circulating Tumor Cells Predict Survival Benefit from Treatment in Metastatic Castration-Resistant Prostate Cancer
TLDR
CTC are the most accurate and independent predictor of OS in CRPC, and this data led to Food and Drug Administration clearance of this assay for the evaluation of CRPC. Expand
Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group.
  • H. Scher, S. Halabi, +17 authors M. Hussain
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2008
TLDR
New consensus criteria for eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone are defined, with increasing emphasis on time-to-event end points as decision aids in proceeding from phase II to phase III trials. Expand
A reevaluation of nonhormonal cytotoxic chemotherapy in the treatment of prostatic carcinoma.
TLDR
It is suggested that the appropriate control arm for phase III testing in endocrine-resistant patients continues to be a no chemotherapy control arm consisting of a best symptomatic care or a uniformly applied second-line endocrine manipulation. Expand
Activity of second‐line chemotherapy in docetaxel‐refractory hormone‐refractory prostate cancer patients
This randomized, noncomparative, multicenter, clinical trial evaluated ixabepilone or mitoxantrone/prednisone (MP) as second‐line chemotherapy for taxane‐refractory, hormone‐refractory, prostateExpand
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